Application of Regulation 1107/2009

Minor uses - Extensions of authorisations

The application of Regulation 1107/2009 from 2009 will result in some significant changes to the UK procedures for off-label (extension of use) applications as follows:

• In future ‘Off-label approvals’ will be referred to as ‘ Extensions of Use.’ 
• Applications for extension of use can be made by authorisation holders, individual growers, or grower organisations.   Applications from authorisation holders must be supported by the necessary data and risk assessments for all aspects of the safety risk assessment.
• When an extension of use is granted it can appear on the product label in a separate section titled ‘Extension of Use.’
• Applicants for extensions of use will be required to submit a letter of access to third party data. 
• Extensions of use can be based on mutual recognition of minor use authorisation and product authorisation in another Member State; with the exception of  authorisation holders who must make an application for a product authorisation.
• The requirements for case for need and urgency will remain unchanged; applications from authorisation holders will need to be supported by growers who need the extension of the authorisation.

Parallel Trade

Important changes will be introduced from 14 June 2011 resulting from the application of Regulation 1107/2009. This means that parallel trade imports to the UK will be regulated by the issue of ‘Permits’ rather than being ‘Authorised’.

• a Permit may only be issued in respect of a product that has a full Authorisation in both the exporting and importing Member State

The applicant for a parallel trade permit is required to provide:

• name and address details of the authorisation holder in the country of origin
• a draft label for the product intended to be placed on the market

The applicant for a parallel trade permit may be required to provide:

• a label and the instructions for use from the product to be imported  at the time of the application 
• A sample of the product which is intended to be placed on the market in the UK where it is considered necessary to verify the origin of a product

Parallel trade provisions will not apply in cases where it is required to import products for either, emergency, or research and development, purposes.

Changes to revocation procedures

Regulation (EC) 1107/2009 introduces significant change to the procedures for revocation of plant protection product authorisations.  From 14 June 2011, when an authorisation is revoked, the maximum grace period will be 6 months for sale and distribution and an additional maximum of 1 year for the disposal, storage and use of existing stocks of the product.  If a product is revoked for safety reasons relating to the protection of human and animal health or the environment, the period of grace may be shorter.  This means that all revocations for non-safety reasons will be restricted to 6 + 12 month wind down, and no extension to this revocation period will be possible.  These timelines will apply in all EU Member States.

Authorisation holders should take careful note of these forthcoming changes before they are implemented so that they can take appropriate action regarding stocks of products that are likely to be affected from 14 June 2011.

Our experts will be pleased to assist if you require any further information on any issues arising from the application of Regulation 1107/2009.  Contact JSC as follows:  +44(0)1423 520245   enquiries@jsci.co.uk