The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

Requirement as to responsible persons

10.—(1) Where a wholesale dealer’s licence relates to relevant medicinal products, the wholesale dealer’s licence holder shall at all times have at his disposal the services of a person (referred to in this regulation as “a responsible person”) who, in the opinion of the licensing authority—

(a)has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate for performing the functions of responsible person; and

(b)has experience in those procedures and activities which is adequate for those purposes.

(2) The functions of the responsible person shall be to ensure, in relation to relevant medicinal products, that—

(a)the conditions under which the licence has been granted have been, and are being, complied with; and

(b)the quality of relevant medicinal products which are being handled by the wholesale dealer’s licence holder are being maintained in accordance with the requirements of the marketing authorizations applicable to those products.

(3) The licence holder shall—

(a)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 responsible person;

(b)notify the licensing authority of any change to the responsible person; and

(c)not permit any person to act as responsible person other than the person named in his licence as responsible person or, subject to paragraph (4) any other such person whose name is notified to the licensing authority.

(4) Where, after giving the licence holder and the person acting as a responsible person the opportunity of making representations to them (orally or in writing), the licensing authority are of the opinion that—

(a)the person so acting does not satisfy the provisions of paragraph (1) as respects qualifications and experience, or

(b)he is failing to carry out the duties referred to in paragraph (2) adequately or at all,

and have notified the licence holder accordingly in writing, the licence holder shall not permit that person to act as a responsible person.