Search results
Results from the WOW.Com Content Network
This regulation builds on the principle of mutual recognition and applies to products which are not covered by the harmonisation of legislation directed by the EU. See also the guidance documents for this regulation which are published by the European Commission. Decision No. 3052/95/EC was repealed with effect from 13 May 2009.
This list of European Union Directives is ordered by theme to follow EU law. For a date based list, see the Category:European Union directives by number . From 1 January 1992 to 31 December 2014, numbers assigned by the General Secretariat of the Council followed adoption, for instance: Directive 2010/75/EU. [ 1 ]
This approval period is proportional to the risks posed by the use of these substances. However, when an active substance is considered necessary by the European Commission, it could be approved for a maximum 5 years, even if not all approval criteria of the Regulation (EC) No 1107/2009 [1] are met.
Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products Directive 75/318/EEC , clarifies requirements of 65/65/EEC1 and requires member states to enforce them Directive 75/319/EEC , requires marketing authorization requests to be drawn up only by qualified experts
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
This list may not reflect recent changes. ... Directive on intra-EU-transfers of defence-related products; R. Race and Ethnicity Equality Directive 2000;
Best Available Techniques (BAT) Reference Document (BREF) is defined in Article 3(11) of the Industrial Emissions Directive 2010/75/EU as: "[...] a document, resulting from the exchange of information organised pursuant to Article 13, drawn up for defined activities and describing, in particular, applied techniques, present emissions and consumption levels, techniques considered for the ...
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis