Privatsphäre-Einstellungen

EMA and EU-Commission – Topical News

Preliminary Proposal on the Extension of the Scope of Applicability of the Variations Regulation (EC) No. 1234/081) to purely National Marketing Authorisations and Update of the Guideline “Handling of Duplicate Marketing Authorisation Applications according to Art. 82 of Regulation (EC) No. 726/2004”

RAin Dr. Brigitte Friese

Rechtsanwaltskanzlei Friese, Betzdorf/Sieg (Germany)

This publication will deal with two topical issues: In Part A, a brief outline is given on the preliminary proposal on the extension of the scope of applicability of the Variations Regulation (EC) No. 1234/08 to purely national marketing authorisation and in Part B, a description is given of the update of the Guideline “Handling of Duplicate Marketing Authorisation Applications according to Art. 82 of Regulation (EC) No. 726/2004”.