Electronic Submission of Information on Medicines after Croatia's Accession to the EU
With the accession of the Republic of Croatia to the European Union on 1 July 2013, marketing authorisation holders for medicinal products will be required to submit electronically to the European Medicines Agency (EMA) information about all medicinal products for human use authorised in Croatia.
This requirement is in accordance with the Art. 57, paragraph 2 of the second sub-paragraph of the Regulation (EC) 726/2004 of the European Parliament and the Council.
Pharmaceutical companies in Croatia should electronically submit the information about the existing and new marketing authorisations issued after 1 July 2013. Marketing authorisation holders may submit information using the internet tools or EMA's tools for entry of data into XEVMPD.
Instructions related to reporting to EMA abot variations to marketing authorisations according to the Commission Guideline (C(2013)2804), published in May this year, will be available soon.
The format for electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA and the list of most frequently asked questions are accessible on the EMA's web page sunder the link "Documents for electronic submission of information on medicines". Practical examples are accessible in Detailed guidance.
The information on the preparation and registration procedure for submitting information to the EMA is available on the EMA's web pages under the link "Registration and training".
For all questions related to the implementation of the Art. 57, paragraph 2, of the regulation (EC) 726/2004 of the European Parliament and the Council, marketing authorisation holders may send their questions to the EMA electronically to art57ma.europe.eu or via phone on: +44 (0)20 7523 7010.