TITLE IV

MANUFACTURE AND IMPORTS
Article 50
The holder of a manufacturing authorization shall at least be obliged to:
1. have at his disposal the services of staff complying with the legal requirements existing in the Member State concerned as regards both manufacture and controls;
2. dispose of the authorized veterinary medicinal products only in accordance with the legislation of the Member States concerned;
3. give prior notice to the competent authority of any changes which he may wish to make to any of the particulars supplied pursuant to Article 45; the competent authority shall, in any event, be immediately informed if the qualified person referred to in Article 52 is replaced unexpectedly;
4. allow the representatives of the competent authority of the Member State concerned access to his premises at any time;
5. enable the qualified person referred to in Article 52 to carry out his duties, particularly by placing at his disposal all the necessary facilities;
6. comply with the principles and the guidelines on good manufacturing practice for medicinal products and use as starting materials only active substances which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials;
7. keep detailed records of all veterinary medicinal products supplied by him, including samples, in accordance with the laws of the countries of destination. The following information at least shall be recorded in respect of each transaction, whether or not it is made for payment:
  - date,
  - name of the veterinary medicinal product,
  - quantity supplied,
  - name and address of the recipient,
  - batch number.
These records shall be available for inspection by the competent authorities for a period of at least three years.
Substituted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.