Regulation (EU) 2019/6 of the European Parliament and of the CouncilDangos y teitl llawn

PART 5 U.K. Particulars and documents

A. INTRODUCTION U.K.

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.

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the number of animals withdrawn prematurely from the studies and reasons for such withdrawal;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

C. FIELD STUDIES U.K.

Particulars concerning field studies shall be sufficiently detailed to enable an objective judgement to be made. They shall include the following:

(1)

a summary;

(2)

name, address, function and qualifications of the investigator in charge;

(3)

place and date of administration, identity code that can be linked to the name and address of the owner of the animal(s);

(4)

details of the trial protocol, giving a description of the methods, apparatus and materials used, details such as the route of administration, the schedule of administration, the dose, the categories of animals, the duration of observation, the serological response and other investigations carried out on the animals after administration;

(5)

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

(6)

identification of the treated and control animals (collective or individual, as appropriate), such as species, breeds or strains, age, weight, sex, physiological status;

(7)

a brief description of the method of rearing and feeding, stating the nature and quantity of any additives contained in the feed;

(8)

all the particulars on observations, performances and results (with averages and standard deviation); individual data shall be indicated when tests and measurements on individuals have been carried out;

(9)

all observations and results of the studies, whether favourable or unfavourable, with a full statement of the observations and the results of the objective tests of activity required to evaluate the product; the techniques used must be specified and the significance of any variations in the results explained;

(10)

effects on the animals’ performance;

(11)

the number of animals withdrawn prematurely from the studies and reasons for such withdrawal;

(12)

the nature, frequency and duration of observed adverse reactions;

(13)

occurrence and course of any intercurrent disease;

(14)

all details concerning veterinary medicinal products (other than the product under study) which have been administered either prior to or concurrently with the test product or during the observation period; details of any interactions observed;

(15)

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.