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Qatar Drug Product Registration

Comprehensive Guide to Pharmaceutical Registration in Qatar: Processes, Requirements, New Product Registration, Variation, Renewal

Territory: Middle East

Official Language: Arabic/English

Regulatory Authority Name: Minister of Qatar’s Public health.

Regulatory Authority website: https://www.moph.gov.qa/english/derpartments/policyaffairs/pdc/Pages/default.aspx

Mail ID: [email protected]

Local Authorised: Yes

Registration Timeline: 12 Months

 Registration Fee: QAR 150,000

License Validity: 1 month before

Special Labelling Requirements: Arabic Language

                   Islamic compliance

                   Safety symbols

                   Prohibited information

Data Requirements This section includes 3 important subsections as follows:

  1. Content & structure of eCTD submission
  2. Hard Copies for Module I
  • Qualifications of the Product File

 

Application type

Folder colour

New registration

Black hard folder

New registration – fast track

Red hard folder

Variation

Grey

Variation – fast track

Yellow

Renewal

Green hard file

 

Requirements

  • Legalized and valid Good Manufacturing Practice (GMP) certificate from the health authority in the country of origin.
  • Legalized and valid Manufacturing License (ML) from the health authority in the country of origin.
  • Legalized relationship letter between the marketing authorization holder (MAH) company and the manufacturer.
  • List of the products manufactured by the manufacturer showing their pharmacological group, Generic name & trade name.
  • Soft copy of the Site master file (according to WHO format).
  • Registration certificate of the manufacturing site in gulf countries and other countries (if available).

Registration Procedure

  • Submission of the application via the electronic system PDCD E-system (E-Service link below).
  • Assessment of the application and notification of the Agent of any further requirements if needed.
  • Presenting the file to registration committee and inform the Agent with the committee decision.
  • In case of approval a printable certificate is autogenerated from the E-System.

Registration Process

  1. Responsibilities of Product License Holder (MAH):
  • Ensure quality, safety, and efficacy of the product throughout its lifecycle.
  • Prepare dossier in eCTD format for submission.
  • Inform PDCD (through local agent) of any product variations or safety signals promptly.
  1. Role of Local Agent:
  • Authorized representative for the product in Qatar, handling dealings with MOPH.
  • Must be a registered Qatari organization meeting MOPH requirements.
  • Responsible for registering MAH and manufacturing sites before product application.
  • Ensures submission of up-to-date information.
  1. Submission Process:

New product registration – Submission and validation

Online Filling of Application:

  • The applicant must complete the appropriate application through the Pharmacy and Drug Control Department (PDCD) E-system.
  • The application undergoes a preliminary administrative review, and an appointment is scheduled for file submission.
  • The agent can request a change in the appointment by emailing the administrative office of the human drugs registration section.
  • Failure to appear on the scheduled date requires a new appointment request.

Acceptance of Submission:

  • During the appointment, the applicant submits the required documents (appendix 1).
  • PDCD staff conducts an initial review to ensure compliance with submission requirements using the PDCD eCTD submission checklist (appendix 3).
  • The file undergoes a virus scan and technical validation based on the latest GCC validation specifications.

2.an Application without Deficiencies:

  • The applicant is informed during the appointment that the submission is accepted, and the file proceeds to the next stage.

2.b Application with Deficiencies:

  • If deficiencies are identified, the applicant is notified during the appointment.
  • Another appointment can be scheduled upon the applicant’s request to re-submit the file, at least 1 month from the first appointment.

Assessment/Review:

  • All applications undergo assessment based on the application type and product.
  • If comments or issues are identified, the applicant is notified via email and given 4 months to respond, as per the registration committee circular (issued in 6/2015).
  • The applicant must ensure that the Marketing Authorization Holder (MAH) receives the comments.
  • Failure to meet PDCD requirements within 4 months results in application rejection, and the applicant is informed to collect the file. Otherwise, the file proceeds to the next stage.

Acceptance of Application:

  • After successful validation, assessment, and meeting MOPH requirements, the file is submitted to the registration committee for review and decision (accept or reject).
  • The committee may request additional documents or raise specific issues, and the applicant is notified of the decision.
  • If additional requirements are requested, the applicant is given 4 months (or equivalent study period) to respond. Failure to respond within this period results in automatic application deletion, requiring the file to be resubmitted as a new application.

Labelling and Packaging:

  • Ensure compliance with Qatari labelling and packaging requirements.
  • Include all required information on the drug’s packaging, such as dosage instructions, warnings, and expiration dates.

Site Inspections:

  • Prepare for potential site inspections by ensuring that manufacturing facilities comply with GMP standards.
  • Address any findings or observations from previous inspections promptly.

Legal and Regulatory Compliance:

  • Ensure that the application complies with all relevant laws and regulations in Qatar.
  • Address any legal or regulatory questions raised during the review process.

Post-Submission Follow-Up:

  • Respond promptly to any requests for additional information or clarification from the QFDA during the review process.
  • Stay informed about the status of the application and be prepared to address any concerns raised by the regulatory authorities.

Variation(s) and Fast Track Review

Variation(s) Submission:

Format: Applicants can submit variation(s) applications for registered products in eCTD format.

Data Requirements: Specific data requirements for each type of variation are detailed in the Qatari data requirements for variation.

Correspondence:

Format: All formal responses to questions and any correspondence directly related to the dossier content must be submitted in eCTD format.

Fast Track Review:

Request Process:

Applicants have the right to request a fast track review with priority consideration.

The request, submitted by hand to the registration administration office, should provide justification and reasons for consideration, along with supporting documents and the proposed submission date.

Approval Requirement: Written approval from PDCD must be obtained before submitting the file, and this approval should be attached to the file upon submission.

Drug Product Re-Registration/Renewal in Qatar

Frequency: Renewal requests must be submitted every five years for drug products with existing marketing authorization.

Submission Period: The applicant can submit the renewal request after the registration certificate expires and up to 6 months after the end of the 5-year registration period.

Consequences of Delay: Failure to submit the renewal request within the specified period leads to automatic cancellation of the product’s registration. In such cases, the applicant must submit a full eCTD file for evaluation, treating it as a new product application.

Renewal Process: The renewal process mirrors the initial registration process. However, specific data requirements for renewal files must be adhered to, as outlined in Qatari data requirements for renewal.

This renewal requirement ensures ongoing compliance with regulatory standards and allows for continued market authorization for drug products in Qatar.

GCC-Centrally Registered Products in Qatar 

As a member of the Co-operation Council for the Arab States of the Gulf (GCC), the Pharmaceutical and Herbal Medicines Registration and Control Administration (PDCD) in Qatar offers a fast-track assessment for new registration applications of products already centrally registered by GCC. This process exempts the application from a full assessment, but certain conditions must be met:

Submission Requirements:

  • A copy of the valid GCC registration certificate, stamped by the GCC executive office, must be included in the file.
  • Any variations approved after the initial GCC registration should be submitted.

Declaration by the Company:

  • The covering letter accompanying the application should include a declaration by the company stating that the product information and studies submitted are identical to those approved by the GCC, with no modifications or alterations.

It’s important to note that while fast-track assessment is facilitated, PDCD reserves the right to treat the submission as an ordinary one and may exercise this discretion when deemed necessary. Applicants should adhere to the specified requirements and clearly indicate the GCC-central registration status in the application form.

Drug Product Re-Registration/Renewal in Qatar

Frequency: Renewal requests must be submitted every five years for drug products with existing marketing authorization.

Submission Period: The applicant can submit the renewal request after the registration certificate expires and up to 6 months after the end of the 5-year registration period.

Consequences of Delay: Failure to submit the renewal request within the specified period leads to automatic cancellation of the product’s registration. In such cases, the applicant must submit a full eCTD file for evaluation, treating it as a new product application.

Renewal Process: The renewal process mirrors the initial registration process. However, specific data requirements for renewal files must be adhered to, as outlined in Qatari data requirements for renewal.

This renewal requirement ensures ongoing compliance with regulatory standards and allows for continued market authorization for drug products in Qatar.

Variation(s) and Fast Track Review

Variation(s) Submission:

Format: Applicants can submit variation(s) applications for registered products in eCTD format.

Data Requirements: Specific data requirements for each type of variation are detailed in the Qatari data requirements for variation.

Correspondence:

Format: All formal responses to questions and any correspondence directly related to the dossier content must be submitted in eCTD format.

Fast Track Review:

Request Process:

Applicants have the right to request a fast track review with priority consideration.

The request, submitted by hand to the registration administration office, should provide justification and reasons for consideration, along with supporting documents and the proposed submission date.

Approval Requirement: Written approval from PDCD must be obtained before submitting the file, and this approval should be attached to the file upon submission.