Regulation 5 Supplementary provisions as to application
The applicant shall in making his application—
take account of the guidance published by the European Commission referred to in the first paragraph of the Introduction to the Annex to Directive 81/852, and
include all information relevant to the evaluation of the product to which the application relates, whether favourable or unfavourable, including all relevant details of any incomplete or abandoned test or trial relating to the product,
and shall confirm in writing that he has done so.
The applicant shall confirm in writing that he has complied with the requirements of the Animals (Scientific Procedures) Act 1986f1 which are relevant to his application.
The applicant shall state which, if any, of the standard provisions for licences it is desired shall be excluded or modified in relation to any product licence granted as a result of the application.
The licensing authority may require the applicant to submit such samples as they may specify—
of the veterinary medicinal product, its active ingredients and its intermediate products or other constituent materials for testing by a laboratory designated for the purposes of Article 9.2 of Directive 81/851, in order to ensure that the applicant’s control testing methods within the meaning of Article 5.9 of that Directive are satisfactory, or
of substances necessary to verify the analytical detection methods to trace residues proposed in the application documents in pursuance of Article 5.8 of that Directive.
Annotations
Footnotes
- f1