The Regulation of the Commission of the Verification of Manufacturing Conditions of Pharmaceuticals and the Regulation for the Registration of Pharmaceuticals (amended) constitute the Albanian legislation dealing with undisclosed information in this field. Both regulations do not define explicitly what an undisclosed information is. But in both of them, it is defined what kind of information must be presented by manufacturers: all documents presented by the manufacturer to take the approval for the manufacturing of drugs and all documents which comprise the drug dossier for obtaining marketing authorization. The regulation defines that the documentation which is confidential is deposited in the National Center of Drugs Control and remains as exclusive property of Albanian authorities that are engaged in the drug registration procedure. (Regulation of the Commission of the Verification of manufacturing Conditions of Pharmaceuticals, point 12; Regulation for the Registration of Pharmaceuticals (amended), point 21)
In the field of veterinary, Regulation No. 4, dated 30 December 1999 "On the registration of the veterinary drugs" based on Law No. 7674, dated 23 February 1996 "On the veterinary service and inspectorate", Article 14 points 2, 3 and 4 define clearly the procedure of registration of any medicine imported and locally produced. The registration is made in the state register - it is valid for 5 years and, when necessary, can be renewed in conformity with the procedure fixed by European Union directives on this problem. The registration is considered done after the issuing of the Minister Order.
The document is conserved in the Commission of Drugs Registration in the Veterinary Division.
