Deadline Looms for the Safe Labelling of Excipients in Medicines

In October 2017, the EMA and European Commission updated the annex to excipient guidelines for new safety advice of 15 excipients and the three-year timeline to implement the change is nearly over.

Excipients are considered to be the ‘inactive’ substances in the medicinal product that are added in addition the drug substance (‘actives’). However, some have a known action or effect in certain circumstances, which is why it is important to display warnings on the labelling of the medicines so they can be used safely.

The annex contains all the excipients that must be declared on a medicine’s labelling and package leaflet and their agreed safety warnings. It also pays specific attention to, for example, the safety of these excipients when used in children or pregnant women.

The 2017 update included 5 new excipients that need to be considered and new safety warnings for 10 existing excipients. It is worth noting that this annex was also revised in 2019, but the 2017 additions need only be implemented by the October 2020 deadline.

An example of a safety warning is that for orally administered medicinal products intended for long term usage that contained fructose, the package leaflets must state “Fructose may damage teeth” (if the product is intended to be in contact with teeth i.e. oral liquids, chewable tablets or lozenges). This also needs to be included if the medicinal product has any flavourings or excipient mixtures that contain fructose.

This annex applies to both centrally and nationally authorised products within the EU. For new marketing authorisation the applicants must have implemented the information in the latest annex in their proposed product labelling. For already authorised medicines, marketing authorisation holders need to submit a type IB variation within three years of the publication of the revised annex, which means the variation needs to be submitted by October 2020 to implement the 2017 safety updates.

If you require any assistance in meeting this deadline, we at Jenson R+ would be happy to support you, please contact us at consultancy@jensongroup.com.

Ben Smith