All applications must be accompanied by a cover letter. This is not only valid for new applications, but also for correspondence rounds, variations, PSURs etc.
We urge you to discuss different subjects in separate letters. One subject per letter.
Contents of the cover letter
In order to speed up the application process, please mention the following details in the heading of your cover letter (preferably in the order shown):
- The names of all products to which your letter refers, and the associated RVG numbers or EU licence numbers of the products that are registered via the Centralised procedure
- Case number (if available)
- Date of our letter to which you are responding
- Type of procedure (National / Mutual recognition / Decentralised / Centralised) with associated procedure number where applicable
- Whether or not preliminary to a MRP with the Netherlands as RMS
- E-mail address contact person
- Brief description of the subject of your letter
The cover letter of an electronic dossier must contain the following additional information:
- The number of CD(s) or DVD(s) for the complete dossier
- A statement that the content of the electronically submitted information is identical to that of the corresponding parts as hard copy
- A statement that the submission has been checked with an up-to-date virus scanner
- A statement that the application has been structured in accordance with the ICH Granularity Document
- A list of the content of the CD(s) or DVD(s)
For a more detailed explanation refer to the "Cover letter" section of the Guidance for Industry on Providing Regulatory Information in Electronic Format: Non-eCTD electronic Submissions (NeeS).