Oman Ministry of Health Circular No. 3/2025
Analytical Requirements for Registration of Biological Products (Biosimilars)
To All: Drug Stores Pharmaceutical Consultancy Services Companies Local Pharmaceutical Industries
After compliments,
Sub: Analytical Requirements for Registration of Biological Products (Biosimilars)
As a part of the ongoing update to the registration process and requirements, and ensuring that the assessment and analysis of the product are completed prior to the registration process, this is to inform you that the following analytical documentation must be submitted along with the product registration dossier for biological products (biosimilars):
Reference standards
Columns
Chemical reagents
Minimum quantity of samples sufficient to conduct the analysis
We appreciate your cooperation in adhering to these requirements to ensure the smooth and timely processing of product registrations.
Yours faithfully,
Dr. Mohammed Hamdan Al Rubaie
Director General