1.
Marketing authorisation holders for medicinal products authorised in the Union shall provide the information for the purposes of Article 9(1), point (e), of this Regulation by 2 September 2022, in the form of an electronic submission to the database referred to in Article 57(1), point (l), of Regulation (EC) No 726/2004. Those marketing authorisation holders shall provide updates when necessary.
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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.