The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) network promotes active cooperation among competent inspection bodies in the area of good manufacturing practice with the aim of international harmonisation of GMP. HALMED has been a member of PIC/S since 1 January 2016.
The American Food and Drug Administration (FDA) has confirmed the Republic of Croatia as one of the first eight EU member states whose inspections of good manufacturing practice in the manufacturing of medicinal products is recognised by the FDA. Based on the conducted assessment, the FDA has ascertained that the inspection system of the Agency for Medicinal Products and Medicinal Devices of Croatia (HALMED) fully complies with the requirements of the FDA. The FDA also expressed its appreciation for cooperation between HALMED, the European Commission and the European Medicines Agency for the great success.
The decision by the FDA to recognise the respective inspections came into force on 1 November 2017 and includes national regulatory bodies for medicinal products from Austria, France, Croatia, Italy, Malta, Spain, Sweden and the United Kingdom. This is the first time that the FDA has decided to recognise inspections conducted by other countries.
The decision by the FDA is a new step in cooperation between the European Union and the United States of America relating to mutual recognition of inspections of manufacturing sites for medicinal products for human use, which are performed on their territories. In June 2019, the European Commission confirmed that inspections of good manufacturing practice conducted by the FDA meet the standards of the European Union and may be recognised by EU member states.
Collaboration with competent bodies of countries outside of the EU
HALMED has established collaboration with agencies in Southeast Europe based on the signed Memorandum of Cooperation and Understanding between the Agency for Medicinal Products and Medicinal Devices of Croatia (HALMED), the Medicines and Medical Devices Agency of Serbia (ALIMS), the Agency for Medicinal Products and Medical Devices of Bosnia-Herzegovina (ALMBiH), the Bureau of Drugs before the Ministry of Health of the Republic of Macedonia and the Agency for Medicines and Medical Devices of Montenegro (CALIMS).
In addition, HALMED has established bilateral protocols on cooperation with CALIMS and ALMBiH.
HALMED also cooperates with competent bodies from Southeast Europe in exchanging information on market supply of medicinal products.