The lists of Standard Terms were initially drawn up in response to a request from the European Commission, and cover pharmaceutical dose forms (also known as dosage forms), routes and/or methods of administration, and containers, closures and delivery devices, for medicines both for human and for veterinary use. The database also contains combinations of terms, for example to describe where two or more items are packaged together, or where a pharmaceutical dose form and a container are described using a single term. Also listed are patient-friendly terms, which are generally shorter terms that, where justified and authorised by the competent authority, may be used on certain labels where space is limited.
The Standard Terms database gives the equivalents of several hundred terms in 33 world languages: Albanian, Bosnian, Bulgarian, Chinese, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Italian, Kazakh, Latvian, Lithuanian, Macedonian, Maltese, Norwegian, Polish, Portuguese, Romanian, Serbian, Slovak, Slovene, Spanish, Swedish, Turkish and Ukrainian.
Standard Terms are used in European Marketing Authorisation applications, the Summary of Product Characteristics (SmPC), labelling and electronic communications.
The database also provides a summary of changes made to the lists on given dates, recent decisions taken by the Standard Terms Working Party and the European Pharmacopoeia Commission, and an explanation of the different statuses of the terms.
via EDQM Publications
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