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European Medicines Agency

European Medicines Agency, Total:54 items.

In the international standard classification, European Medicines Agency involves: Networking.

IX-EU/EC, European Medicines Agency

COM(2013) 472 FINAL-2013 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (2013/0222 (COD); Text with EEA relevan
NO 273/2004-2004 REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on drug precursors
COM(2002) 735 FINAL-2002 Modified proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Ag
COM(2008) 664 FINAL-2008 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medic
NO 1647/2003-2003 COUNCIL REGULATION amending Regulation (EEC) No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of Medicinal Products
2004/9/EC-2004 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the inspection and verification of good laboratory practice (GLP) (Codified version; Text with EEA relevance)
NO 1651/2003-2003 COUNCIL REGULATION amending Regulation (EEC) No 302/93 on the establishment of a European Monitoring Centre for Drugs and Drug Addiction
M 318-2002 MANDATE ADDRESSED TO CEN/CENELEC/ETSI FOR STANDARDISATION IN THE FIELD OF AIR TRAFFIC MANAGEMENT SYSTEMS AND GALILEO LOCAL COMPONENTS
EC/1907/2006 CORR-2006 REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation
COM(2003) 117 FINAL-2003 REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on maximum residue levels of pesticides in products of plant and animal origin
2001/20/EC-2001 Directive of the European Parlament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal
COM(2002) 529 FINAL-2002 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the inspection and verification of good laboratory practice (GLP)(codified version)
COM(2003) 304 FINAL-2003 REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on drug precursors
2004/10/EC-2004 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests
2008/C 114/13-2008 Notice to users of controlled substances in the European Union allowed for essential uses in the Community in 2009 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer
COM(2002) 530 FINAL-2002 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applicat
COM(2008) 1 FINAL-2008 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the colouring matters which may be added to medicinal products
2005/84/EURATOM-2005 COUNCIL DECISION approving the accession of the European Atomic Energy Community to the 'Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management’
2008/C 114/11-2008 Notice to importers in the European Union that propose to import in 2009 controlled substances that deplete the ozone layer under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer
2007/C 266/06-2007 Medicinal products - List of marketing authorisations granted by the EEA EFTA States for the second half of 2006 Subcommittee I - On the free movement of goods
2014/28/EU-2014 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (recast) (Text with EEA relevance)
2006/121/EC CORR-2006 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in ord
EC/1907/2006 CORR-2008 CORRIGENDA Corrigendum to Regulation the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive
2008/31/EC-2008 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 98/8/EC concerning the placing of biocidal products on the market, as regards the implementing powers conferred on the Commission
NO 1451/2007-2007 COMMISSION REGULATION on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (Text with EEA relevance)
1999/11/EC-1999 Commission Directive Adapting to Technical Progress the Principles of Good Laboratory Practice as Specified in Council Directive 87/18/EEC on the Harmonisation of Laws, Regulations and Administrative Provisions Relating to the Application of the Principle
COM(1999) 193 FINAL-1999 Amended Proposal for a European Parliament and Council Directive on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Parctice in the Conduct of Clinical Trials on
NO 816/2006-2006 REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems
2007/211/EC-2007 COMMISSION DECISION on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2007 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2007) 1285)
1999/C/87/02-1999 Proposal for a Council Regulation (EC) on Waste Management Statistics
COM(2007) 194 FINAL-2007 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, and repealing Regulation (EEC) No 2377/
NO 2032/2003-2003 COMMISSION REGULATION on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/ 8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation (EC
2007/47/EC-2007 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and
2004/57/EC-2004 COMMISSION DIRECTIVE on the identification of pyrotechnic articles and certain ammunition for the purposes of Council Directive 93/15/EEC on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil
COM(2003) 32 FINAL-2003 Proposal for a COUNCIL (Euratom) DIRECTIVE Setting out basic obligations and general principles on the safety of nuclear installations Proposal for a COUNCIL DIRECTIVE (Euratom) on the management of spent nuclear fuel and radioactive waste
2007/597/EC-2007 COMMISSION DECISION concerning the non-inclusion of guazatine triacetate in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market
2008/C 114/12-2008 Notice to proposed exporters from the European Union in 2009 of controlled substances that deplete the ozone layer under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer

EU/EC - European Union/Commission Legislative Documents, European Medicines Agency

COM(2016) 498 FINAL-2016 REPORT FROM THE COMMISSION Pharmacovigilance related activities of Member States and the European Medicines Agency concerning medicinal products for human use (2012 – 2014) (SWD(2016) 284 final)
NO 1907/2006 CORR-2008 CORRIGENDA Corrigendum to Regulation the European Parliament and of the Council of 18 December 2006 concerning the Registration@ Evaluation@ Authorisation and Restriction of Chemicals (REACH)@ establishing a European Chemicals Agency@ amending Directive 1

US-HHS, European Medicines Agency

HHS 21 CFR PART 16 CFR PART 54-2011 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

US-FCR, European Medicines Agency

FCR 21 CFR PART 16-2015 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
FCR 21 CFR PART 16-2014 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
FCR 21 CFR PART 16-2013 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

US-CFR-file, European Medicines Agency

CFR 21-16.1-2014 Food and drugs. Part16:Regulatory hearing before the food and drug administration. SubpartA:General provisions. Section16.1:Scope.
CFR 21-20.30-2014 Food and drugs. Part20:Public information. SubpartB:General policy. Section20.30:Food and Drug Administration freedom of information staff.
CFR 21-20.107-2014 Food and drugs. Part20:Public information. SubpartF:Availability of specific categories of records. Section20.107:Food and Drug Administration manuals.
CFR 21-10.90-2014 Food and drugs. Part10:Administrative practices and procedures. SubpartB:General administrative procedures. Section10.90:Food and Drug Administration regulations, recommendations, and agreements.
CFR 21-5.1110-2014 Food and drugs. Part5:Organization. SubpartM:Organization. Section5.1110:FDA public information offices.
CFR 21-20.3-2014 Food and drugs. Part20:Public information. SubpartA:Official testimony and information. Section20.3:Certification and authentication of Food and Drug Administration records.
CFR 21-20.120-2014 Food and drugs. Part20:Public information. SubpartF:Availability of specific categories of records. Section20.120:Records available in Food and Drug Administration Public Reading Rooms.

CEPT - Conference Europeenne des Administrations des Postes et des Telecommunications, European Medicines Agency

CEPT T/PET 1-1974 Objectifs A Suivre Et Actions A Entreprendre Par Les Adnibistrations Des Postes Et Des Telecommunications@ Dans Le Cadre De La Mise En Oeuvre D'Une Politique Europeenne De Teleinformatique

International Organization for Standardization (ISO), European Medicines Agency

ISO/IEC 8802-11:2005/Amd 5:2006 Information technology — Telecommunications and information exchange between systems — Local and metropolitan area networks — Specific requirements — Part 11: Wireless LAN Medium Access Control (MAC)

Institute of Electrical and Electronics Engineers (IEEE), European Medicines Agency

IEEE 802.11H-2003 Information technology - Telecommunications and information exchange between systems - Local and metropolitan area networks - Specific requirements - Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) specifications; Amendment 5: S
ISO/IEC 8802-11:2005/Amd.5:2006(E) IEEE Std 802.11h-2003 ISO/IEC International Standard - Information technology-- Local and metropolitan area networks-- Part 11: Amendment 5: Spectrum and Transmit Power Management Extensions in the 5 GHz band in Europe