Report a product defect: veterinary medicine
Source: gov.uk (2025-10-16)

How a marketing authorisation holder should report a defect with a veterinary medicine.

Reporting a product defect

Only authorised veterinary medicines that are of suitable quality, safety and efficacy are permitted on the market. To ensure protection of animal and public health, we assess information about potentially defective products reported to us.

We receive reports by Marketing Authorisation Holders (MAHs) or by another National Competent Authority (NCA), via a Rapid Alert Notification (RAN) or a Good Manufacturing Practice statement of non-compliance.

If a pharmaceutical company becomes aware of an issue or defect with one of their products or a batch of product they must report this to the Veterinary Medicines Directorate (VMD).

Complete the Product defect report form (https://assets.publishing.service.gov.uk/media/68122454c47c2060a91216ac/1870242-v1-VMD_L4_Authorisations_TEMP_002_C_Product_Defect_Batch_Recall_Report__Recall_2_.odt) (ODT, 38.7 KB) and send it to xxx@xxx.xx (mailto:xxx@xxx.xx).

If the product or batch is likely to be recalled due to the defect you must contact the VMD to discuss the issue. Where appropriate give details of the level of recall, for example wholesaler level, veterinary practice level.

All other reporters should contact the marketing authorisation holder.

List of recalled products

Products recalled in the UK in the last 12 months.

What issues are classed as a product defect

These could include:
- incorrect labelling, such as product strength, name of ingredients
- misinformation or lack of information on the packaging or leaflets
- incorrect manufacture, such as strength of the ingredients or an issue with the container
- contamination of any kind
- stability, such as expiry
- counterfeit or deliberately tampered with product
A suspected defective product is one which:
- proves to be harmful under normal conditions of use
- has a composition that’s not as declared
- has not had the controls on the finished product or during the manufacturing processes or other requirement of the manufacturing authorisation fulfilled
In cases of serious risk to animal or public health, we may instruct MAHs to suspend further supply of a product and/or to recall one or more defective batches from the market.

Legal requirement

The holder of an authorisation referred to in Article 44 of Directive 2001/82/EC (for veterinary products) is required by Article 13 of Directive 91/412/EEC (for veterinary products) to implement an effective procedure for the recall of defective products. The authorisation holder is required to notify the relevant Competent Authority of any defect that could result in a recall and indicate, as far as possible, the countries of destination of the defective product.

For information on human medicines please visit the MHRA Safety Information page (http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/index.htm).

Procedure for submitting product defect reports

MAHs should submit details of suspected defective reports to us on the Product defect report form (https://assets.publishing.service.gov.uk/media/68122454c47c2060a91216ac/1870242-v1-VMD_L4_Authorisations_TEMP_002_C_Product_Defect_Batch_Recall_Report__Recall_2_.odt) (ODT, 38.7 KB). The form requires details of:
- The product name and its marketing authorisation (MA) number
- The name of the MAH or distributor
- The details of the manufacturing site(s) including the batch certification/release/importation sites
- The batch number and expiry date of the product
- The nature of the defect
- Distribution details
- The action taken or being taken by the MAH
Send the completed form to xxx@xxx.xx (mailto:xxx@xxx.xx).

The product defect report will be logged and circulated to our Assessment Group comprising Quality, Safety & Efficacy assessors, GMP inspectors, pharmacovigilance vets and other experts for their comments.

The Assessment Group’s comments and requests for additional information are communicated to the MAH.

Correspondence will continue until we are satisfied that the MAH has effectively dealt with the product defect. This may include a product or batch recall, submission of a variation or even expiry of a product’s authorisation.

Classification of Product Defects

Product defects are classified using the following high level terms (HLTs):

Product Recalls

Where a suspected defective product is considered to pose a serious risk to animal or public health we will normally instruct the MAH to withdraw the affected product from the market, that is, to initiate a product recall. The recall level will depend on the seriousness of the risk. Defects are classified Class 1 to 3 as below:
- Class 1 (Critical): the defect presents a life threatening or serious risk to health
- Class 2 (Major): the defect may cause mistreatment or harm to the animal but it is not critical
- Class 3 (Minor): the defect is unlikely to cause harm to the patient and typically arises from non-compliance with the MA or the product’s specification
Class 1 defects will normally result in a product recall to the end-user, such as to farmer or pet owner.

Class 2 will normally result in a recall to retailer level, such as veterinary surgeon, pharmacist or suitably qualified person (SQP).

Class 3 defects may result in a recall to wholesale dealer although in most cases no recall is considered necessary.

For Class 1 and 2 recalls we will also issue a rapid alert notification (RAN) in accordance with the procedure described in the EMA’s Compilation of Community Procedures on Inspections and Exchange of Information (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-community-procedures-inspections-exchange-information_en.pdf).

In the case of Class 1 recalls, we send a RAN to other national competent authorities including EEA member States, PIC/S, EDQM, WHO, FDA and MRA partners, irrespective of whether the product/batch was exported to that country.

For Class 2 recalls, we send a RAN only to those national competent authorities where we know the batch has been distributed. We generally do not send a RAN for Class 3 recalls.

In some cases MAHs will themselves propose a product recall but in such circumstances the recall and the level must still be authorised by us.

All product recalls are published on GOV.UK (https://www.gov.uk/government/organisations/veterinary-medicines-directorate) and a 12-month rolling list is published on this page.

Contact

By email: xxx@xxx.xx (mailto:xxx@xxx.xx)

Alternatively, submit a call-back request for the Inspections team via xxx@xxx.xx (mailto:xxx@xxx.xx).