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Parallel trade products and extensions of authorisation for a minor use

Regulatory Update: 11/2012

Issued: 30 March 2012

Under Council Directive 91/414/EEC, parallel import plant protection products could be issued Specific Off-Label Approvals (SOLAs) on a minor crop, or major crop with a minor pest problem. Growers or grower organisations could apply for SOLAs for a parallel import plant protection product.

However, under Regulation (EC) No 1107/2009, parallel trade plant protection products are only permitted to be used in accordance with the provisions of the authorisation of the reference product. This means that parallel trade products cannot be authorised in their own right for extensions of authorisation for a minor use (EAMU) (previously known as SOLAs), but if a reference product is authorised for an EAMU , then any parallel trade product of the named reference product may also be used with that EAMU.

With the naming of reference products on parallel trade permits, as announced in Regulatory Update 09/2012 (issued on 26 March 2012), users will be able to benefit directly and use parallel trade products with EAMUs that have been issued for the reference product.

The parallel trade product must be used in accordance with its permit, and the extension of authorisation for its named reference product.

How to find the name of the reference product

Parallel trade permits issued from 2 April 2012 will name the reference product on the permit. Users can then check if there are any extensions of authorisation for a minor use for that reference product which would therefore apply to the parallel trade product.

For permits issued before 2 April 2012, an excel spreadsheet will be available on CRD’s database homepage, after the 2nd April, which details the name of the reference product for each parallel trade product.

Contact Information

If you have any questions regarding this issue, please contact us: link to contact details page.

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