In the Netherlands it is obligatory to submit an electronic dossier for medicinal products for human use. It is preferable for this electronic dossier to be submitted via the Common European Submission Platform (CESP). Alternatively the dossier can also be submitted on a CD or DVD. In the event of submission on a CD or DVD an original, signed paper copy of both the cover letter and, if applicable, the application form must be submitted.
All submissions must be accompanied by a letter. This not only applies to new applications, but also to correspondence rounds, variations, PSURs, etc.
We urge you to send separate letters for different subjects, in other words only one letter per case. PSURs which relate to different active substances are each to be accompanied by a separate letter.
Content of the cover letter
In order to speed up the submission process, please state at the top of the cover letter - insofar as applicable - the following details (preferably in the sequence indicated here):
- All product names to which your letter relates and all corresponding RVG numbers or EU licence numbers of the products which have been registered via the centralised procedure
- Case number (if available)
- Date of our letter to which you are responding
- Type of procedure (National/MRP, DCP/Centralised) with - where applicable - the corresponding procedure number
- Whether or not in preparation for an MRP with the Netherlands as RMS
- Contact person's email address
- Short description of the subject of your letter
The cover letter of an electronic dossier must also state the following additional details:
- The number of CDs or DVDs for the complete dossier
- A statement that the content of the electronically submitted information is identical to that of the corresponding parts on paper
- A statement that the submission has been checked with an up-to-date virus checker
- A statement that the application has been structured in accordance with the ICH Granularity Document
- An overview of the content of the CDs or DVDs
Please refer to the CMDh website for a template of the cover letter.