Biomaterial Database

Health protection in Europe after 1992. 1993

N de Bijl

State University of Limburg, Maastricht, The Netherlands.

Although the European Community (EC) Treaty does not form a legal basis for a common policy in the field of health, various activities in pursuance of the objectives of the treaty directly or indirectly touch upon the health care field and the health protection of consumers and patients. The free movement of persons and services (for example (para) medical professionals) as well as goods (for example pharmaceuticals and medical devices) necessitates that minimum quality standards and requirements must be laid down at EC level. Measures with regard to quality assurance and control of persons and goods relate to two phases, that is rules which are applicable either before or after admittance to the health care market. In this article the consequences of the free movement of persons, services and goods on the health protection of consumers and patients is discussed. The main problems and gaps in the measures the EC has taken till now are reviewed and the relationship between EC rules and national rules and what can be expected from the EC after 1992 are also dealt with.

UI	MeSH Term	Description	Entries
D003257	Consumer Product Safety	The sum total of measures taken and regulatory policies enacted to ensure the safe use of consumer products.	Safety, Consumer Product,Product Approval,Product Approvals,Product Safety, Consumer
D004869	Equipment Safety	Freedom of equipment from actual or potential hazards.	Device Safety,Hazards, Equipment,Medical Device Safety,Safety, Equipment,Device Safety, Medical,Safety, Medical Device,Equipment Hazard,Equipment Hazards,Hazard, Equipment,Safety, Device
D005060	Europe	The continent north of AFRICA, west of ASIA and east of the ATLANTIC OCEAN.	Northern Europe,Southern Europe,Western Europe
D005062	European Union	An economic union with the principal objectives of free movement of goods, capital, and labor. The constituent countries are Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. (https://europa.eu/european-union/about-eu/countries accessed 12/31/2020)	Common Market,Euratom,European Atomic Energy Community,European Coal and Steel Community,European Common Market,European Community,European Economic Community,Community, European Economic,EEC,Economic Community, European,Common Market, European,Common Markets,Common Markets, European,Communities, European,Communities, European Economic,Community, European,Economic Communities, European,European Common Markets,European Communities,European Economic Communities,Market, Common,Market, European Common,Union, European
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D017277	Drug Approval	Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.	Drug Approval Process,New Drug Approval,Food and Drug Administration Drug Approval,Food and Drug Administration Drug Approval Process,New Drug Approval Process,Approval Process, Drug,Approval Processes, Drug,Approval, Drug,Approval, New Drug,Approvals, Drug,Approvals, New Drug,Drug Approval Processes,Drug Approval, New,Drug Approvals,Drug Approvals, New,New Drug Approvals,Process, Drug Approval,Processes, Drug Approval