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RESEARCH PRODUCT

New falsified medicinal products’ distribution prevention regulation: legal issues and good distribution practice for pharmaceutical companies

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The aim of this paper is to analyse the impact of new falsified medicinal products’ distribution prevention regulation on distributors and patients’ rights in Latvia. Starting from the late 2000s the validity of the medicinal products became one of the most important issues to be considered, as the level of falsified medicinal products sales significantly increased. In order to solve this issue, the Directive 2011/62 / EC (3) on falsified medicinal products for human use was introduced and now serves as a basis for the distribution of medicinal products, which only allows licensed pharmacies and approved retailers, including approved Internet service providers, to be included into the movement of the product. This directive introduced safety signs aimed at preventing the entry of falsified medicinal products into the supply chain of legal medicinal products (from the manufacturer to distributors, pharmacies and hospitals) and, consequently, to the patients. It is important that patients can recognize reliable sources and be aware of the risk of illegal sales.