21 August 2017: Major update of Standard Terms database
An updated version of the Standard Terms database was released on 21 August 2017. A new tagging feature has been added, which will allow the introduction of ‘non-traditional’ Standard Terms, i.e. terms that are not intended for use in marketing authorisation applications and labelling, but for other specific purposes such as adverse-event reporting. By default, the tagging system is set to display only the ‘traditional’ Standard Terms in the results; before altering any of the tag filters it is important to read the relevant sections of the Introduction and Guidance for Use, in order to ensure that the appropriate results are displayed.
Standard Terms database
The Standard Terms database contains terms and definitions to describe pharmaceutical dose forms, routes and methods of administration, containers, closures, administration devices and units of presentation. It contains agreed 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. It also contains 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 lists of Standard Terms were initially drawn up by the European Pharmacopoeia Commission further to the request of the EU Commission for use in marketing authorisation applications (MAAs), summaries of product characteristics (SmPCs), labelling and electronic communications. They are currently provided in 35 languages from around the world: 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.
The first list of Standard Terms was published in a special edition of Pharmeuropa in October 1996. It was originally available only as a printed publication, until the 5th Edition, published in December 2004, which was published alongside an online database. Since April 2008 Standard Terms has only been available as an online database. In 2014 the database was completely revised, introducing many new features and functionalities, as well as making access available free of charge. In 2016 an updated version was released, introducing additional features such as units of presentation, mapped terms and APIs (application programme interfaces, or web services). In 2017 a further update was released in the form of the current database, which introduced the tagging system that allows the inclusion of ‘non-traditional’ Standard Terms that are intended only for specific uses such as adverse-event reporting.
Further information is available in the Introduction and guidance for use.
How to access the Standard Terms database
In order to access Standard Terms, you will first need to have an account with the EDQM Publications registration website (Register). If you do not already have an account, instructions for creating a new account are provided on the Register website.
Once connected to your Register account, under the item ‘Free access’ in the menu, select the Standard Terms Online option. You should then follow the instructions provided in order to receive your password by e-mail to allow you access to Standard Terms free of charge.
The database contains information in many different languages, some of which use special characters, diacritics, or non-Latin alphabets. The correct display on a computer monitor and the correct printing of such information depends on the settings of the computer and the software and hardware used. It is not therefore possible to guarantee that the full information will be displayed correctly on every system, even those that comply with the recommended requirements mentioned below.