The Ministry of Health of the Slovak Republic, as a state authority issuing authorisations for large distribution of medicinal products, reminds the holders of the authorisation for large distribution of medicinal products that new provisions have entered into force since 2 January 2013 to prevent counterfeit medicinal products from entering the legal distribution chain.
According to Paragraph 18 (1) (a). (v) Act No. 362/2011 Coll. on medicinal products and medical devices, the holder of the authorisation to distribute medicinal products is obliged to verify whether

  1. the holder of the authorisation for the wholesale distribution of medicinal products for human use from which he procures a medicinal product for human use has a valid authorisation for the wholesale distribution of medicinal products for human use and complies with the requirements of good distribution practice;
  2. the holder of a marketing authorisation for a medicinal product for human use has a valid authorisation to manufacture a medicinal product for human use;
  3. the agent for the purchase or sale of the medicinal product from which he procures the medicinal product for human use complies with the requirements set out in § 18a concerning the intermediation of the purchase or sale of the medicinal product for human use.

According to Paragraph 18 (1) (a). (x) Act No 362/2011 Coll. on medicinal products and medical devices, the holder of the authorisation for the large distribution of medicinal products shall immediately notify the State Institute and the marketing authorisation holder of the medicinal product of the falsification of a human medicinal product or of the suspected falsification of a medicinal product which he has obtained or intends to procure.
According to § 138 paragraph 27 of Act No. 362/2011 Coll. on medicinal products and medical devices, failure to comply with the above provisions is considered to be another administrative offence, for which the Ministry of Health will impose a fine of between EUR 500 and EUR 25 000.
The Ministry of Health of the Slovak Republic asks the holders of the authorisation for large distribution of medicinal products to comply with the obligations imposed by law to effectively prevent the entry of falsified medicinal products into the legal distribution chain.