⚠️ Pharmacovigilance - temporary changes to the adverse reactions reporting
Please note, you cannot currently use the Veterinary Medicines Directorate (VMD) service to report adverse reactions from Solensia (or any other medicine).
VMD is currently reviewing the recent law change, and have temporarily disabled their reporting form. VMD website will be updated as soon as the review is finalized.
As per the Veterinary Medicines Regulations 2013 (VMR 2013), ("Guideline III Adverse Event Reporting", updated on Dec 16, 2024), it is on the Marketing Authorization Holder (MAH) to record and report adverse events associated with their veterinary medicinal products (VMPs) for which Marketing Authorizations (MAs) are held are defined in the VMR 2013 (as amended) Schedule 1 Part 8 paragraph 57-59.
The MAH should report all adverse events occurring worldwide for their VMPs which are authorized in the UK, or the equivalent products authorized elsewhere, to the VMD within 30 calendar days of being made aware of them.
What this means for you?
You cannot currently report any adverse reactions directly to VMD, but are required to do so directly to Zoetis, who must then forward your report to VMD within 30 days.
To report adverse reactions to Zoetis, you can either:
Further information can be found in the Guideline (link above). If you have any questions regarding pharmacovigilance, you can e-mail adverse.events@vmd.gov.uk
We will update you as soon as VMD's form has been reopened.
