18.12.2014
To the attention of Marketing Authorisation Holders
Please be informed that until 31 December 2014 all Marketing Authorisation Holders from the European Union and the European Economic Area should forward information to the European Medicines Agency (EMA) on authorised medicinal products and constantly update this information, in line with Article 57 (2) of Regulation (EC) no. 726/2004, as amended. This represents a mandatory requirement, in accordance with the law, of EU legislation on medicinal products for human use.
For more information, please visit the EMA website.
National Agency for Medicines and Medical Devices of Romania
