Belgium: Modification of medicines packaging to remove any "negative formulations"

In brief

Marketing authorization holders have three years from 17 May 2023 to remove any "negative formulations" from their existing and future medicines packaging. 


 On 17 May 2023, the Belgian Federal Agency for Medicines and Health Products (FAMHP) required marketing authorization holders (MAH) to adapt their existing and future packaging of medicines to remove any negative formulation. Since an European consultation launched in 2019, negative formulations, such as "no sugars", "gluten-free", on medicines' packaging are no longer allowed. Those mentions are considered as encouraging the promotion of medicines which is prohibited by European guidelines and Belgian laws (Royal Decree of 14 December 2006).  

In that sense, MAH has three years from the communication of the FAMHP to comply with the requirements. To do so, MAH can initiate a variation procedure (IB or II category) or send a national notification if no variation procedure has been initiated within three years. 

However, the FAMHP has identified a number of exceptions where the use of negative statements is permitted. For example, medicines specifically intended for diabetics may contain the term "sugar-free" when this is in line with the indications in the Summary of Product Characteristics (SPC).

Copyright © 2024 Baker & McKenzie. All rights reserved. Ownership: This documentation and content (Content) is a proprietary resource owned exclusively by Baker McKenzie (meaning Baker & McKenzie International and its member firms). The Content is protected under international copyright conventions. Use of this Content does not of itself create a contractual relationship, nor any attorney/client relationship, between Baker McKenzie and any person. Non-reliance and exclusion: All Content is for informational purposes only and may not reflect the most current legal and regulatory developments. All summaries of the laws, regulations and practice are subject to change. The Content is not offered as legal or professional advice for any specific matter. It is not intended to be a substitute for reference to (and compliance with) the detailed provisions of applicable laws, rules, regulations or forms. Legal advice should always be sought before taking any action or refraining from taking any action based on any Content. Baker McKenzie and the editors and the contributing authors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The Content may contain links to external websites and external websites may link to the Content. Baker McKenzie is not responsible for the content or operation of any such external sites and disclaims all liability, howsoever occurring, in respect of the content or operation of any such external websites. Attorney Advertising: This Content may qualify as “Attorney Advertising” requiring notice in some jurisdictions. To the extent that this Content may qualify as Attorney Advertising, PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME. Reproduction: Reproduction of reasonable portions of the Content is permitted provided that (i) such reproductions are made available free of charge and for non-commercial purposes, (ii) such reproductions are properly attributed to Baker McKenzie, (iii) the portion of the Content being reproduced is not altered or made available in a manner that modifies the Content or presents the Content being reproduced in a false light and (iv) notice is made to the disclaimers included on the Content. The permission to re-copy does not allow for incorporation of any substantial portion of the Content in any work or publication, whether in hard copy, electronic or any other form or for commercial purposes.