Article 19: Extensions of marketing authorisations
Location:
Chapter IV, section 1
Source:
Eur-Lex1. An application for an extension of a marketing authorisation shall be evaluated in accordance with the same procedure as for the initial marketing authorisation to which it relates.
2. An extension shall either be granted a marketing authorisation in accordance with the same procedure as for the granting of the initial marketing authorisation to which it relates or be included in that marketing authorisation.