U.S.-Morocco Free Trade Agreement

Article 15.10: MEASURES RELATED TO CERTAIN REGULATED PRODUCTS...

1. If a Party requires, as a condition of approving the marketing of a new pharmaceutical and agricultural chemical product, a) the submission of safety and efficacy data, or b) evidence of prior approval of the product in another territory that requires such information, the Party shall not permit third parties not having the consent of the person providing the information to market a product on the basis of the approval granted to the person submitting such information for at least five years for pharmaceutical products and ten years for agricultural chemical products from the date of approval in the Party. For purposes of this paragraph, a new product is one that contains a new chemical entity that has not been previously approved in the Party.¹¹

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FOOTNOTE:

11 It is noted that, at present, neither Party permits third parties not having the consent of the person providing such information to market a product on the basis of such information submitted in another territory or evidence of prior approval of the product in another territory. In addition, when a product is subject to a system of marketing approval pursuant to paragraph 1 and is also subject to a patent in the territory of that Party, the Party shall not alter the term of protection that it provides pursuant to paragraph 1 in the event that the patent protection terminates on a date earlier than the end of the term of protection specified in Article 10.1.