the manufacturing authorisation holder verifies, prior to partly or fully removing or covering those safety features, that the medicinal product concerned is authentic and that it has not been tampered with;

the manufacturing authorisation holder complies with point (o) of Article 54 by replacing those safety features with safety features which are equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering of the medicinal product. Such replacement shall be conducted without opening the immediate packaging as defined in point 23 of Article 1.

Safety features shall be considered equivalent if they:

1. (i)

   comply with the requirements set out in the delegated acts adopted pursuant to Article 54a(2); and

2. (ii)

   are equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products;

the replacement of the safety features is conducted in accordance with applicable good manufacturing practice for medicinal products; and

the replacement of the safety features is subject to supervision by the competent authority.