GMP News - Herbal Medicinal Products (incl. Cannabis)

11.08.21

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.

more

21.07.21

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.

more

14.07.21

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.

more

30.06.21

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.

more

16.06.21

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.

more

09.06.21

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).

more

09.06.21

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?

more

02.06.21

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.

more

05.05.21

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.

more

21.04.21

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.

more

14.04.21

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.

more

14.04.21

Switzerland aims to Facilitate Access to Medicinal Cannabis

The Swiss Narcotics Act is to be amended. Among other things, the amendment provides that cannabis-based treatments can be prescribed directly by doctors without having to obtain an exceptional authorization from the Swiss Federal Office of Public Health. In addition, cultivation and export are to be permitted.

more

24.03.21

Cannabis Glossary and GACP Revision

EMA´s Committee on Herbal Medicinal Products published the 2021 HMPC Work plan. Amongst others the HMPC plans to establish a Cannabis glossary and to revise the GACP guidelines.

more

24.03.21

New THC Threshold for Hemp Products

The German Federal Institute for Risk Assessment has issued a new statement recommending that the assessment of hemp-based food products be based on the EFSA-derived acute reference dose of 1 microgram Δ9-THC/kg body weight.

more

17.03.21

Is Medical Cannabis a Medicinal Product?

The Higher Regional Court (OLG) of Hamburg has decided, in the context of proceedings aimed at the issuance of an interim injunction against a wholesaler, that medical cannabis (cannabis flowers) is not (yet) a medicinal product at the wholesale level.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics