Central American Free Trade Agreement

Article 15.10: Measures Related to Certain Regulated Products

1. (a) If a Party requires, as a condition of approving the marketing of a new pharmaceutical or agricultural chemical product, the submission of undisclosed data concerning safety or efficacy, the Party shall not permit third persons, without the consent of the person who provided such information, to market a product on the basis of (1) such information or (2) the approval granted to the person who submitted 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.¹⁴

(b) If a Party permits, as a condition of approving the marketing of a new pharmaceutical or agricultural chemical product, third persons to submit evidence concerning the safety or efficacy of a product that was previously approved in another territory, such as evidence of prior marketing approval, the Party shall not permit third persons, without the consent of the person who previously obtained such approval in the other territory, to obtain authorization or to market a product on the basis of (1) evidence of prior marketing approval in another territory or (2) information concerning safety or efficacy that was previously submitted to obtain marketing approval in another territory for at least five years for pharmaceutical products and ten years for agricultural chemical products from the date approval was granted in the Party to the person who received authorization in the other territory. In order to receive protection under this subparagraph (b), a Party may require that the person providing the information in the other territory seek approval in the Party within 5 years after obtaining marketing approval in the other territory.

(c) For purposes of this Article, a new product is one that does not contain a chemical entity that has been previously approved in the Party.

(d) For the purposes of this paragraph, each Party shall protect such undisclosed information against disclosure except where necessary to protect the public, and each Party shall not consider information accessible within the public domain as undisclosed data. Notwithstanding the foregoing, if any undisclosed information concerning safety and efficacy submitted to a government entity, or an entity acting on behalf of the government, for purposes of obtaining marketing approval is disclosed by such entity, each Party is required to protect such information from unfair commercial use in the manner set forth in this Article.

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FOOTNOTE:

14 Where a Party, on the date of its implementation of the TRIPS Agreement, had in place a system for protecting pharmaceutical or agricultural chemical products not involving new chemical entities from unfair commercial use which conferred a period of protection shorter than that specified in paragraph 1, that Party may retain such system notwithstanding the obligations of paragraph 1.