Authorisation for a Medicinal Product on the basis of article 126(a) of Directive 2001/83/EC

Overview

This authorisation procedure is being applied mainly to cover the public health need when there are problems with availability and access. 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 a maximum of 3 years.

What you'll get

The authorisation will be valid for a maximum of 3 years.

Eligibility

Companies wishing to place a product on the Maltese market which is already authorised in another EU/EEA Member State, but which, for a justified reason, cannot be authorised in Malta via the established registration routes, such as the Mutual Recognition Procedures. The authorisation in Malta is granted on the basis of the marketing authorisation in that Member State, if the product in not already authorised in Malta with a full marketing authorisation.  The Advisory Committee established by the Malta Medicines Authority will determine the public health need of the product which is the subject of an application through this route.

How to apply

Fill in the online form and submit through the Common European Submission Portal. Medicines Authority
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