Renseignements non divulgués
7. Does your legislation provide for exceptions to this protection of undisclosed information? If so, please explain under what conditions would such exceptions apply?
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 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. Based on decision of the court, disclosure and use of undisclosed information indicated in paragraph 19 of Article 71 of the Health Code shall be allowed if: 1) supplies of pharmaceutical product are not sufficient for satisfaction of needs of population during the period of 12 month from the date of registration in the Republic of Kazakhstan; 2) it is necessary to protect health of population in emergency or guarantee national security; 3) legislation of the Republic of Kazakhstan in the field of competition was infringed".