Life Sciences
The rising popularity of GLP-1-based medications, such as semaglutide and liraglutide, is not only reshaping how people approach weight loss, but is also beginning to influence the food industry. While pharmaceutical companies are seeing a surge in demand for obesity treatments, food producers are f
Compliance with the SmPC and the Presentation of Non-Registration Studies in Advertising
Informing healthcare professionals about the latest findings from studies related to medicinal products is crucial for ensuring effective and safe patient care. Access to the most recent scientific knowledge allows physicians to better understand the effects and potential side effects of medications
Advertising Medicinal Products and Medical Devices: Will the Amendment Bring Clarity or Confusion?
The Chamber of Deputies is currently discussing a long-prepared amendment to the Act on Regulation of Advertising (Chamber of Deputies Document 918, available here). The proposed amendment introduces several significant changes to the rules for advertising of medicinal products and medical devices.
Dual quality of food in the Czech Republic and Slovakia: Current facts and trends
In recent years, the issue of dual quality of food has been a frequently discussed topic, capturing the attention of not only consumers and the media but also European institutions. While the Czech Agriculture and Food Inspection Authority (SZPI) has released current information on this issue based
Advertising of medicinal products: What does the new version of SÚKL’s guidelines bring?
After more than a decade, the State Institute for Drug Control (SÚKL) has released an updated version of its guidelines UST-27 (full text available here: UST-27 version 4 - SÚKL). This new version, effective from 1 January 2025, clarifies the rules for advertising medicinal products, particularly sp
Is a patient program really a medicine advertisement? And why couldn’t a pharmaceutical company organise it?
A draft amendment to the Advertising Regulation Act has recently been published and is now due to be discussed by the Government and Parliament. It proposes a number of changes, including in the area of advertising of medicinal products. The attentive reader will be in for many surprises when readin
Will it be possible to promote hospital medical devices to the general public?
Many stakeholders in the medical device market are unaware that the current Advertising Regulation Act prohibits the promotion of medical devices intended solely for use by healthcare professionals (commonly referred to as “hospital” medical devices) to the general public.
Boundaries of telemedicine defined – what will the new decree bring?
In early October, an amendment to the Health Services Act came into force, which brought a completely new definition of telemedicine – i.e. the provision of health services via information technology. The Ministry of Health has submitted a long-awaited decree to lay down more precise rules for the p
What is the future of medical devices reimbursement regulation?
In July, the General Health Insurance Company of the Czech Republic (VZP), the major Czech payor, published updated guidelines for enlisting hospital medical devices in VZP’s product list. In this respect, Jiří Štěrba, Director of the Medical Devices Department of VZP, told Zdravotnický deník that V
Can we expect new legislation on the reimbursement of medical devices? Hospital medical devices still overlooked
In May, the inter-departmental comment procedure concluded for a new act that would regulate reimbursement of prescription medical devices, such as incontinence pads, prostheses, hearing aids, and glucometers, as well as dental products covered under public health insurance. The proposals include tr
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