Guidance

Guideline VI Pharmacovigilance for other products

Updated 22 August 2024

Applies to England, Scotland and Wales

1. Introduction

Some products available for use in animals in the UK are authorised via different pathways or do not have a marketing authorisation. The VMR 2013 (as amended) detail pharmacovigilance responsibilities in these situations, and information on this is detailed in this guideline. If you require any further information, please e-mail adverse.events@vmd.gov.uk

2. Animal Test Certificate (ATC) holder responsibilities

ATC holders must:

• name a person responsible for pharmacovigilance on the ATC application form
• record all adverse events in treated animals
• report online via the VMD online reporting form all adverse events occurring in treated animals to the VMD within 30 calendar days of being made aware of them, the ATC number should be included in the report

Adverse events must be reported whether an animal was treated with the test product or control product (even if this is a placebo, such as saline).

If the ATC holder is also an MAH, then they must report adverse events via VMDS in accordance with Guideline III Adverse Event Reporting.

MAHs must put in place appropriate arrangements to ensure that ‘blinding’ of products does not interfere with pharmacovigilance responsibilities.

Refer to Animal Test Certificates for further information.

3. Medicines for small animals, exempt from authorisation

The manufacturer or importer of medicines exempt from authorisation because they are intended for use in minor pet species must:

• keep records of all adverse events they are made aware of for 3 years
• provide the VMD with copies of adverse event records on request
• report online via the VMD online reporting form all serious adverse events within 15 days of being made aware of them

If the manufacturer or importer of medicines for small pet animals exempt from authorisation is also an MAH, then they must report adverse events via VMDS in accordance with Guideline III Adverse Event Reporting.

Refer to Exemption from authorisation for medicines for small pet animals for further information.

4. Autogenous Vaccine Authorisation (AVA) holder responsibilities

All adverse events, including lack of efficacy, following use of an autogenous vaccine must be reported to the VMD within 30 days of the AVA holder being made aware of the event. All fields should be filled in as completely as possible, but in particular the report should include:

• a description of the adverse event
• the number and species of animal involved
• the date(s) of administration of the product
• the date(s) that the event occurred
• the clinical signs observed
• the AVA number
• the batch release request number, if available

If the AVA number and/or batch release number are not available then the AVA holder should provide:

• a precise description of the vaccine constituents
• the date the vaccine was produced
• the expiry date of the vaccine

so that the exact product and batch can be identified. This information should be taken from the vaccine container label.

Reports should be submitted using the online reporting form.

If the AVA holder is also an MAH, then they must report adverse events via VMDS in accordance with Guideline III Adverse Event Reporting.

Refer to Specific Manufacturing Authorisations for further information.

5. Products for administration under the cascade

Manufacturers of extemporaneous preparations (ManSA) must report any adverse event, including lack of efficacy, to the VMD within 30 days of being made aware of the event. All fields should be filled in as completely as possible, but in particular the report should include:

• details of the extemporaneous preparation
• ManSA reference numbers

Reports should be submitted using the online reporting form.

If the extemporaneous preparation manufacturer is also an MAH, then they must report adverse events via VMDS in accordance with Guideline III Adverse Event Reporting.

Refer to Specific Manufacturing Authorisations for further information.