Generic medicines, affordable solutions.

Scientific|Regulatory

Intellectual Property

Pharma Review

Legislative Proposals

EGA Position Papers

Legislative Proposals

Variations Regulation

a) Official Documents:

Better Regulation of Pharmaceuticals: Towards a Simpler, Clearer and More Flexible Framework on Variations

• 4 March 2008: adoption of the Commission proposal on variations
  (co-decision part)
  On 4 March 2008 the European Commission adopted its proposal for a Directive of the European Parliament and the European 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 official EU languages on the Commission’s Website:
  • Variations Regulation.
   
  The proposal is accompanied by an:
  • Impact Assessment.
   
  Both the proposal and the impact assessment will be assessed in the European Parliament and the Council. The procedure is expected to be finalised before parliamentary elections in June 2009.
   
• 25 October 2007: Public Consultation Review of the Variations Regulations
  (comitology part)
  The Commission Public Consultation on the comitology part of the revision of the Variations Regulations was launched on 25 October 2007. It was based on two documents:
   
  • The Draft legal proposal,
  • The Consultation paper, which gives detailed explanations on the consultation process
     and on the content of the draft legal proposal.
   
  The Outcome of the Public Consultation on the comitology part was published 14 January 2008 as Comments of all stakeholders:
   
  • Review of the Variations Regulations, contributions public consultation.
  • A summary of the outcome of this consultation prepared by the EC.
   
  This public consultation only addresses the ‘comitology’ part of this Better Regulation initiative, as the aspects of the review requiring ‘co-decision’ were addressed in a previous consultation.
  
  The text of the Regulation will be adopted by Standing Committee without the involvement of the European Parliament and Council. The revised proposal will be presented to the Standing Committee on 3 April 2008.
   
  
• 10 July 2007: Public Consultation
  (co-decision part)
  The Commission launched a Public Consultation on the co-decision part of the revision of the Variations Regulations in July 2007. This public consultation only addresses the ‘co-decision’ part of this Better Regulation initiative, and not those aspects which can be implemented through ‘comitology’.
   
  • The Consultation paper, with detailed explanations on the consultation process.
   
  The outcome of the Public Consultation on co-decision part was published on 3 October 2007, and is available on the Commission website:
   
  • Summary of the outcome of this consultation.
  • Comments from stakeholders.
   
  
• 20 October 2006: New Concept of the Variations System
  European Commission Issue Paper on the Concept of a New System of Variations

b) EGA Positions & Presentations

• EGA Presentation to the DIA Conference, Barcelona
  3 March 2008

• December 2007

• December 2006

Introduction to the Issue

Medicines are regulated throughout their entire lifetime, including all changes subsequent to their being placed on the EU market (eg, changes in the production process, changes in the packaging, changes in the address of the manufacturer, etc). Those changes are all dealt with according to a specific Community legislative framework: the ‘Variations Regulation’.

The handling of variations requires significant administrative and regulatory resources, both on the part of the competent authorities and industry. Whilst regulating changes in pharmaceuticals is essential to ensuring that EU medicines remain of good quality, and are safe and efficacious, it is also important that this regulation does not hinder, but rather stimulates the introduction of changes that are particularly beneficial to patients.

As the experience in dealing with variations under the current system has not been fully satisfactory for neither the competent authorities nor industry, the EC has launched a revision of the existing rules. The principal objective is to simplify the system without compromising human and animal health.

Simplification lies at the core of the ‘Better Regulation’ policy initiative of the European Commission, whose primary goal is to ensure — whenever possible — that Community legislation is made clearer, simpler and more flexible.

Public Consultation

The European Commission has launched a public consultation procedure on the new system of variations to marketing authorisations to gather information for revising this legislation.

This consultation includes the outcome of discussions with Member State competent authorities, the European Medicines Agency (EMEA), the European Directorate for the Quality of Medicines (EDQM) and the pharmaceutical industry on the operation of the current system. Furthermore, the regulatory developments at international level, notably the elaboration of the Q8-Q9-Q10 guidelines of the International Conference on Harmonization (ICH) on medicinal products for human use, have led to the establishment of new concepts which have an important impact on the regulatory handling of post-authorisation changes.