I would appreciate it if someone help me understand the Saudi Arabaian regulation.
One of the sublicensees in EU plans to penetrate in the Saudi Arabian market with our product. They say that in order to get approval in Saudi Arabia, the product will need to be shipped in its final form from the original manufacturer. Is this true?
The background information is as follows.
- We are a Japanese pharmaceutical company.
- The product is originated by us but has not been marketed in Japan yet.
- We do not make the final product in a commercial package.
- Bulk tablets are shipped to the EU licensee and packed and sold in EU countries.
- The licensee asks us to make a small box containing 2x2 PTP packed tablets, small amount of packages for regulatory approval and 100,000+ boxes for an initial commercial use.
I wonder if a final packaged product by us, who only supplies bulk tablets for commercial use, is really needed for the Saudi Arabian registration.
Thank you, in advance.
Toru
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Toru Murakumo RAC
Group Manager
Mitsubishi Tanabe Pharma Corporation
Tokyo
Japan
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