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Home / Activities / Registration / Requirements for dossier submission

Requirements for dossier submission

20/12/2021: The Licensing directorate would like to inform you that from 1 January 2022, the submission through the Common European Submission Portal (CESP) will become mandatory for all applications.   Applications sent via emails will no longer be accepted and only applications submitted through CESP will be considered as official.   Therefore no applications should be sent to generic mailboxes with the exception of applications for the classification of borderline products (Mailbox: classcom.adm@gov.mt).

Centralised, Mutual Recognition/Decentralised and National Procedures

Applicants are reminded to register for submissions through the Common European Portal (CESP).  CESP provides a secure method of communicating with the Regulatory Agencies via one platform, allow submission of one aplication once to reach all required agencies and reduces the burdern of submitting/handling of applications on CD-ROM/DVD.  If you have any difficulties with registration to CESP, please send an email to cesp@hma.eu.

General information an application forms for marketing authorisations, renewals and variations is available in EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use, on the European Commission website.

For Centralised procedures more information is available on the EMA website.

More detailed information on the Mutual Recognition and Decentralised Procedures and all documentation requirements and templates can be found in the CMDh section of the Heads of Medicines Agencies website.

For specific requirements on the electronic submission and methods of submission of all documentation (e.g. on format, required templates, electronic signatures), refer to the Medicines Authority document Guideline for submission of applications and documents for medicinal products authorisation and post-authorisation activities procedures. 

For European procedures, this should be read in conjunction with the following guides for new applications as well as variations and renewals.

Companies are encouraged to submit applications fully electronically through the Common European Submission Platform (CESP) at cesp.hma.eu/. For further information, consult the Medicines Authority document on requirements for submission mentioned above.

IMPORTANT NOTICE

The use of the eAR (electronic application form) is mandatory from 01/01/2016 for all European procedures.  Further details can be found on the European Medicines Agency website on: http://esubmission.ema.europa.eu/eaf/index.html

Updated on 20/12/2021