Medicinal Products

Deadlines for the Submission of Applications for Special and Regular Quality Control before the Accession to the EU

The Agency for Medicinal Products and Medical Devices (HALMED) hereby wishes to inform about the deadline for the submission of applications for special and regular quality control, according to the Medicinal Products Act (Official Gazette No. 71/07, 45/09 and 124/11, item 8, art. 76 and 77) and the Ordinance on medicinal product quality control (Official Gazette No. 56/05).

In order to meet the currently valid, statutory deadlines for the implementation of regular and special quality control in accordance with the above legislation, the deadline for the submission of special quality control applications is May 31, 2013.

The deadline for regular quality control application submissions in order to achieve compliance (the regular quality control of medicines imported from the EU, on the basis of batch analysis certificates) is June 21, 2013.

The deadline for the submission of regular quality control applications for imported batches from outside the European Union is May 31, 2013.