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Home / Activities / Registration / Requirements for dossier submission

Requirements for dossier submission

Requirements for dossier submission

Since January 2022, all applications to the Malta Medicines Authority must be submitted online. Paper submissions are no longer accepted. This ensures faster processing and compliance with European standards.

 

Applications must be submitted through the Common European Submission Portal (CESP). Register your organisation and obtain login credentials before starting. This is the only accepted route for sending applications and related documents.

✅ Important Update – Power of Attorney (POA)

As per GL-LI04 Revision 09 (November 2025):

  • All Power of Attorney (POA) documents submitted with applications must have a validity period clearly stated.
  • The maximum validity allowed is 3 years from the date of issue.
  • Applications with expired or missing POA validity will not be accepted.

Action Required:
Please review your POA documents and ensure they comply with this requirement before submission.

Electronic Format and Forms

All applications must follow the electronic Common Technical Document (eCTD) format. Use the correct electronic application form (eAF):

  • For European procedures (MRP and DCP), use the EMA/CMDh eAF.
  • For national procedures, use the Malta-specific eForm. Documents must be in searchable PDF format and digitally signed where required.

About GL-LI04

GL-LI04 is the Malta Medicines Authority guideline that explains how to prepare and submit applications electronically. It covers dossier structure, naming conventions, and validation steps. Following GL-LI04 helps avoid delays and ensures your application meets technical and regulatory requirements.

Web-Based eAF

The EMA is introducing a web-based eAF via the Product Lifecycle Management (PLM) Portal, replacing older PDF forms. It offers smart data entry, real-time validation, and generates both PDF and XML outputs. This will become mandatory for all procedures in the near future.
Learn more: EMA eAF Guidance

SPOR and PLM – Why They Matter for Your Submission

The European Medicines Agency is implementing ISO IDMP standards to harmonize medicinal product data across the EU. Two key initiatives are:

SPOR – Master Data Services
SPOR stands for Substance, Product, Organisation, and Referential data. These services ensure that all applications use standardised, validated information:

  • Substances (SMS) – Active ingredients and components.
  • Products (PMS) – Details of authorised medicines.
  • Organisations (OMS) – Marketing Authorisation Holders and manufacturers.
  • Referentials (RMS) – Controlled terms for dosage forms, routes of administration, and units.

Using SPOR data means fewer errors, faster validation, and compliance with EU standards. It is already integrated into electronic application forms (eAF) and other EMA systems.
Learn more: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data

 

PLM – Product Lifecycle Management Portal


The PLM Portal is EMA’s secure platform for managing electronic forms and product data. It supports:

  • Web-based eAF for variations and renewals.
  • Automatic population of fields using SPOR master data.
  • Built-in validation to reduce errors.

Benefits for applicants:

What This Means for You
When preparing your dossier:

  • Make sure your organisation and product details are registered in OMS and PMS.
  • Use the web-based eAF via PLM Portal for variations and renewals.
  • Check that referential data (e.g., dosage forms) matches EMA’s RMS lists.

Centralised Procedure

If your product is authorised through the Centralised Procedure, applications are submitted directly to the EMA. These are not handled nationally, but you may need to notify the Malta Medicines Authority. Check EMA guidance for timelines and requirements.

Mutual Recognition and Decentralised Procedures

For products already authorised in another EU/EEA Member State, the Mutual Recognition Procedure (MRP) applies. For products not yet authorised, use the Decentralised Procedure (DCP) to apply simultaneously in multiple Member States.

  • RMS Role: The Reference Member State leads the assessment and issues the initial report.
  • CMS Role: Concerned Member States review and comment on the RMS assessment.
  • Applicant Responsibilities:
    • Ensure the dossier is identical across RMS and all CMS.
    • Check national requirements for each CMS to avoid validation delays.
    • Pay applicable fees and include proof of payment.
    • Submit responses to questions via CESP following ICH folder structure.

For detailed timelines and templates, refer to CMDh guidance:
https://www.hma.eu/human-medicines/cmdh/procedural-guidance/application-for-ma.html

National Procedures

National marketing authorisations are granted under the Medicines Act and EU Directive 2001/83/EC. Applications must:

  • Follow eCTD format.
  • Include updated Module 1 documents (e.g., product name, MAH details).
  • Be submitted via CESP with proof of fee payment. Duplicate applications must comply with CMDh recommendations on multiple applications.

More details: National Procedures – Medicines Authority

Before You Submit

Confirm that:

  • You have CESP access.
  • Your dossier follows eCTD structure.
  • You used the correct eForm /eAF.
  • You have a valid and current Power of Attorney or Letter to communicate on behalf of MAH/Applicant
  • File names comply with GL-LI04.
  • Samples/mock-ups are ready if required.

References

  • GL-LI04-09 – Malta Medicines Authority Guideline for Electronic Submissions
  • EudraLex Volume 2 – EU Rules for Medicinal Products
  • CMDh Guidance – MRP/DCP Procedures
  • EMA Guidance – Centralised Procedure and eAF forms

Further Information

Need Help?

 

Contact the Licensing Directorate:
Email: licensing.medicinesauthority@gov.mt
Phone: 356 23439000
For technical issues with CESP: cesp@hma.eu

 

Updated on 02/03/2026