The Veterinary Medicines (Amendment etc.) Regulations 2024
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Change 1
89 Amendment to paragraph 9
In paragraph 9 (qualified person for manufacture)— (a) in sub-paragraph (1), after “any person” insert “(including the manufacturer of a veterinary medicinal product)”; (b) after sub-paragraph (1) insert— (1A) For the purposes of sub-paragraph (1), a person has sufficient practical experience if they have been engaged in one or more of the activities mentioned in sub-paragraph (1B) for at least two years in the provision of services to the holder of a manufacturing authorisation. (1B) For the purposes of sub-paragraph (1A) the activities are— (a) quality assurance of medicinal products; (b) qualitative analysis of medicinal products; (c) quantitative analysis of active substances. (1C) The Secretary of State may treat the reference in sub-paragraph (1A) to two years of practical experience as a reference to— (a) one year, where the person’s formal course of study lasted for at least five years; (b) six months, where the person’s formal course of study lasted for at least six years. .
89 Amendment to paragraph 9
In paragraph 9 (qualified person for manufacture)— (a) in sub-paragraph (1), after “any person” insert “(including the manufacturer of a veterinary medicinal product)”; (b) after sub-paragraph (1) insert— (1A) For the purposes of sub-paragraph (1), a person has sufficient practical experience if they have been engaged in one or more of the activities mentioned in sub-paragraph (1B) for at least two years in the provision of services to the holder of a manufacturing authorisation. (1B) For the purposes of sub-paragraph (1A) the activities are— (a) quality assurance of medicinal products; (b) qualitative analysis of medicinal products; (c) quantitative analysis of active substances. (1C) The Secretary of State may treat the reference in sub-paragraph (1A) to two years of practical experience as a reference to— (a) one year, where the person’s formal course of study lasted for at least five years; (b) six months, where the person’s formal course of study lasted for at least six years. .
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