Oman Drug Product Registration

NDA Approval Process

1.  Appointment for Submitting Applications

The applicant should request an appointment to submit the application to MOH-DGPA&DC. Appointments will be made for items manufactured/batch released by enterprises registered with MOH-DGPA&DC. The applicant will be advised of the appointment date and time.

If the applicant does not present on the planned day (no show), a new appointment request must be submitted (see Appendix IV for the appointment request format). It’s worth noting that Variations don’t require any prior appointments. If the product was registered in any GCC country, the applicant should include a copy of the Certificate of Analysis with the employment letter. The same should also be included in the dossier.

2. Submission of Application

On the submission day, the applicant must be present at the designated time slot.

Submitted dossiers together with the two CD’s/DVD’s will be reviewed against a checklist of all required papers according to MOH-DGPA&DC submission standards.

3. Phase I Validation

MOH-DGPA&DC will rescan the submission to check for viruses. The dossier will be validated using an Importation tool. The resultant 32-digit MD5 checksum must match the applicant’s submission.

4. Post Phase- I Validation

Valid Drug Application

Applicants will receive a copy of the application form with their allocated eCTD application number. The dossier is subsequently submitted for evaluation and assessment.

Invalid Drug Application

For invalid drug applications, the dossier and samples will be returned to the agency, along with a validation report detailing the mistakes. The applicant has 30 days from the date of submission to fix the inaccuracies.

Once the errors have been corrected, the applicant should contact the MOH-DGPA&DC to schedule a resubmission of the dossier.If the applicant submitted the relevant information within 30 days. The application will be forwarded to the appropriate staff member for further processing and assessment.

If the applicant provided the requested information within 30 days but it was discovered to be incomplete, the applicant may fill the missing information within the remaining 30 days.

In the event of failing to submit within 30 Days.

5. Phase II Review Process

During Phase II (Review), the submitted dossier will undergo technical and content validations before being assessed. If flaws are found during the evaluation, the applicant is asked to supply the necessary papers within 90 days after the request. The response must be in eCTD format with the correct sequence number.

1.If an application does not react within 90 days, their submitted documents will be examined. If the response is unacceptable, the applicant will be notified and given another 90 days to respond.

2. Applications that do not answer within the timetable will be submitted to TCR&P for decision-making.

6.  Phase III (Decision)

Decision on application will be taken by TCR&P.

 Application For Variations (Change)

An applicant should submit a variation application for drug products that have already received marketing permission from MOH-DGPA&DC by submitting the following:

– The variation application form is as shown in Appendix VI.

– An application form may contain multiple variations for a single submission.

– Parallel submissions are only accepted if the variations are unrelated.

– Applications for modifications are accepted weekly on Tuesdays from 9:00 a.m. to 11:59 a.m.

– The variation procedure and required documentation adhere to the current GCC variation rules.

– A CD/DVD containing the relevant papers in eCTD format, together with the validation report.

– Ensure that the cover letter and hard copies of legalized documents are identical to those available in soft copy. There should be no modifications.

Application For Reregistration

Re-registration is the process of renewing a pharmaceutical product’s marketing license.

Applicants must file a renewal request for drug products that have already acquired marketing authorization every five years, at least six months before the end of the registration period.

The re-registration method is the same as that for registering a new product.

The required documentation should be submitted in accordance with Appendix V. In addition, the following documents must be included in the supplementary data folder:

a A declaration letter or part of the cover letter stating that there have been no changes to the product other than those approved by MOH-DGPA&DC.

1. In the event of any revisions, provide a table comparing the previously approved specification to the proposed changes.