Regulation 177 Application of this Part and interpretation

This Part and Schedule 33 apply, except to the extent set out in paragraph (4)(b), in relation to medicinal products that are the subject of—

Schedule 12A applies in relation to medicinal products that are the subject of a F2UKMA(GB), UKMA(UK)(Category 1) or a THR(GB).

Regulations 178 and 179 apply in relation to EAMS medicinal products.

F4Except in regulation 191A, references in this Part F5and Schedule 12A to a “holder” are to the holder of—

and, in relation to such references, “product” means the product to which the authorisation or registration relates.

References to an “authorisation or registration” in this Part and in F6Schedules 12A and 33 are references to—

and “authorised or registered” is to be read accordingly.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

In this Part and in F8Schedules 33 and 33A—

• “co-ordination group” means the group of that name established under Article 27 of the 2001 Directive;

• “Eudravigilance database” means the database and data-processing network set up and maintained by the EMA under Article 24 of Regulation (EC) No 726/2004;

• F9“Implementing Regulation” means Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council.

• “infringement notice” has the meaning given to it in regulation 206 (infringement notices);

• “relevant competent authorities” means the competent authority of each EEA state other than the United Kingdom which has granted in relation to a medicinal product—

  1. (a)

     an authorisation in accordance with Chapter 1 of Title III to the 2001 Directive (marketing authorization);

  2. (b)

     an authorisation in accordance with Chapter 4 of Title III to the 2001 Directive (mutual recognition and decentralised procedure);

  3. (c)

     a registration in accordance with Chapter 2a of Title III to the 2001 Directive (traditional use registration for herbal medicinal products); or

  4. (d)

     an authorisation in accordance with Article 126a of the 2001 Directive;

• “relevant post-authorisation safety study” means a post-authorisation safety study which—

  1. (a)

     is non-interventional;

  2. (b)

     is initiated, managed or financed by the holder voluntarily or pursuant to conditions imposed under regulation 59 (conditions of a UK marketing authorisation: general) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation); and

  3. (c)

     involves the collection of safety data from patients or health care professionals; F10...

• F11“signal” means, in relation to a UKMA(GB) F12, UKMA(UK)(Category 1) or THR(GB), information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action; and

• “UK web-portal” has the meaning given in regulation 203 (obligations on licensing authority in relation to national medicines web-portal).