Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law

Article 5 — Article (5) Marketing Approval

Part Two: Regulation and Circulation of Medical Products

1. Without prejudice to the applicable legislation concerning veterinary preparations, it is not permitted to import, distribute, possess, sell, display, re-market, use, or manufacture any Medical Product in the State for circulation therein, except after obtaining Marketing Approval of any type from the EDE. 2. As an exception to Clause (1) of this Article, all categories of Medical Products that are compounded in licensed compounding pharmacies are exempt from the requirement to obtain Marketing Approval. 3. The Cabinet may, upon the proposal of the President, decide to exempt any other Medical Products from the requirement to obtain Marketing Approval for their circulation.

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