Regulation 2 Amendment of regulation 2(1) of the principal Regulations

after the definition of “the Act” there shall be inserted the following definition–

• ““the 1994 Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994^f1;”;

after the definition of “clinical trial certificate of right” and “animal test certificate of right” there shall be inserted the following definition–

• ““exempt imported product” means a medicinal product as defined in article 1(2) of Council Directive 65/65/EEC^f2 to which paragraph 1 of Schedule 1 to the 1994 Regulations applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorisation has been granted;”; and

after the definition of “licence holder” and “certificate holder” there shall be inserted the following definition–

• ““marketing authorisation” means

  1. (a)

     a United Kingdom marketing authorisation granted by the licensing authority under the 1994 Regulations; or

  2. (b)

     a Community marketing authorisation granted by the European Commission under Council Regulation (EEC) No. 2309/93^f3; or

  3. (c)

     a product licence which has effect as a United Kingdom marketing authorisation in accordance with paragraph 1 of Schedule 6 to the 1994 Regulations;”.