9.—(1) This paragraph applies to a person who has acted as a qualified person since the coming into force of Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products M1.U.K.
(2) A person to whom this paragraph applies may continue to act as a qualified person.
Marginal Citations
M1OJ No L 147, 9.6.1975, p.13, no longer in force.
10.—(1) This paragraph applies to a person who—U.K.
(a)holds a degree, diploma or other formal qualification in a scientific discipline awarded on completion of a university course or course recognised as equivalent; and
(b)began the course before 21 May 1975.
(2) A person to whom this paragraph applies may act as a qualified person provided that sub-paragraph (3) (and, where applicable, paragraph 11) is satisfied.
(3) This sub-paragraph is satisfied if, for at least two years before 21 May 1985, the person has carried out one of the following activities in an undertaking authorised to manufacture medicinal products—
(a)production supervision;
(b)qualitative and quantitative analysis of active substances; or
(c)testing and checking, under the direct supervision of the qualified person in respect of the undertaking, to ensure the quality of the medicinal products.
11. If a person to whom paragraph 10 applies acquired the practical experience mentioned in paragraph 10(3) before 21 May 1965, the person must complete a further one year's practical experience of the kind specified in that paragraph immediately before the person may act as a qualified person.U.K.