The Human Medicines (Amendment) (No. 2) Regulations 2014
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Change 1
8 Amendment of regulation 59
(1) Regulation 59 (general conditions for a UK marketing authorisation) is amended as follows. (2) In paragraph (1) for “The licensing authority” substitute “Unless paragraph (1A) applies the licensing authority”. (3) After paragraph (1) insert— (1A) Where the application concerns a parallel import licence, the licensing authority may— (a) grant a parallel import licence subject to one or more of the conditions in paragraph (2)(a), (c), (d) or (e); or (b) vary or remove a condition in paragraph (2)(a), (c), (d) or (e) to which the parallel import licence is subject. (4) In paragraph (4) for “where necessary” substitute “where relevant and necessary”.
8 Amendment of regulation 59
(1) Regulation 59 (general conditions for a UK marketing authorisation) is amended as follows. (2) In paragraph (1) for “The licensing authority” substitute “Unless paragraph (1A) applies the licensing authority”. (3) After paragraph (1) insert— (1A) Where the application concerns a parallel import licence, the licensing authority may— (a) grant a parallel import licence subject to one or more of the conditions in paragraph (2)(a), (c), (d) or (e); or (b) vary or remove a condition in paragraph (2)(a), (c), (d) or (e) to which the parallel import licence is subject. (4) In paragraph (4) for “where necessary” substitute “where relevant and necessary”.
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