Outcome of the Public Consultation of the Review of the Variations Regulations (Comitology Part) Published

GMP News
6 February 2008

Outcome of the Public Consultation of the Review of the Variations Regulations (Comitology Part) Published

A public consultation was conducted in October 2007 - January 2008 on the comitology aspects of the review of the Variations Regulations. The European Commission has proposed this regulation with the aim to harmonise the differing regulatory requirements regarding variations among Member States so that all changes or variations to pharmaceutical marketing authorisations are subject to the same criteria in the EU. It should also provide a simpler, clear and flexible regime for the handling of licence variations which continues to maintain high levels of public health protection.

Comments from stakeholders were published on 15 January 2008. Contributions were sent in by 16 Member States which are in general positive towards the preliminary proposal. They also welcome the principle of work sharing.

However some of the Member State's agencies fear additional administrative workload for example by grouping variations. Concerns were also raised on the integration of Design Space in the regulation: such an introduction should be accompanied by detailed definitions and guidance in order to obtain a common understanding of the concept.

Twenty-five pharmaceutical companies and industry representatives/ associations have also sent in comments to the respective regulation. Industry strongly supports the Commission's proposal for the revised Variation Regulation and broadly agrees with its objectives and suggested concepts. They appreciate their increased responsibility for change implementation. However, industry is looking for further improvements to the legal drafting to ensure that it fully reflects the Commission's strategy paper and the needs of the pharmaceutical industry.

In general, most comments were made on how to further reduce the need for post-authorisation changes. The proposal that a change within an approved 'design space' does not require a Variations application is welcomed. A "do and tell" approach would be appreciated and supported by both the industry and the authorities of the Member States.

Also, CMD(h), EDQM and EMEA have made detailed contributions. EMEA welcomes the overall streamlining of the handling of variations. However, the agency "is concerned that the flexible and simplified submission requirements are not associated with a simplification of administrative processing and decision-making to the same extent at the level of the regulatory authorities."

Various comments were made on the text as such which is seen complicated and not easy to read. Definitions on type of variations should be defined more precisely and stated as such.

The contributions can be found here: http://ec.europa.eu/enterprise/pharmaceuticals/varreg/cons2008_comitology.htm

A summary of the outcome of this consultation will be published soon.

Learn all relevant aspects to implement and/ or improve your Change Control System which fulfils current and future regulatory GMP requirements in the ECA Education Course Change Control - New Aspects and Best Practices in Munich, Germany, on 5/6 June 2008.
You will get to know the whole process from initiation over implementation to regulatory submissions.

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

Go back

GMP Conferences by Topics