Shorter timetable for procedure for changing parallel package leaflet

The Medicines Evaluation Board (MEB) has decided to implement a shorter timetable for the procedure for changing the parallel package leaflet. This applies to medicinal products for human use. A new version is also available of the ‘declaration accompanying a package leaflet of a parallel importation product’.

  • The first round of the timetable is to be shortened to 30 days. If no comment or objection has been received within 30 days, the proposed change can be implemented in the package leaflet and day 30 [month+year] must be referred to as the date under the package leaflet.
  • If the MEB has any comments on the proposed package leaflet, a second assessment round of 30 days will be applicable.
  • The package leaflet declaration for a parallel importation product has been extended to include a question about possible changes to product-specific characteristics and the extent to which the product to be imported is identical or virtually identical to the Dutch reference product.

The shortened timetable is applicable to changes to the parallel package leaflet which are received by the MEB on or after 30 December 2019.