Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Article 93 Obligations of the holder of a manufacturing authorisation

1. The holder of a manufacturing authorisation shall:

(a) have at its disposal suitable and sufficient premises, technical equipment and testing facilities, for the activities stated in its manufacturing authorisation;

(b) have at its disposal the services of at least one qualified person referred to in Article 97 and ensure that the qualified person operates in compliance with that Article;

(c) enable the qualified person referred to in Article 97 to carry out his or her duties, particularly by providing access to all the necessary documents and premises, and by placing at his or her disposal all the necessary technical equipment and testing facilities;

(d) give at least a 30 days prior notice to the competent authority before the replacement of the qualified person referred to in Article 97 or, if prior notice is not possible because the replacement is unexpected, inform the competent authority immediately;

(e) have at its disposal the services of staff complying with the legal requirements existing in the relevant Member State as regards both manufacture and controls;

(f) allow the representatives of the competent authority access to the premises at any time;

(g) keep detailed records of all veterinary medicinal products which the holder of a manufacturing authorisation supplies in accordance with Article 96, and keep samples of each batch;

(h) only supply veterinary medicinal products to wholesale distributors of veterinary medicinal products;

(i) inform the competent authority and the marketing authorisation holder immediately if the holder of a manufacturing authorisation obtains information that veterinary medicinal products which fall within the scope of its manufacturing authorisation are, or are suspected of being, falsified irrespective of whether those veterinary medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale by means of information society services;

(j) comply with good manufacturing practice for veterinary medicinal products and use as starting materials only active substances which have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practice for active substances;

(k) verify that each manufacturer, distributor and importer within the Union from whom the holder of a manufacturing authorisation obtains active substances is registered with the competent authority of the Member State in which the manufacturer, distributor and importer are established, in accordance with Article 95;

(l) perform audits based on a risk assessment on the manufacturers, distributors and importers from whom the holder of a manufacturing authorisation obtains active substances.

2. The Commission shall, by means of implementing acts, adopt measures on good manufacturing practice for veterinary medicinal products and active substances used as starting materials, referred to in point (j) of paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).