ANNEX

“ANNEX I CHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS

TITLE I REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS

PART 3: SAFETY AND RESIDUES TESTS

B. Residue tests

CHAPTER II: PRESENTATION OF PARTICULARS AND DOCUMENTS

1. Identification of the product

An identification of the veterinary medicinal product(s) used in the testing shall be provided, including:

• composition,

• the physical and chemical (potency and purity) test results for the relevant batch(es),

• batch identification,

• relationship to the final product,

• specific activity and radio-purity of labelled substances,

• position of labelled atoms in the molecule.

The dossier of residue tests shall include:

• an index of all studies included in the dossier,

• a statement confirming that all data known by the applicant at the time of submission, whether favourable or unfavourable, are included,

• a justification for the omission of any type of study,

• an explanation of the inclusion of an alternative type of study,

• a discussion of the contribution that any study that pre-dates GLP can make to the overall risk assessment,

• a withdrawal period proposal.

Each study report shall include:

• a copy of the study plan (protocol),

• a statement of compliance with good laboratory practice, where applicable,

• a description of the methods, apparatus and materials used,

• a description of the results obtained, in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author,

• a statistical analysis of the results where appropriate,

• a discussion of the results,

• an objective discussion of the results obtained, and proposals concerning the withdrawal periods necessary to ensure that no residues which might constitute a hazard for consumers are present in foodstuffs obtained from treated animals.”