The Brazilian Health Regulatory Agency (ANVISA) has published a list of cannabis products that will have automatic approval by the agency for individual importation by Brazilian patients. The list also includes a large number of CBD preparations.
USP´s Expert Committees for Non-Botanical & Botanical Dietary Supplements and Herbal Medicines propose the elaboration of a new USP general chapter <2760> on impurities in food supplements.
MHRA Guidance for the Supply of Medical Cannabis Products
The MHRA published an updated Guidance on manufacturing, importing, distributing and supplying of cannabis-based products for medicinal use. Amongst others, the MHRA will require a valid GMP certificate for the site of manufacture.
EMA Update of the Q&As on Herbal Medicinal Products
The updated EMA document "Regulatory Q&A on herbal medicinal products" contains several revised Q&As including the Q&As regarding the requirements for the simplified registration procedure.
EMA adopts final Public Statement on Pyrrolizidine Alkaloids
The HMPC adopted the final Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination with PAs. Amongst others, it is stated that PA specifications are no longer considered necessary for essential oils.
Malta´s Medicines Authority issued a document which provides general guidance on medical cannabis production. According to the agency applications for medical cannabis production must be completed and the licence and EU-GMP certificate must be granted before production activities are carried out.
FDA Analyses Products from Amazon and Finds Potentially Harmful Drug Ingredients
The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.
The 10th Edition of The International Pharmacopoeia is now available online. It contains recommended procedures for analysis and specifications for APIs and dosage forms.
Will Cannabis for Recreational Purposes be available in German Pharmacies?
According to the German Liberal Democrats (FDP), adults in Germany should be able to purchase cannabis for recreational purposes at pharmacies and specially licensed shops.
A revised version of Ph. Eur. Chapter 2.8.2 Foreign Matter is available. It clarifies the requirements for other foreign matter like moulds and animal contamination and any other unwanted matter (e.g. glass, metal, plastic).
Herbal medicinal products can be registered via the well established use approach within the EU. But what is needed for the simplified registration and how to demonstrate well established use?
Greece is currently discussing a new bill about medical cannabis products. Its purpose is to allow medical cannabis companies in Greece to produce medical cannabis and export it to Europe.
Ph. Eur. Essential Oils: Revised Monograph and New General Chapter
The European Pharmacopoeia (Ph. Eur.) Commission, adopted the revised general monograph on Essential oils and a new chapter on Monographs on essential oils.
