In its new advice the Joint Commission states that nicotine pouches are no longer considered to be a medicinal product. When used normally, the usual doses (around 10 mg) do not pose a risk of poisoning. However, there are some recommendations for manufacturers. These concern the nicotine yield and the maximum daily dose, the use by children and therapeutic claims.
Manufacturing and distribution authorisations and registrations of active pharmaceutical ingredients (API) distributed digitally
Manufacturing authorisations and/or distribution authorisations of medicines and registrations of active pharmaceutical ingredients are no longer automatically sent in paper format by post to the marketing authorisation holder. The FAMHP is now sending these documents in digital format by e-mail. Marketing authorisation holders can still request paper versions.
The FAMHP invites establishments of human body material to apply for regularisation as stool banks. The term "stool" is no longer excluded from the scope of the law of 30 October 2018 on human body material. Establishments carrying out activities on faecal material as described in this law are subject to the implementing Royal Decrees and should apply for regularisation as stool bank.materiaal zoals beschreven in deze wet zijn onderhevig aan de uitvoeringsbesluiten en moeten zich regulariseren als stoelgangbank.