PART 5Marketing authorisations

Obligations of holder of marketing authorisation

Obligation in relation to product information76

1

The holder of a UK marketing authorisation for a medicinal product must ensure that the product information relating to the product is kept up to date with current scientific knowledge.

2

In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.