Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

G. STABILITY TESTS

The particulars and documents accompanying the application for marketing authorisation pursuant to Article 12(3)(f) and (i) shall be submitted in accordance with the following requirements.

A description shall be given of the tests undertaken to support the shelf life proposed by the applicant. These tests shall always be real-time studies; they shall be carried out on a sufficient number of batches produced according to the described production process and on products stored in the final container(s); these tests include biological and physico-chemical stability tests.

The conclusions shall contain the results of analyses, justifying the proposed shelf life under all proposed storage conditions.

In the case of products administered in feed, information shall also be given as necessary on the shelf life of the product, at the different stages of mixing, when mixed in accordance with the recommended instructions.

Where a finished product requires reconstitution prior to administration or is administered in drinking water, details of the proposed shelf life are required for the product reconstituted as recommended. Data in support of the proposed shelf life for the reconstituted product shall be submitted.

Stability data obtained from combined products may be used as preliminary data for derivative products containing one or more of the same components.

The proposed in-use shelf life shall be justified.

The efficacy of any preservative system shall be demonstrated.

Information on the efficacy of preservatives in other similar immunological veterinary medicinal products from the same manufacturer may be sufficient.

(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.