# The Veterinary Medicines Regulations 2013, Paragraph 9: Qualified persons for manufacture

Extent: E+W+S+N.I.

(1) The Secretary of State may appoint as a qualified person (manufacture) any person (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;
(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.

---
Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/2/paragraph/9 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-2/paragraph-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.