Over deze norm
The domain addressed by this CWA is the E-codification of substances used by compounding pharmacists in pharmaceutical compounding. The present document specifies the technical requirements for creating the record structure and Ecodification of the various substances supplied by commercial suppliers and used by the pharmacist in the pharmacy for preparing “Magistral Formula” and “Formula Officinalis” as defined by the European Directive 2001/83, Article 3, Paragraph 1) and 2). The CWA includes a record of the supplier of substances. “Magistral Formula” and “Formula Officinalis” are not themselves part of the present CWA . The users of the CWA are the editors of a databank. In this sense the CWA is not addressed to the final users of the databank but to the subjects which realize and implement the databank (the editors). The purpose of the CWA is to define certain criteria the editors have to comply with, in realizing a databank in order to: allow an unique identification of the single substance in order to avoid any possible misunderstanding; provides pharmacists and physicians with the basic information on each single substance and its administration (see paragraph 6.2, 6.4, 6.6, 6.8); provides pharmacists and physicians with indication on the availability of the substance on the European and international market. The CWA aims at setting forth the basis for establishing a unique language for compounding pharmacists, physicians and providers to the pharmacy of substances. The CWA proposes to fill a gap, in terms of harmonization, that characterizes the pharmaceutical compounding. This shall allow: an increase in the sharing of scientific information concerning substances used in pharmaceutical compounding and basic pharmacological and administration information among physicians and pharmacists; a development of the pharmacy compounding; An increased in ADR reporting concerning substances used in pharmaceutical compounding by physicians, pharmacists and consumers. Any authorized medicinal product is out of the scope of the present CWA. The groups of substances which fall under the scope of the present document are the followings: - Synthetic substances; - Semi-synthetic substances; - Crude drug substances.
||Criteria, methodology and procedures for creating an E-codification concerning substances used in Pharmaceutical compounding