GMP News - Herbal Medicinal Products (incl. Cannabis)

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.

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.

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

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).

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.

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