OpenLegislation

Article 17 Decision

United Kingdom

Original text. Later amendments are not shown.

1.

The decision provided for in Article 16 shall be based exclusively on grounds on which the marketing authorisation holder has been able to comment.

2.

The Commission shall inform the marketing authorisation holder of the judicial remedies available.

3.

The Commission shall communicate the adoption of the decision to the Agency and to the Member States.

4.

When publishing details of its decision in accordance with the second subparagraph of Article 84(3) of Regulation (EC) No 726/2004, the Commission shall have regard to the legitimate interest of marketing authorisation holders and other persons in the protection of their business secrets.

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(n) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)