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 Legislation
Legislative text

1. Summary of Legislation

Safe medicines for Europeans — European Medicines Agency

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 (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.

Contents

1.

Summary of Legislation

2.

Legislative text