SÚKL shall proceed in compliance with Section 19, paragraph 1 of Decree No 228/2008 Coll., on marketing authorisation of medicinal products, as amended, i.e. compliance with the requirements for the quantity of the product adequate to the minimum of 10.000 DDDs (daily defined doses).
This requirement shall be applicable only to products for which the DDD has been determined by the World Health Organisation (WHO).
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