Import of medicinal products after the accession of the Republic of Croatia to the European Union
25.02.2013
Taking into account the soon access of the republic of Croatia to the EU and according to the Articles 40 and 51 of Directive 2001/83/EC, which Croatia has to transpose in its national legislation, the Agency for Medicinal Products and Medical Devices (HALMED) informs all holders of the wholesale license, holders of import/export license and marketing authorisation holders that the import of medicinal products from third countries in the Republic of Croatia may be carried out solely by physical or legal entities having a manufacturing license, that will according to the EU legislation be called "the importer”.
Therefore, holders of a wholesale license, and holders of an import/export license, whose licenses have been granted according to the current Croatian legislation, after the accession of the Republic of Croatia to the EU, will not be able to import medicinal products without having a manufacturing license.
It is necessary to ensure receiving, storage, quality control and batch release of medicinal products imported from third countries. The importer may accomplish those manufacturing parts on his own or in accordance with the GMP guidelines, conclude an agreement on contractual manufacturing with another holder of a manufacturing license and/or GMP certificate. Taking into account that the manufacturing is not finished as long as the batch release decision has not been taken and batch certificate signed by the qualified person of an importer from the EU, the imported medicinal product batch must be stored in a quarantine manufacturing warehouse.
Wholesale license holders and import/export license holders do not poses a manufacturing warehouse, but a wholesale’s one.
More about the batch release after Croatia’s accession to the EU, you may view under subsection Batch release of medicinal products after the accession of the Republic of Croatia to the European Union (in Croatian).
Taking into account the above mentioned, the draft proposal of the new Medicines Act includes a transitional provision foreseeing the expiration of medicinal products export/import licenses with the date of coming into effect of the new legislation.
Hereby, we would kindly inform our wholesale and import/export license holders about the need to consider their business processes and marketing authorisation holders to consider authorised batch release sites in order to continue their operations without delay after the accession of the Republic of Croatia to the EU. Further information about the changes in wholesale and granting wholesale’s licenses for medicinal products will be posted soon on the HALMED webpages.
