EGA Press Release

Thursday, 8 July 2008 | Brussels

EGA WELCOMES THE ADOPTION OF THE REVISED VARIATIONS REGULATION

Considering it a “positive step” toward simplifying and optimising the system of changes to Marketing Authorisations, the EGA welcomes the European Commission’s adoption of the EU Regulation on the examination of amendments to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.

We recognise the importance of this initiative, as the current manner of dealing with variations has become inefficient and is no longer satisfactory, neither to the authorities nor to industry. Due to the high number of variations submitted annually by generic medicines companies, the simplification of the current variations system is greatly appreciated by our industry.

EGA members are recognisant of the fact that this legal process was classified by the EC as one of its priorities and of the Commission’s efforts to finalise this process and to implement the outcome in practice as soon as possible in benefit to all parties concerned.

The generic medicines industry also greatly appreciates being given the opportunity to be involved in the discussions during this legislative process. The continuous dialog between the competent authorities and the industry have resulted in significant improvements to the initial EC proposal and facilitated a acceptable compromises where necessary.

EGA members are very pleased that the European Commission has taken several specific points into consideration during the revision of the initial proposal. In particular the EGA welcomes the possibility to report minor variations to the Authorities on an annual basis, to group several variations into a single application, and to work-share an assessment among several authorities with the CMD taking the leading role as coordinator for nationally authorised products. The EGA views positively that type IB variations are accepted by default, that line extensions are to be included within the scope of the Variations Regulation, and that the guideline on classification and conditions have been separated from the Variations Regulation itself.

We trust that certain other technical points highlighted by the EGA during the consultation process (eg, those related to timeline and detailed steps of procedure) will be taken into consideration during the elaboration of the guidelines on implementing the new variations system, as we are convinced these will help increase the predictability and clarity of the new variations process.

In the meantime, we are now confident that the subsequent steps of the legislative process in the European Parliament and the Council of Ministers, aimed at allowing these same rules to be applied to purely national variations, will be successfully finalised before the upcoming European parliamentary elections.

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