CTIS byl
zřízen farmaceutickým zákonem v rámci Nařízení o klinických studiích (Nařízení (EU) č. 536/2014) a po 30.
lednu 2025 kompletně nahradí původní systém pro klinické studie EudraCT
(Databáze klinických studií orgánů pro regulaci léčiv Evropské unie).
Evropská léková agentura (EMA) průběžně
publikuje zprávy, jak proces přechodu na nový systém pokračuje.
V předchozím článku jsme
ukazovali, jaká byla situace v únoru 2024, v tomto článku jsme informace o počtu
podání a rozhodnutí o přechodu aktualizovali ke konci srpna 2024.
Obr. č. 1 – Změny v počtu
podaných žádostí, resp. v počtu podání, kde již bylo rozhodnuto, v porovnání
s předchozím měsícem
Based on the amendment to Act
No. 235/2004 Coll., on Value Added Tax, as of January 1, 2024, there has been a
change in VAT rates, particularly impacting the increase in prices and
reimbursements for medicinal products. In the infographics, we will illustrate
how the individual rates have changed and examine the international comparison
to assess the impact on the Czech Republic.
While the standard VAT rate
remains at 21 percent, the original reduced rates of 15 percent (for medical
devices) and 10 percent (for medicinal products) have been unified into a
single 12 percent rate. The newly introduced zero rate applies exclusively to
books, although the inclusion of medicinal products could have been possible in
line with European legislation.
The infographics provides an
overview of the changes in rates as follows:
Based on the amendment to Act No. 235/2004 Coll., on Value Added Tax, as of January 1, 2024, there has been a change in VAT rates, particularly impacting the increase in prices and reimbursements...
Drug pricing and reimbursement are based on price referencing, where the foreign price in a foreign currency is converted into Czech koruna. For this purpose, it is essential to obtain the quarterly average exchange rate for the foreign exchange market, as published by the Czech National Bank.
Our new online overview provides: ✔ The required average exchange rate from the previous quarter ✔ The exchange rate development in the current quarter ✔ A monitoring focus on the 7 most commonly used European exchange rates in administrative proceedings
The key information for conducting price referencing in administrative procedures for drug pricing and reimbursement is the average exchange rate from the previous quarter. Now, you can easily...
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant sanofi-aventis, s.r.o., against the decision of the State Institute for Drug Control from 23. 3. 2021, under the no. SUKLS172396/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant sanofi-aventis, s.r.o. - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 9. 4. 2021, under the no. SUKLS182256/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Egis Pharmaceuticals PLC - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 12. 4. 2021, under the no. SUKLS182359/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Egis Pharmaceuticals PLC - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Union of Health Insurance Companies, against the decision of the State Institute for Drug Control from 10. 8. 2022, under the no. SUKLS85858/2022:
the decision under
appeal is reversed and the issue is referred back to the State Institute for
Drug Control for reappraisal.
A decision of the Ministry of Health regarding the appeal of the appelant Union of Health Insurance Companies - the decision is reversed and the issue is referred back for reappraisal.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 15. 3. 2021, under the no. SUKLS246602/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V. - the appeal is dismissed and the decision under appeal is upheld.