F1ANNEX ICHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS
Annotations:
Amendments (Textual)
TITLE IIREQUIREMENTS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
PART 5:PARTICULARS AND DOCUMENTS
A.INTRODUCTION
The dossier of the safety and efficacy studies shall include an introduction defining the subject and indicating the tests which have been carried out in compliance with Parts 3 and 4 as well as a summary, with detailed references to the published literature. This summary shall contain an objective discussion of all the results obtained and lead to a conclusion on the safety and efficacy of the immunological veterinary medicinal product. Omission of any tests or trials listed shall be indicated and discussed.
Substituted by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance).