Adoption of the Commission Proposal on Variations (co-decision part)

GMP News
7 May 2008

Adoption of the Commission Proposal on Variations (co-decision part)

On 4 March 2008, the Commission has adopted its proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products. The proposal is available in all EU official languages.

Background: within the European Community, medicinal products are regulated throughout their entire lifetime. Changes subsequent to their placing on the market are governed either by national provisions or by Community rules: the "Variations Regulations"; Commission Regulations (EC) Nos 1084/2003 and 1085/20031. These Regulations do not apply to changes to marketing authorisations for medicinal products which have been granted at a national level by a Member State competent authority under a national procedure. In the majority of Member States there is no such alignment on Community legislation, which results in discrepancies between the rules of those Member States.

The objective of this proposal is therefore to amend Directives 2001/82/EC and 2001/83/EC in order to empower the Commission to extend the scope of the corresponding Variations Regulation, namely Regulation (EC) No 1084/2003. This would ensure that all medicinal products, regardless of the procedure under which they have been authorised, are subject to the same criteria for the evaluation, approval and administrative treatment of variations.

The proposal is accompanied by an [Impact Assessment], which started in 2006 and was followed by a public consultation in July-September 2007. This public consultation complied with the Commission's general principles and minimum standards for consultation; 19 responses were received (see GMP-News 06 February 2008).

In the Impact Analysis, various options are compared and discussed like:

  • Partial harmonisation

  • Full harmonisation, no transitional period

  • Full harmonisation, with transitional period

  • Social and environmental impacts

  • Uncertainty and sensitivity analysis

  • Impacts outside the European Union

  • Impacts over time

  • Potential obstacles to compliance

Annex III of the Impact Assessment also lists examples of changes (improvements) to medicinal products which industry chose not to implement due to the regulatory environment

The main policy objectives of this initiative are to achieve simplification and harmonisation, thereby ensuring that all authorised medicinal products, irrespective of their legal status, are subject to the same criteria for the evaluation, approval and administrative handling of variations

Both the proposal and the impact assessment will now be discussed in the European Parliament and in the Council

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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