- Y Diweddaraf sydd Ar Gael (Diwygiedig)
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89. 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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