Suisse

Kazakhstan

Renseignements non divulgués

6. Please explain in detail if the legislation of Kazakhstan ensures that undisclosed test or other data submitted by an applicant to the responsible State agency in the procedure for market authorization of a pharmaceutical or of an agricultural chemical product is protected against disclosure and against unfair commercial use by a competitor, for example by prohibiting a second applicant from relying on, or from referring to the original data of the first applicant, when applying subsequently for market authorization for their own product.

According to paragraph 19 of Article 71 of the Code of the Republic of Kazakhstan "On People's Health and Healthcare System" of 18 September 2009 (further – the Health Code) State Expert Organization as well as state body in the field of circulation of pharmaceutical products, medical devices and equipment shall not be allowed without consent of the applicant to disclose and use with commercial purpose of undisclosed information contained in application for state registration, documents on examination as well as in registration dossier of pharmaceutical product that contain new chemical entities during the period of 6 years after state registration of a pharmaceutical product. With regard to agrochemical products it must be mentioned that according to Law No. 302-III "On Safety of Chemical Products" of 21 July 2007 and Government Resolution No. 1396 "On Approval of the Rules on Registration and Production Testing and State Registration of Pesticides" of 30 November 2011, registration requirements for chemical products, pesticides and poisons are the same for every applicant and does not permit the reliance on undisclosed data developed or submitted by another applicant to obtain product registration.