Biological / Biosimilars companies
Pharmaceutical agents
Pharmaceutical Companies
Pharmaceutical Manufacturers
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.