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The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994
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- 1994 No. 103
- Regulation 4
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Amendment of Schedule 3 to the principal Regulations
4.—(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)”.
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