Switzerland

Albania

Undisclosed Information

6. Please explain in detail if your legislation ensures that undisclosed test or other data submitted by an applicant to the responsible State agency in the procedure for market authorisation 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 his own product. Does your legislation provide for exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation set a specific term of protection for undisclosed test or other data of the first applicant?

Protection of undisclosed test or other data submitted by an applicant in the procedure for market authorization of a pharmaceutical is provided under the "Regulation of the Commission for the Verification of Manufacturing Conditions on Pharmaceutical" point 12 and under the Regulation "On a supplement and a change on the regulation No. 393 dated 20 January 1998 - On the Registration of Drugs in the Republic of Albania" point 2. In both of them it is defined that this information is confidential and, after the verification by the Commission, the documentation is deposited in the National Center of Drugs Control together with a copy of the marketing authorisation and is exclusive property of the Albanian authorities. The time period during which Albania protects data submitted to obtain marketing approval for pharmaceuticals is not defined (normally, it can't be less than the period of the working of the factory or the validity of the marketing authorization). Each pharmaceutical company submits the dossier for any drugs to get marketing authorization along with the bioequivalent study, when required. All this information is protected and other applicants or third persons are not allowed to consult it. The legislation does not provide for exceptions to this. Concerning agricultural chemical products, data submitted by companies in order to obtain marketing authorization is protected by the 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 it is defined the protection of data is ensured upon request of the applicant and no time limit is foreseen for this.