Section 34 of Act No 378/2007 Coll., on Pharmaceuticals, as amended (hereinafter referred to as the “Act on Pharmaceuticals”) specifies that a marketing authorisation of a medicinal product shall cease to be valid if within the period of 3 consecutive years since the marketing authorisation came legally into force the medicinal product has not been placed on the market in the Czech Republic. SÚKL does not decide on the cessation of the marketing authorisation. The marketing authorisation shall cease to be valid on the basis of the provisions of the Act.
Marketing authorisations of individual medicinal products validity pursuing is in the interest of every marketing authorisation holder. SÚKL has adopted steps to provide the information to the MA holders, but the respective measures resulting in maintaining the validity of the marketing authorisation are to be taken by the MA holders themselves.
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