Notice to manufacturing license holders and manufacturers, importers and wholesalers of active substances on import of active substances manufactured in third countries
The provision of the Article 46b of the Directive 2001/83/EC of the European Parliament and Council that has been transposed into the national legislation under Art. 83 of the Medicinal Products Act (Official Gazette, No 76/13) came into effect on the 2nd July 2013. Taking account that this provision has not entirely entered into effect in all the EU Member States, the intergovernmental body Heads of Medicines Agency (HMA) published on the 1st July 2013 on its webpages a document defining a proposal for a common approach in all member States in case of import of active substances from third countries that are neither listed by the European Commission (under Art. 111b of the Directive 2001/83/EC of the European Parliament and Council), nor accompanied by a written statement from the exporting third country’s competent authority. The document is accessible here.
In order to ensure the availability of medicines and in agreement with the Agency for Medicinal Products and Medical Devices, the procedure of exceptional import of active substances from third countries not listed by the European Commission and without written statement is defined under Art. 7 of the Ordinance on the requirements and method of establishing the requirements of good manufacturing practice and good practice in the wholesale of active substances and on the procedure of the entry in the register of manufacturers, importers and wholesalers of active substances, and on issuing the certificate for the implementation of good manufacturing practice (Official Gazette No. 83/13).