Paragraph 9 Qualified persons for manufacture

United Kingdom

(1)

The Secretary of State may appoint as a qualified person (manufacture) any person F1(including the manufacturer of a veterinary medicinal product) who is—

(a)

a member of the Royal Pharmaceutical Society or registered with the Pharmaceutical Society of Northern Ireland;

(b)

a Chartered Chemist or a Fellow, Member or Associate Member of the Royal Society of Chemistry; or

(c)

a Chartered Biologist or a Fellow, Member or Associate Member of the Society of Biology;

F2(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.

who qualified on the basis of a formal course of study lasting not less than three years full-time or equivalent and who has sufficient practical experience to carry out the duties under this Schedule.

(2)

The Secretary of State may exceptionally appoint a person who is not a member of one of those institutions to act as a qualified person (manufacture) on being satisfied that that person has the educational qualifications or practical experience to carry out the duties under this Schedule.

Annotations

Textual amendments

F1: Words in Sch. 2 para. 9(1) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 89(a)
F2: Sch. 2 para. 9(1A)-(1C) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 89(b)