Commission Directive 2005/28/ECDangos y teitl llawn

Article 13

The holder of the authorisation shall at least comply with the following requirements:

(a)

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

(b)

to dispose of the investigational/authorised medicinal products only in accordance with the legislation of the Member State 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 Article 10(1) and, in particular, to inform the competent authority immediately if the qualified person referred to in Article 13(2) of Directive 2001/20/EC is replaced unexpectedly;

(d)

to allow 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 13(2) of Directive 2001/20/EC to carry out his duties, for example by placing at his disposal all the necessary facilities;

(f)

to comply with the principles and guidelines for good manufacturing practice for medicinal products as laid down by Community law.

Detailed guidelines in line with the principles referred to in point (f) of the first paragraph will be published by the Commission and revised where necessary to take account of technical and scientific progress.