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Service Details

Registration of Pharmaceutical Product

Pharmaceutical agents icon Pharmaceutical agents
Local Pharmaceutical Companies icon Local Pharmaceutical Companies
Local Pharmaceutical Manufacturers icon Local Pharmaceutical Manufacturers
Multinational Pharmaceutical Companies icon Multinational Pharmaceutical Companies
Biological / Biosimilars companies icon Biological / Biosimilars companies
Vaccines companies icon Vaccines companies
Multinational Pharmaceutical Manufacturer icon Multinational Pharmaceutical Manufacturer
Service provided by Registration & Drug Pricing Section of Pharmacy & Drug Control department, through which the pharmaceutical product is registered, if the required conditions are met.
Conditions:
  • Prior approval of applicant as a pharmaceutical agent.
  • Prior approval of the marketing authorization holder by Registration committee.
  • Prior approval by the registration committee of all manufacturing sites involved in any manufacturing step of the product.
Requirements:
  • Submission of the file in eCTD format as per Qatari guidelines for eCTD submission.
  • Request submission through PDCD online e-system.
  • 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:
  1. Submission of a new pharmaceutical product registration request on PDCD e-system (E-Services Link Below) by the authorized pharmaceutical agent 
  2. Uploading the eCTD dossier to PDCD online Portal
  3. Scheduling appointment for initial file screening in which the file is received along with the product’s samples / standards.
  4. Review and assessment of the file, inform the agent with any further requirements or clarifications.
  5. Presenting the file to registration committee and inform the agent with registration committee decision.
  6. Pricing of the product in case of approval
  7. Printable product registration certificate is autogenerated from the PDCD E-System.

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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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