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Service Details
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Service Details
Pharmaceutical product re-registration
Target Audience
Biological / Biosimilars companies
Pharmaceutical agents
Pharmaceutical Companies
Pharmaceutical Manufacturers
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 pharmaceutical product re-registration is approved, if the required conditions are met
Requirements:
Submission of the file in eCTD format as per Qatari guidelines for eCTD submission as well as data requirements for renewal of registered product
Re-registration request submission through PDCD online e-system (see E-Service link below)
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 re-registration request on PDCD online e-system by the authorized pharmaceutical agent
Scheduling appointment for initial file screening in which the file is received along with samples
Review and assessment of the file, inform the agent with any further requirements or clarifications
Receiving PDCD opinion
Required Attachments
Data Requirements for Renewal of Marketing Authorization for Registered Pharmaceutical Products
Guidance for eCTD Submission
FAQs regarding eCTD submission and renewal submission
Memo no. 12/2019 regarding sample size requirements
Memo no. 15/2019 regarding products re-registration
Documents and Forms
Application form for Re-registration of Pharmaceutical Product
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