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Regulatory environment in non-EU European countries

机译:非欧盟欧洲国家的监管环境

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The existence and functioning of a comprehensive drug regulatory system supported by legislation is a prerequisite for an overall quality assurance system. The first duty of a national regulatory authority is to register pharmaceutical products, thus defining the pharmaceutical market in the country. Iceland, Liechtenstein, and Norway, not joined the EU, have partly committed to the EU's economy and regulations and are a part of the single market through the EEA. Switzerland has similar ties through bilateral treaties. Andorra, Monaco, San Marino, and VaticanCity include the similar co-operation. Countries: Croatia, Republic of Macedonia, Turkey, as Serbia, Bosnia and Herzegovina, Serbian Republic, Montenegro, and Albania, that are officially recognised as potential candidates, as Kosovo and other responding countries (Armenia, Azerbian, Belarus, Georgia, Moldova, Russia, Ukraine), reported about new medicines laws in accordance with the EU legislation, developing EU-harmonization and modernizing their regulatory authority by establishing drug agencies according to models in EU.
机译:立法支持的全面药物监管系统的存在和运作是整体质量保证体系的先决条件。国家监管机构的第一个义务是注册药品,从而定义该国的制药市场。冰岛,列支敦士登和挪威没有加入欧盟,部分致力于欧盟经济和法规,是通过EEA的单一市场的一部分。瑞士通过双边条约具有相似的关系。安道尔,摩纳哥,圣马力诺和副主义包括类似的合作。国家/地区:克罗地亚,马其顿共和国,土耳其,作为塞尔维亚,波斯尼亚和黑塞哥维那,塞尔维亚共和国,黑山,黑山和阿尔巴尼亚,被正式认可为潜在的候选人,如科索沃和其他回应国家(亚美尼亚,阿塞拜亚,白俄罗斯,格鲁吉亚,摩尔多瓦,摩尔多瓦,俄罗斯乌克兰)报道了根据欧盟立法,通过在欧盟的模型确定毒品机构,制定欧盟协调和现代化监管机构的新药法律。

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