State Institute for Drug Control

It concerns all medicinal products authorized by a national as well as MRP or DCP procedures. It does not concern medicinal products authorized centrally (centralized medicinal products are covered by the European Medicines Agency).  

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SUKL will proceed pursuant to Section § 34a of the Act on Pharmaceuticals, as amended.  

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The provision in Section 34 a of the Act on Pharmaceuticals differentiates between two periods of 3 years which are linked to expiration of marketing authorisation.   The first period of 3 years pursuant to Section 34 a (1) of the Act on Pharmaceuticals shall commence on 1 January of the following year after the marketing authorisation has become binding – the marketing authorisation holder shall launch the medicinal product, i.e. introduce it to the distribution chain, pursuant to Section 3a (10) of the Act on Pharmaceuticals in the course of these three years. The other period of 3 years pursuant to Section 34 a (2) of the Act on Pharmaceuticals shall commence on 1 January of the following year after the date of market launch of the medicinal product – at least one pack must be in the market in the course of 3 consecutive years from this date.  

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For the purposes of Section 34a (1) of the Act on Pharmaceuticals, a market launch shall be the first market introduction of a medicinal product after termination of production, pursuant to Section 3a (10) thereof, i.e. introduction to the distribution chain. In simple words, it is the point when the producer finishes production and gives the medicinal product to the distributor. The marketing authorisation holder shall be obliged to notify SUKL (pursuant to Section 33  (2) of the Act on Pharmaceuticals) of market introduction of the medicinal product by means of an electronic form which is available on the SUKL website, see http://www.sukl.cz/hlaseni-uvedeni-preruseni-nebo-ukonceni-uvadeni-na-trh , within two months after the actual market introduction at the latest. For the purposes of Section 34a (2) of the Act on Pharmaceuticals, market introduction shall be every following market launch of medicinal product pursuant to Section 3a (10) thereof.  

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According to the provision in Section 113 (5) of the Act on Pharmaceuticals, the period of 3 years in which the marketing authorisation holder must launch the medicinal product authorized before 31 December 2007 shall commence on 31 December 2007, i.e. when the Act became effective. The period of 3 years in which the marketing authorisation holder must launch the medicinal product authorized after 31 December 2007 shall commence on 1 January of the following year after the marketing authorisation has become binding.  

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Should a medicinal product be jeopardized by the sunset clause, it is in the best interest of the marketing authorisation holder to notify of the date of the first market introduction after 31 December 2007. The period of 3 years in which the medicinal product must be available in the market in a sufficient amount, shall commence on the first day of the year following the year in which this medicinal product was introduced to the market in the Czech Republic . If SUKL does not have the date of market introduction after 31 December 2007 and if consumption of this medicinal product is notified in 2008, SUKL will consider the date of 1 January 2008 to be the date of market introduction after the Act on Pharmaceuticals has become effective.  

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No. Section 34 a (2) of the Act on Pharmaceuticals stipulates that if the medicinal product launched fails to be available in the market in the course of 3 consecutive years, the marketing authorisation shall cease to be valid, and this period shall commence on 1 January of the following year. Obviously, an uninterrupted period of 3 years is meant. Neither the respective clause of Directive 2001/83/EC in Article 24 nor the respective provision of the Act on Pharmaceuticals stipulate that interruption of medicinal product supplies have an impact on the above mentioned. The application of sunset clause thus does not take the interruption of supplies into account.  

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The provision in Section 34a (1) of the Act on Pharmaceuticals stipulates that the period for a generic medicinal product shall commence only on the day on which the period in which it may not be introduced to the market pursuant to Section 27 (1) of the Act on Pharmaceuticals terminates. We kindly ask the marketing authorisation holder to contact SUKL staff by e-mail should they establishes any discrepancies.  

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A medicinal product available in the market means a product notified pursuant to DIS-13.  

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No. Pursuant to Section 5b (7) of the Act No. 40/1995 Coll., on Advertising Regulation, as amended, samples of medicinal products may only be provided exceptionally to individuals authorized to prescribe them in a limited number for one calendar year at most. Every sample must correspond to the smallest pack of a humane medicinal product introduced to the market and must be labelled “Unsalable sample” or “Free sample”. Samples may not be used for a continuous treatment of patients, and patients themselves do not have any access to samples. In case of new pharmaceuticals in the market, samples of medicinal products are provided in order to test the new drug in practice.  

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For the purposes of sunset clause, the marketing authorisation, and thus the marketing authorisation number listed in the marketing authorisation shall be considered. Individual packs have the same marketing authorisation number. Thus, for the purpose of sunset clause evaluation, all the packs consumed are added. It is important to meet the quantitative requirement, which means one pack per marketing authorisation number regardless of the pack type.  

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The new strength of medicinal product shall be authorized separately, it has a new individual marketing authorisation number (there is no change or extension of marketing authorisation of the original medicinal product). The period for sunset clause for the original product shall remain unchanged and uninterrupted. However, the period for the new strength shall be calculated in a standard manner, totalling 3 years beginning on 1 January of the following year after its marketing authorisation.  

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The sunset clause is linked to the marketing authorisation and thus to the marketing authorisation number which is linked to this decision. The period of 3 years when the marketing authorisation holder must introduce the medicinal product to the market shall commence on 1 January of the following year after the date on which the marketing authorisation of medicinal product has become binding, not from the date of differentiation. For medicinal products whose marketing authorisation became binding before 31 December 2007 (see Question 5) Example: MP was authorized in strengths 5, 10 and 20 mg with marketing authorisation number 01/111/11-C. Subsequently, marketing authorisation numbers were differentiated as follows:         5 mg – 01/111/11-A/C 10 mg – 01/111/11-B/C 20 mg – 01/111/11-C/C Only one pack of 5 mg (01/111/11-A/C) was introduced to the market, the period of three years of market availability shall be calculated for all three strengths (5 mg; 10 mg; 20 mg) from 1 January of the following year. In this case, one strength (5 mg) “saves” the remaining two strengths (10 mg; 20 mg).  

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No. Changes of marketing authorisation do not impact on the application of sunset clause, because this is linked to the marketing authorisation, not to the decision on change to marketing authorisation.  

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The transfer of marketing authorisation has no impact on the application of sunset clause. The new holder assumes all rights and obligations of the original holder.  

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