- Print Friendly - Help

Cancellation of Product Licenses and Registrations

The ACVM Group has received questions from proprietors as to the status of products in the market following the cancellation of animal remedy licences or pesticide registrations. This article is to clarify existing policy and processes being followed by the Group in this situation.

Revocation or suspension of animal remedy licences and revocation of pesticide registrations might occur for a number of reasons. These can range from the use of statutory powers to remove a product from the market to manage a serious threat from the product or its ingredients, to the request for cancellation by a proprietor for commercial reasons.

The Group’s approach to product remaining in the market following cancellation of the licence or registration depends on the circumstances of the cancellation. While the impact of a cancellation on product in the market is considered on an individual basis, two general rules apply.

Where statutory powers have been used for a cancellation to manage a serious risk product, removal of the product from the entire distribution chain is required immediately. This rarely happens, and it would be most unlikely to occur without consultation, or other notice being given in advance. Two examples of this type of action might be removal of an active ingredient or product for trade reasons, or removal of a manufacturing authorisation due to sustained non-compliance with GMP. Immediate removal from the market of a single non-complying batch of product may also be required by the ACVM Group; however, this type of product recall is a separate matter that is not concerned with cancellation of a licence, at least initially.

It is more usual for cancellations to occur for commercial reasons including changed company ownership and re-branding, or non-payment of renewal fees. The Group’s policy is that when a product is manufactured and released as being compliant in all respects with the legislation and GMP, it will remain appropriate for sale until its expiry date irrespective of any changes that are not considered as threats to be managed. In these non-risk situations, products that are with distributors and retailers may be sold to remove stocks from the distribution chain. However, from the date of a cancellation of a licence or registration, no further product relating to the cancellation may be released by the manufacturer or by the importer into the distribution chain. Under these circumstances the ACVM Group needs to determine (from the manufacturer or importer) the latest batch number and, where applicable, the expiry date of product released into the distribution chain prior to the date of cancellation.