Masterarbeit
New Conditions in the Pharmaceutical Regulation for Croatia with Accession to the European Union - Preparation, Implementation, Execution ***
Manon Waßmund (2015)
Summary
Language: English
With accession to the EU new member states are obliged to take over the European "Acquis Communautaire" (primary and secondary law, such as regulations, directives and decisions).
This thesis outlines the necessary changes in the pharmaceutical regulation affecting the registration of human medicinal products in Croatia based on the accession of the country to the EU on July 1st, 2013. Prior to the accession the country gradually adapted its national law to the European provisions in course of several Acts and Ordinances, with support and impulses having been given from the Agency for Medicinal Products and Medical Devices of Croatia (HALMED), aiming to timely fully comply with the European "Acquis Communautaire".
Preparation requirements to allow for implementation and meeting of these legislative changes in Croatia and the corresponding efforts made by HALMED and marketing authorisation holders are described. With the accession Commission Decisions and thus CP licenses automatically extend to Croatia. Furthermore, for the European procedures of mutual recognition (MRP and DCP) the country can now be considered as a member state by the applicant. Introduction and execution of the European registration procedures in Croatia is looked upon, also considering possible consequences for the national Croatian marketing authorisations granted prior to the accession.
Concluding the thesis discusses possible advantages and disadvantages resulting from the Croatian accession to the EU for both the new member state itself and the EU.
Pages: 40