Ministry of Public Health - Service Details

Re-registration of Pharmaceutical Product

Target Audience

Biological / Biosimilars companies

Pharmaceutical agents

Pharmaceutical Companies

Pharmaceutical Manufacturers

Related Department/Corporation

Pharmacy and Drug Control Department - Registration & Drug Pricing

Service provided by Registration & Drug Pricing Section of Pharmacy & Drug Control department, through which the pharmaceutical product is registered, if the required conditions are met.

Conditions:

Prior approval of applicant as a pharmaceutical agent.
Prior approval of the marketing authorization holder.
Prior approval by the registration committee of all manufacturing sites involved in any manufacturing step of the product
Prior approval of product registration by PDCD

Requirements:

Submission of the file in eCTD format as per Qatari guidelines for eCTD submission.
Request submission through PDCD online e-system.
Samples and standards for QC analysis purpose as per PDCD memo no. 12/2019 for samples requirements.

Process flow:

Submission of a new pharmaceutical product registration request on PDCD online e-system (eservice link below) by the authorized pharmaceutical agent.
Uploading the eCTD dossier to PDCD online Portal.
Scheduling appointment for initial file screening and receiving the samples.
Review and assessment of the file, inform the agent with any further requirements or clarifications.
Inform the agent of the PDCD decision. In case of approval a printable certificate is autogenerated from the e-system.

Service Details

Re-registration of Pharmaceutical Product

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