Standard Terms Database
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, units of presentation, 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 over 900 terms in 35 world languages: Albanian, Bosnian, Bulgarian, Chinese, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Irish, Italian, Kazakh, Latvian, Lithuanian, Macedonian, Maltese, Norwegian, Polish, Portuguese, Romanian, Russian, Serbian, Slovak, Slovene, Spanish, Swedish, Turkish and Ukrainian.
Standard Terms are used in European marketing authorisation applications, labelling (including summaries of product characteristics (SmPCs)), electronic communications and adverse-event reporting.
The database also provides a summary of changes made to the lists on given dates, a list of ongoing requests, recent decisions taken by the European Pharmacopoeia Commission, an explanation of the different possible statuses of a Standard Term, and technical information such as object identifiers (OIDs) for the different lists of terms.
Additional tools that are made available include: application programming interfaces (APIs, or web services); a mapping section to allow authorised owners of external databases to add their terms and link them to the relevant Standard Terms; and tags for certain terms to allow specific uses to be distinguished (e.g. administrable dose forms, terms for use only in adverse-event reporting).
Further information is available in the Introduction and guidance for use, which explains the structure of the database and details the general principles and instructions for use of the lists of terms. The Change request form is used for requesting additions and modifications; please note that the submission of requests to the EDQM is restricted to national European licensing or pharmacopoeia authorities, the EMA, the EU Commission and selected national or regional competent authorities (e.g. competent authority members of ICH). Links to both of these documents are provided within the database.
Standard Terms was originally a printed publication, until the 5th edition, which was published in December 2004 alongside an online database. Since April 2008, Standard Terms has only been available as an online database. In November 2014 a major new update was introduced with the first version of the database in its current form, and access was made available free of charge for all users after registration with the EDQM Publications registration website. Further updates to the structure of the database were released in March 2016 and in August 2017 to add new features, while the content of the database is updated on a continuous basis.