Amendment of regulation 2(1) of the principal Regulations2.
Paragraph (1) of regulation 2 of the principal Regulations (interpretation) shall be amended as follows–
(a)
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 19945;”;
(b)
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/EEC6 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
(c)
after the definition of “licence holder” and “certificate holder” there shall be inserted the following definition–
““marketing authorisation” means
- (a)
a United Kingdom marketing authorisation granted by the licensing authority under the 1994 Regulations; or
- (b)
a Community marketing authorisation granted by the European Commission under Council Regulation (EEC) No. 2309/937; or- (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;”.