The objective of the call is the translation of the Medical Dictionary for Drug Regulatory Activities (MedDRA) developed to harmonise the regulatory communication between competent authorities (EU – United States – Japan) and facilitate exchange of information.
The Commission has decided to supply grants for translations of this dictionary.
These grants should incite EU Member States, that have not yet completed the translation’s works, to start (PT level – Preferred Terms) or to complete (LLT level – Lowest Level Terms) translations. LLT level represents a specific and more detailed decomposition of the PT terms. Proposals for works covering both levels of the translations may also be submitted.
Detailed information about the structure of this Medical Dictionary is available within the chapters regarding ‘Terminology’ (Section 4).
Each new language inserted in the Medical Dictionary for Drug Regulatory Activities will make the pharmacovigilance networks more efficient. The grants shall be available for translation works starting in 2006.
The translations performed shall be delivered free of charge to the firm MSSO (Maintenance and Support Services Organisation) responsible for making available, maintaining, and updating the database containing the available languages.
Final date for submission: 29.09.2006(delivery by hand: until 4 p.m.)