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Service Details
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Service Details
Registration of Pharmaceutical Product
Target Audience
Pharmaceutical agents
Local Pharmaceutical Companies
Local Pharmaceutical Manufacturers
Multinational Pharmaceutical Companies
Biological / Biosimilars companies
Vaccines companies
Multinational Pharmaceutical Manufacturer
Related Department/Corporation
Pharmacy and Drug Control Department
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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 by Registration committee.
Prior approval by the registration committee of all manufacturing sites involved in any manufacturing step of the product.
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.
Reference for the submitted product from any competent health authority.
Process flow:
Submission of a new pharmaceutical product registration request on PDCD e-system (E-Services Link Below) by the authorized pharmaceutical agent
Uploading the eCTD dossier to PDCD online Portal
Scheduling appointment for initial file screening in which the file is received along with the product’s samples / standards.
Review and assessment of the file, inform the agent with any further requirements or clarifications.
Presenting the file to registration committee and inform the agent with registration committee decision.
Pricing of the product in case of approval
Printable product registration certificate is autogenerated from the PDCD E-System.
Attachments
eCTD and renewal submission FAQs
Guidance for eCTD Submission
Circular No. 12/2019 regarding sample size requirements
Circular No. 13/2019 regarding eCTD dossier
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