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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:

  • 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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