The following are the links related to the Quality Review of Documents (QRD) template and the Lingustic check process.
Glossary of Terms - January 2018
Translated Standard Terms
Translated Annex of the NTA Excipients Guideline
EU/EEA Countries in Maltese
For a full list of templates for product information for use by applicants and marketing authorisation holders, please visit the European Medicines Agency's (EMA) website.
The Maltese template for SmPC, labelling and packaging leaflet can be found in the EMA website from the above link.
For more information on the Maltese language, please visit the website of the National Council for the Maltese Language (Kunsill Nazzjonali tal-Ilsien Malti).
Updated on: 3 January 2018