Chapter 3, Article 20 · Commission Implementing Regulation (EU) 2021/1281

Contents

Article 20Communication#

1.Marketing authorisation holders shall have an overarching communication plan that identifies the relevant stakeholders in the Union, including veterinarians, other healthcare professionals, customers and the general public. In cases of urgent safety concerns, it shall outline the approach to be taken to communicate in a timely manner concerns arising from pharmacovigilance data or in relation to other relevant pharmacovigilance information.

2.The communication plan shall include information on how marketing authorisation holders:

(a)identify the target audience;

(b)identify effective means for communication with the intended target audience;

(c)identify the specific objectives of the communication;

(d)define a timetable for the communication;

(e)ensure the relevance and clarity of the information for the intended target audience;

(f)identify and coordinate all stakeholders involved in the communication;

(g)give prior or simultaneous notification to the competent authority or the Agency, as applicable, of any public announcement on pharmacovigilance information, in accordance with Article 77(11) of Regulation (EU) 2019/6;

(h)measure the effectiveness of the communication.

3.Marketing authorisation holders shall use the data-processing network of the Union pharmacovigilance database for communication of alerts related to pharmacovigilance data.

Defined terms · 3

Show every defined term

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.