Problems relating to Trade and Investment on Gulf Cooperation Council

19. Industrial standards, approval of safety standards
Issue	Issue details	Requests	Reference

(1) Vexatiously Complex Response to Rules and Regulations on Pharmaceuticals, etc.

- When exporting particle beam treatment system or equipment to countries, where legislation is not well organised relative to pharmaceuticals, the purchasers, from time to time, are required to seek application of EU/USA legislation on pharmaceuticals as the governing law. Furthermore, apart from the regulation of pharmaceuticals, in each country, various restrictions exist, including without limitation, restrictions on protection from radiation, restrictions concerning manufacture, import, sales, etc. of pharmaceutical equipment. It is extremely complex to respond properly to each requirement.

- It is requested that GOJ takes steps to negotiate with respective countries to cause the respective countries to accept acquisition of certification of conformity to the Japanese pharmaceuticals law suffices for acquisition of licences and approvals in the respective countries.

- Pharmaceuticals Law, etc.

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