The European Communities (Animal Remedies) (No. 2) Regulations, 2007 require the marketing authorisation holder to notify the IMB of changes in the marketing status of authorised veterinary medicinal products. This provision is termed the ‘sunset clause’.

Under the Regulations, the marketing authorisation ceases to be valid if:

• The product is either not marketed at all for a period of three consecutive years, or 
• The product has been marketed but marketing ceases for a period of three consecutive years.

Exemptions from the three-year rule may be accepted, if justified on public health or animal health grounds.

Further details are available in the IMB Guide to Notification of Marketing Status of Veterinary Medicines.

For notification of marketing status, please complete Notification of Marketing Status of Veterinary Medicines form.

The relevant form and guide are also available from the Publications section of the IMB website.