Directive 2001/83/EC of the European Parliament and of the CouncilDangos y teitl llawn

Article 20 U.K.

Member States shall take all appropriate measures to ensure that:

(a)

the competent authorities verify that manufacturers and importers of medicinal products coming from third countries are able to carry out manufacture in compliance with the particulars supplied pursuant to Article 8(3)(d), and/or to carry out controls according to the methods described in the particulars accompanying the application in accordance with Article 8(3)(h);

(b)

the competent authorities may allow manufacturers and importers of medicinal products coming from third countries, [F1 in justifiable cases], to have certain stages of manufacture and/or certain of the controls referred to in (a) carried out by third parties; in such cases, the verifications by the competent authorities shall also be made in the establishment designated.

Textual Amendments

F1 Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.