The Human Medicines Regulations 2012

The licensing authority and the Ministers

6.—(1) The licensing authority is responsible for the grant, renewal, variation, suspension and revocation of licences, authorisations, certificates and registrations under these Regulations.

(2) In these Regulations “the licensing authority” means either or both of the Ministers.

(3) Any function that—

(a) is conferred on “the licensing authority” by these Regulations; or

(b) is a function within paragraph (4),

may be exercised by either of the Ministers acting alone or by both of them acting jointly.

(4) The functions of a member State, or of the competent authority of a member State, under any of the relevant EU provisions are to be exercised by the licensing authority if—

(a) they relate to medicinal products; and

(b) they are to be exercised by, or by any authority of, the United Kingdom.

(5) Paragraph (4) does not apply to any function that is conferred by these Regulations on a person or body other than the licensing authority.

(6) In these Regulations “the Ministers” means—

(a) the Secretary of State; and

(b) the Minister for Health, Social Services and Public Safety.

(7) Any function that is conferred on “the Ministers” by these Regulations is to be exercised by the Ministers acting jointly.

(8) Paragraph (7) does not apply where these Regulations provide for a function of the Ministers to be exercised by either of them acting alone or both of them acting jointly.