A1. A parallel import licence describes a product that is imported from an EU Member State which is identical to the reference UK product. It differs from a generic licence in that a parallel import PPP is still manufactured by the authorisation holder of the reference product, but it is relabelled and repacked by the parallel import licence holder. For further information please read the HSE Guidance.
A2. A generic licence, also referred to as an ‘off-patent product’, is a product that is manufactured after the expiration of a patent or other exclusive rights, by a company that does not hold the original patent, and without (the need for) a license from the original patent holder. Generic products are developed, authorised, manufactured and marketed under the same strict rules and requirements as the “original” products. For further information please refer to the ECCA website.
A. Yes, in November 2012 the UK HSE issued a regulatory update which states that parallel import PPP’s may be used with the same EAMU’s as the UK reference product. Please click here for the full transcript.
A. Clayton Plant Protection warrant tank mixes for our complete range of parallel import PPP’s as per the original authorisation holders recommended tank mixes for the reference product in the UK.