The Human Medicines Regulations 2012

[F1 Registration in relation to active substances U.K.

45N.— (1) For registration in relation to active substances, the licensing authority must have received a valid registration form from the applicant for import, manufacture or, as the case may be, distribution of an active substance and—

(a) 60 days have elapsed since receipt and the licensing authority have not notified the applicant that an inspection will be carried out; or

(b) the licensing authority—

(i) notified the applicant within 60 days of receipt of a registration form that an inspection will be carried out; and

(ii) within 90 days of that inspection the licensing authority have issued that person with a certificate of good manufacturing practice or, as the case may be, of good distribution practice; and

(c) that person has not instructed the licensing authority to end that person’s registration.

(2) The person applying for registration under paragraph (1) must notify the licensing authority of any changes which have taken place as regards the information in the registration form—

(a) immediately where such changes may have an impact on quality or safety of the active substances that are manufactured, imported or distributed;

(b) in any other case, on each anniversary of the receipt of the application form by the licensing authority.

(3) For the purpose of paragraph (2), changes which are notified in accordance with that paragraph shall be treated as incorporated in the application form.

(4) Any notification to the licensing authority under paragraph (2) must be accompanied by the appropriate fee in accordance with the Fees Regulations.

(5) A registration form is valid for the purpose of paragraph (1) if—

(a) it is provided to the licensing authority; and

(b) is completed in the way and form specified in Schedule 7A.

(6) Paragraph (1) does not apply until 20th October 2013 in relation to a person who had, before 20th August 2013, commenced the activity for which the person would, apart from this provision, need to send a registration form to the licensing authority.]

Textual Amendments

F1 Pt. 3 Chs. 3, 4 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 16