Middle East
Arabic/English
Minister of Qatar’s Public health.
https://www.moph.gov.qa/english/derpartments/policyaffairs/pdc/Pages/default.aspx
Yes
12 Months
QAR 150,000
1 month before
1. Arabic Language
2. Islamic compliance
3. Safety symbols
4. Prohibited information
This section includes 3 important subsections as follows:
Application Type |
Folder Color |
New registration |
Black hard folder |
New registration – fast track |
Red hard folder |
Variation |
Grey |
Variation – fast track |
Yellow |
Renewal |
Green hard file |
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.
Format: All formal responses to questions and any correspondence directly related to the dossier content must be submitted in eCTD format.
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.
Written approval from PDCD must be obtained before submitting the file, and this approval should be attached to the file upon submission.
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.
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:
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.
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.
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.
Format: All formal responses to questions and any correspondence directly related to the dossier content must be submitted in eCTD format.
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.
Written approval from PDCD must be obtained before submitting the file, and this approval should be attached to the file upon submission.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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