Article 11 SME Office

United Kingdom

The Executive Director of the Agency shall set up dedicated administrative structures and specific procedures for the establishment of an SME Office.

The SME Office shall have the following tasks:

(a)

to give advice to applicants on the administrative and procedural steps necessary to comply with the requirements laid down in Regulation (EC) No 726/2004;

(b)

to ensure the appropriate monitoring of all requests and applications submitted by the same applicant and related to a particular medicinal product;

(c)

to organise workshops and training sessions for applicants on the administrative and procedural steps necessary to comply with the requirements laid down in Regulation (EC) No 726/2004.

Notes on the whole EU Regulation

Textual amendments

F1: Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(j) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)