Section 34 of the Act on Pharmaceuticals distinguishes between two 3-year periods which are associated with the invalidation of the marketing authorisation.
The first 3-year period is calculated from the coming of the marketing authorization legally into force – in the course of these three years the marketing authorisation holder must place the medicinal product onto the market, i.e. hand it over to the distribution chain.
The other 3-year period is calculated from the date of placing the medicinal product onto the market – in the course of these 3 years, 10,000 daily defined doses of the medicinal product (in compliance with the definition set forth in Section 19 of Decree No 228/2008 Coll.) must be present on the market, if a DDD for the product has been determined by the World Health Organisation. Where no DDD has been determined for the medicinal product, at least one packaging of this medicinal product must be present on the market in the course of these 3 consecutive years (please refer also to Questions nos. 2 and 3).
After the expiry of the period of three years following the placement of the medicinal product onto the market, SÚKL may, at any time, check whether the medicinal product has been present on the market for the past 3 years in sufficient amount, i.e. either 10,000 DDDs or one package thereof (see above).
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