Change of policy concerning generic product approvals

Following a recent judgment of the European Court of Justice in the 'Novartis' case (Case 106/01), the MHRA has decided to change its policy concerning the assessment of generic equivalents of line extension products.

The MHRA will now accept abridged applications for generic equivalents of line extension products which have not been authorised for ten years, if the original product from the same company (or group of companies) has already been authorised for ten years in the Community. The MHRA will accept such applications only if the line extension is essentially similar to the original product, or if the extension differs from the original product in one or more of the ways envisaged under the proviso to Article 10.1(a) (eg differences of therapeutic indication, route of administration, dose, strength or pharmaceutical form). If the line extension is not essentially similar to the original product, the application should generally be made under the hybrid abridged procedure pursuant to the proviso. But the applicant will be able to rely on the data submitted in respect of the line extension, rather than being required to produce their own bridging data. This does not however exclude the possibility that in specific cases it may be necessary for the MHRA to require additional data from the generic applicant.

Companies whose applications have been invalidated or refused on the basis of the previous policy are entitled to re-submit their applications. The MHRA will assess those applications in accordance with the revised policy.

The MHRA has written to trade associations and further guidance on the practical implications will be published in future issues of 'MAIL', the MHRA updating service for medicines. Specific enquiries should be addressed to the usual MHRA Licensing Division management contact points.


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