As a marketing authorisation holder, you must have a communication plan. This is where you describe your action plan to ensure you can communicate about pharmacovigilance data or other relevant pharmacovigilance information in a timely manner.
Contents of your communication plan
Your communication plan should contain information about the way in which you, as a marketing authorisation holder, will:
- determine the target group, such as veterinarians, other medical professionals, customers or the public;
- identify an effective means of communicating with the target group;
- establish the specific objectives for the communication;
- establish a timetable for the communication;
- ensure that the information is relevant and clear to the target group;
- identify and coordinate all of the interested parties involved in the communication;
- notify the competent authority in advance or at the same time of the public communication of veterinary pharmacovigilance data;
- measure the effectiveness of the communication.
Read the relevant VGVP Guideline for more information.
Legal basis
Section 5 of the Veterinary Medicinal Products Regulation (Articles 73 to 81) describes the rules relating to the monitoring of veterinary medicines. Article 20 of Implementing Regulation (EU) 2021/1281 and the Implementing Act on Good Pharmacovigilance Practices describe the requirements for a communication plan.
More information
If you still have questions about communication plans, please contact the Veterinary Medicinal Products Unit.
Note: This Regulation has completely changed the rules relating to the monitoring of veterinary medicines. It is expected that the procedures will be clarified further over the next few years, and guidance documents will be supplemented or amended. As soon as this happens, we will amend the above text. You can always find the latest information about the new pharmacovigilance rules on the EMA Pharmacovigilance website.