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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
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EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
TITLE III PLACING ON THE MARKET
CHAPTER 1 Marketing authorization
Article 6.(1) No medicinal product may be placed on the market...
Article 7.A marketing authorization shall not be required for a radiopharmaceutical...
Article 8.(1) In order to obtain an authorization to place a...
Article 9.In addition to the requirements set out in Articles 8...
Article 10.(1) By way of derogation from Article 8(3)(i), and without...
Article 10a.By way of derogation from Article 8(3)(i), and without prejudice...
Article 10b.In the case of medicinal products containing active substances used...
Article 10c.Following the granting of a marketing authorisation, the authorisation holder...
Article 11.The summary of the product characteristics shall contain, in the...
Article 12.(1) The applicant shall ensure that, before the detailed summaries...
CHAPTER 2 Specific provisions applicable to homeopathic medicinal products
Article 13.(1) Member States shall ensure that homeopathic medicinal products manufactured...
Article 14.(1) Only homeopathic medicinal products which satisfy all of the...
Article 15.An application for special, simplified registration may cover a series...
Article 16.(1) Homeopathic medicinal products other than those referred to in...
CHAPTER 2a Specific provisions applicable to traditional herbal medicinal products
Article 16a.(1) A simplified registration procedure (hereinafter ‘ traditional-use registration ’...
Article 16b.(1) The applicant and registration holder shall be established in...
Article 16d.(1) Without prejudice to Article 16h(1), Chapter 4 of Title...
Article 16e.(1) Traditional-use registration shall be refused if the application does...
Article 16f.(1) A list of herbal substances, preparations and combinations thereof...
Article 16g.(1) Article 3(1) and (2), Article 4(4), Article 6(1), Article...
Article 16h.(1) A Committee for Herbal Medicinal Products is hereby established....
Article 16i.Before 30 April 2007, the Commission shall submit a report...
CHAPTER 3 Procedures relevant to the marketing authorization
Article 17.(1) Member States shall take all appropriate measures to ensure...
Article 18.Where a Member State is informed in accordance with Article...
Article 19.In order to examine the application submitted in accordance with...
Article 20.Member States shall take all appropriate measures to ensure that:...
Article 21.(1) When the marketing authorization is issued, the holder shall...
Article 21a.In addition to the provisions laid down in Article 19,...
Article 22.In exceptional circumstances and following consultation with the applicant, the...
Article 22a.(1) After the granting of a marketing authorisation, the national...
Article 22b.(1) In order to determine the situations in which post-authorisation...
Article 22c.(1) The marketing authorisation holder shall incorporate any conditions referred...
Article 23.(1) After a marketing authorisation has been granted, the marketing...
Article 23a.After a marketing authorisation has been granted, the holder of...
Article 23b.(1) The Commission shall adopt appropriate arrangements for the examination...
Article 24.(1) Without prejudice to paragraphs 4 and 5, a marketing...
Article 25.Authorization shall not affect the civil and criminal liability of...
Article 26.(1) The marketing authorisation shall be refused if, after verification...
CHAPTER 4 Mutual recognition procedure and decentralised procedure
CHAPTER 4 Mutual recognition and decentralised procedure
Article 28.(1) With a view to the granting of a marketing...
Article 29.(1) If, within the period laid down in Article 28(4),...
Article 30.(1) If two or more applications submitted in accordance with...
Article 31.(1) The Member States, the Commission, the applicant or the...
Article 32.(1) When reference is made to the procedure laid down...
Article 33.Within 15 days of the receipt of the opinion, the...
Article 34.(1) The Commission shall take a final decision in accordance...
Article 35.(1) Any application by the marketing authorization holder to vary...
Article 37.Articles 35 and 36 shall apply by analogy to medicinal...
Article 38.(1) The Agency shall publish an annual report on the...
Article 39.Article 29(4), (5) and (6) and Articles 30 to 34...
TITLE IV MANUFACTURE AND IMPORTATION
Article 40.(1) Member States shall take all appropriate measures to ensure...
Article 41.In order to obtain the manufacturing authorization, the applicant shall...
Article 42.(1) The competent authority of the Member State shall issue...
Article 43.The Member States shall take all appropriate measures to ensure...
Article 44.If the holder of the manufacturing authorization requests a change...
Article 45.The competent authority of the Member State may require from...
Article 46.The holder of a manufacturing authorization shall at least be...
Article 46a.(1) For the purposes of this Directive, manufacture of active...
Article 47.The principles and guidelines of good manufacturing practices for medicinal...
Article 48.(1) Member States shall take all appropriate measures to ensure...
Article 49.(1) Member States shall ensure that the qualified person referred...
Article 50.(1) A person engaging in the activities of the person...
Article 51.(1) Member States shall take all appropriate measures to ensure...
Article 52.Member States shall ensure that the duties of qualified persons...
Article 53.The provisions of this Title shall also apply to homeopathic...
TITLE V LABELLING AND PACKAGE LEAFLET
Article 54.The following particulars shall appear on the outer packaging of...
Article 55.(1) The particulars laid down in Article 54 shall appear...
Article 56.The particulars referred to in Articles 54, 55 and 62...
Article 56a.The name of the medicinal product, as referred to in...
Article 57.Notwithstanding Article 60, Member States may require the use of...
Article 58.The inclusion in the packaging of all medicinal products of...
Article 59.(1) The package leaflet shall be drawn up in accordance...
Article 60.Member States may not prohibit or impede the placing on...
Article 61.(1) One or more mock-ups of the outer packaging and...
Article 62.The outer packaging and the package leaflet may include symbols...
Article 63.(1) The particulars for labelling listed in Articles 54, 59...
Article 64.Where the provisions of this Title are not complied with,...
Article 65.In consultation with the Member States and the parties concerned,...
Article 66.(1) The outer carton and the container of medicinal products...
Article 67.The competent authority shall ensure that a detailed instruction leaflet...
Article 68.Without prejudice to the provisions of Article 69, homeopathic medicinal...
Article 69.(1) In addition to the clear mention of the words...
TITLE VI CLASSIFICATION OF MEDICINAL PRODUCTS
Article 70.(1) When a marketing authorization is granted, the competent authorities...
Article 71.(1) Medicinal products shall be subject to medical prescription where...
Article 72.Medicinal products not subject to prescription shall be those which...
Article 73.The competent authorities shall draw up a list of the...
Article 74.When new facts are brought to their attention, the competent...
Article 74a.Where a change of classification of a medicinal product has...
Article 75.Each year, Member States shall communicate to the Commission and...
TITLE VII WHOLESALE DISTRIBUTION OF MEDICINAL PRODUCTS
Article 76.(1.) Without prejudice to Article 6, Member States shall take...
Article 77.(1) Member States shall take all appropriate measures to ensure...
Article 78.Member States shall ensure that the time taken for the...
Article 79.In order to obtain the distribution authorization, applicants must fulfil...
Article 80.Holders of the distribution authorization must fulfil the following minimum...
Article 81.With regard to the supply of medicinal products to pharmacists...
Article 82.For all supplies of medicinal products to a person authorized...
Article 83.The provisions of this Title shall not prevent the application...
Article 84.The Commission shall publish guidelines on good distribution practice. To...
Article 85.This Title shall apply to homeopathic medicinal products.
TITLE VIIIa INFORMATION AND ADVERTISING
Article 88a.Within three years of the entry into force of Directive...
Article 89.(1) Without prejudice to Article 88, all advertising to the...
Article 90.The advertising of a medicinal product to the general public...
Article 91.(1) Any advertising of a medicinal product to persons qualified...
Article 92.(1) Any documentation relating to a medicinal product which is...
Article 93.(1) Medical sales representatives shall be given adequate training by...
Article 94.(1) Where medicinal products are being promoted to persons qualified...
Article 95.The provisions of Article 94(1) shall not prevent hospitality being...
Article 96.(1) Free samples shall be provided on an exceptional basis...
Article 97.(1) Member States shall ensure that there are adequate and...
Article 98.(1) The marketing authorization holder shall establish, within his undertaking,...
Article 99.Member States shall take the appropriate measures to ensure that...
Article 100.Advertising of the homeopathic medicinal products referred to in Article...
Article 101.(1) Member States shall operate a pharmacovigilance system for the...
Article 102.The Member States shall: take all appropriate measures to encourage...
Article 103.A Member State may delegate any of the tasks entrusted...
Article 104.(1) The marketing authorisation holder shall operate a pharmacovigilance system...
Article 104a.(1) Without prejudice to paragraphs 2, 3 and 4 of...
Article 105.The management of funds intended for activities connected with pharmacovigilance,...
CHAPTER 3 Recording, reporting and assessment of pharmacovigilance data
Section 1 Recording and reporting of suspected adverse reactions
Section 2 Periodic safety update reports
Article 107b.(1) Marketing authorisation holders shall submit to the Agency periodic...
Article 107c.(1) The frequency with which the periodic safety update reports...
Article 107d.The national competent authorities shall assess periodic safety update reports...
Article 107e.(1) A single assessment of periodic safety update reports shall...
Article 107f.Following the assessment of periodic safety update reports, the national...
Article 107g.(1) In the case of a single assessment of periodic...
CHAPTER 4 Supervision of post-authorisation safety studies
Article 107m.(1) This Chapter applies to non-interventional post-authorisation safety studies which...
Article 107n.(1) Before a study is conducted, the marketing authorisation holder...
Article 107o.After a study has been commenced, any substantial amendments to...
Article 107p.(1) Upon completion of the study, a final study report...
Article 107q.(1) Based on the results of the study and after...
TITLE X SPECIAL PROVISIONS ON MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD AND PLASMA
TITLE XI SUPERVISION AND SANCTIONS
Article 111.(1) The competent authority of the Member State concerned shall,...
Article 112.Member States shall take all appropriate measures to ensure that...
Article 113.For the purpose of implementing Article 112, Member States may...
Article 114.(1) Where it considers it necessary in the interests of...
Article 115.Member States shall take all necessary measures to ensure that...
Article 116.The competent authorities shall suspend, revoke or vary a marketing...
Article 117.(1) Without prejudice to the measures provided for in Article...
Article 118.(1) The competent authority shall suspend or revoke the marketing...
Article 119.The provisions of this Title shall apply to homeopathic medicinal...
Article 120.The Commission shall adopt any changes which are necessary in...
Article 121.(1) The Commission shall be assisted by the Standing Committee...
Article 121a.(1) The power to adopt the delegated acts referred to...
Article 121b.(1) The delegation of powers referred to in Article 22b...
Article 121c.(1) The European Parliament or the Council may object to...
Article 122.(1) Member States shall take all appropriate measures to ensure...
Article 123.(1) Each Member State shall take all the appropriate measures...
Article 124.Member States shall communicate to each other all the information...
Article 125.Every decision referred to in this Directive which is taken...
Article 126.An authorization to market a medicinal product shall not be...
Article 126a.(1) In the absence of a marketing authorisation or of...
Article 126b.In order to guarantee independence and transparency, the Member States...
Article 127.(1) At the request of the manufacturer, the exporter or...
Article 127a.When a medicinal product is to be authorised in accordance...
Article 127b.Member States shall ensure that appropriate collection systems are in...
Introduction and general principles
(1) The particulars and documents accompanying an application for marketing authorisation...
(2) The particulars and documents shall be presented as five modules:...
(3) The European Community-CTD-presentation is applicable for all types of marketing...
(4) In assembling the dossier for application for marketing authorisation, applicants...
(5) With respect to the quality part (chemical, pharmaceutical and biological)...
(6) The manufacturing process shall comply with the requirements of Commission...
(7) All information, which is relevant to the evaluation of the...
(8) All clinical trials, conducted within the European Community, must comply...
(9) Non-clinical (pharmaco-toxicological) studies shall be carried out in conformity with...
(10) Member States shall also ensure that all tests on animals...
(11) In order to monitor the benefit/risk assessment, any new information...
PART I STANDARDISED MARKETING AUTHORISATION DOSSIER REQUIREMENTS
3. MODULE 3: CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL INFORMATION FOR MEDICINAL PRODUCTS...
3.2. Content: basic principles and requirements
(1) The chemical, pharmaceutical and biological data that shall be provided...
(2) Two main sets of information shall be provided, dealing with...
(3) This Module shall in addition supply detailed information on the...
(4) All the procedures and methods used for manufacturing and controlling...
(5) The monographs of the European Pharmacopoeia shall be applicable to...
(6) In case where starting and raw materials, active substance(s) or...
(7) Where the active substance and/or a raw and starting material...
(8) For a well-defined active substance, the active substance manufacturer or...
(9) Specific measures concerning the prevention of the transmission of animal...
(10) For adventitious agents, information assessing the risk with respect to...
(11) Any special apparatus and equipment, which may be used at...
(12) Where applicable and if needed, a CE marking which is...
PART II SPECIFIC MARKETING AUTHORISATION DOSSIERS AND REQUIREMENTS
PART III PARTICULAR MEDICINAL PRODUCTS
PART IV ADVANCED THERAPY MEDICINAL PRODUCTS
3. SPECIFIC REQUIREMENTS REGARDING MODULE 3
3.1. Specific requirements for all advanced therapy medicinal products
3.2. Specific requirements for gene therapy medicinal products
3.2.1. Introduction: finished product, active substance and starting materials
3.2.1.1. Gene therapy medicinal product containing recombinant nucleic acid sequence(s) or...
3.2.1.2. Gene therapy medicinal product containing genetically modified cells
3.2.1.3. In the case of products consisting of viruses or viral...
3.2.1.4. In the case of products consisting of plasmids, non-viral vectors...
3.2.1.5. In the case of genetically modified cells, the starting materials...
3.3. Specific requirements for somatic cell therapy medicinal products and tissue...
3.4. Specific requirements for advanced therapy medicinal products containing devices
5. SPECIFIC REQUIREMENTS REGARDING MODULE 5
5.1. Specific requirements for all advanced therapy medicinal products
5.1.1. The specific requirements in this section of Part IV are...
5.1.2. Where the clinical application of advanced therapy medicinal products requires...
5.1.3. Given that, due to the nature of advanced therapy medicinal...
5.1.4. During clinical development, risks arising from potential infectious agents or...
5.1.5. Dose selection and schedule of use shall be defined by...
5.1.6. The efficacy of the proposed indications shall be supported by...
5.1.7. A strategy for the long-term follow-up of safety and efficacy...
5.1.8. For combined advanced therapy medicinal products, the safety and efficacy...
5.2. Specific requirements for gene therapy medicinal products
5.3. Specific requirements for somatic cell therapy medicinal products
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