Import of Active Substances from Third Countries after the Accession of Croatia to the EU
Article 46b of Directive 2001/83/EC, as amended, which entered into force on 2 July 2013, is transposed into national Croatian legislation in Article 83 of Medicinal Products Act (Official Gazzete No. 76/13).
Since the new falsified medicines legislation (or in this respect the delegated act on the importation of an active substance) is not adopted by all Member States on 2 July 2013, Heads of Medicines Agencies (HMA) has published in their web site text which describes a common approach promoted by Member States for importers or later in the supply chain which may facilitate import of active substances intended for the manufacture of medicinal products for human use from third countries that are not included on the "white list" (Article 111b of Directive 2001/83/EC) or without the required written confirmation. You can find the aforementioned text here.
Procedure for import license for exceptional import of an active substance intended for the manufacture of medicinal products for human use coming from third countries that are not included on the "white list" (Article 111b of Directive 2001/83/EC) or without the required written confirmation for the purpose of availability of medicinal product is prescribed in Article 7 of Ordinance on conditions and procedures of establishing requirements of good manufacturing practice and good distribution practice of active substances, the procedure of registration of manufacturer, importer or distributor of active substance and issuing certificates of good manufacturing practice (Official Gazzete No. 83/13).
