HL7 Health Level Seven International, a non-profit international certification organization devoted to offering international standards and services that enable international health information compatibility, was founded in 1996. In its early days, the organization provided a single certification for healthcare professionals in over sixty countries, including Canada. Today, however, it offers a wide variety of certifications and related services for a wide range of medical specialties and settings. Some of the many certifications offered by this international certification body are as follows:
HCPCS – The Hepatitis C Virus and Compatible Systems. This certification is offered by the National Practitioner Data Bank. It is the accepted standard of care for individuals who may have had hepatitis C and who are in contact with contaminated blood, fluid or other infected matter. Individuals who have received a final examination from an approved site and who test negative on the HCV vaccination will be listed on the HCV Compatible System List. Individuals who are in good health and who do not have a history of infection can also be listed on this list. People who have already been vaccinated and who exhibit no evidence of having HCV are also listed.
ICD-9 – The International Clinical Chemistry System. This is an international database that offers access to accurate and current information on the uses and safety of medicines worldwide. The system allows pharmaceutical companies to make reliable drug information product data available to the clinical chemistry research community. Clinical scientists and other healthcare professionals can easily access and compare information regarding safety of drugs, effectiveness of drugs, side effects of drugs and cost of drugs. It also allows other medical professionals to compare different samples of the same drug with those of another company.
EPCBS – The European Committee for Registration of Medicines (ECRM). The EPCBS is a global register of medicinal products that meets the highest standards of the global quality standard for drugs. This is the main international health information exchange system that controls the registration of drugs across the EU. It maintains the Common Drug Facts (CDF) database, which contains complete details of all health-related information on the use of drugs in the EU.
PDSM – The Public Health Service Pharmacopoeia. This is the European drug safety communication system. It is the main source of information on the safety of pharmaceutical ingredients, components and preparations in the EU. All the ingredients of a medicine must be accompanied by a recommendation or label warning about their potential hazards. The PDSM collects and transmits safety information on health care products throughout the EU.
CMC – The Council for Marketing Cosmetic Drugs. This is the European agency that manages the licensing and approval of cosmetic drug products. The CMC requires that drugs or facial treatments meeting the criteria of the CMC and the European Food Safety Authority (EFSA). It also requires that the manufacturers ensure adequate information is provided to healthcare professionals and consumers. This is important because the CMC helps to regulate the production, distribution, safety and effectiveness of cosmetic products.
EPCS – The European Medicines Agency. This is the national healthcare regulator in Europe. It is important to note that the EPCS harmonises the harmonised standards for pharmaceuticals across the EU. The EPCS provides independent advice and recommendations to member states on the regulation of healthcare procedures and standards. It is also responsible for the registration and monitoring of pharmaceutical products in the EU.
The above information on the seven different aspects of EPCS can help you understand how important it is to have the correct information and data when you are looking to use or manufacture a health product. The harmonised standards ensure safety and quality at every stage of development and manufacture of these products. This is particularly important in the case of safety devices that are used to provide assistance to those with impaired sensory perception, mobility or other physical needs.
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