Unauthorized Products Research Articles

Criteria for granting access by an EU member state to a severely ill patient to an unauthorized medicine

The article focuses attention on the fact that a structural element of everyone's subjective legal right to medical care is the right to access to a medicinal product. It is emphasized that the Covid-19 pandemic, the increase in the spectrum of incurable diseases and the number of patients suffering from them, Russia's aggression against Ukraine, the consequences of which are an increase in the number of military personnel and civilians who need the use of medicinal products created using the latest technologies, but which (medicines) are still not allowed in the state, the integration of Ukraine with the EU became the factors that actualized the discussion of scientists and practitioners on the issue of the conditions that must be observed by the EU member state in order to apply the provisions of Article 1. 5 of Directive 2001/83/EC of the European Parliament and of the Council on the Community Code regarding medicinal products intended for human use, the exception is to provide an EU member state with access to a patient to a medicinal product not authorized by the competent authorities of such a member state and thereby fulfill its obligation to provide everyone's constitutional right to medical care. The conditions that must be observed by the EU member state in order to apply the provisions of Article 1. 5 of the Exclusion Directives - for an EU member state to provide a patient with access to a medicinal product that is not authorized by the competent authorities of such a member state: 1) the presence of a norm of national law that allows the supply of a medicinal product for which a permit was not granted; 2) the goal is to meet the special needs of a specific seriously ill patient (private interest) and ensure the protection of public health (public interest); 3) be due to the absence on the national market of any authorized medicinal product - the equivalent of an unauthorized medicinal product; 4) delivery is made in response to a bona fide order on one's own initiative; 5) supply is carried out according to the prescription in accordance with the specifications of the authorized medical worker; 6) an unauthorized medicinal product is prescribed for use by a specific patient under his direct personal responsibility. The signs of the patient's special needs are highlighted: 1) the specific situation of the patient's state of health and the course of his illness; 2) medical reasoning, which is justified; 3) the patient's need for a certain medicinal product. The grounds for an unregistered medicinal product to be prescribed by a doctor are: the doctor's therapeutic considerations; results of research, analyzes of the patient. In a situation where there are authorized medicinal products on the market of an EU member state - analogues of prohibited medicinal products - the import of unauthorized medicinal products can be qualified as an act of non-fulfillment by the EU member state of its obligations, provided for in Article 1. 6 Directives.

Thirteen unauthorised health products seized in Canada

Thirteen unauthorised health products seized in Canada

Perceptions of FDA-authorized e-cigarettes and use interest among young adults who do not use tobacco.

It is unclear how young adults who do not use tobacco perceive FDA-authorized e-cigarettes for market entry. This study explored the perceptions and use interests of FDA-authorized e-cigarettes among this population to inform policy decision-making. We conducted in-depth interviews with young adults in the US, aged 18-29 years, who do not use tobacco (n=25). Participants viewed images of FDA-authorized e-cigarettes and discussed their perceptions and interest in using these products. We used reflexive thematic analysis to analyze interview data. Many participants stated that they were not interested in using FDA-authorized e-cigarettes because they had little interest in using e-cigarettes in general. Additionally, almost all participants found the tobacco flavor and product design of these products unappealing, which further added to their disinterest. Most reported high trust in the FDA and its authorization process for e-cigarette market entry and considered FDA-authorized e-cigarettes safe to use. Most considered FDA-authorized products less harmful than other (unauthorized) e-cigarettes they saw in daily life but were not more interested in using the authorized products. When given the hypothetical scenario where FDA-authorized products come with a variety of fruit and candy flavors, most participants still expressed little interest in using them, mainly due to the high perceived harm from using any e-cigarette products. Although non-tobacco-using young adults in our study reported low interest in using FDA-authorized e-cigarettes for market entry and e-cigarettes in general, the FDA is recommended to continue to evaluate the impact of flavorings and packages on e-cigarette product appeal to reduce e-cigarette use among young people. The FDA should also examine strategies to effectively communicate the purpose of FDA authorization to the public and emphasize that it does not mean these products are 'approved' or safer than unauthorized products.

THE CRIMINAL LAW FRAMEWORK FOR COMBATING DOPING IN SPORTS IN SERBIA

This paper deals with the aspects of criminal law as regards the suppression of doping in sports in the law of the Republic of Serbia. The Law on the Prevention of Doping in Sports prescribes two criminal offences, namely Facilitating the Use of Doping Substances and the Unauthorized Production and Circulation of Doping Substances. These are criminal acts that are prescribed by the so-called secondary criminal legislation of the Republic of Serbia. The analysis of these criminal offences is afforded the central place in this paper. At the same time, for the sake of systematicity, numerous common features of these criminal acts were separated and analysed, such as protective object, object of action (doping agent), consequence of the criminal act, guilt, special intention, etc., and then their other features were separately considered. It is noticeable that the criminal offenses from the Law on the Prevention of Doping in Sports have corresponding regulatory shortcomings, above all they do not include certain important aspects related to the suppression of doping in sports, so certain proposals de lege ferenda were made based on the criminal offenses from the Criminal Code. The paper also gives a cursory review of the most important international documents in this area, i.e. the two most important documents ratified by the Republic of Serbia, namely the International Convention against Doping in Sport and the European Convention against Doping in Sport, bearing in mind that these acts were the basis for adoption of a special anti-doping law in our country. Additionally, the paper clarifies what is considered doping in sports according to the provisions of the positive law of Serbia.

Health Canada seizes unauthorised health products from UU Zone

Health Canada seizes unauthorised health products from UU Zone

FDA seeks fines against stores selling e‐cigarettes that appeal to youth

In September, the U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design e‐cigarettes, a popular youth‐appealing brand. The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products. During follow‐up inspections, the FDA observed the retailers had not corrected the violations, which resulted in these civil money penalty actions.

Tobacco Product Marketing Orders and Online Marketing and Sale of Unauthorized ENDS Products

This study characterizes online marketing of unauthorized electronic nicotine delivery systems (ENDS).

Health Canada seizes unauthorised health products

Health Canada seizes unauthorised health products

Health Canada removes seven unauthorised health products from sale

Health Canada removes seven unauthorised health products from sale

Commentary: Electronic Nicotine Delivery Systems: Seeing Through the Clouds.

Commentary: Electronic Nicotine Delivery Systems: Seeing Through the Clouds.

Cloud-based blockchain technology to identify counterfeits

Multi-stakeholder and organizational involvement is an integral part of the medicine supply chain. Keeping track of the activities associated with medical products is difficult when the system is complex. Their complexity limits transparency and data provenance. Deficiencies within existing supply chains result in the counterfeiting of drugs, illegal imports, and inefficient operations. Due to these limitations, product integrity is compromised, resulting in product wastage. Visibility of the entire product supply chain is crucial for the pharmaceutical industry in terms of product safety and reduction of manufacturing costs. The Cloud-based Blockchain-powered architecture of the system provides a platform for addressing the need of pharma-material traceability, data storage, privacy of data, and quality assurance. This framework comprises of the identification of activities through tagging, information sharing in a secure environment; cloud-based storage using an off-chain Interplanetary File System (IPFS) and an on-chain couch DB; and access to this information that is controlled by the system's regulator. Electronic drug records will be accessed via a smart contract in Hyperledger Blockchain. The system assists in identifying false and cross-border products through the manufacturer and country of origin. A scan will identify counterfeit medications, showing that they are unauthorized products which may pose a risk to patients. Our experiments demonstrated the efficiency and usability of the design platform. Finally, we benchmarked the system using Hyperledger Caliper.

Dangerous trend of methamphetamine use among youths in south-eastern Nigeria: A mini-review

South Eastern Nigeria in the recent times was in the news due to the increased reported cases of illicit use of methamphetamine known in the local dialect as ‘mkpurumiri’ or ‘guzoro’. There were reported homicides and other forms of violence attributed to the increased illicit use of the substance by the young people. This work looked at the possible predisposing factors and solutions to this dangerous trend. The rapid technological innovations and advancement seems to aid the globalized market for the drug sellers and users, with reported unauthorized local production leading to increased availability and accessibility. As psychoactive substance use carries enormous negative consequences, the sudden rise in use of methamphetamine among the youth in the South Eastern part of Nigeria calls for concern, and all hands must be on deck to curb the menace.

Maloletnički narko-kriminal u Srbiji - stanje i kretanje

The growing involvement of minors in drug-related crimes is a problem that our country has been struggling with in recent years. First, it is necessary to point out the increase in the number of drug-related crimes in which juveniles appear in the role of perpetrators, which is the main goal of this paper. The need to highlight the increase in the number of criminal charges and convictions of juveniles for this group of crimes stems from the fact that in other categories of crimes there is a decrease in the number of juvenile offenders, and at the same time, in the group of crimes involving drug abuse the number of juvenile offenders is growing. A worrying circumstance is that juveniles keep pace with adult perpetrators of drug crimes, as in both categories there is a noticeable trend of increasing the representation of this group of crimes. Data from judicial statistics, imprimis of the Republic Bureau of Statistics, provide insight into the new state of juvenile drug crime, while data from the Ministry of the Interior show more detail in the development of this delicate phenomenon. The criminal offense of unauthorized production and distribution of narcotics and the of criminal offense of unauthorized possession of narcotics are committed by a large number of juveniles, and over a period of ten years there has been a marked increase in the number of committed offenses. The age structure of juvenile perpetrators of drug crimes is such that the majority of perpetrators are older juveniles, that is persons aged 16 and 17. When it comes to gender structure, boys constitute the dominant category. The goal of this paper is to draw attention to the prevalence of this problem by presenting the current situation and trends of juvenile drug crime.

Remanufacturing authorization strategy for competition among OEM, authorized remanufacturer, and unauthorized remanufacturer

Engaging authorized manufacturers (ARs) is a strategy that has been adopted by many original equipment manufacturers (OEMs) to compete with unauthorized remanufacturers (URs). As a result, new products, authorized remanufactured products, and unauthorized remanufactured products may coexist in the same market. The OEM needs to strategically determine whether to compete with the UR only through new products or to authorize another independent remanufacturer to compete with the UR. This paper examines a supply chain consisting of an OEM, an UR and an AR competing in the same market. We develop a game-theoretic model and investigate the equilibrium decisions for two scenarios: the unauthorized remanufacturing and authorized remanufacturing scenarios. In the unauthorized remanufacturing scenario, which only the OEM and the UR compete in the market, we derive the OEM's and UR's optimal production quantities and the UR's product quality. We find that the UR would always remanufacture at a high-quality level when the remanufacturing cost is low, and vice versa. In the authorized remanufacturing scenario, the AR remanufactures by cooperating with the OEM through an authorization fee contract. We find that (1) when the AR implements the authorization fee decision, a Pareto improvement region exists when the remanufacturing cost is low; (2) when the OEM implements the authorization fee decision, a Pareto improvement region exists when remanufacturing is lower than a given threshold; and (3) when neither the OEM nor the AR has the full bargaining power to make the authorization fee decision, the UR will benefit from an OEM with a stronger bargaining power. That is because the OEM's authorization fee decision will compromise the AR's competitiveness in the market, which benefits the UR. Finally, we extend the model to investigate whether the OEM should conduct remanufacturing as its optimal strategy.

A Review on Counterfeit Detection of Products and Electronic Devices

The problem of using unauthorized parts, components or products is widespread all around the world. These problems eventually cause a huge loss to the brands. To reduce such malpractices, brands are working on to find out a solution to overcome counterfeit. Counterfeit is basically a non-genuine or a non-brand product. The counterfeit device carries false information and can mislead us claiming about its good performance. The device infringes the intellectual property rights of the registered owner. We need to ensure that the equipment is manufactured and developed according to the requirements. Procurement team members need to establish and maintain robust obtainment processes to minimize the risk of buying non-submissive and counterfeit devices parts and find out a solution that detects the counterfeit parts. RFID tags and readers, DNA and PUF technologies, Cryptography techniques, labeling barcodes can provide a solution to counterfeit product detection problem. This paper compares the parameters and performance criteria of some of the detection techniques.

The joint influence of regulatory and social cues on consumer choice of gambling websites: preliminary evidence from a discrete choice experiment

ABSTRACT Authorities regulate online transactions to protect consumers from unintended negative consequences. Regulatory cues (e.g. certifications) enable consumers to identify formally approved online gambling offers where unauthorized products are available and blocking access is difficult. However, consumers who gamble online are also influenced by peer endorsement and frequently search for peer usage information to make decisions. This study investigates the interaction of regulatory and social cues and shows that these can be either complementary or substitutionary from a consumer perspective. Australian undergraduate students (N= 195, 72.3% female) indicated preferences toward fictitious online gambling websites in a discrete choice experiment involving active searching for cues. The impact of regulatory cues on decision-making increased when social cues indicated high quantities of website users, and when respondents lacked general trust toward gambling websites, but decreased when user social proximity was signaled. Our preliminary findings suggest regulatory cues should be prominent, and policies could aim to heighten mistrust in unauthorized sites. This study provides a foundation for further research designed to inform consumer protection agencies about how to influence consumer choice of online gambling websites in settings where regulatory and social cues may compete.

Estimation of chronic dietary intake of pesticide residues.

ABSTRACTOBJECTIVE To estimate the maximum theoretical daily intake of pesticides potentially consumed, chronically, by the Brazilian population.METHOD By using data from the food consumption section of the 2008–2009 Household Budget Survey to characterize the population diet, a database was built to group the foods based on the NOVA classification. Considering the maximum residue limit values of each pesticide authorized in the country until 2016, the limits of all consumed foods were added and multiplied by the amount consumed, resulting in the maximum theoretical intake index, which was compared with the acceptable daily intake.RESULTS The results show that, of the 283 pesticides considered in the database, 71 (25%) compounds had estimates of zero intake, 144 compounds (50.8%) reached acceptable daily intake values and 68 compounds (24%) showed median intake that exceeded the acceptable daily value. The pesticide intake estimation according to the different regions of the country showed a variation in the amount of compounds that exceeded the acceptable daily intake (48 to 69 substances) due to the different consumption patterns. The categories of products that most exceeded the limits were the insecticides, herbicides and fungicides.CONCLUSION The application of this methodology is valid for the first step in risk assessment, but the resulting values may be different from the actual exposure since they do not include other factors, such as the combined use of pesticides or unauthorized products. The importance of developing research on specific national food consumption data in a systematic way is emphasized, which generates data and analyses that allow a detailed risk assessment.

The impacts of money-back guarantees in the presence of parallel importation

This paper studies the impacts of money-back guarantees (MBGs) in the presence of parallel importation, where a manufacturer sells a product facing customer fit uncertainties in two markets and a parallel importer diverts unauthorized products from the low-price market to the high-price one. The two firms compete in both pricing and MBG strategies. We consider two types of parallel importers, a third-party agent and an authorized retailer in the low-price market, respectively. By applying the certainty equivalent pricing approach, we show that offering MBGs only changes firms’ marginal costs without affecting customers’ purchasing decisions directly. When the net salvage values of returned products are positive in the high-price market, both the manufacturer and the third-party agent offer MBGs. Whenever the manufacturer offers an MBG in the low-price market, there is a price inflation effect that counters parallel importation. Therefore the manufacturer may offer the MBG even if the net salvage value is negative. When the authorized retailer decides refund policies in two markets, the MBG strategy in one market changes the retailer’s profit from the authorized channel and that from the gray market in opposite directions, and has an interaction with the refund policy in another market. No refund may be preferred in either market even if the net salvage value is positive. We find that the manufacturer’s MBG strategy in the high-price market always deters parallel importation while other MBG strategies may achieve Pareto improvements in the equilibrium.

Warning of risks of unauthorised products from Galena Pharm

Warning of risks of unauthorised products from Galena Pharm

WATER POLICY STRATEGY OF UKRAINE: PROSPECTS FOR IMPLEMENTATION

The article is devoted to the development of theoretical approaches to the formation and implementation of the strategy of water policy of Ukraine in the context of climate change. As a result of the conducted research, it is proved that because of influence of various external factors there are changes of basic imperatives of functioning of modern systems of management of water resources. The need to consider these changes by improving the strategic documents that define the priorities and principles of national water management policy is substantiated. It is established that one of the main reasons for the lack of water of good quality is its low value compared to other natural resources. This leads to a lack of legal, organizational, and financial and economic grounds for ensuring the payback of water and water-dependent ecosystem services, which is the reason for lack of funds and relevant work to improve and restore environmental and hydro morphological characteristics of reservoirs and repair and modernization of existing hydraulic structures. In this regard, emphasis is placed on the need to improve methods of economic regulation and the development of mechanisms and tools for financial support of sustainable water management. In the context of the above, it is proposed to include in the list of main tasks of the draft Water Strategy of Ukraine two groups of economic levers to increase the financial base of investment support for sustainable water management. The first group is aimed at improving the rent regulation of special use of water resources and provides for raising standards for unauthorized groundwater production, for companies that produce beverages and sell bottled drinking water, as well as limiting various benefits and preferences when paying special water use fees. The second - to change the system of water resources management, the development of institutional and legal support for their use in a globalized market environment, the implementation of modern instruments of financial and economic support for the formation of territorial water resources on a corporate basis.