State Institute for Drug Control

In compliance with Section 34 paragraph 8 of the amended Act on Pharmaceuticals, the marketing authorisation holder must inform the Institute of the method of recall of the medicinal product and of the time necessary for such recall. As of 2 April 2013, an amended form of the application for revoking of marketing authorisation (REG-72) is available on the Institute’s website at  http://www.sukl.cz/leciva/pokyny-a-formulare, in which the information on the method of recall of the medicinal product and the period necessary for such recall is required for medicinal products that are available in the market of the CR. Where an application for revocation of marketing authorisation is submit after 2 April 2013 on the form that was valid before 2 April 2013, the Institute will request, for medicinal products that are available in the market of the CR, supplementing information on the method of recall of the medicinal product from the market and on the period necessary for such recall.