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Service Details

Registration of Manufacturer company

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 Registration of Manufacturer company is approved, if the required conditions are met

Applied for any MAH company that is intended to register its manufacturer(s) to market its products in Qatar and subjected to law no. (1) of 1986


Conditions:
Prior approval of applicant registration as pharmaceutical agent.
 
Requirements:

  • Legalized and valid Good Manufacturing Practice (GMP) certificate from the health authority in the country of origin.
  • Legalized manufacturing license from the health authority in the country of origin.
  • Legalized relationship letter between the marketing authorization holder (MAH) company and the manufacturer.
  • List of the products manufactured by the manufacturer showing their pharmacological group, Generic name & trade name.
  • Soft copy of the Site master file (according to WHO format).
  • Registration certificate of manufacturing site in gulf countries and other countries (if available).

Process flow:
  • Submission of manufacturer registration request on PDCD online e-system by the authorized pharmaceutical agent. (see E-Service link below)
  • Scheduling appointment for initial file screening in which the file is received.
  • Review and assessment of the file, inform the agent with any further requirements or clarifications and presenting the file to registration committee.
  • Receiving committee decision.

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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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