Registration of medicinal products: Determination of the maximum amount of prices and conditions for reimbursement of medicinal products

Drug life cycle: block of lectures No. 2

We are preparing a series of lectures for PřF students thanks to support from the IntegRECAMO project (OPVK CZ.1.07 / 2.3.00 / 20.0097)

Electronic registration is via www.recamo.cz

No medicinal product may be placed on the market without a marketing authorization granted by the National Medicines Authority or the European Medicines Agency. Registration is therefore a basic condition for the regular entry of a medicinal product on the market in the Czech Republic and the EU.

How does such "registration" of medicinal products in the Czech Republic and within the EU take place? What documentation is submitted and how is it evaluated? What are the differences between the marketing authorization of an original and a generic medicinal product and what is their definition? What are the specifics of the marketing authorization for medicinal products from the "biosimilars" group? How is the simplified registration procedure for traditional herbal preparations and homeopathic medicines carried out? Why do products with the same active substance have other approved indications? This block should provide answers to these and other questions.

The process of deciding on maximum prices and on the amount and conditions of reimbursement of medicinal products (LP) takes place in the regime of administrative proceedings, in which health insurance companies and marketing authorization holders participate by law. The maximum prices and the amount of LP payment are determined mainly on the basis of a comparison of foreign prices, but using different principles. For the purpose of determining the amount and conditions of reimbursement, LPs are evaluated on the basis of an assessment of efficacy, safety and position in clinical practice. With regard to the above criteria, therapeutically interchangeable LPs are classified into reference groups. The cost-effectiveness and impact on the budget when a new LP enters the market or when the amount or conditions of its payment change is also examined.

The next 2 blocks will take place on April 1, 2015 (Life cycle of drugs or what is hidden under this term. Preclinical and clinical research and development of drugs.) And April 29, 2015 (Manufacture of medicinal products. Advertising for medicinal products) and is it is possible to register for them via this website.

Lecturer

MUDr. Jiří Deml Institute of Pharmacology, Faculty of Medicine, Masaryk University

Mgr. Barbora Říhová, Ph.D. Institute of Pharmacology, Faculty of Medicine, Masaryk University

Fee

Thanks to support from EU funds for the IntegRECAMO project (OPVK CZ.1.07 / 2.3.00 / 20.0097), participation in the seminar is free of charge for MU students.

Lectures are intended for undergraduate and postgraduate students of the Faculty of Science, Masaryk University

Place

Bohunice University Campus - building A11 - lecture room 235