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Must Knows

Apply for Registration of Pharmaceutical or Biological Product or Vaccine

  • 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 : Health, Visas and Official Documents
Intended Audience
Citizen:Business Owner

Description

Pharmaceutical agents and representatives and vaccine companies among others may submit a request to the Registration and Drug Pricing Section of the Pharmacy and Drug Control Department (PDCD) to approve the registration of a pharmaceutical or biological product or vaccine that is to be marketed in Qatar by companies subject to Law No.1 of 1986.

Online Instructions

  • Log in to the Pharmacy and Drug Control System (PDCD).
  • Select “Registration of Pharmaceutical or Biological Product or Vaccine” service and enter all the required information.
  • Attach the following documents:

  • Filled out New Product Registration form
  • Proof of prior approval of applicant registration as pharmaceutical agent
  • Prior approval of marketing authorization holder from Permanent Committee for the Registration of Pharmaceutical Companies and Their Products
  • Prior approval of registration of all manufacturing sites involved in any manufacturing step from Permanent Committee for the Registration of Pharmaceutical Companies and Their Products
  • File in eCTD format as per Qatari guidelines for eCTD submission
  • Provide reference for the submitted product from any competent health authority.

  • Submit your application.

Additional Information

  • Samples and standards for quality control analysis purpose as per PDCD memo no. 12/2019 for samples requirements.
  • An appointment is scheduled for initial file screening during which the file is received along with samples.
  • After the application is reviewed, the agent is notified about the result or in case of remarks.
  • The product is presented to the Permanent Committee for the Registration of Pharmaceutical Companies and Their Products, and the agent is notified about the Committee’s decision.
  • The product is priced in case of approval.
  • Please check the circulars and additional documents available on the website of the Ministry of Public Health.

Fees

No fees are required for this service.

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