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EDQM (the European Directorate for Quality of Medicines and Healthcare - a directorate of the Council of Europe) is a leading organisation that protects public health by enabling by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use.   These quality standards are recognised as a scientific benchmark and applied worldwide.

One of these quality standards is the "Standard Terms", a set of concepts used in the definition and description of medicinal products; these include the Pharmaceutical dose form (i.e. the dosage form), Route or method of administration, and certain important Packaging items such as the Container, Closure and Administration device.  These Terms were initially produced by the European Pharmacopoeia (Ph. Eur.) Commission following a request from the EU Commission prior to being overseen by EDQM.  Now, Standard Terms are managed by EDQM in compliance with the ISO 11239 standard for the description of pharmaceutical dose forms, which is itself part of the IDMP (IDentification of Medicinal Products) suite of standards, and as such, gives them global applicability as opposed previously a European focus.  Regulatory agencies beyond Europe may submit requests to EDQM for new Terms; supporting evidence for all requests for new Terms must be provided.

The Terms are designed to be used in marketing authorisation applications, medicinal product labelling (including the summary of product characteristics (SmPC), and in electronic communications about medicines.  Additionally, in the last 5 years, the Standard Terms have been used for related purposes such as adverse event reporting (pharmacovigilance) and clinical trials.  But, whilst having the primary use is in the regulatory domain, the Standard Terms bring information to the patient/user/prescriber through their use in SmPC, and it is this that underpins the requirement to map the EDQM Pharmaceutical Dose Forms to the Pharmaceutical Dose forms in SNOMED CT, where dose form is one of the definitional attributes of the Clinical Drug and Real Clinical Drug concepts.

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Document Scope

This user guide de covers the following topics:

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