Role of the National Medicines Institute in quality assurances and safety of medicinal products and medical devices
Keywords:
quality assurance, risk analysis, quality control, medicinal products, medical devices, dietary supplementsAbstract
In the European Union countries, registration of medicinal products and market authorization of medical devices is strictly connected with the quality of these products, safety and therapeutic effective-ness. The term "quality" includes such attributes as the identity, strength, purity and stability. At a Eu-ropean level the activities of the Official Medicines Control Laboratory (OMCL) &murk is coordinated by the European Directorate for the Quality of Medicines (EDQM). EDQM is a Division of the Council of Europe. In the context of the General Netnork of Official Medicines Control Laboratory (OMCL) an OMCL is, by status, a public institution which only performs laboratory testing for a Competent Au-thority, independently from the manufacturer; for medicinal products prior to or after marketing for the general surveillance of medicines for the safety of human patient and animals. At a national level the OMCL contributes to the protection ofpublic health.
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