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There is currently a broad consensus that children deserve access to medicines that have been specifically developed and researched for use in young patients. However, until recently, the development and testing of pediatric drugs was far from satisfactory. Although awareness of the lack of satisfactory treatment for children in the EU began to rise in the 1990s, the pharmaceutical industry showed insufficient interest in investing in the development of pediatric medicines. Economic considerations have also been a contributing factor to why companies have refrained from investing proactively in this sector. The fact that children grow and mature means that they are not a uniform subgroup. Therefore, in 2007, the EU introduced a regulation to stimulate the development of medicines for children. In this context, this article aims to examine the regulation of pediatric medicines in the European Union, the impact of this legislation, and the need for future changes to the legislative framework in order to achieve the key objectives of the pharmaceutical strategy for Europe. [ABSTRACT FROM AUTHOR]

Counterfeit medicines pose a serious threat to health systems, industry and society. Globalization of commerce and the active online environment have significantly increased the health risks associated with counterfeiting medicines. Considering these alarming issues, the European Parliament and the Council have adopted a legislative framework aimed at combating the entry of falsified medicinal products into the legal supply chain, without affecting the functioning of the internal market for medicinal products for human use. This article aims to present the impact of the new legislative solutions known as the "Falsified Medicines Directive", by which, in 2011, the European Union took an imperative step in protecting public health, establishing the legal basis by which the falsification of medicines is a criminal law action, which deprives patients of safe and quality medical treatment. [ABSTRACT FROM AUTHOR]

In a competitive and stressful world that demands vitality, energy and good health, cosmetics play an increasingly important role for individuals and society as a whole. In this context, customization is a prominent strategy in the beauty industry that can satisfy varied customer preferences. Today's personalized cosmetics can be defined as three major types: (a) previously made by manufacturers according to customer needs (made-to-order services), (b) do-it-yourself (DIY) kits provided for the manufacture of cosmetics by customers themselves at home or (c) performed on site (in situ) by sellers or customers. Most personalized cosmetics belong to type a or b, where safety and quality are previously ensured by the manufacturers. These are considered general commercial cosmetics; therefore, the final products should comply with regulations such as the Cosmetic Act of the Republic of Korea, and EC Cosmetic Regulation 1123/2009 in Europe (European Commission, 2009). Meeting legal regulations for customized cosmetic products can be a challenge, but compliance is achievable in most situations, especially by the Korean Country market through the Cosmetic Act update. The South Korean Ministry of Drug and Safety (MFDS), in March 2020, introduced the world's first regulatory guidelines on custom (personalized) cosmetics. Also, in april 2023, Shanghai issued its first license for on-the-spot on site (in situ) personalized cosmetics service, marking the launch of a pilot program for such a service in the city. In the European Union, from this perspective, a customized cosmetic product on the market (online purchase with production at regular facilities; mixing in situ; mixing with a household device; mixing boosters with a cosmetic base), does not ensure total compliance with the regulations in the field. A new, updated guide harmonizing the regulations for personalized cosmetic products should enable best practices for the single market, ensuring their quality and safety. [ABSTRACT FROM AUTHOR]

Advertising for medicines is any form of information through direct contact, as well as any form of promotion intended to stimulate the prescription, distribution, sale or consumption of medicines. In order to be of interest to users, advertising for any medicine, regardless of the form in which it is carried out) must be of a high standard and comply with legal provisions and, in addition, must not include anything that could be offensive or deceptive. Considering the fact that the entire activity of advertising and promotion of medicines must be done responsibly, ethically and to the highest standard, in order to ensure the safe use of medicines, regardless of their mode of release, this article aims to analyze the legislative measures adopted to regulate the advertising of medicinal products for human use. At the same time, this paper aims to analyze how the National Agency for Medicines and Medical Devices in Romania (ANMDMR), the competent national authority, evaluates and monitors all forms of drug advertising, as well as the role of advertising campaigns that are part of the category medical education. [ABSTRACT FROM AUTHOR]

This paper aims to highlight the historical evolution of the emergence of patient rights, social rights in their essence, as well as their development according to the essential transformations of a society. The present paper aims to show the fact that the patient's rights were born, first of all, through quantitative assimilations, through increases and overlapping of information from one era to another, they are not the "creation" of contemporary times, the fact that they are based on a certain history written before our eyes. The study of the patient's rights is intertwined with the study of political concepts, all the more so since the drafting of legislation is directly dependent on political guidelines, and political institutions are directly involved in the legislative act. The development of social relations, their complexity, the unprecedented multiplication of intra- and inter-social contacts, determined a correlative development of law and the emergence of community law, which in the current social reality, represents the positive law applicable on the territory of the European Union. [ABSTRACT FROM AUTHOR]

Although the European Union has long faced the problem of the shortage of medicines, the European Parliament resolution of 17 September 2020 on the shortage of medicines [1] states that due to the increasing global demand for medicines and the COVID-19 pandemic, medicine shortages have become even more acute, affecting Member States' health systems and posing considerable risks to patients' health and care. The Committee on Industry, Research and Energy, in its opinion of 16.6.2020 [2], recognises that parallel trade can cause a shortage of medicines and calls on the Commission and the Member States to adequately address the problems of parallel trade in medicines in the EU, in order to prevent export shortages caused by considerable differences in the price of a medicine between Member States. In this context, this article aims to analyse the regulations at the level of the European Union, the case law of the Court of Justice of the European Union, as well as the national legislative measures relating to intra-EU trade on the pharmaceutical market. [ABSTRACT FROM AUTHOR]

As a result of the evolution of information and communication technologies, medicines, like other goods, are now increasingly marketed on the EU internal market through these channels. When examining the compatibility of the conditions for the supply of retail medicinal products with European Union law, the Court of Justice has recognized the specific nature of medicinal products, whose therapeutic effect significantly distinguishes them from other goods. Taking into account all these aspects, this article aims to analyse the centralized regulation of online pharmacies in relation to European Union law, the jurisprudence of the Court of Justice of the European Union, as well as the legislative measures taken at national level to provide medicinal products to the population through the Internet. [ABSTRACT FROM AUTHOR]

Drug precursors are the chemical substances used in the illicit manufacture of drugs, psychotropic and narcotic substances - their salts, as well as mixtures containing such substances, with the exception of pharmaceutical preparations and other preparations with these substances, which cannot be recovered or used for this purpose by laboratory methods. Taking into account the fact that the National Anti-Drug Agency, subordinate to the Ministry of Internal Affairs, through the Precursors Service, is the competent authority in the sense of European regulations, having the obligation to ensure compliance at national level with all the obligations established by them, this article aims to analyze the legislative measures taken at the national level in the matter of drug precursors. At the same time, the present work aims to analyze how operations with drug precursors are authorized, as well as the sanctioning regime. [ABSTRACT FROM AUTHOR]

One of the most important aspects of a medicinal product is represented by its quality assurance, which makes it safe and reliable to use. Unfortunately, in recent years, the counterfeit medicine industry has been growing steadily, which has necessitated the introduction of new regulations and methods to control the quality of medicines. In the first part of the study, the counterfeit product has been described and the methods by which it can be brought to market, with the development of the online environment being one of the main reasons for the growth of this illegal industry. The study continues with some examples of counterfeit pharmaceuticals and how they can be recognized by health professionals, and then the impact of these drugs on society today is presented. Finally, some ways to combat this phenomenon were presented, with an emphasis on the introduction of the serialization of medicines, a very important directive implemented by the OSMR. Counterfeiting of medicines is a global problem, and there is a need for increased and effective international coordination and cooperation to ensure the effectiveness of anti-counterfeiting strategies, particularly in relation to the sale of such products on the Internet. To this end, the Commission and the Member States should cooperate closely and support the ongoing work of international forums on this issue, such as the Council of Europe, Europol, and the UN. [ABSTRACT FROM AUTHOR]

Artificial intelligence (A.I.) represents various intelligent processes and behaviors, developed by computational models, algorithms or a set of rules that support the machine to imitate the cognitive functions of humans, such as learning, problem solving. AI technologies in healthcare include machine learning (ML), natural language processing (NLP), physical robots, robotic process automation. Regulators should collaborate with existing networks of ethics committees and AI expert groups on the ethical issues of AI in the development, use and regulation of human medicines, promoting collaboration between drug and medical device regulatory authorities to harmonize views, needs and requirements. [ABSTRACT FROM AUTHOR]

Severe acute respiratory syndrome (SARS CoV2) is an unparalleled challenge for the global medical community. Although the main clinical manifestation is pulmonary, with variations ranging from asymptomatic to mild flu-like illness to severe pneumonia and acute respiratory distress syndrome with potential fatality. The essential mechanism consists of the binding of the virus to ACE2 receptors through a viral envelope protein (protein S or SPIKE) followed by the appearance of a serum protease TMPRSS2 which mediates the binding of the virus at the cellular level. Because ACE2 is a cell membrane peptidase in the lungs, heart, blood vessels, kidneys, brain and gastrointestinal tract, COVID19 infections can occur at any of these levels. All ACE2-expressing cells are at risk of infection. Currently, viral pericarditis associated with both SARS CoV2 infection and vaccination against this virus is becoming more and more common, regardless of the vaccine used. Since April 2021 in the US there have been over 1000 reports in VAERS of myocarditis and post-vaccination pericarditis m RNA Covid-19 (BioNTech, Modern). Although the frequency of myocarditis and pericarditis was rare post-vaccination - 0.0018% of cases reported between December 2020 and July 2021 - the number of cases is certainly much higher, these complications being underdiagnosed, and therefore incorrectly managed and treated. In fact, government organizations also considered these complications, on June 23, 2021 the safety committee of the US Centers for Disease Control and Prevention stated that there is a likely association between Pfizer - BioNTech and Moderna vaccines and myocarditis and pericarditis in some young people (16 -24 years), but that the benefits clearly outweigh the risks. As a result of all these signals, the US Food and Drug Administration said it will add this risk to the mRNA vaccine fact sheets, although it considers that such complications are "extremely rare" and that "most cases have been mild". [ABSTRACT FROM AUTHOR]