XVI. Add I.7. Publication of educational materials on marketing authorisation holders on specific websites

When agreed by the competent authority of the Member State, the marketing authorisation holder may publish educational materials on a specifically dedicated website, provided that the marketing authorisation holder respects the following:

• Access to the website should be given to the competent authority of the Member State;
• A statement that the information of the website is consistent with the agreed material should be submitted;
• The specific website should not include any reference to documents or to other websites/pages or weblinks not agreed with the competent authority of the Member State;
• All elements and information on the specific website should be expressed in the official language(s) as required by the Member State or, in exceptional cases with the agreement of the competent authority of the Member State, in English;
• The specific website should not contain references to or information about medicinal products not marketed in that Member State.

Other relevant documents such as the SmPC, the PL and the summary of the RMP may be referred to.