Glossary

Abridged Application

Abridged applications are applications where, subject to certain conditions, the applicant is not required to provide the results of pharmacological and toxicological tests or the results of clinical trials. An abridged application can only be lodged with the authority that evaluated and authorised the original product as this authority holds the dossier on the medicinal product, which is essentially similar to that second application. [EMA]

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