State Institute for Drug Control

The supervisory and control activities of the State Institute for Drug Control (hereinafter as SUKL) have recently identified significant reduction in availability of some drugs used for treatment of serious illnesses, despite the quantity of packages put into circulation by holders of registration decisions corresponds to the planned production capacities as well as the data on the needs of patients in the Czech Republic provided by health insurance companies. Evaluation of the reported data on supplies and dispensing of drugs in ČR indicates that this is mainly caused by continuously increasing volume of export of drugs abroad by some holders of licenses for foreign distribution of drugs.

SUKL is obliged to apply all legal instruments to provide secure availability of drugs. Therefore, SUKL hereby notifies all distributors of drugs of the obligations stipulated by Section 77 (1) (h) of the Act no. 378/2007 Coll., on drugs, as amended which obliges all distributors to provide for supplies of drugs for human use distributed by them to operators authorised to supply drugs, in quantities and time intervals adequate to the needs of patients in the Czech Republic.

The implementing regulation, the Regulation no. 229/2008 Coll., on production and distribution of drugs obliges all distributors of drugs to agree within the principles of best distribution practice (Section 35 (e) of the Regulation) on the quantities and time intervals with persons authorised to supply drugs under Section 82 (2) of the Act on Drugs based on the requirements of such persons, so that the drugs distributed by them are secured in adequate quantities for the purpose of providing healthcare to patients in the Czech Republic pursuant to Section 77 (1) (h) of the Act on Drugs.

SUKL shall consider any failure to comply with the above obligations by distributors of drugs a major breach of the Act on Drugs and rules of best distribution practice, for which a penalty of up to CZK 1,000,000 may be imposed on the distributor pursuant to Section 107 (1) (d).

SUKL hereby also notifies all distributors of drugs that compliance with the obligations related to providing for adequate availability of drugs shall be one of the key priorities of the control activities of SUKL in the year 2012.