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- Regulation of sales and advertising of non-prescription drugs The diploma thesis deals with the problems of the regulation of sales and advertising of non-prescription medicinal products which can be dispensed without a prescription. The main goal of this work is to evaluate this regulation in the context of ensuring the safety of users of medicinal products. Such safety might be threatened by placing easily available non- prescription medicinal products in stores and the growing promotion of medicines, which may pose a threat in case of using a fear for own health for marketing purposes. The first part of the thesis defines the basic concepts important for its topic. The second part presents the basic sources of legal regulation of sales and advertising of non-prescription medicinal products. Following chapter is devoted to the issue of registration of medicinal products with an emphasis on their classification for dispensing without prescription. A separate sub-section is also devoted to borderline products and differences in the regulation of their sales and advertising over medicinal products. The next section deals with the issue of sales of non- prescription medicinal products. Here are specified the conditions of the sales, which are compared with the conditions set for the dispensing of...

Legal regulation of advertising of medicinal products in the Czech Republic Abstract This thesis deals with the advertising of medicinal products for human use and its development and legislation. The introductory part is set the objectives of this thesis and the reasons for choosing this topic. The first chapter is devoted to advertising, its legislation, the definition of advertising, history of advertising and this chapter also highlights the institution supervising advertising. The second chapter is to set the legal regulation of advertising in the Czech Republic. Regulation can be divided into the regulation of advertising public and private, together are in this dividing developed individual laws regarding advertising and is not omitted non-legal regulation of advertising. Ethical self-controller in this case especially the Rada pro reklamu and professional organizations. The third chapter is devoted to advertising of medicinal products for human use. This part is essential, because interpret basic definition related to medicinal products for human use. Further subdivision is dividing of medicinal product for human use. The basic consideration is whether product is successively authorised as a human medicinal product or not. In the case of an authorized as a human medicinal product dividing is...

Price regulation of preparations for medical treatment Abstract The present master thesis describes and analyzes the system of medicinal product's pricing regulation in the Czech Republic after the year 1989. The aim is to execute an analysis of the current legal regulation in the context of previous regulation, of particular phases of the process of regulation of medicinal product's prices and to provide a summary of the principles and recommendations as well as to attempt a proposition of future development possibilities. The thesis focuses on Czech legal regulation, decision-making by the judicial bodies, public bodies' activity, as well as on European legislative and jurisdiction. The thesis is divided into five chapters. The first chapter involves the system of pricing and reimbursement regulation of medicinal products into pharmaceutic legislation. The second chapter is divided into two sub-chapters. The first presents the current legal regulation of pricing and reimbursement regulation of medicinal products in the context of international legislation, European legislation and European jurisdiction, as well as domestic legislation. The second chapter also considers public bodies - the Ministry of Health of the Czech Republic and the State Institute for Drug Control - and their activity regarding this...

The Issue of Reimbursement and Price Regulation of Medicinal Products during Provision of Health Services This master thesis deals with the price and reimbursement regulation of medicinal products in the Czech Republic and with selected problematic aspects of this field. The thesis describes and analyzes the issue in broader, especially economic, contexts and aims to give the reader a comprehensive view of the subject. The work itself is divided into nine chapters. The introductory chapter outlines the issue of prices of medicinal products in general and outlines healthcare reforms that have attempted to focus more or less successfully on problematic aspects of the field. The following chapter is devoted to explaining the terms that are key or somehow unclear to health or pharmaceutical law. The third chapter deals with an economic approach to regulation and aims to explain to readers why regulation by state authorities in modern society is in some cases important and in some cases even necessary. There are also described and explained the tools of regulation and at the conclusion of the chapter the economic approach is directly reflected in the situation of the market of medicinal products in the territory of the Czech Republic. The following chapter characterizes the actual entry of a particular...

5 Abstract Legal regulation of healthcare in the Czech Republic The subject matter of this thesis is legal analysis of provision of healthcare in the Czech Republic and outline of basic problems of provision of healthcare, including proposals for their possible solution and comparison with Supreme Court and Constitutional Court jurisprudence. The thesis deals not only with the specific legal regulations in which the provision of healthcare is regulated, but also with the interpretation of their content, as well as with the legal relations between the entities involved in the provision of healthcare. In addition, the thesis discusses the introduction of the electronization of healthcare, which has the potential to improve the healthcare system in the Czech Republic and make the provided healthcare better, cheaper and more accessible. The thesis is divided into five chapters, which are further subdivided into subchapters. The first chapter is about the basic sources of legal regulation of healthcare at international, European and national level. The second chapter deals with the methods of financing the provided healthcare with a particular emphasis on the public health insurance system in the Czech Republic. Subsequently, chapter three deals more closely with healthcare itself and with the interpretation of...

Magistro baigiamajame darbe yra nagrinėjamas dabartinis nanomedicinos teisinis reglamentavimas ES ir JAV. Ši tema Lietuvoje iki šiol dar nebuvo tyrinėjimų objektu. Pirmoji darbo dalis supažindina skaitytoją su nanomedicina bei su ja susijusių sąvokų problematiką. Antroji dalis atskleidžia nanomedicinos teisinio reglamentavimo prielaidas ES, o trečioji dalis – JAV. Be to, atsižvelgiant į gautus rezultatus, yra įvertinamos galimos nanomedicinos teisinio reglamentavimo perspektyvos ateityje. Darbe plačiai analizuojami atitinkami pasirinktų tarptautinės teisės subjektų teisės aktai bei specialioji teisinė literatūra (įvairių institucijų dokumentai, teisės mokslininkų darbai) bei tam tikra mokslinė-techninė literatūra (įvairių institucijų ir organizacijų ataskaitos ir tyrimai, mokslininkų tyrimai). / The master thesis researches the current regulation of nanomedicine in the EU and the US. Until now, this topic has not yet been researched in Lithuania. In the first part of the thesis nanomedicine and the problem of nanomedicine-related definitions are introduced to the reader. The second part reveals the basis of the regulation of nanomedicine in the EU, and the third part – in the US. Furthermore, considering the achieved results, the perspective of the future regulation of nanomedicine is assessed. The thesis extensively analyses the legal acts of the chosen subjects of international law and specific legal literature (documents of various institutions, works of law scholars) as well as some scientific-technical literature (reports and researches of various institutions and organizations, scientists’ researches).

Ministry of Health Decision Practice in the area of Administrative Offences according to The Act on Pharmaceuticals Key Words: Medicinal Products, Administrative Offence, Ministry of Health In the first chapter of this master thesis I dealt with the general issue of administrative offences. I also introduced the Act on Pharmaceuticals and explained the fundamental term "a pharmaceutical," which includes medicinal products and active substances. The state administration is provided by State Institute for Drug Control which adjudicates in administrative offences in the first instance, and Ministry of Health that hears appeals against these decisions. In the second chapter, there is interpreted a material law part of the Act on Pharmaceuticals. I also introduced the elements of administrative offences, responsibility for them, sanctions, speciality and subsidiarity, analogy within the administrative sentencing etc. The third chapter is dedicated to procedural matters concerning the Act on Pharmaceuticals. The whole procedure starts with a control of an operator. If he/she does not abide the relevant rules of law, State Institute for Drug Control will initiate an administrative procedure and after finding necessary facts this institution renders a meritorious decision. If the operator was not satisfied...

1 Current Issues of Supplementary Protection Certificates for Medicinal Products in the Case Law of the European Court of Justice Abstract Supplementary protection certificates (SPCs) are a sui generis industrial property right. Under the conditions, which are explained in more detail in this thesis, they can be obtained for the active ingridients of certain products. The type of products eligible for SPC protection are, inter alia, medicinal products which are characterized by their social importance and therefore by the need to ensure their safety, efficacy and quality. Given that the process of providing these guarantees is both costly and time consuming and that the commercialization of the product is conditional on such guarantees, the period for which medicinal products can benefit from patent protection is therefore shortened. The aim of the SPCs is to compensate for this shortening by an additional period of protection in order to incentivise research that has a positive effect on human health and quality of life. This work analyzes the evolution of the case law of the Court of Justice with regard to an interpretative shift or clarification, in particular as regards the substantive conditions for obtaining a certificate and provisions pertaining to the term of the SPC as laid down in the SPC...

A general nurse may, without clinical supervision, administer medicinal products with the exception of intravenous injections (IV) or infusions in newborns and children under 3 years of age and with the exception of radiopharmaceuticals. This activity is regulated in Decree No. 55/2011 Coll. by Ministry of Health of the Czech Republic. The preparation and administration of the medicinal product is an integral part of the everyday practice of a l nurse; however, the dimensions of this procedure are very broad, and it does not start and end with the administration of the prescribed medicinal product. In the wider context, this is a multi-disciplinary process, in which other health professionals can participate with their well-founded roles. Determining individual roles and collaboration in the multi-disciplinary team composed of a doctor, a nurse and a clinical pharmacist has an effect on the correct pharmacological treatment of the patient. Of all professions, nurses spend time with patients. 40 % of their time administering medications; therefore, they play a key role in the reduction of medication errors. (Miller et all, 2016). The aim of the research is to analyze the current role of the nurse in the administration of medicinal products from the perspective of a clinical pharmacist. The research...