Parallel Trade Permits for BPs – Streamlining Authorization and Market Entry
BPs can be also made available on the market using a parallel trade permit. A parallel trade permit is relevant when a company is interested in purchasing an authorised BP in a specific MS (MS of origin). And making it available on the market in another MS (MS of introduction-MSI). Where an identical product has already been authorised. The applicant does not need to be the BP authorisation holder.
The applicant for a parallel trade allow does not need to submit data to show that the BP it wishes to make available. On the market in the MSI is safe and efficacious. Only that it is identical to the BP already authorised in the MS of introduction (the reference BP) . Additional information such as example labels are also required as part of the application. If the application is successful, the MSI shall grant the permit within 60 days of receipt of the applicable fees from the applicant (this may take longer where additional information is required from the MS of origin).
A parallel trade permit should be granted under the same terms and conditions as the authorisation for the reference BP. Furthermore, its expiry date is the same as the expiry date of authorisation of the reference BP.