Main topics of the second panel of lectures focused on the drug life cycle will be linked with clinical trials of the drugs and with medicinal product entering the market. We will discuss marketing authorization of medicinal products and determination of the maximum prices and level and conditions of reimbursement of the medicinal products following from the valid legislation in the Czech Republic.
Marketing Authorization of Medicinal Products, Determination of Prices and Reimbursements.
No medicinal product may be launched without the decision on marketing authorization granted by the national authority or by the European Medicines Agency. Marketing authorization is the basic prerequisite for standard medicinal product entering the market in CR and EU.
How does the “marketing authorization” of medicinal products in CR and within the EU countries proceed? What documentation has to be submitted and how is it assessed? What are the differences between marketing authorization of the original and the generic medicinal product and what is their definition? What are specific features of marketing authorization of the medicinal products from the group "biosimilars"? How does the simplified marketing authorization procedure run for traditional herbal medicinal products and homeopathic remedies? Why do the medicinal products with the same active substance have different approved indications? The lecture should answer these and other questions.
The process of decision taking concerning the maximum prices and the level and conditions of reimbursement of the medicinal products (MP) takes place in the regime of the administrative proceedings; under the applicable law the health insurance companies and the marketing authorization holders are obliged to participate in these proceedings. The maximum prices and the level of reimbursement of the medicinal products are determined mainly based on comparison with the prices from abroad, but with application of differing principles.
For purpose of determination of the level and conditions of reimbursement the medicinal products are valued by assessing efficacy, safety and status in clinical practice. With respect to the criteria above the therapeutically replaceable medicinal products are included in the reference groups. The cost efficacy and impact on budget (if a new medicinal product is launched or in case of changed level or conditions of its reimbursement ) is examined as well.
The lecture is thanks to the support of EU funds free of charge.
If you have questions, contact Dr. ŘÍHOVÁ email@example.com, mobile: 725 828 387