Pharmaceutical Services

As of 1st January 2020, all applications (eAF) and documentation for regulatory procedures for medicinal products via the national and MRP/DCP procedures must be submitted through the Common European Submission Portal (CESP). More information is available at

The Pharmaceutical Services accepts electronic signatures certified through approved trusted service providers and, following a decision of the Medicines Council, applications with scanned signatures are also accepted. Therefore, the submission of an original printed copy of the signed application form and cover letter (in addition to the electronic submission) for regulatory procedures through the national and MRP/DCP procedures are not required.

The documentation submitted together with the application form must be in accordance with the Common Technical Document (CTD), in accordance with Directive 2003/63/EC. The CTD is organised into 5 modules

Module 1: Administrative and Product Information (Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL), etc.)

Section 2: Quality Overall Summary, Non-Clinical Overview / Summary, Clinical Overview / Summary

Section 3: Chemical, Pharmaceutical and Biological Documentation

Section 4: Non-Clinical Study Reports

Section 5: Clinical Study Reports

More information regarding Modules 1 to 5 can be found in “EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use” which is located at the following link:

It should be noted that the current version of the electronic CTD (eCTD) must be included in submissions, which is located at the following link: