Regulation 2004/726 - Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency - Main contents

SUMMARY OF:

Regulation (EC) No 726/2004 — procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

WHAT IS THE AIM OF THE REGULATION?

It seeks to guarantee high standards of quality and safety of medicines in the EU, and includes measures to encourage innovation and competitiveness.

It sets out procedures for authorising and supervising medicinal products for human and veterinary use and sets up the European Medicines Agency (EMA).

KEY POINTS

The regulation introduces a centralised authorisation procedure for medicinal products in addition to existing national systems.

This centralised procedure is compulsory for:

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  products derived from biotechnology, i.e. the use of living organisms,
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  advanced therapy medicinal products, i.e. based on the manipulation of genes, cells or tissues,
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  orphan medicinal products, i.e. for the treatment of rare diseases, or
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  products containing any new substance to treat:

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    acquired immune deficiency syndrome (AIDS),
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    cancer,
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    neurodegenerative disorder,
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    diabetes, or
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    other immune disorders and viral diseases.

The procedure is optional where:

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  a new active substance is involved, or
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  an innovation is of interest at EU level.

Authorisation is based on quality, safety and efficacy, lasts for 5 years, and is renewable.

Veterinary products

Similar principles, with some adjustment, apply to products intended for veterinary use.

Authorisation may be refused on the grounds of health and welfare of animals or consumer safety, or if human food from treated animals could contain harmful residues.

Monitoring (Pharmacovigilance)

The regulation also reinforces monitoring procedures. EU countries must inform the EMA and the European Commission where the manufacturer or importer fails to fulfil their obligations under an authorisation.

Where urgent action is essential to protect human health or the environment, an EU country may suspend use of a medicinal product. The holder of the authorisation must notify the EMA, the Commission and other EU countries of any such variation or suspension.

The EMA administers the EudraVigilance database to collate monitoring information, reporting to the Commission, the European Parliament and the Council.

European Medicines Agency

The EMA, and its committees, comprise representatives from EU countries and expert advisors. It is responsible for:

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  scientific advice;
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  coordinating the evaluation of the quality, safety and efficacy of medicinal products, and coordinating monitoring systems;
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  keeping information on authorised medicinal products and potential adverse reactions;
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  assisting EU countries with communication with healthcare professionals;
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  creating a database on medicinal products accessible to the general public; and
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  advising on limits for residues of veterinary medicinal products.

EMA’s headquarters

Under Regulation (EU) 2018/1718, in the context of the United Kingdom’s intention to withdraw from the EU, the seat of the EMA is to be relocated from London to Amsterdam as of 30 March 2019.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 20 May 2004 apart from certain rules which have applied since 20 November 2005 (Titles I, II, III and V) and 20 May 2008 (point 3, 5th and 6th indents of the annex).

BACKGROUND

For more information, see:

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  Medicinal products (European Commission)
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  Human medicines: regulatory information (EMA).

MAIN DOCUMENT

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 (OJ L 136, 30.4.2004, pp. 1-33)

Successive amendments to Regulation (EC) No 726/2004 have been incorporated into the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Regulation (EU) 2018/1718 of the European Parliament and of the Council of 14 November 2018 amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (OJ L 291, 16.11.2018, pp. 3-4)

Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (OJ L 189, 27.6.2014, pp. 112-127)

See consolidated version.

Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (OJ L 65, 8.3.2013, pp. 17-18)

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, pp. 11-22)

Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, pp. 7-24)

See consolidated version.

Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, pp. 10-19)

See consolidated version.

Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, pp. 6-9)

Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329, 16.12.2005, pp. 4-7)

Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 35, 15.2.1995, pp. 1-5)

See consolidated version.

last update 08.03.2019

This summary has been adopted from EUR-Lex.