Under the column Croatian accession to the EU, a new subcolumn has been launched: Documentation upgrading for medicinal products
17.07.2012
Within the column CROATIAN ACCESSION TO THE EU - Instructions for marketing authorisations on the webpages of the Agency for medicinal products and medical devices, a new subcolumn has been launched under the title Documentation upgrading for medicinal products.
The new subcolumn contains useful instructions for marketing authorisation holder with regard to dossier upgrading which means a harmonisation of the documentation for medicinal products with the acquis communautaire for products authorised in Croatia before the accession to the EU.
Within the aforementioned column there were informations posted with regard to medicines authorisation via centralised , mutual recognition, decentralised and national procedure as well as the information to marketing authorisation holders related to application submissions before the accession. The column will be regularly updated with new information.
