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- Service Type : E-Service
- Service Mode : Online
- Service Provider : Ministry of Public Health
- Service Classification : G2B
- Topic : Business and Finance, Health, Visas and Official Documents
Intended Audience
Citizen: Business Owner, Employee
Resident: Employee
Service Description
Pharmaceutical agents and representatives and vaccine companies among others may submit a request, via the e-services page of the Ministry of Public Health (MOPH), 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 the State of 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 shall be submitted 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 MOPH website.
Fees
No fees are required for this service.
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Related Services
- Apply for Cancelation of Herbal ProductPharmaceutical agents and representatives may submit a request to the Registration and Drug Pricing Section of the Pharmacy and Drug Control Department to approve the cancelation of a herbal product if all requirements are met.
- Apply for Registering Pharmaceutical Company or ManufacturerPharmaceutical 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.
- Apply for Minor Variations in Registered Pharmaceutical ProductPharmaceutical agents and representatives may submit a request to the Registration and Drug Pricing Section of the Pharmacy and Drug Control Department to approve minor variations in registered pharmaceutical product.
- Apply for Registering as Local Supplier at Health MinistryThe Ministry of Public Health (MoPH) invites all potential vendors and contractors interested to participate in MoPH tenders to apply for a new registration or request an update of the existing registration details through the Contracts and Procurement Department at the MoPH. The details and information submitted are then reviewed to ensure compliance with MoPH requirements before notifying the vendors and contractors about the completion of registration.