Transfer of Marketing Authorisation Holder During the Authorisation Procedure

The transfer procedure must be used where the legal entity of an authorisation/registration holder is changed and the product is transferred to a new company during the authorisation procedure stage. When an authorisation is transferred during the national phase but before the granting of the marketing authorisation, the new holder must notify the Medicines Authority using Transfer Form B. Once the application is considered valid, the transfer will be processed within approximately 60 days.

Legislation

Medicines Act

Medical Devices and In-vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations