6. This Regulation does not apply to: 6. 本条例不适用于: (a) in vitro diagnostic medical devices covered by Regulation (EU) 2017/746; (a) 2017/746年条例(EU)所涵盖的体外诊断产品; (b) medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether...
Kolch M, Schnoor K, Fegert JM: The EU-regulation on medicinal products for paediatric use: impacts on child and adolescent psychiatry and clinical research with minors. Eur Child Adolesc Psychiatry 2007, 16:229-235.Kolch M, Schnoor K, Fegert JM: The EU-regulation on medicinal products for...
北京时间今天凌晨(2022年4月27日),欧盟发布了今年的第5份指南:MDCG-5: Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices(MDR法规下的医疗器械和医药产品界限指南)。 此份指南是关于医疗器械法规 (EU) 2017/745(也就是MDR)与欧盟人用药...
2003/94/ECformedicinalproductsforhumanuseandDirective91/412/EECfor veterinaryuse,andRegulation(EU)No536/2014onclinicaltrialsonmedicinalproducts forhumanuse,andCommissionDelegatedRegulation(EU)2017/1569supplementing it. Statusofthedocument:Newannex.
7) 药品直接包装(法规(EC) No 726/2004、指令2001/82/EC或指令2001/83/EC)Immediate packaging of medicinal products (Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC) 送TA礼物 1楼2023-05-02 22:35回复 登录百度帐号 下次自动登录 忘记密码? 扫二维码下载贴吧客户端 ...
category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation...
北京时间今天凌晨(2022年4月27日),欧盟发布了今年的第5份指南:MDCG-5: Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices(MDR法规下的医疗器械和医药产品界限指南)。 此份指南是关于医疗器械法规(EU) 2017/745(也就是MDR)与欧盟人用药品...
Update ofMDCG 2022-5 rev.1- Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745. (New) First publication ofMDCG 2024-13- Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices. ...
◆ mdcg 2022-5 guidance on borderline between medical devices and medicinal products under regulation (eu) 2017/745 on medical devices ◆ background note on the use of the manual on borderline and classification for medical devices under the directives ...
Chinou I; Knoess W; Calapai G.Regulation of herbal medicinal products in the EU: an up-to-date scientific review.Phytochem Rev.2014.539-545Chinou I, Knoess W, Calapai G (2014) Regulation of herbal medicinal products in the EU: an up-to-date scientific review. Phytochem Rev. : 10....