Batch release after the accession of the Republic of Croatia to the EU
18.01.2013
Taking into account the soon accession of the Republic of Croatia to the European Union, HALMED would like to inform marketing authorisation holders about the Article 51 of the Directive 2001/83/EC, which Croatia has to transpose in its national legislation, that from 1 July 2013 every batch of a medicinal product authorised in Croatia will have to be released by the qualified person for batch release (QP) in the EU/EEA.
The aforementioned means that a medicinal product manufactured in a third country (out of EU/EEA territory) will be the subject of re-testing after importing into the EU/EEA territory, except in the case where a Mutual Recognition Agreement (MRA) or other adequate arrangements apply encompassing the Good Manufacturing Practice for the imported product. If such an agreement is in effect, the quality control (testing) in the country of origin may be accepted.
It is worth to mention that a Mutual Recognition Agreement includes only the quality control (testing) of a medicinal product batch, whereas the batch release must be completed in the EU/EEA for every batch authorised in Croatia.
Detailed information on the batch release after the accession of the Republic of Croatia to the EU will be available in the section Croatian accession to the EU/Batch release after Croatia’s accession to the EU.
