Requirements as to qualified persons
4.—(1) Subject to paragraphs (7) and (8), where a manufacturer’s licence relates to the manufacture, assembly or importation of relevant medicinal products, a manufacturer’s licence holder shall ensure that he has at all times at his disposal the services of at least one qualified person who is responsible for carrying out, in relation to those products, the duties specified in Article 51 of the Directive in respect of relevant medicinal products manufactured, assembled or imported by him.
(2) If a licence holder satisfies the requirements as to qualifications and experience specified in the definition of “qualified person” in regulation 1(2), he may act as the qualified person in accordance with paragraph (1) for the purposes of that licence.
(3) For the purposes of this paragraph, but without prejudice to paragraph (4) below, the licence holder may regard a person as satisfying the provisions of Article 49 or 50 of the Directive as respects formal qualifications if he produces evidence that—
(a)he is a member of—
(i)the Institute of Biology,
(ii)the Pharmaceutical Society,
(iii)the Royal Society of Chemistry, or
(iv)such other body as may appear to the licensing authority to be an appropriate body for the purpose of this paragraph; and
(b)he is regarded by the body of which he is a member as so satisfying those provisions.
(4) The licence holder—
(a)shall notify the licensing authority of the name and address and degrees, diplomas or qualifications and experience of the person who will carry out the functions of qualified person;
(b)shall notify the licensing authority of any change to the qualified person; and
(c)shall not permit any person to act as qualified person other than the person named in his licence as qualified person or, subject to paragraph (5), any other such person whose name is notified to the licensing authority.
(5) Where, after giving the licence holder and the person acting as a qualified person the opportunity of making representations to them (orally or in writing), the licensing authority is of the opinion that—
(a)the person so acting does not satisfy—
(i)the provisions of Articles 49 and 50 of the Directive as respects qualifications and experience, or
(ii)the requirements as to qualifications and experience specified in paragraph (b) of the definition of “qualified person” in regulation 1(2); or
(b)he is failing to carry out the duties referred to in paragraph (1) adequately or at all,
and has notified the licence holder accordingly in writing, the licence holder shall not permit that person to act as a qualified person.
(6) Subject to paragraph (7), the licence holder shall at all times provide and maintain such staff, premises, equipment and facilities as will enable the qualified person who is at his disposal pursuant to paragraph (1), to carry out the duties referred to in that subsection.
(7) A licence holder shall not be required to meet the requirements of this regulation in relation to any activity carried out pursuant to his licence which consists of the manufacture, assembly or import from a third country of relevant medicinal products pursuant to a manufacturer’s licence insofar as such activity is limited to the manufacture, assembly or importation of —
(a)exempt relevant medicinal products; or
(b)products which may be placed on the market in any EEA State without a marketing authorization by virtue of legislation adopted by that State under Article 5(2) of the Directive.
(8) Where the conditions specified in paragraph 2 of Article 51 of the Directive are satisfied, a qualified person shall not be required to meet the requirements of point (b) of the first sub-paragraph of paragraph 1 of Article 51 of the Directive in respect of the import of any relevant medicinal product from a third country.