OpenLegislation

Article 2 Scope

United Kingdom

Original text. Later amendments are not shown.

1.

This Regulation shall apply to SMEs within the meaning of Recommendation 2003/361/EC in the version of 6 May 2003 which are established in the Community.

2.

Unless otherwise specified, this Regulation shall apply both to applications concerning medicinal products for human use and to applications concerning veterinary medicinal products, within the meaning of Directives 2001/83/ECf1 and 2001/82/ECf2 of the European Parliament and of the Council respectively.

Annotations

Footnotes

f1

OJ L 311, 28.11.2001, p. 67.

f2

OJ L 311, 28.11.2001, p. 1.

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)