Marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit a variation to change the names of liposomal medicines, but only if there is a high risk of medication errors which would raise concerns regarding the safe use of the medicinal product.
EMA’s human medicines committee (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) adopted these clarifications at their September 2019 meetings, following their initial joint recommendation on liposomal medicines issued in July.
The CHMP and the CMDh have now clarified that for medicines administered topically or by other routes of administration, the qualifier ‘liposomal’ or ‘pegylated liposomal’ should only be added to the invented name in those cases when a clear risk of medication errors has been identified. Elements such as route of administration, medication error reporting or long established use should be taken into consideration when assessing the need for the qualifier.
In those cases where a name change is considered necessary, applicants are requested to update the name throughout the product information, including all annexes. This is an addition to the communication from July, in which they were instructed to amend only section 1 of the summary of product characteristics.
Marketing authorisation holders are requested to submit an A.2.a variation before the end of September 2019 to update the name of liposomal medicines in line with the new recommendation from the CHMP and the CMDh…