In November, the EDQM (European Directorate for the Quality of Medicines & Healthcare) launched a new version of its Standard Terms database. Access is now free of charge (it used to cost €70), which is good news for new medical translators and those who hadn’t accessed the database until now. It’s a little tricky to reach the new Standard Terms, and both new and old users have to complete the same registration process, so I thought it would be useful to share some step-by-step instructions.
What is the Standard Terms database?
It’s a list of dosage forms, routes and methods of administration, and packaging information applied to medicinal products for human and veterinary use. These standard terms are mandatory in the EU when you translate marketing authorisation applications and product information (summary of product characteristics and labelling).
- Create a user account at EDQM Publications. You’ll be sent a password to your registered email address. You can skip this step if you have access to the old Standard Terms because you already have an EDQM account.
- Now you need to get another password for the Standard Terms. Use your email address and account password to log on at the same EDQM Publications page.
- Go to “Free access”, tick the box next to “Subscribe to Standard Terms Online” and click “Register”:
- Now go to “List my registered products”. Under “Publication EPID”, click the long ID for Standard Terms Online (Free Access 2014) and wait for a new email.
- When you receive the new Standard Terms password, go to https://standardterms.edqm.eu and enter your email and new password. The login area is tucked up at the top of your screen:
- You’ve got there! You should be on the News page:
Note: I wrote the above steps after I’d completed the registration process myself, based on my experience and drawing on useful advice posted in an ITI MedNet forum thread on this topic. I can’t guarantee these instructions work. If you have problems, check out the Electronic Publications Helpdesk FAQ and, if necessary, contact EDQM for further assistance through the link on the same page.
The old database is still accessible at the moment but it’s no longer updated, so make sure you register for the new database and start using it now.
All in all, the free access to the new EDQM Standard Terms is excellent news for translators who are just starting out in the medical field and for anyone who has been translating marketing authorisation applications and product information without using this resource.
Remember, the EDQM Standard Terms are mandatory in these fields. Now, with free access, there’s no excuse not to use them.