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Community Code on Medicinal Products In force since 6 November 2001

Directive 2001/83/EC on the Community code relating to medicinal products for human use
32001L0083 · official text on EUR-Lex

Articles

• Article 1 — For the purposes of this Directive, the following terms shall bear the following meanings:
• Article 2
• Article 3 — This Directive shall not apply to:
• Article 4
• Article 5

Chapter 1 Marketing authorization

• Article 6
• Article 7
• Article 8
• Article 9 — In addition to the requirements set out in Articles 8 and 10(1), an application for authorization to market a radionuclide generator shall also contain the following information and particulars:
• Article 10
• Article 11 — The summary of the product characteristics shall contain the following information:
• Article 12

Chapter 2 Specific provisions applicable to homeopathic medicinal products

• Article 13
• Article 14
• Article 15 — An application for special, simplified registration may cover a series of medicinal products derived from the same homeopathic stock or stocks. The following documents shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned:
• Article 16

Chapter 3 Procedures relevant to the marketing authorization

• Article 17
• Article 18 — Where a Member State is informed in accordance with Article 8(3)(l) that another Member State has authorized a medicinal product which is the subject of an application for authorization in the Member State concerned, that Member State shall forthwith request the authorities of the Member State which has granted the authorization to forward to it the assessment report referred to in Article 21(4).
• Article 19 — In order to examine the application submitted in accordance with Articles 8 and 10(1), the competent authority of the Member State:
• Article 20 — Member States shall take all appropriate measures to ensure that:
• Article 21
• Article 22 — In exceptional circumstances, and following consultation with the applicant, an authorization may be granted subject to certain specific obligations, including:
• Article 23 — After an authorization has been issued, the authorization holder must, in respect of the methods of manufacture and control provided for in Article 8(3)(d) and (h), take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods.
• Article 24
• Article 25
• Article 26 — The marketing authorisation shall be refused if, after verification of the particulars and documents listed in Articles 8 and 10(1), it proves that:

Chapter 4 Mutual recognition of authorizations

• Article 27
• Article 28
• Article 29
• Article 30 — If several applications submitted in accordance with Articles 8, 10(1) and Article 11 have been made for marketing authorization for a particular medicinal product, and Member States have adopted divergent decisions concerning the authorization of the medicinal product or its suspension or withdrawal, a Member State, or the Commission, or the marketing authorization holder may refer the matter to the Committee for application of the procedure laid down in Article 32.
• Article 31 — The Member States or the Commission or the applicant or holder of the marketing authorization may, in specific cases where the interests of the Community are involved, refer the matter to the Committee for the application of the procedure laid down in Article 32 before reaching a decision on a request for a marketing authorization or on the suspension or withdrawal of an authorization, or on any other variation to the terms of a marketing authorization which appears necessary, in particular to take account of the information collected in accordance with Title IX.
• Article 32
• Article 33 — Within 30 days of the receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law.
• Article 34
• Article 35
• Article 36
• Article 37
• Article 38
• Article 39
• Article 40
• Article 41 — In order to obtain the manufacturing authorization, the applicant shall meet at least the following requirements:
• Article 42
• Article 43
• Article 44
• Article 45
• Article 46 — The holder of a manufacturing authorization shall at least be obliged:
• Article 47 — The principles and guidelines of good manufacturing practices for medicinal products referred to in Article 46(f) shall be adopted in the form of a directive, in accordance with the procedure referred to in Article 121(2).
• Article 48
• Article 49
• Article 50
• Article 51
• Article 52 — Member States shall ensure that the duties of qualified persons referred to in Article 48 are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct.
• Article 53
• Article 54 — The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:
• Article 55
• Article 56
• Article 57 — Notwithstanding Article 60, Member States may require the use of certain forms of labelling of the medicinal product making it possible to ascertain:
• Article 58
• Article 59
• Article 60
• Article 61
• Article 62
• Article 63
• Article 64
• Article 65 — As necessary, the Commission shall publish guidelines concerning in particular:
• Article 66
• Article 67
• Article 68
• Article 69
• Article 70
• Article 71
• Article 72
• Article 73
• Article 74
• Article 75
• Article 76
• Article 77
• Article 78 — Member States shall ensure that the time taken for the procedure for examining the application for the distribution authorization does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application.
• Article 79 — In order to obtain the distribution authorization, applicants must fulfil the following minimum requirements:
• Article 80 — Holders of the distribution authorization must fulfil the following minimum requirements:
• Article 81 — With regard to the supply of medicinal products to pharmacists and persons authorized or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of a distribution authorization which has been granted by another Member State, any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorized to engage in equivalent activities.
• Article 82 — For all supplies of medicinal products to a person authorized or entitled to supply medicinal products to the public in the Member State concerned, the authorized wholesaler must enclose a document that makes it possible to ascertain:
• Article 83 — The provisions of this Title shall not prevent the application of more stringent requirements laid down by Member States in respect of the wholesale distribution of:
• Article 84
• Article 85
• Article 86
• Article 87
• Article 88
• Article 89
• Article 90 — The advertising of a medicinal product to the general public shall not contain any material which:
• Article 91
• Article 92
• Article 93
• Article 94
• Article 95
• Article 96
• Article 97
• Article 98
• Article 99
• Article 100 — Advertising of the homeopathic medicinal products referred to in Article 13(2) and Article 14(1) shall be subject to the provisions of this Title with the exception of Article 87(1).
• Article 101 — The Member States shall take all appropriate measures to encourage doctors and other health care professionals to report suspected adverse reactions to the competent authorities.
• Article 102 — In order to ensure the adoption of appropriate regulatory decisions concerning the medicinal products authorized within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall establish a pharmacovigilance system. This system shall be used to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, and to evaluate such information scientifically.
• Article 103 — The marketing authorization holder shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.
• Article 104
• Article 105
• Article 106
• Article 107
• Article 108
• Article 109
• Article 110
• Article 111
• Article 112
• Article 113
• Article 114
• Article 115
• Article 116 — The competent authorities of the Member States shall suspend or revoke an authorization to place a medicinal product on the market where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking, or where its qualitative and quantitative composition is not as declared. Therapeutic efficacy is lacking when it is established that therapeutic results cannot be obtained with the medicinal product.
• Article 117
• Article 118
• Article 119
• Article 120
• Article 121
• Article 122 — Member States shall take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements for the manufacturing authorizations or marketing authorizations are fulfilled.
• Article 123
• Article 124
• Article 125 — Every decision referred to in this Directive which is taken by the competent authority of a Member State shall state in detail the reasons on which it is based.
• Article 126 — An authorization to market a medicinal product shall not be refused, suspended or revoked except on the grounds set out in this Directive.
• Article 127
• Article 128 — Directives 65/65/EEC, 75/318/EEC, 75/319/EEC, 89/342/EEC, 89/343/EEC, 89/381/EEC, 92/25/EEC, 92/26/EEC, 92/27/EEC, 92/28/EEC and 92/73/EEC, amended by the Directives referred to in Annex II, Part A, are repealed, without prejudice to the obligations of the Member States concerning the time-limits for implementation set out in Annex II, Part B.
• Article 129
• Article 130 — This Directive is addressed to the Member States.