Centralised Procedure

In order to obtain a community authorisation through the Centralised procedure, a marketing authorisation (MA) application must be submitted to the European Medicines Agency (EMA).  Products authorised by the Centralised system (Centrally Authorised Products) can be automatically marketed in Malta, as their MA is valid in all EU/EEA countries. 

More detailed information and application forms on the Centralised Procedure can be found in EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use. 

More information on these products can be found on the EMA website.