can marketing authorisation be granted after mrp/dcp submission without dutch translations, if the medicine in question will not be marketed in the netherlands
The MEB is aware of the fact that in some cases medicinal products are not always marketed immediately after authorisation. Following the European Decentralised or Mutual Recognition procedures (DCP/MRP), it is possible that medicinal products are authorised but subsequently not released on the Dutch market. There are various reasons for this, such as replica procedures with NL as RMS or a delayed market introduction as a result of patents. In addition, starting in 2013 - as a result of Review 2001,one will have to take into consideration that medicinal products submitted and authorised 8 years after the innovator will only be marketed after 10 years.
In view of the above, the Medicines Evaluation Board (MEB) decided to allow the following exceptions:
- The option of granting a marketing authorisation in the Netherlands for a product accepted via a MRP or DCP without having to submit Dutch translations of the product information and mock-ups. The MEB will register medicinal products from the MRP/DCP procedure that will not be released on the Dutch market with only the European (English) confirmed product information.
- The option of submitting a request for a marketing authorisation with further conditions for medicinal products with Dutch product information that have already been registered, but that have not been introduced on the market yet.
- The option of granting a marketing authorisation in the Netherlands for a product accepted via a MRP or DCP with a Dutch translation of the product information or accepted via a national recognition procedure, without submitting mock-ups.
For medicinal products for which the Dutch product information has already been approved and that have already been introduced on the market, the obligation to keep the Dutch product information up-to-date remains.
Please refer to the policy document for further explanation of this policy.