§ Mr. RowlandsTo 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 since350W 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 BottomleySince 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.