MHRA: Code of practice for pack design for over the counter medicines

Council Directive 2001/83/EC as amended, requires that marketing authorisation holders (MAH) inform the competent authority of all changes to the labelling which are not connected to changes to the Summary of Product Characteristics (SPC) [Article 61(3)]. Notwithstanding the need to notify the competent authority of the amendment, responsibility for the information presented on the packaging rests solely with the MAH.