GMP News - Herbal Medicinal Products (incl. Cannabis)


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.



Medical Cannabis in Malta

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.



10th Edition of The International Pharmacopoeia

The 10th Edition of The International Pharmacopoeia is now available online. It contains recommended procedures for analysis and specifications for APIs and dosage forms.



BfArM starts Sale of medical Cannabis "Made in Germany"

Finally it´s done: The BfArM has started the state sale of medical cannabis from German cultivation. However, importation remains possible.



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.



Ph. Eur. General Notices Chapter - New Structure and Content

The European Pharmacopoeia Commission adopted a revised version of Ph. Eur. chapter 1. General Notices to provide greater clarity for users.



Foreign Matter in Herbal Drugs

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 Drugs - What is Well-Established Use?

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?



Medical Cannabis in Greece

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.



No Distribution of CBD Products Allowed?

According to recent decisions of two Administrative Courts in Germany, Berlin and Hamburg, food supplements containing cannabidiol may not be marketed without further action.



Illegal Selling of CBD-Products: FDA Continues Issuing Warning letters

The FDA still warns companies for illegal selling Over-the-Counter CBD Products for pain relief including products listing CBD as an inactive ingredient.


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