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Service Details

Pharmaceutical product re-registration

Biological / Biosimilars companies icon Biological / Biosimilars companies
Pharmaceutical agents icon Pharmaceutical agents
Pharmaceutical Companies icon Pharmaceutical Companies
Pharmaceutical Manufacturers icon Pharmaceutical Manufacturers
Service provided by Registration & Drug Pricing Section of Pharmacy & Drug Control department, through which pharmaceutical product re-registration is approved, if the required conditions are met
Requirements:
  • Submission of the file in eCTD format as per Qatari guidelines for eCTD submission as well as data requirements for renewal of registered product
  • Re-registration request submission through PDCD online e-system (see E-Service link below)
  • Samples and standards for QC analysis purpose as per PDCD memo no. 12/2019 for samples requirements
  • Reference for the submitted product from any competent health authority

Process flow:
  • Submission of re-registration request on PDCD online e-system by the authorized pharmaceutical agent
  • Scheduling appointment for initial file screening in which the file is received along with samples
  • Review and assessment of the file, inform the agent with any further requirements or clarifications 
  • Receiving PDCD opinion


Required Attachments

Data Requirements for Renewal of Marketing Authorization for Registered Pharmaceutical Products Guidance for eCTD Submission FAQs regarding eCTD submission and renewal submission Memo no. 12/2019 regarding sample size requirements Memo no. 15/2019 regarding products re-registration

Documents and Forms

Application form for Re-registration of Pharmaceutical Product

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P.O.box : 42
Phone : 44070000
Email : GHCC@MOPH.GOV.QA
Official Working Hours :
Sunday - Thursday 7:00 AM - 2:00 PM

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