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EMA Regulation In force since 20 November 2005

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
32004R0726 · official text on EUR-Lex

This English text is a careful, terminology-researched translation prepared by eucite.com — not an official government translation. The German original linked above is the legally authoritative text.

Articles

• Article 1 — The purpose of this Regulation is to lay down Community procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use, and to establish a European Medicines Agency (hereinafter referred to as "the Agency").
• Article 2 — The definitions laid down in Article 1 of Directive 2001/83/EC and those laid down in Article 1 of Directive 2001/82/EC shall apply for the purposes of this Regulation.
• Article 3
• Article 4

Chapter 1 Submission and examination of applications - Authorisations

• Article 5
• Article 6
• Article 7 — In order to prepare its opinion, the Committee for Medicinal Products for Human Use:
• Article 8
• Article 9
• Article 10
• Article 11
• Article 12
• Article 13
• Article 14
• Article 15

Chapter 2 Supervision and penalties

• Article 16
• Article 17
• Article 18
• Article 19
• Article 20

Chapter 3 Pharmacovigilance

• Article 21
• Article 22 — The Agency, acting in close cooperation with the national pharmacovigilance systems established in accordance with Article 102 of Directive 2001/83/EC, shall receive all relevant information concerning suspected adverse reactions to medicinal products for human use which have been authorised by the Community in accordance with this Regulation. Where appropriate, the Committee for Medicinal Products for Human Use shall, in accordance with Article 5 of this Regulation, draw up opinions on the measures necessary. These opinions shall be made publicly accessible.
• Article 23 — The holder of an authorisation for a medicinal product for human use granted in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.
• Article 24
• Article 25 — Each Member State shall ensure that all suspected serious adverse reactions occurring within their territory to a medicinal product for human use authorised in accordance with this Regulation which are brought to their attention are recorded and reported promptly to the Agency and the marketing authorisation holder, and no later than 15 days following receipt of the information.
• Article 26 — The Commission, in consultation with the Agency, Member States and interested parties, shall draw up a guide on the collection, verification and presentation of adverse-reaction reports. This guide shall contain, in particular, for the benefit of health-care professionals, recommendations concerning the communication of information on adverse reactions.
• Article 27
• Article 28
• Article 29

Chapter 1 Submission and examination of applications - Authorisations

• Article 30
• Article 31
• Article 32
• Article 33
• Article 34
• Article 35
• Article 36
• Article 37
• Article 38
• Article 39
• Article 40

Chapter 2 Supervision and sanctions

• Article 41
• Article 42
• Article 43
• Article 44
• Article 45

Chapter 3 Pharmacovigilance

• Article 46
• Article 47 — The Agency, acting in close cooperation with the national pharmacovigilance systems established in accordance with Article 73 of Directive 2001/82/EC, shall receive all relevant information about suspected adverse reactions to veterinary medicinal products which have been authorised by the Community in accordance with this Regulation. Where appropriate the Committee for Medicinal Products for Veterinary Use shall, in accordance with Article 30 of this Regulation, draw up opinions on the measures necessary. These opinions shall be made publicly accessible.
• Article 48 — The holder of the marketing authorisation for a veterinary medicinal product granted in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.
• Article 49
• Article 50 — Each Member State shall ensure that all suspected serious adverse reactions, and adverse human reactions, occurring within its territory to a veterinary medicinal product authorised in accordance with the provisions of this Regulation which are brought to its attention are recorded and reported promptly to the Agency and the holder of the marketing authorisation for the veterinary medicinal product, and no later than 15 days following receipt of the information.
• Article 51 — The Commission, in consultation with the Agency, Member States and interested parties, shall draw up a guide on the collection, verification and presentation of adverse-reaction reports. This guide shall contain, in particular, for the benefit of health-care professionals, recommendations concerning the communication of information on adverse reactions.
• Article 52
• Article 53
• Article 54

Chapter 1 Tasks of the Agency

• Article 55 — A European Medicines Agency is hereby established.
• Article 56
• Article 57
• Article 58
• Article 59
• Article 60
• Article 61
• Article 62
• Article 63
• Article 64
• Article 65
• Article 66 — The Management Board shall:

Chapter 2 Financial Provisions

• Article 67
• Article 68
• Article 69
• Article 70

Chapter 3 General Provisions governing the Agency

• Article 71
• Article 72
• Article 73 — Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(22) shall apply to documents held by the Agency.
• Article 74
• Article 75 — The staff of the Agency shall be subject to the rules and regulations applicable to officials and other staff of the European Communities. In respect of its staff, the Agency shall exercise the powers which have been devolved to the appointing authority.
• Article 76
• Article 77
• Article 78
• Article 79
• Article 80 — To ensure an appropriate level of transparency, the Management Board, on the basis of a proposal by the Executive Director and in agreement with the Commission, shall adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products which is not of a confidential nature.
• Article 81
• Article 82
• Article 83
• Article 84
• Article 85
• Article 86
• Article 87
• Article 88 — Regulation (EEC) No 2309/93/EC is hereby repealed.
• Article 89
• Article 90 — This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.