The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994

• Citation: S.I. 1994/103
• Sections: 4

Section 1 Citation, commencement and interpretation

(1) These Regulations may be cited as the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994, and shall come into force on 14th February 1994.

(2) In these Regulations, “the principal Regulations ” means the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 .

Section 2 Amendment of regulation 2 of the principal Regulations

In regulation 2 of the principal Regulations (interpretation), in paragraph (1)—

(a) after the definition of “blood product” there shall be inserted the following definition—

“certificate of registration” means a certificate granted under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;

(b) in the definition of “product to which Chapters II to V of the 1965 Directive apply” for “and Article 1 of Council Directive 89/381/ EEC ” there shall be substituted “, Article 1 of Council Directive 89/381/EEC and Article 9(1) of Council Directive 92/73/EEC ” .

Section 3 Amendment of Schedule 2 to the principal Regulations

(1) Schedule 2 to the principal Regulations (standard provisions for manufacturer’s licences and manufacturer’s licences of right) shall be amended in accordance with the following paragraph.

(2) In paragraph 16—

(a) after paragraph (a) of sub-paragraph (3) there shall be inserted the following paragraph:

(aa) where there is in relation to the product which has been manufactured or assembled, a certificate of registration, to ensure that each batch of the product has been manufactured or assembled and checked in compliance with that certificate and the provisions of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 ;

(b) in paragraph (b) of sub-paragraph (3), after “(a)” there shall be inserted “or (as the case may be) (aa)”;

(c) in sub-paragraph (5) the words “or to medicinal products that are homoeopathic products” shall be omitted.

Section 4 Amendment of Schedule 3 to the principal Regulations

(1) Schedule 3 to the principal Regulations (standard provisions for wholesale dealer’s licences including wholesale dealer’s licences of right) shall be amended in accordance with the following paragraphs.

(2) In paragraph (6), in sub-paragraph (1) after the words “product licence” in both places in which they appear there shall be inserted “or certificate of registration”.

(3) In paragraph 8—

(a) at the end of paragraph (a) of sub-paragraph (3) there shall be inserted “or”;

(b) after paragraph (a) of sub-paragraph (3) there shall be inserted the following paragraph:

(aa) where there is in relation to the imported proprietary product, a certificate of registration, to ensure that each batch of product has been tested in accordance with the manufacturing and control file submitted with the application for that certificate;

(c) in paragraph (b) of sub-paragraph (3), after “(a)” there shall be inserted “or (as the case may be) (aa)”.