Article 46
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) to comply with the principles and guidelines of good manufacturing practice for medicinal products as laid down by Community law.