Call for proposals - Action n° 4 MedDRA

June 18, 2004

Brussels, 17 Jun 2004

Objective of the call

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 by way of grants the completion of this dictionary. These grants should incite 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) these translations. LLT level represents a specific and more detailed decomposition of the PT terms.

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 2004. 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.

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