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

3. Well-established veterinary use

For veterinary medicinal products the active substance(s) of which has/have been in ‘well-established veterinary use’ as referred to in Article 13a, with recognised efficacy and an acceptable level of safety, the following specific rules shall apply.

The applicant shall submit Parts 1 and 2 as described in Title I of this Annex.

For Parts 3 and 4, a detailed scientific bibliography shall address all aspects of the safety and efficacy.

The following specific rules shall apply in order to demonstrate the well-established veterinary use:

3.1.

The following factors shall be taken into account in order to establish a well-established veterinary medicinal use of constituents of veterinary medicinal products:

(a)

the time over which an active substance has been used;

(b)

quantitative aspects of the use of the active substance;

(c)

the degree of scientific interest in the use of the active substance (reflected in the published scientific literature);

(d)

the coherence of scientific assessments.

Different periods of time may be necessary for establishing well-established use of different substances. In any case, however, the period of time required for establishing a well-established veterinary use of a constituent of a medicinal product shall not be less than 10 years from the first systematic and documented use of that substance as a veterinary medicinal product in the Community.

3.2.

The documentation submitted by the applicant shall cover all aspects of the safety and/or efficacy assessment of the product for the proposed indication in the target species using the proposed route of administration and dosage regimen. It must include or refer to a review of the relevant literature, taking into account pre- and post-marketing studies and published scientific literature concerning experience in the form of epidemiological studies and in particular of comparative epidemiological studies. All documentation, both favourable and unfavourable, shall be communicated. With respect to the provisions on well-established veterinary use, it is in particular necessary to clarify that bibliographic reference to other sources of evidence (post-marketing studies, epidemiological studies etc.) and not just data related to tests and trials may serve as a valid proof of safety and efficacy of a product if an application explains and justifies the use of these sources of information satisfactorily.

3.3.

Particular attention must be paid to any missing information and justification must be given as to why demonstration of an acceptable level of safety and/or efficacy can be supported although some studies are lacking.

3.4.

The detailed and critical summaries regarding safety and efficacy must explain the relevance of any data submitted which concern a product different from the product intended for marketing. A judgement must be made whether or not the product studied can be considered as similar to the product, for which application for a marketing authorisation has been made in spite of the existing differences.

3.5.

Post-marketing experience with other products containing the same constituents is of particular importance and applicants shall put a special emphasis on this issue.

(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.