Applications for Marketing Authorisation

• Template: Cover letter for new applications submitted through MRP/DCP (July 2025) [Track version]

• Template: Letter of access for informed consent applications (April 2015)

Request for RMS in a Decentralised Procedure, medicinal products for human use
 

• Common request form (September 2025) [Track version]
  Please download the document for editing. 

Template for applicants to prepare report on similarity with authorised orphan medicinal products
 

• Template: Similarity report (September 2022)