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Slovakia: new pharmaceutical regulations

Slovakia
24/07/2006
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Changes to the way pharmaceuticals are regulated were introduced on 1 June 2006. The key changes include:

  • a new requirement to register all tested products and tested drugs
  • further cooperation between EU bodies and member states in supervising good clinical practice
  • a new requirement to register traditional drugs which are made from plants and known to the community for at least 15-30 years
  • a new requirement to for Braille labelling of all new drugs, with the same requirement to be introduced for existing drugs by 1 June 2011
  • new regulations for veterinary and generic drugs

Generic drugs are copies of brand-name drugs with identical dosage, safety, strength, quality, means of application, performance and intended use. No generic drugs can be introduced unless they are first licensed. From 1 June 2006, no application to license a generic drug may be made until 10 years after the original brand-name drug was licensed (and, in some cases, 11 years). Applications made before the protected period will be refused, and the licence holder of the brand-name drug will be notified.

Law: Act no 342/2006 Coll. amending the Act on Medical Drugs and the Trade Licensing Act and Advertising Act.

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