EU Regulation (EC) No 726/2004 - Centralised Authorisation Procedure and the European Medicines Agency

What it says

This Regulation establishes the centralised procedure for authorising and supervising medicinal products in the EU and creates the European Medicines Agency, whose Committee for Medicinal Products for Human Use gives the opinion on which the European Commission bases a single authorisation valid across the EU. The procedure is mandatory for certain categories of products, such as those derived from biotechnological processes, and optional for others.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A centrally authorised product has one authorisation across the EU, but manufacturing sites are still inspected by national authorities.
• Post-authorisation changes follow the Variations Regulation, and for centrally authorised products the EMA is involved in assessing them.
• The Regulation also covers supervision and pharmacovigilance of centrally authorised products.

What inspectors look for

• Whether manufacturing is consistent with the authorised dossier.
• Whether changes have been handled through the correct variation procedure.
• Whether the site meets the GMP requirements that support the authorisation.

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