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EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. [8] EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10]
Commission Directive 66/683/EEC of 7 November 1966 eliminating all differences between the treatment of national products and that of products which, under Articles 9 and 10 of the Treaty, must be admitted for free movement, as regards laws, regulations or administrative provisions prohibiting the use of the said products and prescribing the use of national products or making such use subject ...
The European Packaging and packaging waste directive 94/62/EC (1994) deals with the problems of packaging waste and the currently permitted heavy metal content in packaging. The Directive obligates member states to meet targets for the recovery and recycling of packaging waste. The Directive covers all packaging placed on the Community market.
The European Chemicals Agency (ECHA; / ˈ ɛ k ə / EK-ə) is an agency of the European Union working for the safe use of chemicals. It manages the technical and administrative aspects of the implementation of the European Union regulation called Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
The ISO 22715 standard Cosmetics — Packaging and labelling provides guidelines for manufacturers in the best practices for cosmetic packaging and labelling of all cosmetic products. This standard applies to products that fall under the category of cosmetics that are sold or given away as free samples. ISO 22715 was initially published in ...
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
All guidelines follow a few basic principles: [2] [6] Manufacturing facilities must maintain a clean and hygienic manufacturing area. Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
The pictogram for harmful substances of the Globally Harmonized System of Classification and Labelling of Chemicals.. The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is an internationally agreed-upon standard managed by the United Nations that was set up to replace the assortment of hazardous material classification and labelling schemes previously used around ...