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Act XCV of 2005

on Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products

The purpose of this Act is to set forth the fundamental regulations pertaining to medicinal products, the supply of medicinal products and the rights of users of medicinal products, in harmony with Community legislation and international regulations and recommendations.

Responsibility for laying down provisions for the supply of medicinal products shall lie with the State. As part of this duty, the State shall determine the set of requirements necessary to ensure that persons in need of safe and effective medicinal products, whose quality is in conformity with statutory requirements, shall be able to obtain them on a regular basis.

As part of the State's responsibilities for the preservation and restoration of human health, and guided by its responsibility for such,

in light of the fact that the essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health, and that the measures adopted within the framework of public policies concerning the distribution and use of medicinal products are aimed to ensure any person in need shall have access to sufficient medicinal products for treatment,

recognizing, however, that, characteristic of the market of medicinal products for human use, the users of medicinal products or the patients have little influence at this time on selecting the medicinal product that is right for them, and

in addition to the above, taking into consideration that this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community,

Parliament has adopted the following Act:

Section 1.

For the purposes of this Act:

1) 'medicinal product' shall mean any substance or combination of substances presented for treating or preventing diseases in human beings or any substance or combination of substances which may be used in, or directly applied to, the human body, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

2) 'magistral formula' shall mean any medicinal product prepared by a pharmacist in a pharmacy in accordance with the instructions set out in the Hungarian or European Pharmacopoeia (hereinafter referred to as "Pharmacopoeia") or in the Catalogue of Standard Prescriptions (Fo-No) (hereinafter referred to as "Catalogue of Prescriptions") in accordance with a doctor's prescription or upon his own initiative in accordance with the prescriptions of the Pharmacopoeia and which is intended to be supplied directly to the patients served by the pharmacy in question;

3) 'homeopathic medicinal product' shall mean any medicinal product prepared from substances called homeopathic stocks made according to the homeopathic manufacturing procedure described by the Pharmacopoeia in accordance with a homeopathic manufacturing procedure described by the Pharmacopoeia; a homeopathic medicinal product may contain a number of principles;

4) 'narcotic drug' shall mean the substances listed in Annex I and II of the Schedule to Law-Decree No. 4 of 1965 promulgating the Single Convention on Narcotic Drugs done at New York on 30 March 1961;

4/a) 'medicinal product classified as a narcotic drug' shall mean any medicinal product that contains any active substance that is classified as narcotic and listed in Annex I and II of the Schedule to Law-Decree No. 4 of 1965 promulgating the Single Convention on Narcotic Drugs done at New York on 30 March 1961;

5) ‘psychotropic substance’ shall mean the substances listed in Annexes I-IV of Law-Decree No. 25 of 1979 promulgating the Convention on Psychotropic Substances done at Vienna on 21 February 1971, as well as the substances listed in appendices of the Schedule to the Act on Medicinal Products for Human Use;

5/a) 'medicinal product classified as a psychotropic substance' shall mean any medicinal product that contains any active substance that is classified as a psychotropic substance and listed in Annexes II-IV of Law-Decree No. 25 of 1979 promulgating the Convention on Psychotropic Substances done at Vienna on 21 February 1971, as well as the substances listed in Appendix B) of the Schedule to the Act on Medicinal Products for Human Use;

6) 'investigational medicinal product' shall mean a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products that already have a marketing authorization but are used or assembled (formulated or packaged) in clinical trials in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form of the medicinal product in question;

7) 'clinical trial' shall mean any investigation in human subjects conducted at a single site or according to a single protocol but at more than one site:

a) intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or,

b) to identify any adverse reactions to one or more investigational medicinal product(s) and/or,

c) to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy, and the risk-benefit balance,

not including non-interventional trials;

8) 'non-interventional trial' shall mean a study:

a) where the medicinal product(s) with a marketing authorization is (are) prescribed not for the trial;

b) where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorization;

c) where the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study;

d) where no additional diagnostic or monitoring procedures are applied to the patients; and

e) where only epidemiological methods are used for the analysis of collected data;

9) 'marketing authorization holder' shall mean a natural or legal person or unincorporated organization, to whom the competent authority has granted authorization for the marketing of a specific medicinal product;

10) 'representative of the marketing authorization holder' shall mean a natural or legal person or unincorporated organization designated by the marketing authorization holder to represent him in the territory of Hungary in the cases specified by the marketing authorization holder;

11) 'manufacture of medicinal products' shall mean the authorized production of medicinal products in a controlled industrial environment;

12) 'production batch' shall mean a specific quantity of starting materials, packaging materials or products produced during a continuous manufacturing process or a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such;

13) 'name of the medicinal product' shall mean the name given to a medicinal product as indicated in the marketing authorization, which may be either an invented name (which shall not be liable to be confused with the common name used), or a common or scientific name, together with a trade mark or the name of the marketing authorization holder;

14) 'international non-proprietary name' shall mean the common name recommended by the World Health Organization, or, if one does not exist, the usual common name used;

15) 'classification of a medicinal product' shall mean the category of a medicinal product that is indicated in the marketing authorization, or in connection with magistral formulas in the Pharmacopoeia or the Catalogue of Prescriptions, declaring it a prescription or non-prescription medicinal product;

16) 'non-prescription medicinal product' shall mean all medicinal products qualified as such by the licensing authority in the marketing authorization, or in the case of magistral formulas, which are qualified as such in the Pharmacopoeia or the Catalogue of Prescriptions;

17) 'summary of product characteristics' shall mean a guide contained in the marketing authorization and addressed to doctors and pharmacists, containing the particulars, dosage and administration and characteristics of the medicinal product in question;

18) 'package leaflet' shall mean a leaflet containing information for the user (patient) in a comprehensible manner according to this Act, which accompanies the medicinal product;

19) 'immediate packaging' shall mean the container or other form of packaging immediately in contact with the medicinal product;

20) 'outer packaging' shall mean the packaging into which is placed the immediate packaging;

21) ‘Pharmacopoeia’ shall mean the official publication, published and amended by the government body for pharmaceuticals for mandatory use by the manufacturers and distributors of medicinal products and for doctors and pharmacists, containing the general rules for the manufacture of medicinal products, the quality of medicinal products and pharmaceutical ingredients, the control of medicinal products and the classification of medicinal products, and the quality norms and composition of certain medicinal products;

22) ‘Standard Catalogue of Prescriptions (Fo-No)’ shall mean the official publication, published and amended by the government body for pharmaceuticals for mandatory use by the manufacturers and distributors of medicinal products and for doctors and pharmacists, containing regulations for the preparation of magistral formulas, and the quality norms and composition of certain medicinal products;

23) 'patient care interests deserving special consideration' shall mean a situation where a medicinal product which does not have a valid marketing authorization in Hungary offers the potential of successful treatment, and no medicinal product currently on the Hungarian market has the capacity of achieving such success; and if access to a medicinal product with marketing authorization for a specific indication is inhibited to an extent where it would likely to delay the treatment prescribed for the patient, hence causing disproportionately great risk of irreversible health impairment;

24) 'European Medicines Agency' shall mean the European Medicines Agency established under Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

25) 'risks related to use of the medicinal product' shall mean any risk relating to the quality, safety or efficacy of the medicinal product as regards patients' health or public health, and any potential risks presented by the medicinal product for the environment;

26) 'risk-benefit balance' shall mean an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined in Point 25;

27) 'post-authorization safety study' shall mean all studies conducted in connection with medicinal products with marketing authorization with the aim of identifying, characterizing or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures;

28)

29) 'advanced therapy (novel) medicinal product' shall mean any of the medicinal products shown in Article 2 (1) a) of Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004.

30) 'pharmacovigilance' shall mean the activities designed to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance, aiming to reduce the risks of, and increase the benefits from, such medicinal products;

31) 'Pharmacovigilance Risk Assessment Committee' shall mean the scientific committee of the European Medicines Agency;

32) 'risk management system' shall mean a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions;

33) 'risk management plan' shall mean a detailed description of the risk management system;

34) 'pharmacovigilance system' shall mean a system used to fulfil pharmacovigilance tasks and responsibilities and designed to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance;

35) 'pharmacovigilance system master file' shall mean a detailed description of the pharmacovigilance system used by the marketing authorization holder with respect to one or more authorized medicinal products;

36) 'coordination group' shall mean the body referred to in Article 27 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use;

37) 'new psychoactive substance' shall mean a new substance or compound never before used in the field of medicine that, acting on the central nervous system, functions as a mood altering drug, having the capacity to change human behavior and perception, and that may consequently pose a comparable threat to public health as the substances listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961, promulgated by Law-Decree No. 4 of 1965, or in Schedules I and II to the treaty on psychotropic substances signed in Vienna on 21 February 1971, promulgated by Law-Decree No. 25 of 1979, or in the lists of psychotropic substances contained in the Schedule to the Act on Medicinal Products for Human Use, and that has been classified on that basis as a psychoactive substance by the relevant government decree.

38) 'active substance' shall mean any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;

39) 'excipient' shall mean any constituent of a medicinal product other than the active substance and the packaging material;

40) 'brokering of medicinal products' shall mean all activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include the physical handling of medicinal products and that consist of negotiating independently and on behalf of another legal or natural person;

41) 'broker of medicinal products' shall mean any natural or legal person engaged in the pursuit of brokering of medicinal products.

42) 'falsified medicinal product' shall mean any medicinal product with a false representation - excluding unintentional quality defects - of:

a) its identity, including its packaging and labeling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients,

b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorization holder,

c) its history, including the records and documents relating to the distribution channels used,

without prejudice to infringements of intellectual property rights.

43) 'parallel import' shall mean the importation into Hungary of a version of a medicinal product for human use authorized for placing on the market which meets the conditions set out in the ministerial decree on the pursuit of the business of wholesale distribution and parallel importation of medicinal products, from any States which are parties to the EEA Agreement where the medicinal product has already received a marketing authorization.

44) 'recall' shall mean any measure aimed at achieving the return of a medicinal product that has already been made available to the end user or that is found at distributors;

45) 'withdrawal from the market' shall mean any measure aimed at preventing a product in the supply chain from being made available on the market;

46) ‘economic operator’ shall have the same meaning as defined in the Code of Civil Procedure.

Scope

Section 2.

(1) The provisions of this Act shall apply to the manufacture, production, placing on the market, distribution and use of medicinal products for human use, and to the clinical trial and use of investigational medicinal products.

(2) Where there is any doubt in connection with a product - taking into consideration of what is contained in Subsection (1) - to which the definition set out in Point 1 of Section 1 applies, and that may be subject to the definition of another product contained in another piece of legislation as well, the provisions of this Act shall prevail.

(3) This Act shall not apply to whole blood, plasma or blood cells of human origin, except for plasma which is prepared by a method involving an industrial process, nor to medical devices, food preparations, dietary supplements, cosmetics, and other products intended for human use, governed by other legislation, as well as disinfectants not used in or on the human body, and medical laboratory diagnostic agents.

Clinical Trial

Section 3.

(1) Concerning the authorization and conduct of clinical trials the provisions of the Health Care Act pertaining to medical research in human subjects shall apply subject to the exceptions set out in this Act.

(2) The authorization of the government body for pharmaceuticals - issued on the basis of the opinion of the competent research ethics committee of the Medical Research Council or relying on the prior express consent of the special authority granted upon the client’s request lodged before the opening of the proceedings - shall be required for the clinical trial of any investigational medicinal product in the territory of Hungary.

(3)

(4) The administrative time limit for the authorization of clinical trials shall be sixty days, within which period the assessment for ethics purposes shall be completed within not more than forty-two days. The administrative time limit for clinical trials involving investigational medicinal products for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms shall be ninety days from the date of submission of the application, within which period the assessment for ethics purposes shall be completed within not more than seventy-two days. The administrative time limit for clinical trials involving investigational medicinal products for xenogenic cell therapy shall be twelve months from the date of submission of the application, within which period the assessment for ethics purposes shall be completed within not more than eleven months.

(5) The sponsor of a clinical trial shall obtain sufficient liability insurance cover for any damage, or for restitution payable in connection with any violation of rights relating to personality that may occur in connection with a clinical trial, from an insurance company that is established or has a branch in any Member State of the European Economic Area (hereinafter referred to as “EEA”), or in any State enjoying equal treatment with EEA Member States by virtue of an international agreement with the European Communities or with the EEA (hereinafter referred to as “States which are parties to the EEA-Agreement”). The liability insurance policy shall afford sufficient cover for any and all potential claims for damage and restitution in connection with the clinical trial.

(6) Commencement of authorized clinical trials shall be notified to the government body for pharmaceuticals.

(7)

(8) The sponsor of the clinical trial shall enter into an agreement for the conduct of the clinical trial with the medical service provider conducting it, or with the head of the clinical trial. The agreement shall be deemed valid only on the basis of the consent of the government body for pharmaceuticals granted on the basis of the opinion of the competent research ethics committee of the Medical Research Council or relying on the prior express consent of the special authority granted upon the client’s request lodged before the opening of the proceedings.

Provisions for the Manufacture of Medicinal Products

Section 4.

(1) With the exception of magistral formulas produced in pharmacies, medicinal products may only be produced in the territory of Hungary in possession the authorization of the government body for pharmaceuticals granted for this specific purpose. The organization holding a license for the manufacture of a medicinal product shall be construed as the manufacturer of that medicinal product.

(2) The government body for pharmaceuticals shall authorize the production of a medicinal product if the applicant is able to satisfy the personnel and infrastructure requirements set out in specific other legislation to ensure that the quality of the medicinal products manufactured will be in conformity with the requirements laid down in the marketing authorization. An authorization for the manufacture of a medicinal product shall also constitute entitlement for trading the manufacturer's own products on the wholesale market, on condition that the manufacturer is able to comply in its wholesale distribution operations with the personnel and infrastructure requirements set out in specific other legislation for the wholesale distribution of medicinal products.

(3) Another precondition for the authorization referred to in Subsection (1) is for the applicant to have liability insurance coverage for any potential claims for damages in connection the technological processes in the manufacture of medicinal products.

(4) Applications for authorization shall be submitted to the government body for pharmaceuticals on the standard forms containing the information decreed by the competent minister.

(5) The government body for pharmaceuticals shall inspect the production site and shall check to ascertain as to whether the applicant is able to comply with the personnel and infrastructure requirements prescribed in specific other legislation for the manufacture of medicinal products, and has sufficient facilities for documentation and quality assurance.

(6) The government body for pharmaceuticals shall adopt a decision concerning the application within ninety days.

(6a) If based on the findings of an inspection of any manufacturing site of medicinal products, or of active substances and excipients used as starting materials for the manufacture of medicinal products, or the facilities of wholesalers of medicinal products, carried out by way of sampling and analysis or the inspection of the related documents it is determined that the inspected entity does not comply with the legal requirements and/or the principles and guidelines of good manufacturing practice or good distribution practices as provided for by Union law, the government body for pharmaceuticals shall take the measures necessary and shall send its findings to the European Medicines Agency.

(7) Any person engaged in the manufacture of medicinal products classified as narcotic and psychotropic substances and medicinal products containing any active substance falling under the scope of the legislation on regulatory procedures relating to drug precursors and laying down provisions concerning the powers and responsibilities of public authorities must have a separate authorization for that particular purpose.

(8) The authorized manufacturer of medicinal products shall make arrangements:

a) in connection with the medicinal products produced:

aa) for quality control or certification of quality, and for a computerized system in connection with the certification of quality;

ab) for setting up a laboratory in compliance with the requirements set out in specific other legislation for reasons of quality assurance;

ac) for the withdrawal from circulation and for their seizure;

b) for keeping the records prescribed in specific other legislation and for retaining at least two complete factory package units from each production batch for the purposes of investigation for the period of the proposed shelf life indicated, plus one year;

c) for notification of the authority issuing the marketing authorization concerning any medicinal product deemed defective, indicating the defect and the serial number;

d) for the withdrawal from the market of any medicinal products it has produced and placed on the market and for notifying the authority issuing the marketing authorization concerning the nature of the defect;

e) for collecting the complete batch of the medicinal products that were withdrawn from the market from the buyers to whom they were delivered;

f) for the destruction of defective products and documentation of the process;

g) for drawing up warehousing procedures.

(9) All products shipped to the buyer from the warehouse shall be accompanied by a quality certificate. The factory packaging of products delivered shall have affixed the manufacturer's corporate logo to permit identification of the products' place of origin subsequently.

(10) Authorized manufacturers of medicinal products shall notify the government body for pharmaceuticals of the suspension of their operations of manufacture of medicinal products for any period over six months, indicating the proposed duration of suspension, at least three months before the scheduled date of suspension.

(11) Authorized manufacturers of medicinal products shall notify the government body for pharmaceuticals without delay concerning any changes in their particulars listed under Subsection (2). The government body for pharmaceuticals shall adopt a decision concerning the amendment of the authorization under Subsection (1) according to the changes notified within thirty days. The administrative time limit for proceedings opened upon such notification may be extended on one occasion by maximum sixty days.

(12) At the request of a manufacturer of medicinal products, the government body for pharmaceuticals shall issue an official certificate based on the report drawn up on the inspection of production. The official certificate shall contain:

a) the manufacturer's particulars (name, address);

b) if the inspection pertains to the production of a specific medicinal product or pharmaceutical form, the identification data of these;

c) the date and time of the inspection;

d) the date of the certificate; and

e) the findings of the inspection.

(13)

Section 4/A.

(1) The authorization of the government body for pharmaceuticals for the manufacture of medicinal products (hereinafter referred to as “authorization for the manufacture of medicinal products”) is required for the importation of medicinal products from outside the EEA, or from any State enjoying equal treatment with States which are parties to the EEA-Agreement by virtue of an agreement with the European Communities or with the European Union (hereinafter referred to as “third country”), or for the manufacture of such products for export only.

(2) An authorization for the manufacture of medicinal products is not required for medicinal products imported from outside the EEA for research purposes, not including medical research in human subjects, and the importer notified the government body for pharmaceuticals thereof, as decreed by the minister in charge of the healthcare system. Any medicinal product imported under this Subsection for the purpose of research may not be used for other purposes. Any medicinal product not used for research purposes shall be destroyed. Upon the completion of research activities the government body for pharmaceuticals shall be notified without delay.

(3) An authorization for the manufacture of medicinal products is not required for medicinal products imported by a wholesaler of medicinal products authorized for the wholesale distribution of medicinal products.

Authorization for the Marketing of Medicinal Products

Section 5.

(1) Marketing authorization is the official resolution issued by the authority of competence and jurisdiction permitting a medicinal product to be administered to humans for therapeutic purposes. Unless this Act contains provisions to the contrary, a medicinal product - not including magistral formulas - may be placed on the market only if authorized by the government body for pharmaceuticals or by the European Commission in accordance with Regulation (EC) No. 726/2004 of the European Parliament and of the Council, Regulation (EC) No. 1901/2006 of the European Parliament and of the Council or Regulation (EC) No. 1394/2007 of the European Parliament and of the Council.

(2) The government body for pharmaceuticals shall grant a marketing authorization for a medicinal product if:

a) the qualitative and quantitative particulars of the constituents are known and declared, including the manufacturing process; and

b) its therapeutic efficacy has been clinically substantiated, except for homeopathic medicinal products for which the simplified registration procedure is authorized; and

c) the risk-benefit balance is favourable.

(2a) Where so justified by safety concerns concerning a medicinal product, the government body for pharmaceuticals may render marketing authorization for such medicinal product conditional upon compliance with one or more of the following requirements within the prescribed deadlines:

a) to take certain measures for ensuring the safe use of the medicinal product to be included in the risk management system;

b) to conduct post-authorization safety studies;

c) to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in specific other legislation;

d) any other conditions or restrictions with regard to the safe and effective use of the medicinal product;

e) the existence of an adequate pharmacovigilance system;

f) to conduct post-authorization efficacy studies taking into account the scientific guidance published by the European Medicines Agency where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed.

(3) In proceedings for the granting of marketing authorizations the government body for pharmaceuticals shall accept the findings of investigations conducted in States other than those which are parties to the EEA-Agreement if:

a) it is prescribed by law or international agreement; or

b) it is satisfied that the method of execution and control of tests conducted in any State that is not a party to the EEA-Agreement is in compliance with requirements set out in Hungary.

(4) The government body for pharmaceuticals shall refuse to grant a marketing authorization if the information that is to be conveyed in a comprehensible manner according to this Act on the immediate or outer packaging (hereinafter referred to as "label") or if the package leaflet is not in compliance with the requirements set out in this Act and in specific other legislation pertaining to labelling and to the package leaflet, or it is not consistent with the summary of product characteristics.

(5) The marketing authorization, in addition to the medicinal product's identification data, shall contain:

a) the number of the marketing authorization, the name of the marketing authorization holder and the manufacturer's address;

b) the summary of product characteristics;

c) the label information;

d) the package leaflet;

e) the classification of the medicinal product;

f) the expected shelf life of the medicinal product and storage instructions.

(6) The administrative time limit for marketing authorization procedures is two hundred and ten days from the day following the date of submission of the application. Marketing authorization may be granted only if the applicant is established in any State that is a party to the EEA-Agreement. The marketing authorization holder shall be responsible for marketing the medicinal product. The designation of a representative shall not relieve the marketing authorization holder of his legal responsibility concerning the product.

(7) The marketing authorizations issued under Subsections (1)-(6) shall remain in effect for five years. The authorization may be renewed upon request, if submitted at least nine months before the expiry of the prescribed period of validity and subject to reassessment of the risk-benefit balance. Once renewed, the marketing authorization shall be valid for an unlimited period, unless the government body for pharmaceuticals decides, on justified grounds relating to pharmacovigilance under this Subsection, including exposure of an insufficient number of patients to the medicinal product concerned, to proceed with one additional five-year renewal only.

(8)

(9) The marketing authorization holder shall notify any change in the person of the manufacturer of the medicinal product or in the person of the marketing authorization holder to the government body for pharmaceuticals within thirty days following the effective date of the change in question.

(10) Applications for any amendments concerning the products for which the government body for pharmaceuticals has granted authorization by means other than the procedures specified in a binding legislation of the European Union shall be assessed in accordance with the procedure laid down by Commission Regulation (EC) No. 1234/2008.

Section 6.

(1) The government body for pharmaceuticals, under patient care interests deserving special consideration, may - ex officio - authorize the marketing of a medicinal product that has been authorized for marketing in any State that is a party to the EEA-Agreement.

(2) In connection with the authorization of a medicinal product for marketing in accordance with Subsection (1) hereof, prior to granting the authorization the government body for pharmaceuticals:

a) shall notify the marketing authorization holder in the State that is a party to the EEA Agreement where the medicinal product in question has been authorized, concerning its intention to grant a marketing authorization for the product by virtue of this Act; and

b) shall request the competent authority of that State to supply a copy of the assessment report prepared in accordance with specific other legislation for the medicinal product in question and a copy of the marketing authorization of the medicinal product.

(3) Upon receipt of a request specified in Paragraph b) of Subsection (2) hereof from a State that is a party to the EEA Agreement, the government body for pharmaceuticals shall satisfy the request within thirty days of the date of receipt and shall send a copy of the assessment report and of the marketing authorization of the medicinal product in question.

Provisional and Special Marketing

Section 7.

(1) At the manufacturer's request and if justified by patient care interests deserving special consideration, the government body for pharmaceuticals may grant a provisional marketing authorization, before all trials are completed in full, for a product that is deemed to be of appropriate quality based on the assessment already completed and where the risk-benefit balance is considered to be favourable for therapeutic value, for a maximum period of one year. The government body for pharmaceuticals shall lay down in the provisional marketing authorization the reporting requirements for the marketing authorization holder pertaining, in particular, to the safety of the product. The conditions set out by the government body for pharmaceuticals shall be reported at the times prescribed in the authorization to the government body for pharmaceuticals.

(2) The government body for pharmaceuticals may temporarily authorize access to and the application of an unauthorized medicinal product for the period referred to in Subsection (1) in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm and hence may present a substantial risk to public health.

(3) Upon request and in justified cases deserving special consideration, the government body for pharmaceuticals may grant a special marketing authorization for the distribution of an unauthorized medicinal product that meets the criteria set out in Paragraph a) of Subsection (2) of Section 5, however, the requirements set out in Paragraphs b) and c) are merely suspected and cannot be confirmed since the number of patients involved in the clinical trial of the product is insufficient due to the rarity of the disease. The government body for pharmaceuticals shall lay down in the special marketing authorization the reporting requirements for the marketing authorization holder pertaining, in particular, to the safety of the product. The conditions set out by the government body for pharmaceuticals shall be reported at the times prescribed in the authorization to the government body for pharmaceuticals.

(4) The government body for pharmaceuticals shall assess compliance with the requirements set out in Subsections (1)-(3) at least once a year. At the manufacturer's request the government body for pharmaceuticals may extend the time limit specified in the provisional marketing authorization to maximum one year.

Obligation to Conduct Post-Authorization Studies

Section 7/A.

(1) After the granting of a marketing authorization, the government body for pharmaceuticals may impose an obligation on the marketing authorization holder to conduct a post-authorization safety study if there are concerns about the risks of an authorized medicinal product, where so justified by new, or previously underestimated, hazards. If the same concerns apply to more than one medicinal product, the government body for pharmaceuticals shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorization holders concerned to conduct a joint post-authorization safety study.

(2) After the granting of a marketing authorization, the government body for pharmaceuticals may impose an obligation on the marketing authorization holder in writing to conduct a post-authorization efficacy study when the understanding of the disease - including the emergence of information unknown at the time of authorization - or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly.

(3) In the application of Subsections (1) and (2) hereof, the government body for pharmaceuticals shall notify in writing:

a) the reasons for imposing the obligation;

b) the objectives for conduct of the study;

c) the timeframe for submission of the findings of the study; and

d) an indication that the marketing authorization holder is provided with an opportunity to present written observations in response to the imposition of the obligation within thirty days of receipt of the written notification.

(4) The government body for pharmaceuticals, if deemed necessary on the basis of the written observations submitted according to Paragraph d) of Subsection (3), shall impose the obligation to conduct the study under Subsection (1) or (2) hereof, and shall amend the marketing authorization to include said obligation as a condition of the marketing authorization.

(5) The holder of the marketing authorization shall update the risk management system according to the resolution.

Updating the Risk Management System

Section 7/B.

The holder of the marketing authorization shall update the risk management system to include the activities prescribed by the government body for pharmaceuticals under Subsection (2a) of Section 5, Section 7 and Section 7/A.

Labelling and Package Leaflet

Section 8.

Unless otherwise prescribed in this Act, the outer packaging of medicinal products, if any, and the immediate packaging shall have affixed the information prescribed in specific other legislation.

Section 9.

A package leaflet must be inserted in the packaging of all medicinal products if the information prescribed in specific other legislation is not indicated on the outer or the immediate packaging.

Section 10.

(1) One or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the government body for pharmaceuticals enclosed with the request for marketing authorization.

(2) Applications for the authorization of changes pertaining to labeling and the package leaflet, which do not effect the summary of product characteristics, shall be submitted to the government body for pharmaceuticals. If the government body for pharmaceuticals fails to render its decision within ninety days following the date of receipt of the application for modification, the authorization shall be considered granted.

(3) The package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professionals. The package leaflet must be clearly legible in the Hungarian language and shall contain the information prescribed in specific other legislation. Apart from Hungarian the leaflet may be printed in several languages, provided that the same information is given in all the languages used.

(4) The government body for pharmaceuticals may exempt labels and package leaflets for specific medicinal products from the obligation that all particulars shall appear and that the labeling and the leaflet must be in the Hungarian language, when the product is not intended to be delivered directly to the patient for self-administration, or where there are severe problems in respect of the availability of the medicinal product, or if the marketing authorization was granted under Subsection (1) of Section 6, and it does not jeopardize the health of patients.

(5)

Wholesale Distribution of Medicinal Products

Section 11.

(1) Wholesale distribution of medicinal products shall comprise all activities relating to the supply of medicinal products to retailers, including the storage and transportation of medicinal products, exporting to and importing from States which are parties to the EEA-Agreement, and exporting to States outside of this area, in consequence of which medicinal products are conveyed from the manufacturer or producer to persons authorized to supply medicinal products to the public. Unless this Act contains provisions to the contrary, all activities relating to the wholesale distribution of medicinal products must be authorized by the government body for pharmaceuticals.

(2) The government body for pharmaceuticals shall grant the above-specified authorization, if the applicant is able to satisfy the personnel and infrastructure requirements set out in specific other legislation.

(3) Authorized wholesale distributors of medicinal products - subject to the exceptions set out in specific other legislation - shall not be authorized to supply medicinal products directly to the public, and shall be authorized to supply medicinal products only to persons with authorization or entitlement to engage in activities for the wholesale distribution of medicinal products or for providing medical services.

(4) The authority shall adopt a decision concerning applications for authorization and for the amendment of existing authorizations within ninety days following the date of receipt of the application. Wholesale distribution authorizations shall remain valid until revoked.

(5) Where medicinal products are exported to a third country by a wholesaler, the wholesaler shall take steps to ensure that the medicinal products are delivered to an authorized wholesaler in the third country of destination, or to persons authorized or entitled to supply medicinal products to the public in the third country of destination.

Parallel Import

Section 11/A.

(1) In the case of parallel importation the parallel importer shall inform of the proposed importation the holder of the marketing authorization for Hungary of the imported medicinal product and the government body for pharmaceuticals, or the European Medicines Agency if the medicinal product in question had been authorized under Regulation (EC) No. 726/2004 of the European Parliament and of the Council, thirty days before the proposed date of importation.

(2) The parallel importation of any medicinal product for which the government body for pharmaceuticals has already granted a marketing authorization shall be subject to authorization pursuant to the ministerial decree on the pursuit of the business of wholesale distribution and parallel importation of medicinal products.

Supply of Medicinal Products

Section 12.

(1) Supply of medicinal products shall comprise all the activities by which medicinal products are made available directly to the users, including the manufacture, production, storage and distribution of medicinal products.

(2) Unless otherwise provided for by law, medicinal products may be procured on the behalf of and dispensed to patients by pharmacies.

(3) Unless otherwise prescribed by law, pharmacies may procure medicinal products only from economic operators authorized to engage in activities relating to the wholesale distribution of medicinal products.

(4) Where a pharmacy is unable to supply a particular medicinal product from stock immediately, the patient concerned shall be informed of the estimated date of availability.

(5) In the case defined in Subsection (2) of Section 16, institutional pharmacies may procure medicinal products of which there is a shortage from other institutional pharmacies as well.

(6) Institutional pharmacies may purchase supplies of medicinal products from the body delegated to manage the Central Healthcare Reserve within the framework of independent procurement procedures in accordance with the Government Decree on the National System of Centralized Procurement of Medicinal Products, Medical Devices and Disinfectants for Inpatient Medical Institutions.

Section 13.

Section 14.

Special Provisions Relating to Narcotic Drugs and Psychotropic Substances, Medicinal Products Classified as Narcotics or Psychotropic Substances and New Psychoactive Substances

Section 15.

(1) The activities governed by the relevant legislation relating to narcotic drugs, psychotropic substances and new psychoactive substances may be carried out in possession of a general research authorization or a single license issued for a specific study, or in possession of an official certificate issued after registration. The decisions of the government body in charge of the healthcare system adopted in proceedings under this Subsection may not be appealed.

(2) The regulations pertaining to the manufacture, storage and wholesale distribution of medicinal products classified as narcotic and psychotropic substances, as well as the registration and data disclosure obligations of the persons authorized to engage in these activities, furthermore, the regulations for the prescription of these products, their sale in pharmacies - including storage, records, and their dispensation from pharmacies -, and for the use of these products in medical institutions and the records on such usage is laid down in specific other legislation.

(3) The authorization and registration proceedings relating to narcotic drugs, psychotropic substances and new psychoactive substances, and the issue and amendment of authorizations shall be subject to an administrative service fee payable in accordance with the provisions of specific other legislation.

(4) The authorization referred to in Subsection (1) may be granted to an whose executive officer has no prior criminal record and who is not restrained by court order from exercising the profession required for holding an executive office in an economic operator or business association, or from practicing the profession required for the pursuit of healthcare activities.

(5) The person nominated to be appointed as narcotics duty officer, deputy narcotics duty officer or as a person responsible for narcotic drugs under specific other legislation shall have no prior criminal record and shall not be restrained by court order from practicing the profession required for the pursuit of healthcare activities.

(6) Enclosed with the application submitted in accordance with specific other legislation for authorization, the executive officer of the applicant economic operator and the person nominated to be appointed as narcotics duty officer or deputy narcotics duty officer shall produce official documentary evidence to verify that he has no prior criminal record, and that he is not restrained by court order from practicing the profession referred to in Subsection (4) or (5), or shall request the body operating the penal register to disclose information to the authority delegated under specific other legislation based on an official request lodged for the purpose of assessment of the application for authorization.

(7) As regards the data request lodged by the authority delegated under specific other legislation to the body operating the penal register shall be limited to the information necessary to determine as to whether the person applying for authorization has no prior criminal record, and that he is not restrained by court order from practicing the profession referred to in Subsection (4) or (5).

(8) Enclosed with the application submitted for authorization by a person of citizenship other than Hungarian, the applicant shall produce the translation of official documentary evidence made out according to the laws of his home state - pertaining to official certificates - to the authority delegated under specific other legislation to verify that he has no prior criminal record, and that he is not restrained by court order from practicing the profession referred to in Subsection (4) or (5).

(9) The government body in charge of the healthcare system shall maintain an official public register on authorizations for activities with narcotic or psychotropic substances, or with new psychoactive substances.

(10) The register referred to in Subsection (9) shall contain the economic operator’s:

a) name,

b) registered office,

c) places of business,

d) authorization number and the period of validity,

e) sphere of activities,

f) registered number or the number of admission into the official register of private entrepreneurs.

(11) The government body in charge of the healthcare system shall maintain a register on economic operators engaged in the export-import and transfer of decorative poppy and cannabis plants, in the purchase of poppy seeds contaminated with unpurified poppy straw residues, and providing for the cleaning of such, and in the storage of industrial poppy straw, in using new psychoactive substances for industrial purposes, and in the export-import, transfer and distribution of new psychoactive substances.

(12) The register referred to in Subsection (11) shall contain:

a) the economic operator’s:

aa) name,

ab) registered office,

ac) places of business;

b) the number of the official instrument;

c) positive indication of the nature of the activity and the place where it takes place;

d) the name of the person responsible for narcotic drugs;

e) the registered number or the number of admission into the official register of private entrepreneurs.

(13) The register referred to in Subsection (11) shall be construed as an official public register having regard to the data under Paragraphs b)-d) of Subsection (12).

(14) The government body in charge of the healthcare system shall maintain a register on economic operators engaged in the transport of narcotic drugs, psychotropic substances and new psychoactive substances.

(15) The register referred to in Subsection (14) shall contain:

a) the economic operator’s:

aa) name,

ab) registered office;

b) the number of the official instrument;

c) positive indication of the nature of the activity;

d) the name of the person responsible for narcotic drugs;

e) the registered number or the number of admission into the official register of private entrepreneurs.

(16) The register referred to in Subsection (14) shall be construed as an official public register having regard to the data under Paragraphs b) and c) of Subsection (15).

Section 15/A.

(1) The authority delegated under specific other legislation shall check in the course of a regulatory inspection as to whether the person holding authorization has no prior criminal record and that he is not restrained by court order from practicing the profession referred to in Subsection (4) or (5) of Section 15.

(2) With a view to being able to verify the circumstances referred to in Subsection (1), the authority delegated under specific other legislation shall be authorized to process the personal data:

a) of the person applying for authorization,

b) of the person holding an authorization,

contained in the official certificate made out by the body operating the penal register for this purpose.

(3) The authority delegated under specific other legislation shall be authorized to process the personal data obtained under Subsection (2):

a) until the final and binding conclusion of the procedure for authorization, or

b) for the duration of the regulatory inspection if the authorization is granted, or until the final and binding conclusion of the procedure for the withdrawal of the authorization.

Section 15/B.

(1) A substance or compound may be classified as a new psychoactive substance upon the prior scientific evaluation of the notification referred to in Article 4(1) of Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances (hereinafter referred to as “notification”).

(2) The substances and compounds classified as new psychoactive substances shall be defined in the relevant government decree.

(3) The prior scientific evaluation referred to in Subsection (1) shall be aimed at determining whether there is any information available to the relevant Hungarian authorities or expert institutions relating to the substance or compound indicated in the notification:

a) that would imply the medicinal use of the substance or compound indicated in the notification, and

b) that would exclude that the substance or compound pose a comparable threat to public health as the narcotic drugs referred to in Point 4 of Section 1 or as the substances listed in Annexes I and II of the Schedule to Law-Decree No. 25 of 1979 promulgating the treaty on psychotropic substances signed in Vienna on 21 February 1971, or in appendices of the Schedule to the Act on Medicinal Products for Human Use.

(4) The prior scientific evaluation referred to in Subsection (1) hereof shall be carried out by an expert body designated by government decree.

Section 15/C.

(1) Within one years of classification of substances as new psychoactive substances, the risk assessment of such new psychoactive substances shall be carried out, if it was not requested by the Council of the European Union or the World Health Organization.

(2) If based on the risk assessments of new psychoactive substances carried out in Hungary or at Union level, or by the special UN bodies it is determined that such psychoactive substances pose a comparable threat to public health as the narcotic drugs referred to in Point 4 of Section 1 or as the substances listed in Annexes I and II of the Schedule to Law-Decree No. 25 of 1979 promulgating the treaty on psychotropic substances signed in Vienna on 21 February 1971, or in Appendixes A) and B) of the Schedule to the Act on Medicinal Products for Human Use, they shall be listed in the appropriate schedules of psychotropic substances, and classification as a new psychoactive substance shall be withdrawn.

(3) If the risk assessment offers no evidence that a new psychoactive substance poses a comparable threat as the narcotic drugs referred to in Point 4 of Section 1 or as the substances listed in Annexes I and II of the Schedule to Law-Decree No. 25 of 1979 promulgating the Convention on Psychotropic Substances done at Vienna on 21 February 1971, or in the appendices of the Schedule to the Act on Medicinal Products for Human Use, it shall be deleted from the list of new psychoactive substances and shall be allocated to another list provided for in a government decree.

(4) If according to the findings of the expert body, the data available is insufficient to conclude the risk assessment within one year in accordance with Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances, the classification of the new psychoactive substance may be extended by one additional year.

Section 15/D.

(1) The government body for pharmaceuticals shall maintain an official public register on all medicinal products containing narcotic or psychotropic substances with marketing authorization.

(2) The register referred to in Subsection (1) shall contain:

a) the medicinal product’s name and pharmaceutical form;

b) the medicinal product’s classification;

c) the medicinal product’s status;

d) quantification of the active substance in a dosage unit;

e) the international non-proprietary name of the medicinal product’s active substance;

f) the medicinal product’s marketing authorization number;

f) the holder of the medicinal product’s marketing authorization;

h) the medicinal product’s sales presentation,

i) the legal status of the medicinal product for dispensing;

j) the list of countries where the medicinal product cannot be marketed.

Sections 15/E-15/F.

Public Service Obligation Placed on Marketing Authorization Holders, Authorized wholesale distributors of medicinal products and Operators of Pharmacies Relating to the Supply of Medicinal Products

Section 16.

(1) In the event where a marketing authorization holder intends to temporarily suspend the distribution of a specific medicinal product in the territory of Hungary, or wishes to discontinue the distribution of such medicinal product, the wholesalers of medicinal products engaged under contract and the government body for pharmaceuticals must be notified accordingly at the time of delivery of the last production batch to the medicinal product wholesaler, in any case at least two months before the scheduled suspension or termination of distribution, and shall be liable to provide a supply of the medicinal products in question until the date estimated for the suspension or termination of distribution in the quantity required to cover demand as estimated from previous turnover data. The government body for pharmaceuticals shall verify the availability of supplies notified by the marketing authorization holder in the quantity estimated to satisfy demand.

(1a) The marketing authorization holder shall disclose the reasons for the suspension or termination of distribution provided for in Subsection (1) to the government body for pharmaceuticals, and shall enclose a statement indicating if the suspension or termination is required on the grounds mentioned in Paragraphs a)-e) of Subsection (5) of Section 18.

(2) Where a marketing authorization holder is unable to maintain adequate and steady supplies of specific medicinal products in Hungary resulting in a (potential) shortage of supplies under Subsection (4) of Section 21 of Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products (hereinafter referred to as “Medicine Act”), the marketing authorization holder shall forthwith notify the wholesalers of medicinal products engaged under contract, the government body for pharmaceuticals and the health insurance administration agency accordingly, and shall communicate the expected duration of such shortage and the quantity of supplies available during this period.

(3) Authorized wholesale distributors of medicinal products shall be required to procure and supply the medicinal products to which their authorization for wholesale distribution pertains.

(4) The supply obligation of operators of pharmacies is governed in specific other legislation on the implementation and operation of pharmacies.

(5) The marketing authorization holder shall ensure that any medicinal product wholesaler authorized in Hungary shall be given adequate opportunity to distribute the marketing authorization holder’s medicinal products on the wholesale market, if the wholesalers specifically indicates that there is solid demand in Hungary for the medicinal product requested. The medicinal products purchased under this Subsection may be sold to Hungarian healthcare service providers only, and may not be exported within the framework of wholesale trading activities. The wholesaler shall keep records of the medicinal products purchased under this Subsection separately, as decreed by the minister in charge of the healthcare system.

(5a) The marketing authorization holder shall ensure that the medicinal product wholesalers authorized in Hungary for the wholesale distribution of medicinal products together shall have adequate supplies of medicinal products of the active substance decreed by the minister in charge of the healthcare system available at their disposal in the territory of Hungary, in the quantity defined therein. The types of active substances referred to above shall be defined on a recommendation by the government body for pharmaceuticals.

(6) The government body for pharmaceuticals shall publish the notice of shortage of specific medicinal products referred to in Subsection (2) on its website, and shall notify the administrator of state healthcare, catastrophe and safety reserves and the health insurance administration agency thereof.

(7) In the event of shortage in the supplies of specific medicinal products referred to in Subsection (2) hereof, the marketing authorization holder and wholesalers of medicinal products are required to cooperate as decreed by the minister in charge of the healthcare system with the administrator of state healthcare, catastrophe and safety reserves, the government body for pharmaceuticals and the health insurance administration agency in the interest of control of the shortage.

(8) If the government body for pharmaceuticals obtains information regarding the export of medicinal products originally intended to be supplied in Hungary to the general public to an extent where it is considered to jeopardize the continuous supply of the medicinal products in question, the government body for pharmaceuticals shall have authority to ban - for a period not exceeding one year - further export of the medicinal product within the framework of wholesale trading activities so as to guarantee the security of supply, if it considers that further exports are likely to disturb the supply of medicinal products.

(9) The marketing authorization holder shall notify the government body for pharmaceuticals without delay:

a) concerning all measures taken in a State that is a party to the EEA Agreement for the suspension of distribution of a medicinal product, for recalling a medicinal product, or for requesting the withdrawal of marketing authorization, including the reasons,

b) if did not apply for the renewal of marketing authorization for a medicinal product in a State that is a party to the EEA Agreement, including the reasons.

(10) The notice under Subsection (9) shall have enclosed a statement indicating if the measure was required on the grounds mentioned in Paragraphs a)-e) of Subsection (5) of Section 18.

(11) The notice referred to in Subsection (9) shall be submitted also if the marketing authorization holder took the actions referred to in Paragraphs a) and b) of Subsection (9) in a third country, if they were required on the grounds mentioned in Paragraphs a)-e) of Subsection (5) of Section 18.

(12) The marketing authorization holder shall also notify the European Medicines Agency of having taken the actions referred to in Paragraphs a) and b) of Subsection (9), indicating if they were required on the grounds mentioned in Paragraphs a)-e) of Subsection (5) of Section 18.

Supervision and Regulatory Control of Medicinal Products and the Supply of Medicinal Products

Section 17.

(1) Holders of marketing authorization and pharmacists engaged in the wholesale distribution of medicinal products or in the supply of medicinal products to the public, retail suppliers of medicinal products other than pharmacies, as well as the doctors administering the medicinal products shall report any suspected deficiency in the quality of a medicinal product or production batch, and information on any suspected falsified medicinal product to the government body for pharmaceuticals without delay upon gaining knowledge about such deficiency.

(2) The party reporting a suspected deficiency in quality shall, at the time of reporting, provide a specimen of the medicinal product in question, in the volume prescribed in specific other legislation for the purpose of quality control.

(2a) The government body for pharmaceuticals shall have powers to check the quality of any medicinal products produced or marketed in Hungary, including the documents pertaining to production or marketing, and shall be entitled to take samples and second samples for counter analysis at its own expense, unless these costs are charged to others by law.

(3) If the government body for pharmaceuticals finds, in connection with the report referred to in Subsection (1), or on the basis of the proceedings opened under Subsection (2a) or of information received through other channels, that a medicinal product does not comply with the requirements specified in the marketing authorization, it shall order the suspension of distribution of the medicinal product or production batch in question, or to have them withdrawn from the market or recalled. The government body for pharmaceuticals shall publish on its website the resolution thereof, with business secrets removed. The procedure for withdrawal from the market, recall and for the suspension of distribution shall be decreed by the minister in charge of the healthcare system.

(4)

(5) The costs for the removal of a medicinal product from circulation, including the cases defined in Subsections (1)-(3) with the exception of measures taken in connection with falsified medicinal products, shall be borne by the marketing authorization holder.

Section 17/A.

(1) Where a medicinal product for which the government body for pharmaceuticals has already granted a marketing authorization is not actually present on the market in Hungary for three consecutive years, the marketing authorization of such medicinal product shall be cancelled by decision of the government body for pharmaceuticals.

(2) Under patient care interests deserving special consideration or in order to prevent any disturbance in the supply of medicinal products, the government body for pharmaceuticals may disregard the provisions contained in Subsection (1).

Section 17/B.

(1) With a view to ascertaining the relevant facts of the case, the government body for pharmaceuticals shall have authority to request - in proceedings conducted within the framework of regulatory inspections - any person and organization to make a statement, and when so requested by the government body for pharmaceuticals any person and organization shall be liable to make available data from their records and copies of documents in their possession with facilities for reading and copying to the government body for pharmaceuticals. The government body for pharmaceuticals shall have powers to make a hard mirror image of the data medium held by any person, and to inspect the contents through this image if there is reason to believe that it contains information relating to the proceedings conducted under Section 20 within the framework of regulatory inspections.

(2) With a view to ascertaining the relevant facts of the case in connection with proceedings conducted within the framework of regulatory inspections, the government body for pharmaceuticals shall have authority to access the records of other authorities for data obtained during their inspections.

(3) The government body for pharmaceuticals shall be entitled to inspect and process - in connection with proceedings conducted within the framework of regulatory inspections - the personal data of the client and other persons who may be tied to the client. Where a means of evidence contains personal data that does not pertain to the investigation, and if this data cannot be detached without compromising the probative value of the evidence, the government body for pharmaceuticals shall be entitled to process all personal data affected, however, the entitlement to inspect the personal data that does not pertain to the investigation is valid only to the extent required to ascertain that the data is not connected to the infringement investigated.

(4) In connection with proceedings conducted within the framework of regulatory inspections, the government body for pharmaceuticals shall have authority to search any premises, to access such premises under probable cause under his own authority, without the consent of the owner (tenant) or any other person in the premises, and to open any sealed-off area or building for this purpose. In the process of the search the acting officer shall be entitled to demand information, written or oral, from the client, the client’s representative (former representative) or employee (former employee), and may gather intelligence in any other way. An on-site inspection may be carried out in the private domain, including vehicles and other premises, if it is in the use of any former or current executive officer of the client, employee or representative, or any other person who effectively exercises control or who used to exercise control.

(5) The investigative measures specified under Subsection (4) shall be carried out subject to the public prosecutor’s prior consent. The prosecuting authority shall authorize the above-specified investigative measure if the government body for pharmaceuticals is able to substantiate probable cause that any other investigative measure is unlikely to produce the required results, and if there is reason to believe that the source of information - relating to the illegal activity investigated - indicated is in the location for which the court order is requested and it is presumed that this information will not be surrendered voluntarily or that it would be destroyed. If the investigative measure is only partially accepted, the prosecuting authority shall specify the type of procedure and the person who is the subject of such procedure. On the basis of having in possession the prosecuting authority’s consent the investigative measure may be carried out within a period of ninety days from the date of issue.

(6) Regarding the investigative measure carried out under Subsection (4) the persons affected shall be informed verbally at the time the investigative measure commences, and it shall be carried out if possible in the presence of these persons. Before the investigative measure is carried out the prosecuting authority’s consent shall be presented and the purpose of the investigative measure shall be communicated.

(7) Upon hearing a witness, the government body for pharmaceuticals may ex officio order to keep the witness’s data confidential if deemed necessary with a view to ascertaining the relevant facts of a case.

(8) The administrative time limit for proceedings conducted within the framework of regulatory inspections shall be ninety days, and it may be extended by the head of the competent authority - before it expires - in justified cases on one occasion, by maximum thirty days.

Pharmacovigilance

Section 18.

(1) Marketing authorization holders shall record all suspected adverse reactions in the States which are parties to the EEA-Agreement or in third countries which are brought to their attention, whether reported spontaneously by patients or healthcare professionals, or occurring in the context of a post-authorization study.

(2) Healthcare professionals shall be required to report any suspected adverse reaction discovered or noticed to the government body for pharmaceuticals without delay. The government body for pharmaceuticals shall record - by way of the means specified in the relevant legislation - and forward all suspected adverse reactions that occur in the territory of Hungary which are brought to its attention from healthcare professionals and patients.

(3) The government body for pharmaceuticals shall be informed of any suspected adverse reactions arising from an error associated with the use of a medicinal product that are brought to the attention of an authority.

(4) The government body for pharmaceuticals shall evaluate the data relating to pharmacovigilance, and - if urgent action is considered necessary - inform other Member States of the European Union and the European Medicines Agency. If the European Medicines Agency decides not to conduct an urgent Union procedure, the government body for pharmaceuticals shall proceed to take the necessary measures under Subsections (7) and (8). The government body for pharmaceuticals shall inform the notifier, the marketing authorization holder and - by way of public notice - the healthcare service providers affected concerning the measures taken and the underlying particulars, and shall make available its decision on such actions to the general public on its website as well.

(5) The government body for pharmaceuticals may suspend further distribution of a medicinal product, and may prohibit the use of such medicinal product if:

a) the information brought to its attention indicate that the medicinal product is harmful;

b) the information brought to its attention indicate that therapeutic results cannot be obtained from the medicinal product;

c) the information brought to its attention indicate that the risk-benefit balance of the medicinal product has changed to the point where safe use of the medicinal product can no longer be ascertained;

d) the qualitative and quantitative composition of the medicinal product is not as declared in the marketing authorization;

e) the controls on the medicinal product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorization has not been fulfilled;

f) the particulars supporting the application for marketing authorization or for its renewal are incorrect or have not been amended;

g) the marketing authorization holder failed to apply for the amendment of the marketing authorization in due time; or

h) so required in order to comply with the request received from the European Commission.

(6) The government body for pharmaceuticals shall revoke the marketing authorization if:

a) it considers that the problems specified in Paragraphs a)-d) of Subsection (5) cannot be remedied within any foreseeable period of time; or

b) the marketing authorization holder failed to remedy the discrepancies by the deadline prescribed in the resolution referred to Subsection (5);

c) the marketing authorization holder failed to satisfy the special requirements set out in the marketing authorization.

(7) When urgent action under Subsections (5) and (6) is considered necessary as a result of the evaluation of data resulting from pharmacovigilance activities, it may be carried out if the government body for pharmaceuticals notifies the European Commission, the European Medicines Agency and other States which are parties to the EEA Agreement on the proposed measures and the reasons in advance, after which the Agency declares its decision not to initiate an urgent Union procedure upon the notification. However, if the application of Subsection (5) is nevertheless deemed necessary for public health reasons as temporary measures, the government body for pharmaceuticals may convey the information mentioned in this Subsection on the next working day after the day when the action was carried out. This Subsection shall not apply if the action was carried out pursuant to Paragraph h) of Subsection (5) or to Subsection (8).

(8) Furthermore, the government body for pharmaceuticals may suspend, revoke or refuse renewal of a marketing authorization based on a unanimous decision adopted by the coordination group of the European Medicines Agency, or based on the European Commission’s decision, or may encourage the marketing authorization holder to apply for the amendment of the marketing authorization as appropriate.

(9) Where a medicinal product has been withdrawn from the market in accordance with this Section, and there is no suitable replacement available, the government body for pharmaceuticals may allow - during a transitional period - the supply of the medicinal product to patients who are already being treated with the medicinal product.

Section 18/A.

(1) The government body for pharmaceuticals shall operate a pharmacovigilance system to collect information on the risks of medicinal products as regards patients’ or public health. That information shall in particular refer to adverse reactions in human beings, arising from use of the medicinal product within the terms of the marketing authorization as well as from use outside the terms of the marketing authorization, and to adverse reactions associated with occupational exposure.

(2) The government body for pharmaceuticals shall evaluate all information collected by means of the pharmacovigilance system referred to in Subsection (1) scientifically, consider options for risk minimization and prevention and take regulatory action concerning the marketing authorization as necessary.

(3) The government body for pharmaceuticals shall perform a regular audit of the pharmacovigilance system it operates and report the results to the European Commission on 21 September 2013 at the latest and then every two years thereafter.

(4) In order to improve the efficiency of the pharmacovigilance system, the government body for pharmaceuticals shall:

a) encourage patients and healthcare professionals to report suspected adverse reactions of medicinal products, and for these tasks, professional organizations and non-governmental organizations may be involved as appropriate;

b) facilitate patient reporting of suspected adverse reactions through the provision of alternative reporting formats in addition to web-based formats;

c) take all appropriate measures to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

d) ensure that the public is given important information on pharmacovigilance concerns relating to the use of a medicinal product in a timely manner through publication on the national web-portal and through other means of publicly available information as necessary;

e) ensure, through the methods for collecting information and where necessary through the follow-up of suspected adverse reaction reports, that all appropriate measures are taken to identify clearly any biological medicinal product prescribed, dispensed, or sold in Hungary which is the subject of a suspected adverse reaction report, with due regard to the name of the medicinal product, in accordance with Point 13 of Section 1, and the batch number.

Section 18/B.

The marketing authorization holder shall operate a pharmacovigilance system for the fulfillment of his pharmacovigilance tasks equivalent to the pharmacovigilance system mentioned under Subsection (1) of Section 18/A. The pharmacovigilance tasks related to the pharmacovigilance system are laid down in the relevant legislation.

Section 18/C.

(1) The government body for pharmaceuticals shall set up and maintain a national medicines web-portal which shall be linked to the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

(2) By means of the national medicines web-portal, the following shall be made publicly available:

a) public assessment reports, together with a summary thereof;

b) summaries of product characteristics and package leaflets;

c) summaries of risk management plans for authorized medicinal products;

d) the list of medicinal products referred to in Article 23 of Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency which are subject to additional monitoring;

e) information on the different ways of reporting suspected adverse reactions to medicinal products to national competent authorities by healthcare professionals and patients, including the web-based structured forms referred to in Article 25 of Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

Section 18/D.

(1) If the marketing authorization holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product, he shall be required to inform the government body for pharmaceuticals, the European Commission and the European Medicines Agency concerning the contents of the announcement by way of the means set out in the relevant legislation.

(2) When the government body for pharmaceuticals makes public information on pharmacovigilance concerns, any information of a commercially confidential nature shall be deleted unless its public disclosure is necessary for the protection of public health. Information on pharmacovigilance concerns may contain the personal data of a person affected only if deemed necessary to avert a life-threatening situation and if the purpose of the information cannot be achieved otherwise.

Section 18/E.

Under the conditions set out in the relevant legislation marketing authorization holders are required to submit periodic safety update reports.

Section 19.

The government body for pharmaceuticals shall routinely inspect the laboratories contracted for testing the safe use of medicinal products as well as medical service providers conducting clinical trials for the purpose of checking their compliance with the professional requirements laid down in specific other legislation

Section 20.

(1) The government body for pharmaceuticals shall have authority to supervise the obligations conferred under this Act or other legislation adopted by authorization of this Act relating to the manufacture, distribution, placing on the market of medicinal products, active substances and excipients, to pharmacovigilance, brokering of medicinal products, as well as the public service obligation for the supply of medicinal products, furthermore, to the clinical trial of investigational products and the activities of laboratories contracted for testing medicinal products for reasons of safety. In connection with pharmacies, other healthcare service provider and retail suppliers, supervisory authority shall be conferred upon the government body in charge of the healthcare system as well. The regulations concerning the promotion of medicinal products and for the enforcement of the provisions relating to business-to-consumer commercial practices shall be laid down in the Act on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products, including the provisions for any infringement of these provisions.

(1a) As regards inspections carried out in Hungary and in third countries, the government body for pharmaceuticals shall take into account the guidance published by the European Commission and shall cooperate with the European Medicines Agency, within the framework of which it shall share information with the European Medicines Agency relating to proposed inspections and the findings of inspections completed.

(2) In the control proceedings the government body for pharmaceuticals shall establish the facts, and shall take the measures consistent with the nature and severity of any discrepancies and irregularities, and shall monitor their implementation.

(3) Where the government body for pharmaceuticals finds that the authorized natural or legal person is in non-compliance with the conditions and requirements set out in this Act or any other legislation adopted by authorization of this Act, or is in breach of the obligations conferred upon it, the government body for pharmaceuticals may:

a) order the state of infringement to be terminated; or

b) prohibit continuation of the illegal conduct; or

c) order or initiate the medicinal product or the production batch that is deemed harmful to life, health or physical safety to be removed from the market; or

d) order the person affected to eliminate the discrepancies within the prescribed deadline, or suspend his authorization until the said discrepancies are eliminated; or

e) in the case of repeat offenders, or in connection with any severe infringement constituting a public health emergency, revoke the authorization or such offenders or shall remove them from the register where the activities are subject to notification.

(4) The government body for pharmaceuticals and the government body in charge of the healthcare system shall have powers to impose penalties upon the person having committed the infringement. In the case of multiple violations the amount of fines imposed may be cumulative. In those proceedings the provisions of Act XXXIV of 2004 on Small and Medium-sized Enterprises and the Support Provided to Such Enterprises shall not apply.

(5) The amount of the fine imposed for any violation of the public service obligation conferred in this Act concerning the supply of medicinal products shall be determined having regard to the scope and gravity of the injury caused to patients, the duration of the illegal conduct, including repeat offenses where applicable, as well as the material circumstances weighing on the gravity of the infringement. The fine shall be between one hundred thousand and five hundred million forints.

(6) As regards the implementation of Subsection (2) of Section 18, additional obligations of healthcare professionals are laid down in the relevant legislation.

(7) The above-specified fines shall be payable to the account of the imposing government body for pharmaceuticals or the government body in charge of the healthcare system.

(8) Other aspects in connection with the control of persons engaged in the supply of medicinal products to the public are governed in specific other legislation.

(9) The final resolution of the government body for pharmaceuticals adopted under Subsections (3) and (4):

a) imposing a fine in excess of one million forints, or

b) imposing a fine of less than one million forints in the case of repeat infringement,

shall be published with the contents specified in Subsection (10).

(10) The documents published as specified above shall indicate:

a) the date of publication;

b) the name of the competent authority;

c) the case number and the subject matter of the case;

d) the name of the infringer;

e) a summary statement of the relevant facts of the case;

f) the statutory provisions infringed upon;

g) the operative part of the decision; and

h) an indication if the decision has been appealed.

(11) Upon being apprised of the decision of an authority or a court ruling delivered in the redress procedure for overturning a decision, the government body for pharmaceuticals shall - immediately upon receipt of the authority’s decision or court ruling - publish, using the same means:

a) the information under Subsection (10) relating to the decision to which the appeal pertains;

b) the decision of an authority or a court ruling adopted in the remedy proceedings, including a brief explanation; and

c) the date of publication.

Liability for Damages in Connection with Investigational Medicinal Products or the Administration of Medicinal Products and Liability for Violations of Rights Relating to Personality

Section 21.

(1) If, during the clinical trial of an investigational medicinal product, or as a consequence thereof, a natural person suffers health impairment, the injured person, or in the event of death, his/her family member provided for in the Civil Code, shall be paid restitution by:

a) the sponsor of the trial carried out in accordance with an investigation program approved by the authority which has authorized the clinical trials;

b) the sponsor of the trial if the death, disability or severe health impairment occurred in consequence of the sponsor withholding any information of knowledge from the authority which has authorized the clinical trials;

c) the authority which has authorized the clinical trials, if the death, disability or severe health impairment occurs in consequence of the specifications issued by such authority;

d) the institution carrying out the clinical trials in the event of any deviation from the investigation program approved by the authority which has authorized the clinical trials, and the health impairment occurs in consequence thereof;

or shall be compensated for damages linked to death, disability or severe health impairment.

(2) In respect of liability stemming from the application of medicinal products:

a) for restitution payable in connection with death, disability or severe health impairment, and

b) for compensatory damages for loss of property under Paragraph a),

the provisions of the Civil Code on restitution and product liability shall apply subject to the exceptions set out in Subsection (4).

(3) Where death, disability or severe health impairment results from the proper application of a medicinal product, and in the case of damage caused by defective products as provided for in the Civil Code, Subsection (2) of Section 2:52 and Section 6:555 of Act V of 2013 of the Civil Code shall apply.

(4) Where a medicinal product was used in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation in possession of authorization by the government body for pharmaceuticals granted according to Section 6 or Subsection (2) of Section 7, the State shall compensate such injured party or the person who suffered loss, or in the case of death, his/her dependent relative. The provisions of Section 6:564 of the Civil Code shall apply mutatis mutandis to the mode and measure of indemnification.

(5) For the purposes of this Section ‘dependent relative’ shall mean a person supported by the injured party or the person who suffered loss pursuant to statutory provision or contract.

Specific Provisions Relating to Active Substances and Excipients

Sections 22.

(1) The manufacture, import and distribution of active substances shall comply with good manufacturing practice and good distribution practices for active substances, and the manufacture of excipients shall be in compliance with the principle of good manufacturing practice for excipients, in accordance with the Decree on the Personnel and Infrastructure Requirements for the Manufacture of Medicinal Products for Human Use.

(2) The importers, manufacturers and distributors of active substances having a registered office or branch in the territory of Hungary shall notify the data specified in the Decree on the Personnel and Infrastructure Requirements for the Manufacture of Medicinal Products for Human Use to the government body for pharmaceuticals at the latest sixty days before the date of taking up the pursuit of their activities.

(3) Where this is deemed necessary by the government body for pharmaceuticals on account of the risks related to a given active substance, it shall inform the applicant within fifteen days of receipt of the notification that an inspection will be carried out, the activity shall not begin before the government body for pharmaceuticals has notified the applicant that he may commence the activity.

(4) If within the time limit specified in Subsection (3) hereof the government body for pharmaceuticals has not notified the applicant that an inspection will be carried out, or has notified the applicant after the inspection that he may commence the activity, it shall enter the information provided in accordance with Subsection (2) of this Section in the Union database managed by the European Medicines Agency. If the government body for pharmaceuticals carried out an inspection under this Section, it shall decide within sixty days after the notice of inspection whether or not to authorize the commencement of the activity referred to in Subsection (1) hereof.

Brokering of Medicinal Products

Section 23.

(1) Persons brokering medicinal products shall have a permanent address in the EEA, and shall be registered by the competent authorities of the State where the permanent address is located.

(2) The detailed regulations concerning the registration of brokers of medicinal products and relating to brokering shall be laid down in specific other legislation.

Patients' Rights in Connection with the Use of Medicinal Products

Section 24.

(1) In respect of patients' rights related to medicinal products the provisions of the Health Care Act pertaining to patients' rights shall be applied with the additions set forth in Subsection (2).

(2) When dispensing any medicinal product that is not subject to medical prescription at the users (patients) request (hereinafter referred to as "self-medication") pharmacists shall be required to provide prudent information concerning:

a) the therapeutic value and any potential side effects of such product;

b) interaction with other medicaments when taking more than one at the same time;

c) the need for medical attention or assistance if deemed appropriate in his judgement based upon the health of the user (patient);

d) any available substitutes and the price of the medicinal product.

General Provisions Relating to the Use of Medicinal Products

Section 25.

(1) Medicinal products may be prescribed in accordance with Section 129 of Act CLIV of 1997 on Health Care - with the exceptions set out in this Act and in the decree implementing it - in accordance with the indications referred to in the summary of product characteristics as approved in the marketing authorization, or in the Catalogue of Standard Prescriptions where applicable. Medicinal products may be prescribed by any doctor or dentist (hereinafter referred to collectively as “doctor”) who is qualified to engage in activities subject to a doctor’s diploma and who has an official stamp for authorization as laid out in specific other legislation, to prescribe medicinal products.

(2) Any medicinal product that has been authorized for marketing in a country other than in the States which are parties to the EEA Agreement may be used for a medicinal purpose in exceptional cases if justified by patient care interests deserving special consideration, and if it has been authorized by the government body for pharmaceuticals in accordance with the requirements set out in specific other legislation. Any medicinal product that has been authorized for marketing in any of the States which are parties to the EEA Agreement may be used for a medicinal purpose if it has been notified to the government body for pharmaceuticals in accordance with the provisions of specific other legislation. Patient care interests deserving special consideration shall be determined in terms of safety and efficacy of the therapeutic procedure following consultation with the competent advisory board.

(3) The detailed regulations on the prescription of medicinal products by doctors are laid down in specific other legislation.

(4) Donations of medicinal products may be exported, or may be imported into and used in the territory of Hungary under the following conditions:

a) with respect to any medicinal product that has been authorized for marketing in a country other than in the States which are parties to the EEA-Agreement, exportation and importation must be authorized by the government body for pharmaceuticals;

b) with respect to any medicinal product that has been authorized for marketing in any of the States which are parties to the EEA-Agreement, exportation and importation must be notified to the government body for pharmaceuticals.

(5) Where any defect in quality is suspected the government body for pharmaceuticals may proceed to ban the use of the medicinal product in Hungary within three days, or shall notify the competent authority of the country to which the medicinal product was exported.

(6) Medicinal product may be prescribed and used otherwise than for the authorized indications contained in the summary of product characteristics (hereinafter referred to as “prescription for an unauthorized indication”), only if:

a) treatment of a patient with another authorized medicinal product is not possible or unsuccessful according to the summary of product characteristics, and based on the experimental evidence defined in specific other legislation, administering the medicinal product for an unauthorized indication offers the potential of successful treatment, or to improve or stabilize the patient’s condition;

b) the medicinal product in question is authorized for distribution in the Republic of Hungary or in another country; and

c) the doctor specializing in the specific therapeutic area has requested individual authorization from the government body for pharmaceuticals for using the medicinal product for an unauthorized indication for the specific patient under the relevant conditions set out in specific other legislation, and the government body for pharmaceuticals has granted such authorization.

(6a) In addition to what is contained in Subsection (6), a medicinal product may be prescribed and/or used for an unauthorized indication if:

a) access to a medicinal product with marketing authorization for a specific indication is inhibited to an extent where it would likely to delay the treatment prescribed for the patient, hence causing disproportionately great risk of irreversible health impairment, or

b) the risk/benefit balance of the medicinal product prescribed for an unauthorized indication is better than that of the medicinal product with marketing authorization for a specific indication,

and based on the experimental evidence defined in the relevant legislation, administering the medicinal product for an unauthorized indication offers the potential of successful treatment, and/or to improve or stabilize the patient’s condition, and the conditions set out in Paragraphs b)-c) of Subsection (6) are satisfied.

(7) If the summary of product characteristics of the marketing authorization of a medicinal product contains contra-indications, it may not be prescribed for an unauthorized indication.

(8) The government body for pharmaceuticals shall adopt a decision for the issue of an authorization under Subsections (6)-(6a) within twenty-one days following the date of receipt of the application - or immediately, in any event within not more than three days in urgent case - following consultation with the competent trade organization if necessary.

(9) The regulations for prescriptions of medicinal products for unauthorized indications in cases of emergency are laid down in specific other legislation.

(10) The doctor shall provide a copy of the authorization referred to in Subsection (8) to the patient before starting to apply the medication, and the patient shall verify receipt by his/her signature. The doctor shall attach this certificate of receipt to the patient’s medical file.

(11) The government body for pharmaceuticals shall keep records of the medicinal products prescribed under Subsections (6)-(6a) with a view to monitor the patient’s condition and the efficacy of the medicinal product, where these records are to contain the doctor’s name and the serial number of his seal, the patient’s name, date of birth and TAJ number, the name of the medicinal product, the active substance, strength, pharmaceutical form and packaging, and a description of the indication for which the doctor wishes to prescribe the medicinal product in question, including the proposed dosage and duration of treatment.

(12) The detailed regulations concerning the applications mentioned in Subsections (6)-(6a), the authorizations referred to in Subsection (8) and the information to be provided to patients under Subsection (10) are laid down in specific other legislation.

Section 25/A.

Section 25/A.

The government body for pharmaceuticals shall authorize the manufacture of any advanced therapy (novel) medicinal product that does not have the marketing authorization under Point 29 of Section 1, which is prepared on a non-routine basis according to specific quality standards, and used in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient [hereinafter referred to as “custom-made advanced therapy (novel) medicinal product prepared in a hospital”].

Fees Charged for Authorization Procedures Relating to Medicinal Products

Section 25/B.

(1) Authorization and modification procedures and other proceedings - shown in Schedule No. 1 - relating to the manufacturing, placing on the market and distribution of medicinal products for human use, the continuation of the marketing authorization, the wholesale distribution of medicinal products, the reclassification of therapeutic substances and preparations which are not classified as medicinal products, parallel imports, clinical trial of investigational medicinal products, the application of principles of good laboratory practice shall be subject - with the exception set out in Subsection (2) - to an administrative service fee (hereinafter referred to as “fee”) as specified in Schedule No. 1, payable by the person requesting the opening of the proceedings or by the applicant of the authorization, or an annual renewal fee for the continuation of the marketing authorization as specified in Schedule No. 1.

(2) Proceedings for the authorization of non-commercial clinical trials - described in the relevant government decree - are free of charge.

(2a) The administrative service fee and renewal fee referred to in Subsections (1) and (5) need not be paid in the case of proceedings related to medicinal products having preferential status under the Medicine Act.

(2b) In the case provided for in Subsection (1c) of Section 21 of the Medicine Act, the marketing authorization holder is required to pay the administrative service fee and renewal fee referred to in Subsections (1) and (5).

(3) The fee charged for the procedures listed in Points I, II and III/A-G of Schedule No. 1 shall be paid separately for each clinical trial and each medicinal product.

(4) The fees shown in Schedule No. 1 shall be determined in consideration of the following:

a) where a homeopathic medicine contains - apart from the homeopathic component - other non-homeopathic (allopathic) components as well, the marketing authorization fees relating to allopathic preparations shall be applied;

b) where a medicinal product is placed in the market as a homeopathic product, that is made by such process and claiming to have therapeutic efficacy, it shall be treated as a non-homeopathic medicine for reasons of assessment of the fee.

(5) In the event of any changes in the particulars contained in the authorizations referred to in Subsection (1), or in the particulars of the marketing authorizations of specific medicinal products, each and every request for modification, independent from any other such request shall be subject to procedural fees separately for each pharmaceutical form or strength, regardless of whether the application is submitted individually or together with other requests pertaining to more than one medicinal product. As regards the modification of the authorization of a clinical trial, each and every request - described by law - lodged independently for modification as to content shall be subject to procedural fees separately, regardless of whether the application is submitted individually or together with other requests pertaining to more than one clinical trial.

(6) The fee shall be paid at the time the application is submitted, whereas the annual renewal fee shall be paid by 31 January of the given year to the government body for pharmaceuticals in the manner decreed by the minister in charge of the healthcare system.

(7) With the exceptions set out in other legislation, the proceeds from the fees shall constitute revenue for the government body for pharmaceuticals, and the special authorities participating in the proceedings as required by law. The records and accounting of such fees shall fall within the scope of the legislation governing the bookkeeping obligations of the central budget. The government body for pharmaceuticals and the special authorities shall be entitled to a part of the revenues from fees in the percentage decreed by the minister in charge of the healthcare system.

(8) As regards the procedures for which the fees are charged, and the persons liable for the payment of such fees, Subsections (2)-(3) of Section 28 of Act XCIII of 1990 on Duties (hereinafter referred to as “Duties Act”) and the first sentence of Subsection (1) of Section 31 of the Duties Act shall apply, respectively, with the exception that any reference made in the Duties Act to duties shall be understood as fees.

Miscellaneous Provisions

Section 26.

(1) Manufacturers and wholesalers of medicinal products and the operators of pharmacies shall provide for proper destruction of medicinal products which are no longer marketable (inadequate quality, expired) in compliance with the provisions set forth in legal regulations governing environmental protection, and shall partake - in compliance with the provisions of specific other legislation - in the collection and disposal of medicinal waste products from the general public. The destruction of medicinal products classified as narcotic or psychotropic substances shall be governed in specific other legislation.

(2) The provisions for the destruction of medicinal products and the procedures to be followed, the special safety regulations to be applied for medicinal products classified as narcotic or psychotropic substances, and the control and enforcement of environmental protection requirements shall be decreed by the minister in charge of the healthcare system.

(3) The government body for pharmaceuticals shall maintain an official register of the medicinal products authorized for placing on the market and distribution in Hungary.

(4) The manufacturer's (importer's) prices and retail prices, and the amount of support of medicinal products authorized for distribution in Hungary with public financing shall be published according to the provisions laid down in specific other legislation.

(5) The health insurance administration agency and government body for pharmaceuticals shall post all information that has been published in their official journals concerning the placing on the market and prescription of medicinal products and the amount of social security subsidies provided for the various products, on their official websites as well.

(6) The decisions of the government body for pharmaceuticals adopted in accordance with this Act, or relating to the registration and placing on the market of therapeutic substances and preparations not classified as medicinal products may not be appealed; however.

(7) The government body for pharmaceuticals shall maintain an official public register on all therapeutic preparations which are not classified as medicinal products that have been authorized for marketing in Hungary, containing their name and the date of authorization.

(8) Decisions adopted in authorization and supervisory proceedings under this Act or under the legislation adopted by authorization of this Act shall be enforceable irrespective of any petition for the suspension of enforcement.

Sections 27

Electronic communication as referred to in Section 28/B of the APA shall be carried out - with the exceptions set out in Subsections (1)-(6a) of Section 25 of this Act and in Subsections (2)-(3) of Section 3 of the legislation on the pursuit of the business of wholesale distribution of medicinal products in conjunction with the importation of medicinal products - via the IT systems of the government body for pharmaceuticals and the government body in charge of the healthcare system in connection with the regulatory proceedings of the government body for pharmaceuticals and the government body in charge of the healthcare system concerning medicinal products, investigational products and products registered as therapeutic substances and preparations which are not classified as medicinal products, and concerning laboratories and individual test sites operating in conformity with the principles of good laboratory practice.

Section 28-29.

Section 30.

Section 31.

Closing Provisions

Section 32.

(1) This Act shall enter into force on 30 October 2005.

(2)

(3) Subsection (2) of Section 4 shall apply to the authorization proceedings opened subsequent to this entering into force; manufacturers of medicinal products wishing to engage in the wholesale distribution of their own medicinal products shall satisfy the personnel and infrastructure requirements prescribed in specific other legislation for the wholesale distribution of medicinal products by 1 March 2006, of which the government body for pharmaceuticals shall be notified accordingly. After 1 March 2006 manufacturers of medicinal products may only engage in wholesale distribution if having satisfied the above-mentioned obligation notification.

(4) The Government is hereby authorized to decree:

a) the detailed conditions for the manufacture, placing on the market, retail and wholesale distribution of medicinal products classified as narcotic and psychotropic substances, for the importation into and exportation of such medicinal products from the territory of Hungary, furthermore, their purchase and use for scientific purposes, the procedures for issuing the authorization for such activity, the contents of the register - other than personal data - of authorized operators, and the detailed procedural rules for operating the register, furthermore, the sanctions for any infringement of the provisions of the relevant legislation or of the resolutions adopted by the competent authorities;

b) the sphere of application and procurement of medicinal products classified as narcotic or psychotropic within the meaning of international conventions for scientific purposes;

c) the amount of penalty to be imposed for any violation of the public service obligation conferred in this Act for the supply of medicinal products.

d) the designation of the government body or bodies for pharmaceuticals

e) in connection with new psychoactive substances:

ea) the substances and compounds classified as new psychoactive substances,

eb) the detailed regulations for classification as a new psychoactive substance, and for the risk assessment of such new psychoactive substances,

ec) the designation of an expert body to carry out prior scientific evaluations upon notifications,

ed) the detailed conditions for activities with new psychoactive substances, the rules for the submission of applications for the authorization of such activities and for the authorization procedure, and

ee) the sanctions for any infringement of the provisions of the relevant legislation or of the resolutions adopted by the competent authorities.

(5) The minister in charge of the healthcare system is hereby authorized to decree:

a) the detailed regulations for the issue of marketing authorization for medicinal products, the requirements for authorization, the procedure for the removal of medicinal products from circulation, and for the suspension of distribution rights;

b) the various types of the medicinal products falling within the scope of this Act;

c) the detailed regulations relating to the application of the principles of good laboratory practice, and for the operation and supervision of laboratories contracted for testing medicinal products for reasons of safety;

d) the conditions for conducting clinical trials, the documents required for the authorization of clinical trials, the detailed regulations for the authorization procedure, the proceedings of the research ethics committee, and the professional requirements for the conduct and control of clinical trials;

e) the conditions for the change of classification of therapeutic substances and preparations which are not classified as medicinal products to be classified as such;

f) the detailed regulations for engaging in the wholesale distribution of medicinal products in conjunction with the importation of medicinal products;

g) the regulations for the prescription of medicinal products by doctors for unauthorized indications in cases of emergency, and for any shortage in supplies of medicinal products;

h) the rules for the institutional supply of medicinal products;

i) the qualification requirements for the authorized persons participating in the manufacture of medicinal products and the persons contracted to participate in activities for the wholesale distribution of medicinal products;

j) the procedures for prescription of medicinal products classified as narcotic and psychotropic substances, their sale in pharmacies - including storage, records, and their dispensation from pharmacies -, and for the use of these products in medical institutions and the records on such usage;

k) the personnel and infrastructure requirements for the manufacture of medicinal products for human use;

l) the sphere of diagnostic agents which are not used in or on the human body;

m) the mandatory use of the Pharmacopoeia and the Catalogue of Prescriptions for manufacturers and distributors of medicinal products and for doctors and pharmacists;

n) the regulations relating to the labelling and package leaflets of medicinal products;

o) the form and professional requirements for dispensing medicinal products in pharmacies, and the regulations on consultation by pharmacists;

p) the regulations for the destruction of medicinal products and the procedures to be followed, the special safety regulations to be applied for medicinal products classified as narcotic or psychotropic substances, and the control and enforcement of environmental protection requirements.

q) the regulations relating to custom-made advanced therapy medicinal products prepared in hospitals.

r) the formal and content requirements for a doctor’s certificate - prescribed according to international convention - on medicinal products classified as narcotic or a psychotropic substance required for the movement of travelers through customs carrying such medicinal products that are necessary for their medical treatment.

s) the inventories required to be maintained, including the active substances, with a view to ensuring the continued supplies under Subsection (5) of Section 16;

t) the provisions relating to pharmacovigilance;

u) the rules governing cooperation between the marketing authorization holder, wholesalers of medicinal products, the administrator of state healthcare, catastrophe and safety reserves, the government body for pharmaceuticals and the health insurance administration agency in the interest of control and prevention of any shortage in the supplies of specific medicinal products.

v) the provisions on the brokering of medicinal products;

w) the rules concerning good manufacturing practice and good distribution practices for active substances, and the rules concerning good manufacturing practice for excipients.

(6) The minister in charge of the healthcare system is hereby authorized to decree, in agreement with the minister in charge of taxation, the types of administrative service fees, including their amounts and other regulations relating to payment terms and conditions, payable:

a) for proceedings relating to the authorization of narcotic and psychotropic substances, and for the issue and amendment of such authorizations;

b) for the authorization procedures relating to new psychoactive substances, and for the issue and amendment of authorizations;

c)

d) for proceedings relating to certification of the conditions for the manufacture of products registered as therapeutic substances and preparations which are not classified as medicinal products for public health and epidemiological considerations, and for the issue of the certificate;

e) for the examination (certification) of a production batch of immunological products.

(7) Manufacturers and/or distributors of products registered as therapeutic substances and preparations which are not classified as medicinal products pursuant to the decree on the registration and marketing of therapeutic substances and preparations not classified as medicinal products may apply for having their preparations - containing any ingredient of plant origin - reclassified as medicinal or other products until 31 March 2011. Following the entry of this Act into force no proceedings may be launched for the registration and marketing of any new therapeutic preparations which are not classified as medicinal products.

(8) The conditions for the reclassification of the products under Subsection (7) as medicinal products shall be established by specific other legislation.

(9) Products registered as therapeutic substances and preparations which are not classified as medicinal products, which may be considered traditional herbal medicinal products on account of all their specificities and are available in commercial circulation on 31 March 2011, may be marketed with reference to having medicinal properties until their expiry date, or until 1 April 2013 at the latest.

(10) The minister in charge of the healthcare system is hereby authorized to decree, in agreement with the minister in charge of taxation, the regulations relating to the management, registration and distribution of the fees referred to in Section 25/B.

Section 32/A.

Subsection (7) of Section 5, as established by Act CLXXVI of 2011 on the Amendment of Health Regulations, shall apply to applications submitted after 21 July 2012.

Section 32/B.

The importers, manufacturers and distributors of active substances having a registered office or branch in the territory of Hungary, and the brokers of medicinal products who pursued their activities before 2 January 2013 shall submit the notification referred to in Subsection (2) of Section 22, or Subsection (1) of Section 23, as established by Act CCXII of 2012 on the Amendment of Health Regulations, by 2 March 2013.

Section 33.

(1) This Act contains regulations that may be approximated with the following legal regulations of the European Communities together with the ministerial decrees adopted for the implementation of this Act by authorization conferred under Subsection (5) of Section 32:

a) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;

b) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use;

c) Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use;

d) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances;

e) Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.

f) Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorization of the manufacturing or importation of such products.

g) Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorizations for medicinal products.

h) Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use.

i) Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.

j) Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance.

(2) This Act contains regulations for the implementation of the following legislation of the Communities:

a) Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

b) Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for pediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004;

c) Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004.

d) Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products.

Schedule No. 1 to Act XCV of 2005

Amount

I Non-homeopathic (allopathic) preparations

I.A. All allopathic preparations, except allergens

I.A.1. New marketing authorization

I.A.1.1. National procedure

I.A.1.1.a. Original, or original product line extension 1 350 000

I.A.1.1.b. Generic, or generic product line extension 675 000

I.A.1.1.c. Other, or other product line extension 675 000

I.A.1.2. Mutual recognition procedure

I.A.1.2.a. Original, or original product line extension

I.A.1.2.a.1. RMS 3 150 000

I.A.1.2.a.2. CMS 2 250 000

I.A.1.2.b. Generic, or generic product line extension

I.A.1.2.b.1. RMS 1 575 000

I.A.1.2.b.2. CMS 1 175 000

I.A.1.2.c. Other, or other product line extension

I.A.1.2.c.1. RMS 1 575 000

I.A.1.2.c.2. CMS 1 175 000

I.A.2. Modification of marketing authorization

I.A.2.1. National

I.A.2.1.a. Type IA-IB 180 000

I.A.2.1.b. Type II 270 000

I.A.2.2. Mutual recognition procedure

I.A.2.2.a. Type IA-IB

I.A.2.2.a.1. RMS 250 000

I.A.2.2.a.2. CMS 180 000

I.A.2.2.b. Type II

I.A.2.2.b.1. RMS 350 000

I.A.2.2.b.2. CMS 270 000

I.A.2.3. Changes not effecting the summary of product characteristics, pertaining only to the labeling and the package leaflet [Act XCV of 2005, Subsection (2) of Section 10] 20 000

I.A.2.3.a Submissions lodged under Subsection (4) of Section 3 of Decree No. 30/2005 (VIII. 2.) EM on the Labels and Package Leaflets of Medicinal Products for Human Use 100 000

I.A.2.3.b Other submissions 20 000

I.A.2.4. Transfer of marketing authorization (succession) 180 000

I.A.2.5. In the Hungarian marketing authorization, addition or removal of packaging units that have already been authorized under the mutual recognition procedure 100 000

I.A.2.6. Switching to the global identification system 100 000

I.A.2.7. Change in the classification of the product 270 000

I.A.3. Renewal of marketing authorization

I.A.3.1. National

I.A.3.1.a. Original 675 000

I.A.3.1.b. Generic 325 000

I.A.3.1.c. Other 325 000

I.A.3.2. Mutual recognition procedure

I.A.3.2.a. Original

I.A.3.2.a.1. RMS 1 575 000

I.A.3.2.a.2. CMS 1 125 000

I.A.3.2.b. Generic

I.A.3.2.b.1. RMS 775 000

I.A.3.2.b.2. CMS 550 000

I.A.3.2.c. Other

I.A.3.2.c.1. RMS 775 000

I.A.3.2.c.2. CMS 550 000

I.A.4. Withdrawal of marketing authorization 67 500

I.A.5. Annual maintenance of marketing authorization 180 000

I.B Allergens

I.B.1. New marketing authorization

I.B.1.1. National

I.B.1.1.a. Starting materials (mono-component) 45 000

I.B.1.1.b. Mixed allergens (multi-component) 315 000

I.B.1.1.c. Other 315 000

I.B.1.2. Mutual recognition procedure

I.B.1.2.a. Starting materials (mono-component)

I.B.1.2.a.1. RMS 245 000

I.B.1.2.a.2. CMS 90 000

I.B.1.2.b. Mixed allergens (multi-component)

I.B.1.2.b.1. RMS 1 215 000

I.B.1.2.b.2. CMS 565 000

I.B.1.2.c. Other

I.B.1.2.c.1. RMS 1 215 000

I.B.1.2.c.2. CMS 565 000

I.B.2. Modification of marketing authorization

I.B.2.1. National

I.B.2.1.a. Type IA-IB

I.B.2.1.a.1. Starting materials (mono-component) 9 000

I.B.2.1.a.2. Mixed allergens (multi-component) 45 000

I.B.2.1.a.3. Other 45 000

I.B.2.1.b. Type II

I.B.2.1.b.1. Starting materials (mono-component) 20 000

I.B.2.1.b.2. Mixed allergens (multi-component) 100 000

I.B.2.1.b.3. Other 100 000

I.B.2.2. Mutual recognition procedure

I.B.2.2.a. Type IA-IB

I.B.2.2.a.1. RMS

I.B.2.2.a.1.1. Starting materials (mono-component) 9 000

I.B.2.2.a.1.2. Mixed allergens (multi-component) 45 000

I.B.2.2.a.1.3. Other 45 000

I.B.2.2.a.2. CMS

I.B.2.2.a.2.1. Starting materials (mono-component) 9 000

I.B.2.2.a.2.2. Mixed allergens (multi-component) 45 000

I.B.2.2.a.2.3. Other 45 000

I.B.2.2.b. Type II

I.B.2.2.b.1. RMS

I.B.2.2.b.1.1. Starting materials (mono-component) 30 000

I.B.2.2.b.1.2. Mixed allergens (multi-component) 200 000

I.B.2.2.b.1.3. Other 200 000

I.B.2.2.b.2. CMS

I.B.2.2.b.2.1. Starting materials (mono-component) 20 000

I.B.2.2.b.2.2. Mixed allergens (multi-component) 100 000

I.B.2.2.b.2.3. Other 100 000

I.B.2.3. Changes not effecting the summary of product characteristics, pertaining only to the labeling and the package leaflet [Act XCV of 2005, Subsection (2) of Section 10] 20 000

I.B.2.3.a Submissions lodged under Subsection (4) of Section 3 of Decree No. 30/2005 (VIII. 2.) EM on the Labels and Package Leaflets of Medicinal Products for Human Use 100 000

I.B.2.3.b Other submissions 20 000

I.B.2.4. Transfer of marketing authorization (succession) 180 000

I.B.2.5. In the Hungarian marketing authorization, addition or removal of packaging units that have already been authorized under the mutual recognition procedure 100 000

I.B.2.6. Switching to the global identification system 100 000

I.B.2.7. Change in the classification of the product 270 000

I.B.3. Renewal of marketing authorization

I.B.3.1. National

I.B.3.1.a. Starting materials (mono-component) 45 000

I.B.3.1.b. Mixed allergens (multi-component) 180 000

I.B.3.1.c. Other 180 000

I.B.3.2. Mutual recognition procedure

I.B.3.2.a. RMS

I.B.3.2.a.1. Starting materials (mono-component) 145 000

I.B.3.2.a.2. Mixed allergens (multi-component) 765 000

I.B.3.2.a.3. Other 765 000

I.B.3.2.b. CMS

I.B.3.2.b.1. Starting materials (mono-component) 90 000

I.B.3.2.b.2. Mixed allergens (multi-component) 615 000

I.B.3.2.b.3. Other 615 000

I.B.4. Withdrawal of marketing authorization 9 000

I.B.5. Annual maintenance of marketing authorization

I.B.5.1. Starting materials (mono-component) 9 000

I.B.5.2. Mixed allergens (multi-component) 45 000

I.B.5.3. Other 45 000

II Homeopathic preparations

II.A. New authorizations

II.A.1. Mono-component medicinal product

II.A.1.1. If the active constituent indicated appears in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 67 500

II.A.1.2. If the active constituent indicated does not appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 270 000

II.A.2. Multi-component medicinal product

II.A.2.1. If the active constituent indicated is the combination of active substances which appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 135 000

II.A.2.2. If the active constituent indicated (also) contains active substances which does not appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 540 000

II.A.3. Other 540 000

II.B. Modification of marketing authorization

II.B.1. Type IA-IB

II.B.1.1. Mono-component medicinal product

II.B.1.1.a. If the active constituent indicated appears in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 9 000

II.B.1.1.b. If the active constituent indicated does not appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 9 000

II.B.1.2. Multi-component medicinal product

II.B.1.2.a. If the active constituent indicated is the combination of active substances which appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 90 000

II.B.1.2.b. If the active constituent indicated (also) contains active substances which does not appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 90 000

II.B.1.3. Other 90 000

II.B.2. Type II

II.B.2.1. Mono-component medicinal product

II.B.2.1.a. If the active constituent indicated appears in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 18 000

II.B.2.1.b. If the active constituent indicated does not appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 18 000

II.B.2.2. Multi-component medicinal product

II.B.2.2.a. If the active constituent indicated is the combination of active substances which appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 180 000

II.B.2.2.b. If the active constituent indicated (also) contains active substances which does not appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 180 000

II.B.2.3. Other 180 000

II.B.2.3.a. Submissions lodged under Subsection (4) of Section 3 of Decree No. 30/2005 (VIII. 2.) EM 100 000

II.B.2.3.b. Other submissions 20 000

II.B.3. Changes not effecting the summary of product characteristics, pertaining only to the labeling and the package leaflet [Act XCV of 2005, Subsection (2) of Section 10] 20 000

II.B.4. Transfer of marketing authorization (succession) 180 000

II.B.5. In the Hungarian marketing authorization, addition or removal of packaging units that have already been authorized under the mutual recognition procedure 100 000

II.B.6. Switching to the global identification system 100 000

II.B.7. Change in the classification of the product 270 000

II.C. Renewal of marketing authorization

II.C.1. Mono-component medicinal product

II.C.1.1. If the active constituent indicated appears in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 45 000

II.C.1.2. If the active constituent indicated does not appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 180 000

II.C.2. Multi-component medicinal product

II.C.2.1. If the active constituent indicated is the combination of active substances which appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 90 000

II.C.2.2. If the active constituent indicated (also) contains active substances which does not appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States 350 000

II.C.3. Other 350 000

II.D. Annual maintenance of marketing authorization

II.D.1. Mono-component medicinal product 9 000

II.D.2. Multi-component medicinal product 45 000

II.E. Withdrawal of marketing authorization 27 000

III Other procedures

III.A. New parallel import authorization 500 000

III.B. Modification of parallel import authorization 180 000

III.B.1. Type IA-IB 180 000

III.B.2. Type II 270 000

III.C. Renewal of parallel import authorization for five more years 250 000

III.D. Maintenance of parallel import authorization 180 000

III.E. Extension of the shelf life of a production batch 27 000

III.F. Authorization of deviation from the marketing authorization for certain production batches 27 000

III.G. Clinical trials on investigational medicinal products, other than the non-commercial trials referred to in Paragraph q) of Subsection (1) of Section 2 of Decree No. 35/2005 (VIII. 26.) EM on the Clinical Trial of Investigational Medicinal Products for Human Use and on the Implementation of Good Clinical Practice

III.G.1. Authorization 580,000

III.G.2. Modification of authorization for clinical trial 110,000

III.H. Authorization for the manufacture of medicinal products

III.H.1. On-site inspection (each facility) 450 000

III.H.2. New authorization for the manufacture of medicinal products 225 000

III.H.3. Modification of authorization for the manufacture of medicinal products 90 000

III.I. Authorization for the wholesale distribution of medicinal products

III.I.1. On-site inspection (each facility) 360 000

III.I.2 New authorization for the wholesale distribution of medicinal products 90 000

III.I.3. Modification of authorization for the wholesale distribution of medicinal products 90 000

III.I.4. Registration of the activities of brokers of medicinal products 90,000

III.J. Inspection of laboratories involved in safety testing of investigational medicinal products in accordance with the principles of good laboratory practice, and issue of the related certificate 382 500

III.K. Issue of certificate verifying inspection of the manufacturing and distribution of medicinal products that have been authorized for marketing in Hungary on a regular basis, and the conformity of such medicinal products, separately for each product and certificate 22,500

III.L. Hourly charge for expert services and activities, consultation 8 000

III.M. Reclassification as medicinal products 405 000

III.N. Authorization for genetic modification operations

III.N.1. Authorization for the genetic modification of natural organisms: separately for each genetic modification procedure 70,000

III.N.2. Implementation of facilities engaged in genetic modification operations: separately for each facility 260,000

III.N.3. Contained use of genetically modified organisms and products produced therefrom: separately for each genetic modification operation 135,000

III.N.4. Deliberate release into the environment of genetically modified organisms and products produced therefrom: separately for each genetic modification operation and for each site of release 300,000

III.N.5. Placing on the market of genetically modified organisms and products produced therefrom: separately for each genetic modification operation 250,000

III.N.6. Exportation and importation of genetically modified organisms and products produced therefrom: separately for each application 180,000

III.N.7. Carriage of genetically modified organisms and products produced therefrom: separately for each application 70,000

III.O. Reclassification of a test site to a first grade clinical pharmacological test site 450,000

III.P. Therapeutic substances (preparations) other than pharmaceuticals

III.P.1. Modification of marketing authorization 90,000

III.P.2. Renewal of marketing authorization 90,000

III.Q. Registration of production, import and distribution of active substances of medicinal products

III.Q.1. Registration of production, import and distribution of active substances of medicinal products, for those with prior manufacturing authorization 90,000

III.Q.2. Registration of the production of active substances of medicinal products, for those not registered as such manufacturers before 1 July 2013 675,000

III.Q.3. Registration of importing of active substances of medicinal products, for those not registered as such importers before 1 July 2013 675,000

III.Q.4. Registration of distribution of active substances of medicinal products, for those not registered as such distributors before 1 July 2013 225,000