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Apply for Registering Pharmaceutical Company or Manufacturer

  • Last Updated 28 Dec, 2020
  • Service Type : E-Service
  • Service Mode : Hybrid (Online and Offline)
  • Service Provider : Ministry of Public Health
  • Service Classification : G2B
  • Topic : Business and Finance, Health, Visas and Official Documents
Intended Audience
Citizen:Business Owner

Description

Pharmaceutical agents and representatives, companies and manufacturers may submit a request to the Registration and Drug Pricing Section of the Pharmacy and Drug Control Department to approve the registration of a pharmaceutical company or manufacturer if all requirements are met.

Online Instructions

  • Log in to the Pharmacy and Drug Control System (PDCD).
  • Fill out the manufacturer registration application entering all the required information.
  • Attach the following documents:

  • 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 the World Health Organization (WHO) format.
  • Registration certificate of manufacturing site in gulf countries and other countries (if available).

Additional Information

  • Only MAH companies intending to register their manufacturers to market their products in Qatar and subject to Law No.1 of 1986 are entitled to this service.
  • There shall be a prior approval of applicant registration as pharmaceutical agent in Qatar.
  • After the application is received, an appointment is scheduled for initial file screening and receipt, then the file is reviewed and the agent is informed of any further requirements or clarifications (if any), and the file is eventually presented to the permanent committee to register pharmaceutical companies and their products, and the agent is notified about the committee’s decision.
  • Please check the requirements for registration of pharmaceutical companies or manufacturers.

Fees

No fees are required for this service.

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