The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004

Amendment of regulation 2 of the General Fees Regulations

4.  In regulation 2 of the General Fees Regulations (interpretation), in paragraph (1)—

(a) after the definition of “concerned member State”(1) insert the following definition—

““contract laboratory” means a laboratory carrying out the tests specified in paragraph 5A(2) of Schedule 2 or paragraph 8(3)(a) of Schedule 3 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971(2) on behalf of a holder of a manufacturer’s licence or a wholesale dealer’s licence, pursuant to Article 20(b) of the 2001 Directive;”;

(b) after the definition of “medicinal product” insert the following definition—

““operator”, in relation to a contract laboratory, means the person having control of the contract laboratory;”; and

(c) after the definition of “parallel import licence”(3) insert the following definition—

““penalty fee” means a fee payable under regulation 18A;”.

(1)

The definition of “concerned member State” was inserted by regulation 2 of S.I. 2000/3031.

(2)

S.I. 1971/972; relevant amending instruments are S.I. 1977/1053 and 1992/2846.

(3)

The definition of “parallel import licence” was inserted by regulation 5(1)(c) of S.I. 2001/795.