Excipient guideline update
The updated Annex to “Excipients in the labelling and package leaflet of medicinal products for human use” guideline was published on the 09/10/2017. This updated Annex in all EU languages can be found here:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001646.jsp
In addition, Notice to Applicants Volume 2C has been updated in March 2018 to reflect this updated annex.
What does it mean?
Marketing Authorisation (MA) Holders for approved products and Marketing Authorisation Applications for new MAs are required to list certain excipients in the labelling information, as outlined in Directive 2001/83/EC, as amended. These include all excipients for parenteral, ocular and topical products, and specific excipients in other products. These specific excipients are listed in the Annex for ease of access.
What’s new?
The newly added or updated specific excipients listed in the Annex include:
Aspartame (E 951)
Benzalkonium chloride
Benzoic acid (E 210) and benzoates
Benzyl alcohol
Boric acid (and borates)
Cyclodextrins
Fragrances containing allergens
Fructose
Phenylalanine
Phosphate buffers
Propylene glycol (E 1520) and esters of propylene glycol
Sodium
Sodium laurilsulfate (E 487)
Sorbitol (E 420)
Wheat starch (containing gluten)
What do you need to do?
For any of your currently approved products, you should use the first regulatory opportunity to revise any wording in line with the annex. This could be any when you are submitting any variation that involves changing the product information, for instance.
We can help…
Ivowen can advise you on the requirements and assist you with any of the updates and variations that you might have.
Please contact us for further information at any time.
