Article 1Amendments to Directive 2001/82/EC
Directive 2001/82/EC is hereby amended as follows:
1.
the following Article shall be inserted:
‘Article 27b
The Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this Directive.
The Commission shall adopt these arrangements in the form of an implementing regulation. That measure, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’
2.
the second and third subparagraphs of Article 39(1) shall be deleted.