Regulatory Update: 17/2012
Issued: 16 May 2012
Background
Notices issued for Extensions of Authorisation for Minor Use (EAMUs) (formerly known as Specific Off-Labels Approvals or SOLAs) previously included a specific expiry date, which is usually the same as the final use date which appears on the product authorisation. CRD is changing how the expiry date appears on the EAMU documentation
What is changing?
As many products have their final expiry dates extended, stating a specific expiry date for EAMUs meant that each extension also had to be individually re-issued to reflect the new expiry date.To streamline this process and remove the need to re-issue many notices unnecessarily, in future all EAMUs will be issued with the following phrase:
| This Extension of authorisation ends: | on the final expiry date of use for the authorised product
(unless otherwise stated) |
How can I check the actual EAMU expiry date?
The EAMU search results screen will remain unchanged, so that the expiry date for that notice can easily be found in the results table. As is currently the case, any expired EAMUs will not appear in the search results area.
The final use date for the authorised product can also be found on the product Authorisation documents available on the product searches on our web site.
What if the EAMU has a shorter deadline than the authorised product?
Where the EAMU has a shorter deadline than the final use date for the authorised product, this date will be specified in place of the new phrase. This may occur for example where the EAMU had a specific data requirement, or where the EAMU has not been supported through re-registration.
What happens when a product or EAMU is withdrawn?
Whenever an amendment is made to an EAMU which shortens the expiry date, a new notice will be issued which contains the revised expiry date.This may arise, for example, because of a change in condition of use or because a product or EAMU is withdrawn.The reason for the re-issue of the Extension will be found in the Explanatory Notes section of the EAMU.The new date will also appear in the search results screen.
When will this happen?
All EAMUs issued from now on will contain the new phrase.The current EAMUs will not be changed and will continue to have a specific expiry date until they are re-issued as a result of a new regulatory decision
Contact information
If you have any questions relating to this Regulatory Update, please contact CRD Applicant Enquiries and your enquiry will be sent to the appropriate person to respond:
Email: applicant-enquiries@hse.gsi.gov.uk
Postal address: Pesticides Branch, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX, UK.
