Revision of policy on parallel importation
The Medicines Evaluation Board (MEB) has confirmed a new version of the policy on parallel importation. This policy applies to medicinal products for human use. There is a new version of the comparison form. There is also a form for withdrawal of a parallel marketing authorisation at the request of the parallel marketing authorisation holder.
The most important changes:
- Instructions have been included for making changes to an approved product.
- If the marketing authorisation for the reference medicinal product in the Netherlands is withdrawn, the MEB will no longer automatically withdraw the parallel marketing authorisation.
- There is more information about the policy in the case of a difference between the reference medicinal product and the parallel product.
- The comparison form has been simplified if the medicinal product from the country of origin and the reference medicinal product in the Netherlands have been authorised via the same Mutual recognition procedure or Decentralised procedure.
- The policy for parallel importation of vaccines and blood products has been expanded.
The new rules are compulsory for all new parallel applications submitted to the MEB on or after 12 August 2015. The rules for making changes to the dossier of authorised parallel importation products also apply as of 12 August 2015.
New electronic structure for parallel applications
The MEB has confirmed an electronic format for parallel applications. The use of this format is compulsory as of 12 August 2015. After this date, parallel applications will only be accepted for processing if they match this new electronic format.
The standard was established in collaboration with a number of pharmaceutical companies with ample experience in parallel applications. Initial experiences of these companies and the MEB with this new format have resulted in the new structure.
The existing European harmonised formats NeeS and eCTD for electronic submission are not deemed suitable for parallel applications. The structure is only suitable for national parallel applications submitted to the MEB.
More information and a manual about this format are available on the MEB website under parallel import.