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The European Directive on Traditional Herbal Medicinal Products (THMPD), formally the Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, was established by the European Parliament and Council on 31 March 2004 to provide a simplified regulatory approval process for traditional ...
The directive applies since 2 January 2013. The European Commission Delegated Regulation, (EU) 2016/161, supplements Directive 2001/83/EC with rules regarding safety features for the packaging of medicinal products for human use. The regulation was adopted in October 2015.
They had until 1 December 2010 to propose "provisional classifications" for these substances, which have been used for the labelling of pure substances since that date. The deadline for classifying mixtures was 31 May 2015. The deadline for re-labelling and re-packaging of products already on the market was two years later: 1 June 2017. [9]
EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines. [20] Within the EU, EudraLex maintains the collection of rules and regulations governing medicinal products in the European Union, and the European Medicines Agency acts to regulate many of these ...
The European Medicines Verification Organisation was established by the European Commission to administer the Falsified Medicines Directive in 2015. The legal basis is Regulation (EC) No. 726/2004 and Directive 2001/83/EC. [1] The main stakeholders are: European Federation of Pharmaceutical Industries and Associations; Medicines for Europe
The Directive ceased to be in force on 31 May 2015 and was repealed by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text ...
BRUSSELS (Reuters) -The European Commission published its first list of critical medicines, as part of a wider overhaul of laws governing the 136 billion euro ($148 billion) pharmaceuticals ...
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 ...