Essentials of European Medical Device Regulatory Affairs - October 2019

European/International Bodies and Institutions

DG Trade

European Commission Trade European Directorate for the Quality of Medicines and healthcare The European Medicines Agency (EMA) Committee for Environment, Public Health and Food Safety Employment, Social Policy, Health and Consumer Affairs Council

http://ec.europa.eu/trade/

EDQM

www.edqm.eu

EMA

www.ema.europa.eu

ENVI

http://www.europarl.europa.eu/ comparl/envi/default_en.htm

EPSCO

http://www.consilium.europa.e u/policies/council- configurations/employment,- social-policy,-health-and- consumer- affairs.aspx?lang=en

European Commissio n Enterprises and Industry

Public Health

http://ec.europa.eu/health/hum an-use/index_en.htm

Medicinal Products for Veterinary Use

http://ec.europa.eu/health/veter inary-use/index_en.htm

http://ec.europa.eu/health/docu ments/eudralex/index_en.htm

Eudralex (Access to copies of directives, guidelines, Notice to Applicants etc.) Heads of Medicines Agencies Including links to national authorities(located in Directory) International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

HMA

www.hma.eu

ICH

www.ich.org

OECD

Organisation for Economic Co- operation and Development

http://www.oecd.org/

PIC/S

Pharmaceutical Inspection Cooperation Scheme

www.picscheme.org

VICH

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products

http://www.vichsec.org/

WHO

World Health Organization

www.who.int

WHO GMP

World Health Organization, GMP

www.who.int/entity/medicines/ areas/quality_safety/quality_as

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September 2013