Unión Europea
Albania
Información no divulgada
45. Please explain how your legislation defines data submitted to governments or governmental agencies.
On plant protection products, the data deposited by the interested companies asking for the permission to market such products in the Republic of Albania, are protected by Decision of the Council of Ministers No. 72 dated 15 February 2001 "On the approval of the regulation of plant protection products". In Article 6 of this regulation is defined that the protection of data is made on the basis of the request of the applicant and there is no a defined period of time for their protection. Albania protects data submitted to obtain marketing approval for pharmaceutical or agricultural chemicals utilizing a new chemical entity. For the protection of their confidentiality, in the Regulation of the Commission of the Verification of Manufacturing Conditions on Pharmaceutical point 12 is defined: "After the verification from the Commission, documentation which is confidential is deposited in National Center of Drugs Control together with a copy of authorization."