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ANNEX II U.K. REQUIREMENTS REFERRED TO IN POINT (B) OF ARTICLE 8(1) (1)

TITLE II U.K. Requirements for immunological veterinary medicinal products

PART 5 U.K. Particulars and documents

B. LABORATORY STUDIES U.K.

The following shall be provided for all studies:

(1)

a summary;

(2)

the name of the body having carried out the studies;

(3)

a detailed experimental protocol giving a description of the methods, apparatus and materials used, details such as species or breed of animals, categories of animals, where they were obtained, their identification and number, the conditions under which they were housed and fed (stating, inter alia, whether they were free from any specified pathogens and/or specified antibodies, the nature and quantity of any additives contained in the feed), dose, route, schedule and dates of administration, a description and a justification of the statistical methods used;

(4)

in the case of control animals, whether they received a placebo or no treatment;

(5)

in the case of treated animals and where appropriate, whether they received the test product or another product authorised in the Community;

(6)

all general and individual observations and results obtained (with averages and standard deviations), whether favourable or unfavourable. The data shall be described in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author. The raw data shall be presented in tabular form. By way of explanation and illustration, the results may be accompanied by reproductions of recordings, photomicrographs, etc.;

(7)

the nature, frequency and duration of observed adverse reactions;

(8)

the number of animals withdrawn prematurely from the studies and reasons for such withdrawal;

(9)

a statistical analysis of the results, where such is called for by the test programme, and variance within the data;

(10)

occurrence and course of any intercurrent disease;

(11)

all details concerning veterinary medicinal products (other than the product under study), the administration of which was necessary during the course of the study;

(12)

an objective discussion of the results obtained, leading to conclusions on the safety and efficacy of the product.

(1)

This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.