Marketing Authorisation for Medicines via Centralised Procedure in Turkey
Marketing authorisation could be laso granted for Turkey to comapnies on-going cantalised procedure by EMEA, according to investigation of FarmavitaR+ consultant from Istanbul, Turkey.
An application sould be filed in TR prior to the registration decision of EMEA. Original dossier sould be submitted. Turkish Authority will wait for the final decision of EMEA before giving the registration decision which means if EMEA rejects the application then the Turkish Authority suspends the dossier as well.
If it is an original product, not generic, it is obligatory to have the registration in the Country of Origin.
Applicant shoudl have legal address in Turkey and licensed person for PV.
FarmavitaR+ offers support of local regulatory affirs consultants in TR, BG, RO, MK, SRB, BiH, HR, SL, HU and CZ, as well as other countries coverd by Regulanet network.
