S.L. 458.47 Art. 11Holder to comply with requirements.

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

(a) have at his disposal the services of staff that comply with the legal requirements as regards manufacture and controls;

(b) dispose of the investigational and authorised medicinal products only in accordance with the legislation in force;

(c) give prior notice to the Authority of any changes he may wish to make to any of the particulars supplied pursuant to regulation 8(1) and, in particular, to inform the Authority immediately if the qualified person referred to in Article 13(2) of Directive 2001/20/EC is replaced unexpectedly;

(d) allow agents of the Authority access to his premises at any time;

(e) 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) comply with the principles and guidelines for Good Manufacturing Practice for medicinal products as laid down by Community law.