TERMIUM Plus®

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DEMANDE CLARIFICATION [1 record]

Record 1 2021-12-06

English

Subject field(s)
  • Public Administration
CONT

The purpose of a Clarification Request is to expand on, seek clarification on specific information or re-analyze existing information in the submission/application during the screening period. For example, Clarification Request may be used to locate misplaced documents, etc.

OBS

Clarification Requests should not be used to request missing documents or new data such as, new clinical and/or pre-clinical information, including bioavailability studies or chemistry and manufacturing data not previously submitted.

French

Domaine(s)
  • Administration publique
OBS

Terme souvent utilisé à la DGPS [Direction générale de la protection de la santé].

Spanish

Campo(s) temático(s)
  • Administración pública
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