Marketing authorisation holder (MAH) information about PSUR submission, content, synchronisation, worksharing and active substances.
As a marketing authorisation holder (MAH) you must submit a Periodic Safety Update Report (PSUR) to the Veterinary Medicines Directorate (VMD) at intervals of between 6 months and 3 years for each product you sell.
Submit a PSUR
You can electronically submit a PSUR securely using either of:
In each PSUR you should summarise the following for the period of the report:
- the amount of product you have sold
- all adverse event reports you have received
- information about your product from other sources (published literature, new studies etc)
Reporting periods and worksharing
Your PSUR reporting period must follow on from the last PSUR without gaps or overlaps. The cut-off date for information to be included in a PSUR is called the Data Lock Point (DLP) and is the end date of the reporting period. You can take part in the Heads of Medicines Agencies (HMA) ‘worksharing’ scheme for products that contain the ingredients (active substances) that have been agreed by the NCAs and MAHs. The scheme reduces the number of PSURs you have to submit and the number of questions you will be asked.
You can find information about the scheme and a list of DLPs for each active substance on the HMA website.
PSURs: what to include
You must include all the information described in Volume 9B of the Rules Governing Medicinal Products in the European Union, Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use.
You will find additional guidance on the Veterinary Pharmacovigilance: your responsibilities page, which describes specific UK requirements.
The VMD and other European National Competent Authorities (NCAs) use this information to weigh up the benefits and risks of each product. If necessary, we will tell you to make changes to your product’s instructions or warnings.
Telephone: 01932 338427
Published: 28 October 2014