§ Mr. Simon HughesTo ask the Secretary of State for Health if he will make a statement on the means by which the Licensing Authority has, since 1 January 1995, implemented its responsibilities to the European Medicines Evaluation Agency. [33985]
§ Mr. MaloneThe Licensing Authority implements its responsibilities under the European drug regulatory system through adoption of the following European directives: the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, (S.I. 3144, and European Council Regulation 2309/93.