Browsing by Author "Karev N."

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    A PROPOSAL FOR THE OPTIMIZATION OF THE COST PRODUCTION IN THE ENTERPRISES PRODUCING CONCENTRATE FOR THE METALLURGICAL INDUSTRY
    (2020-01-01) Karev N.
    In the article is tracked the technological process „ crushing of ore “ in the enterprises of mining and processing of ore in order to obtain concentrate for metallurgical industry. The materials and intangible resources needed for realization of the process have been described, analyzed and assessed. On the basis of published information about the produced and realized concentrate, the costs have been determined and the method of the Break Even Point has been applied. It permitted to obtain the minimal amount of produced and realized concentrate, necessary for the successful functionality of the enterprises. A proposal for the optimization of the production process has been made as well as a comparison between the costs before and after the implemented measures for optimization.
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    BASIC STAGES OF THE ON-BOARDING PROCESS TO THE EUROPEAN SYSTEM FOR VERIFICATION OF THE MEDICINAL PRODUCTS
    (2021-01-01) Karev N.
    Falsified medicines are a major threat to public health and safety. Since the falsifications become more sophisticated, the risk of falsified medicines to be proposed to patients in the EU increases every year. Such medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level. With the Falsified Medicines Directive and its supplementing Delegated Regulation the legislator has taken the necessary steps to preven falsified medicines from entering the legal supply chain. One of the measures that is being undertaken to achieve this goal is to mandate pharmaceutical companies and parallel distributors of mainly prescription medicines to apply safety features to their outer packaging. This guideline provides all manufacturers and parallel distributors with assistance in the upcoming implementation of the required measures for protection against falsification and describes in detail the on-boarding process to the European system against falsified medicines
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    Serialization of pharmacetical products: Eu delegated act 2016/161 to protect against falsified medicines (review)
    (2019-01-01) Karev N.; Raychev D.
    The European Union's Falsified Medicines (FMD) Directive 2011/62/EU modifies Directive 2001/83/EC to ensure public health by protecting the pharmaceutical supply chain from infiltration by counterfeit medicines. It also introduces new rules to regulate more strictly the supply chain. The Commission Delegated Regulation (EU) 2016/161 completes Directive 2001/83/EC with detailed rules regarding safety features for the packaging of medicinal products for human use. The regulation was adopted in October 2015 and published in the Official Journal of the European Union in February 2016, and came into force at the end of February 2019. This article will provide an overview of the directive, its impact on the distribution of medicines, and the latest update affecting pharmaceutical manufacturers.