Marketing Authorisation for a Medicinal Product

Overview

This authorisation procedure is being applied mainly to cover the public health need created by the lack of applications for Marketing Authorisations for products which were on the derogation list and for products which were authorised in the period between the publication of the derogation list and the date of accession. An authorisation is granted in accordance with Regulation 4(2) of the Medicines (Marketing Authorisation) Regulations (Subsidiary Legislation 458.34), under the Medicines Act, 2003 (Chapter 458 of the Laws of Malta). The authorisation is valid for 5 years. A renewal application should be submitted at least 6 months before the end of validity of the authorisation.

What you'll get

The authorisation will be valid for 5 years. A renewal application should be submitted at least 6 months before the end of validity of the authorisation.

Eligibility

Companies wishing to place a product on the Maltese market which is already authorised in another EU/EEA Member State. The authorisation in Malta is granted on the basis of the marketing authorisation in that Member State. This authorisation is granted in cases of public health demand and if the product in not already authorised in Malta with a full marketing authorisation.

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