The Human Medicines Regulations 2012

Conditions of certificate of registration

105.—(1) The licensing authority may—

(a) grant a certificate of registration subject to conditions; or

(b) vary or remove a condition to which the certificate of registration is subject.

(2) The powers in paragraph (1) may be exercised only after consultation with the applicant for the certificate or (as the case may be) its holder.

(3) The power in paragraph (1)(a) to grant an authorisation subject to conditions may be exercised only—

(a) in exceptional circumstances; and

(b) when the applicant can show that the applicant is unable to provide comprehensive data on the safety of the medicinal product under normal conditions of use.

(4) The conditions must relate to a matter addressed by Annex I to the 2001 Directive.

(5) The conditions may, in particular, relate to the safety of the product to which the certificate relates.

(6) The conditions may, in particular, require that, where there is an incident relating to the use of the product—

(a) the incident must be reported to the licensing authority; and

(b) such other action as may be specified in the conditions must be taken.

(7) The licensing authority must keep under review—

(a) the conditions to which a certificate of registration is subject; and

(b) the holder’s compliance with those conditions.

(8) The licensing authority must consider those matters no less frequently than—

(a) at the end of the period of one year beginning with the date on which the certificate was granted; and

(b) at the end of each subsequent period of one year.

(9) Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a certificate of registration is subject.