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;”.