Renewal of marketing authorization (MA)- Region: GCC

FIELD Saudi Arabia GHC UAE Bahrain Oman Qatar Kuwait

Taawon Procurement National Health MOH Pharmacy and Kuwait Institute
Saudi Food and Drug Portal (taawon- Ministry of Health and Regulatory Ministry of Health Drug Control for Medical
Authority websites Authority ghc.com) Prevention Authority Sultanate of Oman Department Specialization
Primary information
Renewal of
Registration of a
PPR_Guideline_Me
Tables mentioned in the Pharmaceutical 82cb68ba-aa84-
dicines Renewals Ministry of Public
GCC data Requirements Product for General 6eed-1a88- Link not
Guidelines for Human Drugs
1 (taawon-ghc.com)
Sale | Services |
Guideline_V2.0_20
a9f8f0644b14
Health - Service
available
220308.pdf Details (moph.gov.qa)
Submission (sfda.gov.sa) Ministry of Health and (moh.gov.om)
(nhra.bh)
Prevention - UAE
(mohap.gov.ae)
Registration Validity 5 Years 5 Years 5 Years 5 Years 5 Years 5 Years 5 Years
Renewal application accepted
before the product 3 months 3 months 3 months 3 months 6 months 3 months 3 months
registration expiry
Administrative (Module 1)
Required (online
Required (online eSDR) Required Required Required PDCD online system Required
Application form application form)
Marketing Approval certificate Not applicable Not applicable Required Not applicable Not applicable Not applicable Required
GHC (GCC DR ) approval
certificate (based on GHC
registration) Not applicable Not applicable Required Not applicable Not applicable Not applicable Not applicable
CPP Not applicable Required legalized legalized Required legalized legalized
Artworks Not applicable Required Required Required Required Required Required
https://www.moph.go
2 samples
v.qa/_layouts/downlo
(Original
2 samples 1 sample (Original ad.aspx?SourceUrl=/A
samples of the
Samples Not applicable (Original samples of samples of the Not applicable dmin/Lists/Services%2
product for the
Not applicable the product for the product for the 0Attachments/Attach
same countries
same countries as same countries as ments/143/attachme
as Kuwait)
UAE.) Bahrain.) nt%20no%206.pdf
Required
Manufacturing facility license (issued by
valid Not applicable Not applicable Required Not applicable Not applicable Not applicable kuwait)
Variation var. approval or Not applicable Required Required Required
approval/submission copy Not applicable Not applicable submission Receipt
GMP Finished Product Not applicable Not applicable Required Required Required Required Not applicable
 Renewal of marketing authorization (MA)- Region: GCC
FIELD Saudi Arabia GHC UAE Bahrain Oman Qatar Kuwait
GMP of current approved API
manufacturer Not applicable Not applicable Required Required Required Required Required
Finished product certificate of
analysis Not applicable Not applicable Required Required Required Not applicable Required
Letter of Authorization Or CEP Not applicable Required Required Required Required Required Not applicable
TSE Certificate Not applicable Required Required Required Required Required Not applicable
PPR_FEES_Applicat
ions Fees as per
10,000 SAR 30,000 SAR 3500 AED Resolution 500 OMR Not published Not published
17_20210907.pdf
Applicable fees (nhra.bh)
Active pharmaceutical
certificate of analysis Not applicable Not applicable Required Required Required Not applicable Not applicable
Price certificate Required Required Required Required Required Not applicable Not applicable
Other Administrative Additional data Additional data
Information Not applicable Not applicable Not applicable (refer guideline) (refer guideline) Not applicable Not applicable
Submission options
(eCTD/Paper CTD/ electronic eCTD (PDCD online Original file &
Non-eCTD) eCTD on eSDR eCTD soft copy (PDF) eCTD eCTD system) PDF( soft copy )
Quality requirements (Module
3)
Drug Substance (DMF & CEP
with 3.2.S sections) Not applicable Required Required Required Required Required Not applicable
Finished
product specs &
Method of
Drug Product Not applicable Required Required Required Required Required analysis
stability study (Recent five
years) Not applicable Required Required Required Required Required Required
Regional Requirements /3.2.A
Appendices Not applicable Required Required Required Required Required Not applicable
M 5 Requirements
safety reports (PSUR) Not applicable Not applicable Required Not applicable Not applicable Not applicable Not applicable
Regulatory status worldwide. Not applicable Not applicable Required Not applicable Not applicable Not applicable Not applicable
Lab file Not applicable Not applicable Required Not applicable Not applicable Not applicable Not applicable
Pharmacovigilance System Not applicable Not applicable Required Not applicable Not applicable Not applicable Not applicable