Import of Medicinal Products from Third Countries after the Accession of Croatia to the EU
Considering the approaching accession of the Republic of Croatia into the European Union, and in accordance with paragraphs 40 and 51 of Directive 2001/83/EZ, which the Republic of Croatia is obligated to transpose into its legislation, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs the carriers of wholesale sales authorisations, import/export authorisations and marketing authorisations that the importation of medicinal products from third countries into the Republic of Croatia will only be possible by a natural person or legal entity carrying a production authorisation called, according to EU legislation, an 'importer'.
Therefore, on the accession of the Republic of Croatia into the European Union, authorisation carriers for wholesale sales and import/export, authorised according to the currently valid legislation in the Republic of Croatia, will not be able to conduct medicinal product importation from third countries without carrying a production authorisation.
Receiving, storage, quality control and marketing need to be provided for medical products imported from third-countries. The importer can deal with these segments of production independently or, according to the principles and guidelines of good production practice for storage and quality control, create a contract with another carrier of production authorisation and/or good production practice confirmation. Considering that the production of the medicinal product is not finalised until the marketing-authorisation decision has been taken and the batch certificate has been signed by a person (from the EU) qualified for marketing an imported batch, the imported medicinal product batch must be kept in a quarantine production storage facility.
Wholesale medicinal product distribution authorisation carriers and import/export authorisation carriers do not have production storage facilities (but rather sales facilities).
More information on medicinal product batch marketing after the accession of the Republic of Croatia into the EU can be found at: Medicinal product batch marketing after the accession of Croatia into the EU.
Considering all the above, the proposal of the Medicinal Products Act has created a transitional directive predicting that when the new Law is instated, authorisations for medicinal product import/export cease to be valid.
This notification aims to urge wholesale medicinal product distribution authorisation carriers and import/export authorisation carriers to assess their business processes, and medicinal product marketing authorisation carriers to assess the status of approved medicinal product marketing locations so that they can conduct business unimpeded after the accession of the Republic of Croatia into the EU. Further information on changes in the area of wholesale medicinal product distribution and issuing wholesale medicinal product authorisations will be published on the HALMED web site soon.