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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).


Els Janssens is a Counsel in commercial law, litigation and healthcare regulatory issues in the Brussels office. Els worked as a senior regulatory legal counsel for Johnson & Johnson supporting the company's global safety operations and advising on regulatory issues in relation to specific medicinal products. Els also worked as legal advisor in the European Medicines Agency where she advised management, scientific committees, CMD(h) and the European Commission on a wide variety of issues in connection with authorisation procedures, submission requirements, pharmacovigilance obligations and procedures as well as inspections. Based in Abu Dhabi from 2014 to 2019, she advised both multinational medical devices and pharmaceutical clients on healthcare regulations in the EU and UAE.


Olha Sviatenka is an Associate in Baker McKenzie, Kyiv office.

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