Article 19

The holder of an authorization referred to in Article 16 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; to dispose of the authorized proprietary medicinal products only in accordance with the legislation of the Member States concerned; 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 17 ; the competent authority shall in any event be immediately informed if the qualified person referred to in Article 21 is replaced unexpectedly; to allow the agents of the competent authority of the Member State concerned access to his premises at any time; to enable the qualified person referred to in Article 21 to carry out his duties, for example by placing at his disposal all the necessary facilities.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.