GMP News - Herbal Medicinal Products (incl. Cannabis)

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.

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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).

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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?

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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03.03.21

Ph. Eur. Adopts New General Chapter on Contaminant Pyrrolizidine Alkaloids

The Ph. Eur. Commission adopted a new Ph. Eur. general chapter on contaminant pyrrolizidine alkaloids. The chapter will be implemented on 1 January 2022.

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24.02.21

UK Guidance on Limits for Controlled Cannabinoids in CBD Products

Extracts or isolates containing Cannabidiol are used in cosmetics and food supplements supplied to the UK market. One question still remains: How to interprete the 1 mg UK limit for controlled cannabinoids?

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17.02.21

EMA Clarifies GMP Requirements for Herbal Substances Used as APIs

When does EU GMP Guide Part II apply to the manufacture of herbal extracts? A new EMA Q&A document on GMP for herbal extracts used as active substances in herbal medicinal products gives the answer to this question.

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09.12.20

UN Commission Reclassifies Cannabis

The United Nations (UN) Commission on Narcotic Drugs (CND) has decided to reclassify cannabis. With this, the Commission followed the WHO recommendation of 2019.

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