{"id":4859,"date":"2021-06-15T06:32:01","date_gmt":"2021-06-15T06:32:01","guid":{"rendered":"https:\/\/osmr.ro\/?p=4859"},"modified":"2021-06-15T07:09:16","modified_gmt":"2021-06-15T07:09:16","slug":"siguranta-pacientului-prin-siguranta-medicamentului-osmr-anmdmr","status":"publish","type":"post","link":"https:\/\/osmr.ro\/en\/siguranta-pacientului-prin-siguranta-medicamentului-osmr-anmdmr\/","title":{"rendered":"\u2018Patient\u2019s Safety through Medicines\u2019 Safety\u2019 – OSMR & ANMDMR"},"content":{"rendered":"

The alarming growth in the number of falsified medicines in the European Union (EU) has been the basis for the development and implementation of the Falsified Medicines Directive. This involves introducing a European Medicines Verification System, which became operational in all EU countries on February 9th<\/sup>, 2019, following the entry into force of the Commission Delegated Regulation (EU) 2016\/161 of 2 October 2015 supplementing Directive 2001\/83\/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.<\/p>\n

Since the beginning, it was extremely important to define the notion of \u201cfalsified medicine\u201d in order to be able to have a clear differentiation between other types of illegal medicines or products that did not abide by intellectual property rights.<\/p>\n

Therefore, the definition of the falsified medicinal product, included in art. 699 point 40 of Law 95\/2006 on health care reform, republished, with subsequent amendments and updates, refers to any medicinal product with a false representation of: its identity, its source, or its history. These products usually contain sub-standard or falsified ingredients, or no ingredients or ingredients, including active substances, in the wrong dosage thus posing an important threat to public health.<\/p>\n

The falsified medicines market targets both the innovative medicines industry, as well as the generic medicines industry.<\/p>\n

According to the European Medicines Agency, in developed countries, the medicines that were frequently falsified were expensive \u201clifestyle\u201d medicines, like for example: hormones, steroids and antihistamines. \u00a0In recent years, the falsified medicines market has grown, encompassing an increasing number of products, including expensive anticancer or highly in demand medicines, such as antivirals. \u00a0\u00a0(source:https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/public-health-threats\/falsified-medicines-overview<\/a>).<\/p>\n

Out of wishing to protect patients\u2019 health, a communication channel has been opened and strengthened between the National Competent Authorities, medicines manufacturers, marketing authorisation holders, parallel import authorisation holders, wholesalers, pharmacies, hospitals and software suppliers.<\/p>\n

\u201cAll stakeholders understood the complexity and uniqueness of this project, which was a real challenge for all European countries, and made every effort to achieve the deadline, to have a successful project implementation<\/em>\u201d, states Lauren\u021biu MIHAI, OSMR General Manager<\/strong>.<\/p>\n

As part of the overall planning of the national implementation of the European Medicines Verification System project, Working Groups were created to cover the areas impacted by the project implementation.<\/p>\n

The efficient collaboration between the groups\u2019 members was supported by the National Competent Authorities representatives. The support of the Authorities has had and continues to have a special contribution in the implementation of the provisions of the Commission Delegated Regulation (EU) 2016\/161.<\/p>\n

Ms. Roxana \u0218tefania STROE, President of the National Agency for Medicines and Medical Devices in Romania<\/strong>, emphasizes the importance of a project of such magnitude:<\/p>\n

\u201cPatient safety is a priority for NAMMDR<\/em> (ANMDMR), so we will continue to closely monitor the compliance with the Commission Delegated Regulation (EU) 2016\/161, contributing to prevent falsified medicines from entering the legal supply chain and providing patients\u2019 access to authentic medicines.<\/em>\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

The alarming growth in the number of falsified medicines in the European Union (EU) has […]<\/a><\/p>\n","protected":false},"author":6,"featured_media":4863,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24],"tags":[],"class_list":["post-4859","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-stiri"],"translation":{"provider":"WPGlobus","version":"3.0.3","language":"en","enabled_languages":["ro","en"],"languages":{"ro":{"title":true,"content":true,"excerpt":false},"en":{"title":true,"content":true,"excerpt":false}}},"_links":{"self":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/posts\/4859","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/comments?post=4859"}],"version-history":[{"count":3,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/posts\/4859\/revisions"}],"predecessor-version":[{"id":4861,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/posts\/4859\/revisions\/4861"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/media\/4863"}],"wp:attachment":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/media?parent=4859"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/categories?post=4859"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/tags?post=4859"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}