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.

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