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

Article 81 Signal management process

1. Marketing authorisation holders shall carry out a signal management process for their veterinary medicinal products, if necessary, taking into account sales data and other relevant pharmacovigilance data of which they can reasonably be expected to be aware and which may be useful for that signal management process. That data may include scientific information gathered from scientific literature reviews.

2. Where the outcome of the signal management process identifies a change to the benefit-risk balance or a new risk, marketing authorisation holders shall notify it without delay and no later than within 30 days to the competent authorities or to the Agency, as applicable, and take the necessary action in accordance with Article 77(10).

The marketing authorisation holder shall record, at least annually, all results and outcomes of the signal management process, including a conclusion on the benefit-risk balance, and, if applicable, references to relevant scientific literature in the pharmacovigilance database.

In the case of veterinary medicinal products referred to in point (c) of Article 42(2), the marketing authorisation holder shall record in the pharmacovigilance database all results and outcomes of the signal management process, including a conclusion on the benefit-risk balance, and, if applicable, references to relevant scientific literature according to the frequency specified in the marketing authorisation.

3. The competent authorities and the Agency may decide to perform a targeted signal management process for a given veterinary medicinal product or a group of veterinary medicinal products.

4. For the purpose of paragraph 3, the Agency and the coordination group shall share the tasks related to the targeted signal management process and shall jointly select for each veterinary medicinal product or group of veterinary medicinal products a competent authority or the Agency as responsible for such targeted signal management process (‘lead authority’).

5. When selecting a lead authority, the Agency and the coordination group shall take into account the fair allocation of tasks and shall avoid duplication of work.

6. Where the competent authorities or the Commission, as applicable, consider that follow-up action is necessary, they shall take appropriate measures as referred to in Articles 129, 130 and 134.