Before adoption of the report provided for in Article 10, the Agency shall invite the marketing authorisation holder to submit written observations.
It shall do so in writing, indicating a time-limit for the submission of those observations, which shall be at least four weeks.
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04
CitationArticle 9 of Commission Regulation (EC) No 658/2007 (LawPlayer, data as of 2026-07-04)