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EGA Press Release

Wednesday, 10 March 2004

European Reference Product Needs Rapid Implementation.

Rapid implementation of the European Reference Product (ERP) must be top of the agenda for the EU 25 when considering transposition of the new EU pharmaceutical legislation.

This is the main message that EGA will give at this week’s DIA Euro Meeting being held in Prague (March 10th-12th).

Of all the various measures included in the new EU pharmaceutical legislation the ERP is the most time sensitive and must be in place immediately after Accession. It should be recalled that the ERP was created to help New Member States ensure that generic products on their markets can fulfill EU regulatory requirements.

According to EGA Director General, Greg Perry:

“The ERP needs to be transposed into the national legislation as quickly as possible since its very purpose is to ensure that on Accession the medicines agencies in the 10 New Members States can rely on the reference product in one of the 15 Member States to maintain nationally approved generic medicines if no such reference product exists on their market.

Whilst we hope that the 10 New Member States could be relied upon to transpose the ERP quickly, we are very concerned that the existing 15 Member States will not give it such urgency. If these 15 countries fail to transpose quickly, then the ERP becomes redundant and many generic medicines might have to be withdrawn from markets in the 10 New Member States simply because they have no reference product.

The European Commission has already clarified that any Member State can transpose parts of the legislation at different stages and, therefore, the ERP provisions could be implemented without waiting for other parts. Whilst it would be nice to see everything done at once and in harmony between Member States, this is unlikely to happen and in the case of the ERP there is no way health care systems or the industry can wait for total transposition of all parts of the legislation.”

The EGA will also be contacting health ministries in all the 25 countries to request rapid introduction of the ERP and to stress the urgency of the situation for generic medicines in the 10 New EU Member States.

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