Philmans Pharm,, The German Patient Roundtable

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Legal framework for the distribution of cannabidiol in Germany

Published on August 23, 2016 by 

The deputy Dr. Harald terpene (Alliance 90 / The Greens) has asked a question on the legal status of cannabidiol in the German Bundestag. Question Rationale: CBD should be available on prescription . Here the question and the answer of the Federal Government.

Source: German Bundestag Printed Matter 18/8659 ; 18th legislature 03/06/2016; Written questions with the commitments of 30 May 2016 the week answers the federal government

47th MP Dr. Harald terpene (Alliance 90 / The Greens)

Under what legal conditions and taking into account the recommendation of the Committee of Experts on medical prescription in accordance with § 53 paragraph 2 of the Medicines Act (AMG) of 19 January 2016 that cannabidiol prescription in accordance with § 48 AMG is to be assumed, must cannabidiol (CBD), for example in the forms 10-percent CBDExtrakt the manufacture of cosmetics, 1-percent CBD portion in hemp seed oil (as a body oil), CBD as a natural part of Nutzhanfblütentee and other Nutzhanfprodukten that are intended to be eaten, hemp seed oil (or other foods) with added 0.5 -prozentigem CBD and loose Nutzhanfblüten with 1.5-percent CBD portion are currently sold in Germany, and which limits be adopted for CBD compared to tetrahydrocannabinol (THC) in foods and cosmetics?

Answer by Parliamentary State Secretary Dr. Maria Flachsbarth from June 2, 2016

On the subject of food:

For hemp foods containing cannabidiol, there are no specific provisions applicable to foodstuffs. The general rules, in particular Regulation (EC) no. 178/2002 (so-called. Basic Regulation in Food Law) and the Food and Feed Code.Thereafter, it is especially forbidden foods that are not safe to manufacture or place on the market. Food business operators must ensure conformity of the marketed by them with the relevant legislation in the context of their duty of care.The enforcement of food law is for the competent authorities of the countries in Germany.

The Federal Institute for Risk Assessment (BfR) has announced that exist for CBD in hemp foods other than for tetrahydrocannabinol no health-based guideline (Health-based Guidance Values, HBGV). In this respect there is no basis for the establishment of limit values for CBD in hemp foods. Products containing CBD containing extracts from the hemp plant, are – provided they have no pharmacological effect – classified as a novel food in the EU. Novel foods should be placed on the market if they are to health evaluation and approval.

On the subject of cosmetic products:

Cosmetic products are regulated at the level of the European Union to Regulation (EC) no. 1223/2009. There are no material specific rules in the Regulation to CBD. Considerations to the European Commission is not aware of the federal government. The regulation defines cosmetic products as substances or mixtures, which are intended, with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or to come into contact with the teeth and the mucous membranes of the oral cavity, and namely to perfume to view exclusively or mainly to cleaning them, changing their appearance, to protect them, to keep them in good condition or correcting body odors.
For classification as a cosmetic product is in each individual case on the basis of a concrete product to examine whether the vast cosmetic purpose is given.

Under the Regulation, available on the market cosmetic products under normal or reasonably foreseeable conditions of use for human health must be safe. Before the initial deployment of a cosmetic product on the market a safety assessment is carried out. The so-called responsible person (usually the manufacturer or importer) must make available to the relevant documents for official controls. In the safety review all the ingredients of a cosmetic product shall be considered.

On the subject of drugs:

Recommendations of the Committee of Experts on medical prescription in accordance with § 53 of the Medicines Act only concern aspects of the prescription of drugs.


Over the last 4 decades I have been involved in the fight for patient rights in America, and now here in Germany. During my career I have served as a Board of Director for the World Trade Center San Diego and as a Lead Consultant for Deutsche Telekom's Executive Board, Co-Founded the San Diego Software Council and the Dayton Human Trafficking Accords and was Director of LawInfo's Lead Council Program. Previously I was a C-Level Business Development Executive in the technology sector, but also involved with the cannabis industry since 1977. More recently I have been fulltime in the legal medical marijuana industry here in Europe, helping international companies navigate the biggest potential market in the world. This website is light on details due to confidentiality issues with clients but be rest assured I am knowledgeable, professional and with street cred in the industry that can immediately assist your growth in some way. Consulting Services: Sales and Business Development Assist with Strategic Direction Professionally represent your firm Special Projects management Licensing and compliance Sales and Distribution networks Qualify potential partners I am your resource on the ground in Europe, contact me directly to schedule an initial discussion on the German Cannabis-as-Medicine market. Thank you, Philip J. Cenedella IV Call +1.888.206.3264 USA + GERMANY Skype: philip.j.cenedella eMail: LinkedIN:

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