The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

Duties on holders of Article 24 authorisations

25.  The holder of an Article 24 authorisation shall—

(a)comply with the applicable provisions of Article 27(a) to (e) of Directive 81/851;

(b)comply with the applicable principles and guidelines of good manufacturing practice set out in Articles 4 to 14 of Directive 91/412 as interpreted in accordance with the second paragraph of Article 3 of that Directive;

(c)keep a detailed record, in accordance with the provisions of Article 27(g) of Directive 81/851, in respect of a registered product or sample of such product supplied by him;

(d)make such record available to the relevant enforcement authority for inspection for a period of three years from and including the date on which such record is made;

(e)have permanently and continuously at his disposal the services of at least one qualified person (who may be himself if he fulfils the conditions laid down in Article 31 of Directive 81/851) who is responsible in particular for carrying out the duties specified in Article 30 of Directive 81/851; and

(f)furnish the relevant enforcement authority, upon request, with proof that he has carried out the applicable control tests specified in Article 35 of Directive 81/851.