III.C.1. Sharing of information

The Agency and the Member States shall cooperate to facilitate the exchange of information on inspections and in particular:

• information on inspections planned and conducted in order to avoid unnecessary repetition and duplication of activities in the EU and optimise the inspection resources;
• information on the scope of the inspection in order to focus future inspections;
• information on the outcome of the inspection, in particular when the outcome is that the marketing authorisation holder does not comply with the requirements laid down in legislation and relevant guidance. A summary of the critical and/or major findings and a summary of the corresponding corrective and preventive actions with their follow-up(s) should be exchanged.

Tools and procedures will be developed at EU level to facilitate and optimise the exchange and sharing of information and the communication across the Union.