Renewal of a Marketing Authorisation

Overview

Marketing Authorisations (MA) granted in the Community shall have an initial duration of 5 years according to Regulation 19(1) of the Marketing Authorisation Regulations (Article 24(1) of Directive 2001/83/EC, as amended). After these 5 years, the MA needs to be renewed on the basis of a re-evaluation of the risk-benefit balance. An application for renewal of a MA shall include the below documents:
Signed covering letter in paper format (if submitting through CESP);
EU application form for renewal list of all post-authorisation submissions since authorisation/last renewal;
Certificate of compliance with Good Manufacturing Practice;
Quality overview (quality expert statement);
Addendum to clinical overview (if required);
Reports of post-marketing experience (PSURs).

The renewal application should be submitted according to the EU-CTD format. All the information can be sent electronically through CESP or if on DVD/CD, these should be accompanied by a signed cover letter.

What you'll get

Once renewed, the MA shall be valid for an unlimited period unless the Medicines Authority decides, on justified grounds relating to pharmacovigilance, to proceed with an additional 5 year renewal (Article 24(3) of Directive 2001/83/EC as amended). In addition, the 5 year cycle of Periodic Safety Update Reports (PSURs) with renewal will be replaced by a 3 year cycle.

Eligibility

Pharmaceutical companies who wish to market their medicinal products are first to apply with the Medicine Authority in Malta.

How to apply

Fill in the online form through the Common European Submission Portal or by sending application on electronic media (CD/DVD) to the:
Medicines Authority
Licensing Directorate
The Malta Life Sciences Park
Sir Temi Zammit Buildings
San Ġwann SGN 3000