Czech Republic introduced yearly maintenance fees for medicinal products

With the new law on Pharmaceuticals 378/2007 Coll. valid from December 31st 2007 Czech Republic introduced yearly  maintenance fees for registered medicinal products. However, related Decree was released on Decemer 15th 2008 stating the amount of these fees.

Fees are as follows:

  • Yearly maintenance fee (except situations below)-19,500 CZK
  • Yearly maintenance fee for medicinal product where CZ acted as RMS-39,100 CZK
  • Yearly maintenance fee for medicinal product of MAH which is considered to be a micro-sized enterprise-5,000 CZK
  • Yearly maintenance fee for medicinal product of MAH which is considered to be a small enterprise-9,500 CZK
  • Yearly maintenance fee for homeopatic product-6,000 CZK

Description of small- and micro-sized enterprise follows Commission Regulation (EC) No. 70/2001 of 12th January 2001 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises which defines:

  • Small enterprise: as enterprise which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million.
  • Micro enterprise: as enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million.)

    -The fees must be paid per each registered MA No. (i.e. ALL products including not marketed ones.)
    -MAH do not pay for the calendar year in which the product was registered.
    -The fees must be paid BEFORE end of the year IN ADVANCE FOR THE NEXT YEAR. As the  original law on Pharmaceuticals introducing maintenance fees came into force on December 31st 2007, the fees must be paid for year 2008 as well.

Additionaly, SUKL for this year allows MAHs to make the payments till end of January 2009, which means by end of January MAHs must pay fee for 2008 and also -in advance- for 2009.

Fees are to be paid by bank transfer using an unique number which is generated specially for this fee and product (similar to varible symbols for other procedures). When SUKL checks the transfer and amount, they will send an confirmation on yearly payment to MAH.

With this Decree also fees of other procedures have risen, valid from procedures which are submitted from December 15th 2008. The full list is not available in English yet, but prices basically doubled. (e.g. generic MRP/DCP is 90,000CZK instead of former 43,900CZK, another strength is 40,000 CZK instead of former 19,500 CZK variation II in MRP is 50,000CZK). For specific upcoming procedures please ask for current fees.

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