Annex I inclusion of previously withdrawn active substances

The UK regulatory authority has recently issued new guidance for changes to authorisations for existing products and for the registration of new products and uses.  This is to take account of the situation where voluntarily withdrawn active substances have now received a positive decision for Annex I inclusion.

• Changes to authorisations - following a positive decision for Annex I inclusion CRD will accept applications to revise current national authorisations in line with the standard transitional arrangements.
  
  These arrangements apply immediately following the inclusion decision (that is before the entry into force date) until the final Commission Step 2 deadline for the product (normally 4 years after entry into force).
• New products and uses under Directive 91/414 - following a positive decision for Annex I inclusion of all voluntary withdrawn substances within a product, CRD will accept applications for new uses and products.  The submission must be supported by a complete Annex II and III data package.

Such applications will be evaluated following a positive inclusion decision, however no authorisation would be granted before the date of entry into force of the Inclusion Directive.

Please contact JSC if you require advice on these changes or on any other regulatory matters: +44(0)1423 520245   enquiries@jsci.co.uk