Marketing authorisation holders for medicines for which the marketing authorisation  was  granted before 30 October 2005 had a 5 years transitional period to amend the labelling to comply with Articles 54(a), 54(e) and 56(a). The MHRA has reminded MAHs to submit their applications by the 1 August 2010 to ensure compliance  by 30 October 2010.

The new requirements to comply with the above articles are:

• displaying the common names of the active substances clearly on the packaging
• including a space for the prescribed dose to be indicated
• displaying the name registered in section 1 of the SmPC in braille on the packaging