Information about the new process structure in the Agency for Medicinal Products and Medical Devices
10.02.2012
As of February 1st, HALMED introduced a new internal organisation with the aim to improve the work processes and the effectiveness of the Agency. New processes will be introduced in steps into the existing ones and will be implemented in the next few months. We would like to inform our marketing authorisation/renewal/variation applicants that the applications submitted from January 1st will be handled according to new processes.
Applications submitted earlier, will be handled according to the existing processes. According to the new internal work share, type IA variations are handled independently from other variations. Therefore, we would kindly ask our applicants to submit type IA variations separately from other variation types. Exceptionaly, in case of more variations (type I or II), that are consequent of a one single variation, the applicant submits a single common application and a single variation application form. In that case, it is necessary to list all consecutive variations and explain their mutual linkage, pursuant to the Art. 21 of the Ordinance on Amendments to the Ordinance on the Procedure and Method for Granting Marketing Authorisation for Medicinal Products (Official Gazette No. 155/09).
We would kindly ask our applicants for their understanding with regard to the time schedule needed for introducing new processes to HALMED that will additionaly increase the speed and the quality of services provided to our customers.
