European Medicines Agency’s new version for human medical products

European medicines

Fernanda is our Life Sciences colleague at ALTEN Portugal. She tells us everything about the new version of the European Medicines Agency (EMA).

EMA published a new updated version of the Annex to the European Commission guideline. It refers to “Excipients in the labelling and package leaflet of medicinal products for human use”.

This annex contains a list of all excipients known to have a recognised action or effect and outlines the information which should appear in the package leaflet, for these excipients. The annex is effective from 22 November 2019.

Product labels and the package leaflet play an essential part in the safe and effective use of the medicine by both the patients and healthcare professionals. The approval of the label and package leaflet is an intrinsic part of the authorisation process for all medicinal products.

Excipients are any part of a drug except the active pharmaceutical ingredient. The excipients of a medicine are the most important part. Which have the important functions of guaranteeing the dosage, stability and bioavailability of the active principle. The components employed as excipients must present the characteristics required by their technological function. In addition, as with any substance administered to man, they must also correspond to suitable safety requirements. In fact, in the past the importance of evaluating the possible adverse effects of excipients was underestimated, because their inertia and innocuity were taken for granted. Some excipients can cause reactions in certain circumstances. For instance, lactose sometimes is a filler in drug tablets, as a result it cause reactions in lactose intolerant people.

According to Directive 2001/83/EC, all excipients in parenteral, ocular and topical medicines must appear on the labelling.  For all other medicinal products, the European Commission guideline on “Excipients in the labelling and package leaflet of medicinal products for human use” with its annex to the European Commission guideline identifies excipients that have to be listed on the labelling. Furthermore, the annex sets out the specific information (e.g. warnings) required in the package leaflet.

The European Commission has published the revision 1 of the guideline in 2003 and a revision 2 in March 2018. The 1st version of the annex was published in 2003 and the revised version on 9 October 2017. The updated annex published in November supersedes the 2017 version. For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the revised annex.

For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a type IB variation.

The updated annex pays specific attention to Ethanol used as an excipient in medicinal products for human use. It is used in the pharmaceutical industry in a variety of manufacturing processes. Certainly, it has bactericidal activity and is widely used as a solvent and preservative in pharmaceutical preparations.


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