OpenLegislation

Article 12 User Guide

United Kingdom

Original text. Later amendments are not shown.

The Agency shall, upon agreement of the Commission, publish a detailed User Guide on the administrative and procedural aspects of the provisions laid down in Regulation (EC) No 726/2004, which are of particular relevance for SMEs. The User Guide shall be kept updated.

The User Guide shall also contain references to existing national provisions for SMEs applicable to the pharmaceutical sector.

For the purposes of the second paragraph, the Member States shall communicate those references to the Agency.

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)