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11. 11. 2024 · Publications and newsletters
HAVELEX – Your guide to pharmaceutical law and the life cycle of a medicinal productThis Pharma Flash issue uses the fictional medicine HAVELEX to walk through the life cycle of a medicinal product and summarise the key rules of Czech pharmaceutical law applicable at each stage.
9. 5. 2024 · Publications and newsletters
Proposed changes to the Czech public health insurance systemThe Czech Ministry of Health has proposed an amendment to the Public Health Insurance Act, effective 1 January 2026, covering price and reimbursement rules for medicines and medical devices, preventive care incentives,…
15. 6. 2023 · Publications and newsletters
Czech government approved new obligations to ensure availability of medicines – is the market ready?The Czech government approved an amendment to the Act on Medicines on 14 June 2023, requiring marketing authorisation holders, distributors and pharmacies to secure medicine availability via extra supply duties, limited-availability labelling…
27. 7. 2022 · Publications and newsletters
Changes to the rules for reimbursement of medicinal products from public health insurance announced to be effective from 1 August 2022An amendment to the Slovak Act on Reimbursement of Medicinal Products, effective from 1 August 2022, shifts MEA-contract negotiations from health insurance companies to the Ministry of Health, while existing contracts stay…
28. 1. 2022 · Publications and newsletters
New Health Technology Assessment Regulation – a step forward in promoting innovative health technologies in the EU?Regulation (EU) 2021/2282 on health technology assessment, applicable from 12 January 2025, sets up an EU Coordination Group and mandatory joint clinical assessments for new medicines and high-risk medical devices, though states…
20. 9. 2021 · Publications and newsletters
What’s new in the amendment to the Public Health Insurance ActThe Chamber of Deputies approved a wide-ranging amendment to the Public Health Insurance Act overhauling reimbursement of highly innovative medicinal products and orphan drugs, introducing a definition of patient organisation, and raising…
8. 6. 2021 · Publications and newsletters
Clinical trials as of 31 January 2022 under new “EU” regimeFrom 31 January 2022, EU Regulation No. 536/2014 on clinical trials becomes fully applicable, replacing Directive 2001/20/EC with a single EU portal and database for trial applications, uniform authorisation rules and a…
29. 1. 2020 · Publications and newsletters
New price rules of the Ministry of Health in the field of medicinal productsNew Ministry of Health price rules effective 1 January 2020 tighten price and trade mark-up regulation of orphan and originator medicinal products in the Czech Republic and introduce a dedicated price regime…
11. 2. 2019 · Articles and Interviews
New Health Ministry Price Regulations for Medicinal ProductsPrice regulation 1/2019/FAR of the Czech Ministry of Health, effective 1 January 2019, cut maximum pharmacy mark-ups in the 7th and 8th pricing bands to 4% and 2% and set new rules…
3. 1. 2019 · Publications and newsletters
New Health Ministry Price Regulations for Medicinal ProductsHAVEL & PARTNERS' January 2019 Pharma Flash reports that price regulation 1/2019/FAR of the Ministry of Health, effective 1 January 2019, cut maximum mark-ups in pricing bands 7 and 8 to 4%…
1. 12. 2018 · Publications and newsletters
12-2018 Pharma FlashThe December 2018 issue of HAVEL & PARTNERS' Pharma Flash newsletter covers a CJEU ruling that reimbursing a medicinal product for off-label use does not breach EU law.
26. 11. 2018 · Articles and Interviews
Czech Republic: One Year after Adoption of the Amendment to the Act on PharmaceuticalsOne year after a major amendment to the Czech Act on Pharmaceuticals, distributors' duty to supply medicines within two business days and manufacturers' market-share supply obligation have proven unworkable and are already…
