News and Educations

New column launch: CROATIAN ACCESSION TO THE EUROPEAN UNION – guidelines for marketing authorisation holders

08.05.2012

The Agency for Medicinal Products and Medical Devices (HALMED) has launched a new column named "CROATIAN ACCESSION TO THE EUROPEAN UNION" - guidelines for marketing authorisation holders, which will be making publicly available useful guidelines to marketing authorisation holders relating to harmonisation of marketing authorisation procedures, what awaits us with the accession of Croatia to the EU. The answers that are being posted on this website, HALMED has received from the European Commission, European Medicines Agency and Heads of Medicines Agencies (HMA) intergovernmental network.

The column will be regularly updated and supplemented with new informations encompassing all the marketing authorisation procedures for medicinal products.

The first text that is published in this column refers to centrally authorised medicinal products.

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