IN FORCE Procedural & compliance ·? undated

72 Circular regarding subbission of online applications of PSURs MA of New Drugs SNDs FDCs Biologicals Veterinary 2024-Feb-26 263 KB

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File No.: PSUR-13011(14)/2/2024-eoffice Government of India Directorate General of Health Services Central Drugs Standard Control Organization (PSUR/PV/AEFI Division)

FDA Bhawan, Kotla Road, New Delhi100002 Dated: rcp ono

CIRCULAR

Subject: Submission of online applications of PSURs w.r.t Marketing Authorization (MA) of New Drugs/SNDs/FDCs/Biologicals/Veterinary Reg.

In order to streamline the regulatory submission procedure, the submission of applications of PSURs (Period Safety Update Reports) w.r.t Marketing Authorization of New Drugs/ Subsequent NewDrugs(SND/ Fixed Dose Combinations(FDC)/ Biologicals/ Veterinary is functional now through online system of Sugam portal at www.cdscoonline.gov.in.

in All applicants submitting PSURs shall apply through online portal as per checklist the Portal .The facility of offline submission of applications in hard copy or any other mode will not be available for processing from 11.03.2024.

ung (Dr. Raj i ghuvanshi) Drugs Controller General (India)

To

  1. All Stake holders through CDSCO website

  2. All Zonal/Sub-Zonal offices of CDSCO

  3. CRU Section of CDSCO(HQ)

  4. CDAC Team.

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