Regulation 89 Amendment to paragraph 9

in sub-paragraph (1), after “any person” insert “(including the manufacturer of a veterinary medicinal product)”;

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.”.