Commission Implementing Regulation (EU) 2021/1281

In forceThis text since 23 Aug 2021law://eu/reg/2021/1281/art_7@2026-11-11

Article 7Performance indicators#

Marketing authorisation holders shall use relevant performance indicators to continuously monitor the performance of pharmacovigilance activities and the outcome of risk minimisation measures. They shall keep a list of those performance indicators including the reason why they have been chosen and a description on how to use them in Annex IV, point (iii) to the pharmacovigilance system master file.

Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.

Key facts

Type: Implementing regulation · Commission Implementing Regulation (EU) 2021/1281 · EEA relevant
Adopted: 2 Aug 2021
In force: 23 Aug 2021
Applies from: 28 Jan 2022
Made by: Directorate-General for Health and Food Safety, European Commission
Official: EUR-Lex 32021R1281 · ELI

Topics

application of EU law consumer information disclosure of information health control labelling market approval marketing standard pharmaceutical legislation pharmacology veterinary medicinal product Medicinal products Veterinary legislation

History · 1 version

23 Aug 2021Reading

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Defined terms · 3

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performance indicator
means an item of information collected at regular intervals to monitor the performance of a system;
quality management system
means a formalised system that provides for comprehensive processes, procedures, and responsibilities for achieving quality policies and objectives to coordinate and direct an organisation’s activities and improve its effectiveness and efficiency in this regard on a continuous basis;
signal
means information that arises from one or multiple sources, including observations and experiments, which suggests a potentially new causal association, or a new aspect of a known causal association between an intervention and an adverse event or a set of related adverse events, that is judged likely to justify further investigation of possible causality.