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Apply for Reregistration of Pharmaceutical Product
- 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 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 reregistration of a pharmaceutical product when all requirements are met.
Online Instructions
- Log in to the Pharmacy and Drug Control System (PDCD).
- Select “Reregistration of Pharmaceutical Product” service and enter all the required information.
- Attach the following documents:
- Filled out Reregistration of pharmaceutical product form
- 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.
- Reference shall be provided for the submitted product from any competent health authority.
- 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.
- 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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