News and Educations

Standard Terms available exclusively via EDQM database


The Agency for Medicinal Products and Medicla Devices (HALMED) starts to use Standard Terms exclusively directly via database of the European Directorate for the Quality of Medicines & Healthcare (EDQM & Healthcare). Namely, in the beginning of 2015 the EDQM decided to make publically accessible for free its Standard Terms data base. This notice was published on 12 January 2015 on the HALMED webpages.

The lists of Standard Terms were initially drawn up by the European Pharmacopoeia Commission in response to a request from the European Commission., for use in the marketing authorisation application, summary of product characteristics, package leaflet, labelling and electronic communications. The Standard Terms database gives the equivalents of terms in 33 world languages and as of 2008 are available only as an online database. Standard Terms cover pharmaceutical forms, routes and method s of administration, containers closures and administration devices for medicinal products for human and veterinary use. The database contains also a combination of terms in cases where two or more items are packaged together, or where a container is specified alongside the pharmaceutical dose form. Patient-friendly terms are also provided, which are generally shorter terms that, where justified and authorised by the competent authority, may be use on certain labels where space is limited.

The free EDQM's Standard Terms database is accessible under this link.

By using the EDQM's Standard Terms database users will have a direct insight in terms they are interested in and may promptly find equivalents in the Croatian language. This is to avoid duplication of databases and users are directly involved in using the international databases that are intended to them.