IMPORTANT: This guidance should be implemented alongside the Implementation explainer: Pharmacovigilance at [link to Implementation Explainer going up tomorrow] which includes important information on transitional requirements and timelines following the Veterinary Medicines (Amendment etc.) Regulations 2024 coming into force.
What is pharmacovigilance
The World Health Organization has defined pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. This principle also applies to veterinary medicines.medicinal products.
Adverse effects may be undesirable side effects, such as adverse reactions, or a medicine may not work as expected, known as a lack of expected efficacy. The effects may be seen, for example, in the animal being treated, in other animals, the person handling the medicine or in the environment.
Veterinary pharmacovigilance legislation
Statutory Instrument 2013 Number 2033, the Veterinary Medicines Regulations 2013 (as amended), hereinafter referred to as the VMR,VMR 2013 (as amended), sets out the legal framework for the pharmacovigilance of veterinary medicinesmedicinal inproducts Great(VMPs) Britainin (GB).GB.
Although Although Part 8 of Schedule 1 of of the VMR 2013 (as amended) contains the majority of pharmacovigilance provisions in the legislation, you can find other requirements directly relevant to the conduct of pharmacovigilance in other Schedules and Parts of the VMR.Parts.
This guidance document applies to all products authorised in GreatGB. Britain.Products All products authorised in Northern Ireland (NI) are required to follow the EUEuropean acquisUnion and(EU) thereforeacquis. should follow the guidance set out in EudraLex Volume 9B. Notwithstanding, specifically for reporting of adverse events cases occurring in NorthernNI, Ireland,this guidance provided by this document should be followed and these reports should continue to be submitted to the VMD.
Who is responsible for pharmacovigilance
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This guidance has been prepared by the VMD and is specifically related to pharmacovigilance concerning veterinary medicines.medicinal products. It should be noted that this guidance will be regularly reviewed and updated.
The VMR 2013 (as amended) also details legal obligations for some products which do not have an MA. Guidance on this is available in Guidance VI Pharmacovigilance for other products.