Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (c. 83)

TITLE IV U.K. MANUFACTURE AND IMPORTATION

Article 46 U.K.

The holder of a manufacturing authorization shall at least be obliged:

(a)

to have at his disposal the services of staff who comply with the legal requirements existing in the Member State concerned both as regards manufacture and controls;

(b)

to dispose of the authorized medicinal products only in accordance with the legislation of the Member States concerned;

(c)

to give prior notice to the competent authority of any changes he may wish to make to any of the particulars supplied pursuant to Article 41; the competent authority shall, in any event, be immediately informed if the qualified person referred to in Article 48 is replaced unexpectedly;

(d)

to allow the agents of the competent authority of the Member State concerned access to his premises at any time;

(e)

to enable the qualified person referred to in Article 48 to carry out his duties, for example by placing at his disposal all the necessary facilities;

(f)

[F1 to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.

This point shall also be applicable to certain excipients, the list of which as well as the specific conditions of application shall be established by a Directive adopted by the Commission in accordance with the procedure referred to in Article 121(2).]

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.