Ec Regulations Articles & Analysis
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The Report provided positive feedback on Tetra's drug development plan for QIXLEEF™ and eligibility for submitting a Marketing Authorization Application (MAA) under Directive 2001/83/EC (Directive). The SAA Report endorsed Tetra's proposed plan to address the nonclinical safety requirements for submitting a marketing approval application for QIXLEEF™. ...
This included obtaining a product jurisdiction decision for the regulation of QIXLEEF™ as a drug-device combination product. This type of decision is binding and defines the regulatory path to marketing approval for a combination product. ...
Cosmetics containing ingredients in the form of nanomaterials must contain a reference to this effect in the list of ingredients in line with the EU cosmetics regulation (EC Reg. No. 1223/2009). The names of these components must be followed by the word “nano” in brackets. ...
Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of November 30, 2009, on Cosmetic Products will come into force on July 11, 2013, and repeals the Cosmetics Directive Regulation (Directive 76/768/EEC) provisions concerning carcinogenic, mutagenic, or toxic for reproduction (CMR) substances that have applied since ...
The regulation would also require the manufacturers of new cosmetic products containing nanomaterials to notify the European Commission (EC) and provide certain information six months before the product is placed on the European market. ...