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Latest regulatory changes
Update RD on narcotic drugs and psychotropic substances
Belgium Annex IA: 0,2% Cannabis has been changed to 0,3% CannabisThe below substances are added :2-METHYL-AP-237ETAZENE (ETODESNITAZENE)ETONITAZEPYNEPROTONITAZENE Annex IIB: The below substances are added:ADB-BUTINACAalpha-PiHP3-METHYLMETHCATHINONE (3-MMC) Annex IIC:...
Update of the IML code of ethics
Luxembourg The IML Code outlines the ethical standards that its members have committed to follow when promoting medicines to healthcare professionals (HCPs) and engaging with HCPs, healthcare organizations (HCOs), and patient organizations (POs). These guidelines...
New regulation Ecodesign for Sustainable Products
Europe We would like to inform you of a significant new EU regulation—the Ecodesign for Sustainable Products Regulation (ESPR)—which came into force on July 18th, 2024, replacing the previous 2009 legislation. This regulation is designed to make products more...
Update instructions for distribution of DHPC/aRMM in Luxembourg + introduction MA overview
Luxembourg La Division de la Pharmacie et des Médicaments de la Direction de la Santé (DPM) has published updated instructions for the distribution of DHPC (version 3.0 - 06/2024) and aRMM (version 4.0 – 06/2024) in Luxembourg. A change in the updated version is the...
Revocation health claim on monacolin K from red yeast rice
Europe The Commission Regulation (EU) 2024/2041, dated 29 July 2024, which amends Regulation (EU) No 432/2012 concerning the health claim for monacolin K from red yeast rice, was published in the Official Journal on 30 July. The European Commission's regulation...
Planned legislation for transparency in the Netherlands
The Netherlands Disclosure of financial interactions between pharmaceutical companies and healthcare professionals and organisations, and patient organisations can be reported in the Transparency Register Zorg in the Netherlands (www.transparantieregister.nl)....
Farmaline’s non-compliance with Belgian Advertising Regulations
Belgium BACHI, the Belgian industry association for OTC medicines and pharmacy-based health products, communicated about collaborating with Farmaline, a well-known online pharmacy. According to BACHI, it was found that Farmaline does not respect Belgian legislation on...
Packaging liquid food supplements
Belgium The packaging of liquid food supplements (e.g. syrups, dropper bottles) is not required to have attached caps, the so-called “tethered caps” like e.g. soda drinks do. The only exception are "shots", as they are consumed immediately and in… one shot. Source:...
Pharma.be address changes
Belgium From October 2024 onwards, the pharma.be offices will be located at the following address: Central Gate - 4th floorCantersteen 471000 Brussels
Appropriate online advertising for self-care products
The Netherlands Online advertising for self-care products by influencers is increasing significantly, raising concerns about control and misinformation. Influencer registry A registry of certified influencers was opened in April. These influencers annually complete an...
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