HC Deb 01 February 1990 vol 166 cc349-50W
Mr. Rowlands

To ask the Secretary of State for Health whether there have been any changes in the data required for the granting of an abridged product licence since January 1987; and whether there has been any change in the interpretation of the existing regulations governing the granting of an abridged product licence.

Mrs. Virginia Bottomley

Since January 1987 there have been changes in the data required from applicants in support of an abridged product licence application. This is as a result of directive 87/21/EEC which amended directive 65/65/EEC and new guidelines issued by the EC Committee on Proprietary Medicinal Products entitled "Rules Governing Medicinal Products in the European Community", a copy of which is in the Library. Medical, pharmaceutical and other scientific interpretation of existing regulations was adapted to reflect the revised EC requirements.

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