Marketing Medicinal Product Batches after the Accession of Croatia to the EU
Considering the accession of the Republic of Croatia into the European Union, HALMED wishes to inform authorisation holders that in accordance with paragraph 51 of Directive 2001/83/EZ, which the Republic of Croatia is obligated to transpose into its legislation, every batch of finished medicinal products with marketing authorisation in the Republic of Croatia will have to be marketed by a qualified person for marketing medicinal product batches in the European Union/European Economic Area (EU/EEA).
This also means that a medicinal product manufactured in a third-country (a country outside the EU/EEA) will have to be re-examined for batch quality after import into EU/EEA territory, unless a Mutual Recognition Agreement (MRA) has been signed with the country of production or another relevant agreement that encompasses good production practice for the medicinal product being imported. If such an agreement is already in effect, the quality control assessment for the medicinal product batch conducted in the country of production can be accepted.
It is important to note that the Mutual Recognition Agreements only encompass the quality control (testing) of medicinal product batches, while the marketing of the medicinal product will have to be carried out on EU/EEA territory for each batch approved for marketing in the Republic of Croatia.
For this reason, authorisation holders are urged to report, if necessary, any changes in the authorisation without delay so the Agency can issue the medicinal product authorisation (this can include further tests of medicinal product quality) of the manufacturer responsible for marketing and situated on the territory of the Republic of Croatia or the EU/EEA as soon as possible, so they can continue uninterrupted supply to the market of the Republic of Croatia after the accession process has been concluded.
In this case, a medical product manufacturer from the EU/EEA with an adequate production permit for medicinal product importation (importer status, according to Directive 2001/83/EZ) can apply for the role of the manufacturer responsible for marketing the medicinal product, as can a medicinal product manufacturer from the Republic of Croatia with an adequate production permit.
Detailed guidelines on issuing certificates on the part of the responsible party for medicinal product marketing and medicinal product batch marketing in the EH/EEA for medicinal products with a marketing authorisation or that are intended for export can be found in the document "Annex 16 to the EU Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release".