Labelling of medicines: Reminder – update to labelling to comply with Article 54(a), 54(e) and 56(a)

UK legislation was amended in 2004 to implement the new medicines labelling provisions in Title V of Council Directive 2001/83/EC [as amended]. The relevant statutory instrument is The Medicines (Marketing Authorisations etc) Amendment Regulations 2005 number 2759 [SI 2005/2759].

The legislation provided a transitional period for the labelling of medicines which were the subject of a granted marketing authorisation at the time the regulations came into force on 30 October 2005. This transitional period ends on 30 October 2010 by which time the necessary applications must have been approved to bring the marketing authorisations into compliance.

The new requirements for labelling under the articles cited above are as follows:

• Following the brand name of the medicine (where one has been registered) the packaging must include reference to the common name(s) of the active substances in the formulation (where up to three active substances are present in the formulation). The common name(s) must be prominently displayed on the packaging.
• Space for the prescribed dose to be indicated – in the UK this is in the form of space for a dispensing label to be indicated on the outer packaging. Such space should be 35mm by 70mm in size. Although not required by the legislation, best practice suggests that the space should be marked on the pack and appear on a face where the name of the medicine is displayed.
• The name registered in section 1 of the summary of product characteristics must be displayed in Braille on the packaging.

Detailed guidance on how to apply for these changes and the criteria which apply are available in the leaflets and packaging section of the MHRA website.

Action required
Where the necessary changes have not already been implemented, marketing authorisation holders must submit applications by 1 August 2010 to ensure compliance by 30 October 2010.

Further information is available from patient.information@mhra.gsi.gov.uk or by telephoning Mrs Jan MacDonald on 020 7084 2267.