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Question: (EC) According to Article 128.1 of the Intellectual Property Law, applicants for licenses for trading in or circulating pharmaceuticals or agrochemical products need to specifically request such data to be kept secret. Please also access the compliance of Article 128 with the Article 39 of the TRIPS Agreement.

Answer: In compliance with Article 39 of the TRIPS Agreement, the IP Law provides protection of sceret data if such data meet certain conditions (as mentioned in the question above), but not protection of all data in the request for circulation of the product. In order…

Question: (US) Regarding Article 2(3) “Regulation on Data Security of Drug Registration Records” (“Regulation on Data Security”), please explain what is meant by “circulated pharmaceutical substances.” Regarding the term “business secret” as it is used throughout the Regulation on Data Security, please explain the criteria by which it is determined that information received from financial investment or intellectual activities becomes qualified to be a “business secret”, and what laws, regulations, decrees, etc., provide for any such criteria.Regarding Article 4 (2), please explain what constitues “significant effort”.According to Article 4(1), data to be secured must qualify as a “business secret”. Please explain the resoning behind the requirement that date to be secured under Article 10(2) must qualify as a “business secret”.

Answer: The above regulations stipulated in the Regulation on data security of drug registration records (issued by the Decision No. 30/2006/QD-BYT of 30 September 2006”) should be interpreted as follows: - “Circulated pharmaceutical subtances” can be interpreted that subtances of the final drugs are allowed to…

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