HALMED announces the beginning of operations of its Registry Office at two locations
We inform all our applicants that the Registry Office of the Agency for Medicinal Products and Medical Devices will operate, as of 16 August, 2012 on two locations.
The opening hours of the Registry Office at the current address in Ksaverska cesta 4 will be from 8.00 a.m. to 3.30 p.m., whereas the sample submission will be from 8.00 a.m. to 2.00 p.m.
Samples, the documentation for medical devices, documentation for Central Ethics Committee and all other documentation except the documentation for medicinal products (marketing authorisations, variations, renewals) and pharmacovigilance. For the submission of more than four applications, a meeting has to be scheduled at +385 1 4884 162.
The opening hours at the new location Ulica Roberta Frangeša Mihanovića 9 (Sky Office Building) is from 8.00 a.m. to 3.00 p.m.
The documentation for medicinal products (marketing authorisations, variations and renewals) and all the documentation for pharmacovigilance, including including that related to the authorised clinical trials (SUSAR, DSUR). For the submission of more than four applications, a meeting has to be scheduled at +385 1 4884 162.
All mail is to be delivered to the address Ksaverska cesta 4, HR-10 000 Zagreb.