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PRICE LIST LAST UPDATE 15-03-2023
SUPP 15-03-2023
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List of registered pharmaceutical Manufactures & products
List of registered pharmaceutical Manufactures
List of drugs under registration :
1) List of products under registration by Active Ingredients.
List of required pharmacutical product for registration.
List of Registered Herbal Medicines
List of Registered Health Products
List of Registered Medicated Medical Devices
List of Herbal Companies
- Product Classification
Submission for Classification should be online as per the below link:
https://www.moh.gov.om/en_US/product-classification
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Pharmaceutical companies and products
a) Registration of pharmaceutical company as per below form:
b) Registration of pharmaceutical products:
eCTD Guideline
eCTD Guidline version 3 (oman) - Draft
eCTD Guideline version 2 (Oman)
c) Submission of Variation of pharmaceutical products:
Guidance on submission of variation of registered pharmaceutical companies/products.
GCC Guideline for variation (version 6.1)
D) Biocovigilance Registration Guidelines
BCS Biowaiver Application Form
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Herbal Companies & Products
Registration of Herbal companies and products as per Circular no.28/2008:
1) Herbal companies registration (Form)
2) Herbal product registration (Form)
- Health Products
Guidance on the requirements for registration of Health Products
1) Circular 64/2005 (guideline for health products registration)
2) Circular 46/2008(variation application)
3) Circular 56/2021 Registration Application form of Health Products
4) Circular 225/2022 Registration Application form of Medicated Cosmetic Products
- Medicated Device
Guidance on the requirement for marketing approval of medical devices containing medicinal products (Circular 20/2012)
Regn. Of Medical Devices -FORM M