Electronic submission of information on medicines following accession of Croatia to the European Union
21.06.2013
With the accession of Croatia to the European Union on 1 July 2013, marketing authorisation holders are required to electronically submit information on all medicinal products for human use authorised in Croatia to the European Medicines Agency (EMA).
This is in compliance with Article 57(2), second subparagraph of Regulation (EC) 726/2004.
Pharmaceutical companies in Croatia should submit electronically information on existing marketing authorisations and new marketing authorisations granted after 1 July 2013. Marketing authorisation holders can use in-house tools or the XEVMPD data-entry tool (also known as EVWEB) provided by the EMA to submit the information. Instructions on registration requirements and how to perform testing are published on the EMA’s website. Furthermore, EMA is supporting marketing authorisation holders on the data submission process through online and face-to-face training and a dedicated helpdesk.
Instructions on how to inform EMA of any varied marketing authorisations ("Article 57(2) maintenance”) taking into account Commission guidance (C (2013) 2804) recently published in May, will be communicated shortly.
Details on the legal provisions and requirements are available in Regulation (EC) No 726/2004 and the Legal Notice.
The format (detailed guidance and XEVMPD messaging schemas) of the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency and a frequently asked questions document are available: Documents for electronic submission of information on medicines.
Working examples are included in the detailed guidance.
Information on training and how to register to submit data to the EMA are available: Registration and training.
For any questions on the implementation of Article 57(2), marketing authorisation holders are advised to use the EMA’s dedicated mail box: art57@ema.europa.eu and dedicated helpline +44 (0)20 7523 7010.
