Medicines21/03/04 / cata_european-union-news

Hitherto, EU law has in effect made provision for two different procedures when registering medicinal products (i) registration with the competent authority in the member state (for instance, following the accession of CR to the EU, by the Medicinal Products State Inspection Office in the CR) and (ii) registration via a centralised evaluation body (European Medicines Evaluation Agency, London).

The two new regulations set out the steps for variations in marketing authorisations applicable under both procedures. The intention is to simplify and expedite procedures for certain types of variations in registration, as well as to clarify legislation in this area. Upon registration in a member state, the variation will be examined by a competent authority of the member state. Provisions governing administrative procedures and requirements for variation of registration will differ according to the type of variation, as set out in the attached schedules. Procedures have been simplified, particularly where there is a need to adopt emergency measures or to combat an influenza pandemic.

Commission Directive 2003/94/EC of 8 October 2003 setting out the principles and guidelines for good manufacturing practice relating to medicinal products for human use

Official Journal of the EU L 262 of 14 October 2003

This Directive introduced a change in the requirements relating to correct manufacture of medicinal products intended for human use and replaces existing Directive 91/356/EEC. It incorporates new provisions on the rights of supervisory bodies to carry out inspections, quality control and other matters requiring attention following experience in implementing the existing provisions. At national level the Directive is mostly reflected in secondary legislation. The deadline for implementation of the Directive into national legal order expires on 30 April 2004.