The applicability of certain specific provisions of Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council ( 6 ) and of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products ( 7 ) depends on the recognition at Union level, in the framework of Decision No 2119/98/EC, of an emergency situation or of a pandemic situation with respect to human influenza. Those provisions allow for the accelerated marketing of certain medicinal products in the case of urgent need, by means, respectively, of a conditional marketing authorisation and of the temporary option of granting a variation to the terms of a marketing authorisation for a human influenza vaccine even where certain non-clinical or clinical data are missing. However, in spite of the utility of such provisions in the event of a crisis, to date no specific procedure exists for issuing such recognitions at Union level. It is therefore appropriate to provide for such a procedure as part of laying down the standards of quality and safety for medicinal products.
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New version applies from 26/12/2022.
57 provisions change.
Recital 23 is deleted from 26/12/2022.