OpenLegislation

Article 11 Recognition of inspection conclusions

United Kingdom

Original text. Later amendments are not shown.

Inspectors shall carry out inspections on behalf of the Union. The results of those inspections shall be recognised by all Member States.

In case of divergences between Member States in relation to the verification of compliance with the applicable legislation, the Member States, or the European Medicines Agency within the framework of its powers as provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Councilf1, shall inform the Commission. The Commission, after consulting those Member States and the European Medicines Agency, may request a new inspection.

Annotations

Footnotes

f1

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).