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EGA Press Release

Monday, 22 March 2004

EGA Welcomes Clarification on the European Reference Product from the European Commission.

Rapid progress on the implementation of the European Reference Product is now possible thanks to an important clarification made by the European Commission at the DIA Euro Meeting held in Prague March 10th–12th.

According to the European Commission, the European Reference Product (ERP) could be operational in any New EU Member State very quickly after adoption of the new law, as it does not require transposition in all the EU 25 but only in those countries, which want to benefit from this provision earlier than the final deadline of transposition.

According to EGA Director General, Greg Perry: “This is major clarification for European generic medicines producers since we were very concerned that the ERP required transposition in the existing 15 Member States which may have resulted in delays in the operation of this measure.(1) It is now clear the ERP becomes operational by the quick transposition of this measures in the 10 New States – which have major interest in the ERP in regards the updating of dossiers.”

At the DIA Conference the European Commission clarified that any Member State can transpose parts of the legislation at different stages, and therefore the ERP could be transposed without waiting for other parts. Moreover, Philippe Brunet, Head of the Pharmaceutical Unit of DG Enterprise, stressed that transposition of the ERP by the interested Member State alone is sufficient because an exchange of information and cooperation between national Authorities and European institutions is already guaranteed within the EU Treaty. Consequently, any competent Authority in the EU 25, which has authorised a Reference Product, can provide any other competent Authority with all information necessary to assess a generic application.

It should be recalled that the objective of the ERP was to stop strategic withdrawals of the reference products as well as to help New Member States ensure that generic products on their markets can fulfill EU regulatory requirements on date of Accession.

(1) See EGA Press Release of 10 March 2004

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