Cenedella.de

Patient Advocate since 1977.

Cannabis as medicine: Federal Institute for Drugs and Medical Devices is setting up cannabis agency for future cannabis cultivation in Germany

Leave a comment

Press release number7/17
Date 03.03.2017

With the coming into force of the law “Cannabis as medicine”, a cannabis agency is established in the Federal Institute for Drugs and Medical Devices ( BfArM ). The cannabis agency will control and control the cultivation of cannabis for medical purposes in Germany. Immediately after its establishment, the cannabis agency will start an EU- wide tendering procedure and then award contracts for cultivation to suitable companies. The aim is to ensure the supply of low-skilled patients with pharmaceutical-grade cannabis grown in Germany.

Lutz Stroppe, State Secretary in the Federal Ministry of Health: “In the future, trafficked patients will be able to receive cannabis in medicinal quality from the statutory health insurance scheme. This is a good and important step to relieve pain and suffering. The Cannabis Agency at the Federal Institute for Drugs and Medical Devices will ensure that cannabis cultivation in Germany is controlled and controlled.

BfArM President Prof. Dr. Karl Broich: “The new law is an important step for disabled patients who are dependent on the supply of cannabis medicines. With the Cannabis Agency, we are helping to ensure their supply of cannabis in pharmaceutical quality. In addition, we will be able to gain further important insights into the medicinal use of cannabis with the companion. ”

The cannabis agency is established as a new specialty in the “Special Therapies” section of the BfArM . Further tasks will be settled at the Bundespiumstelle in the BfArM . This includes a companion survey to gain further insights into the effects of cannabis as a medicine. As before, the Federal Office will also monitor the imports of cannabis, which ensure the care of the patients, as long as no harvest can take place in Germany. The BfArM assumes that cannabis from the cultivation will be available in Germany in 2019, since the cultivation under the anesthetic and medicinal law regulations must first be implemented. The import of cannabis will also be possible beyond this time. Currently, cannabis is imported from the Netherlands and Canada for medical purposes. Basically, cannabis can be imported from any country that can carry out the cultivation of cannabis for medical purposes under state control and can offer cannabis in medicinal quality.

Cannabis will be grown exclusively for medical purposes. It is therefore a medicine. This cannabis must therefore meet all drug and narcotic requirements. Only such cannabis will be used, which has been grown according to the “Good Practice and Collection Practice” (GACP) and meets the requirements of the relevant monographs and guidelines.

When cultivation takes place in Germany, the cannabis agency will take possession of the crop and control delivery to pharmacies to provide care to patients. However , cultivation is not carried out in the BfArM or by the BfArM itself, but by companies selected in the tendering procedure and commissioned by the cannabis agency. The harvest is not transported to the BfArM , it is not stored there, nor is it redistributed from there. These steps will be located spatially at the respective construction companies or other commissioned companies. According to the provisions of the Single Convention, the cannabis agency must buy the cannabis. The cannabis agency will then set a producer’s fee and sell the cannabis to cannabis drug manufacturers, wholesalers or pharmacies. The BfArM is not allowed to make any profits or surpluses. In the case of pricing, however, the personnel and material costs incurred by the BfArM are taken into account. However , the BfArM does not have any influence on the actual fee in the pharmacy . The distribution channels of manufacturers and dealers will comply with the legal regulations and are thus identical with the regulations for the distribution of other drugs containing narcotic drugs. The BfArM is not allowed to make any profits or surpluses. In the case of pricing, however, the personnel and material costs incurred by the BfArM are taken into account. However , the BfArM does not have any influence on the actual fee in the pharmacy . The distribution channels of manufacturers and dealers will comply with the legal regulations and are thus identical with the regulations for the distribution of other drugs containing narcotic drugs. The BfArM is not allowed to make any profits or surpluses. In the case of pricing, however, the personnel and material costs incurred by the BfArM are taken into account. However , the BfArM does not have any influence on the actual fee in the pharmacy . The distribution channels of manufacturers and dealers will comply with the legal regulations and are thus identical with the regulations for the distribution of other drugs containing narcotic drugs.

In view of the expected and required consumption and harvest quantities, the BfArM will be determined in the tender. However, the exact future demand for quantities can only be estimated at present. So far, about 1,000 patients had an exemption for the acquisition of cannabis for medical purposes. With an average daily requirement of one gram per person, 365 kilograms per year would be needed to supply these patients continuously via the prescription of cannabis. For the future, it will be necessary to look closely at how the prescription behavior develops and to what extent cannabis is an adequate treatment for patients.

By the entry into force of the amended amending act, the prescription capacity for further cannabis medicines is established. In the future, doctors can also prescribe medicinal cannabis blossoms or cannabis extract in pharmaceutical quality on an anesthetic prescription. They must comply with drug and narcotic drug requirements. In addition to the new regulations, the existing therapeutic and prescription options for the finished medicinal products Sativex® and Canemes® as well as the prescription drug Dronabinol will continue.

The BfArM is not advised on the therapy itself or on the application areas of cannabis medicines. As with other medicines, the BfArM does not offer any therapeutic recommendations. Delivery of the corresponding medicinal products to the patients will take place after the administration of the narcotics prescription in the pharmacy. The previous licensing procedure pursuant to § 3 para. 2 BtMG for the acquisition of medical cannabis for the purpose of medically-assisted self-therapy will be dispensed with.

Individual patients will in future be given medicinal cannabis or cannabis extract. Cannabis blossoms consist of the flowering, dried shoots of the female plant of Cannabis sativa L. (Cannabaceae). The two main ingredients involved in the action of cannabis are delta-9-tetrahydrocannabinol and cannabidiol. The content of delta-9-tetrahydrocannabinol and cannabidiol varies according to variety.
A cannabis extract is made from cannabis flowers using a pharmaceutical grade excerpt. An extract contains a certain content of delta-9-tetrahydrocannabinol and is converted in the pharmacy into a customary pharmaceutical dosage form such as, for example, capsules or dripping solution, For the intake by the patients processed.
Only limited information on efficacy and safety has so far been available on the use of cannabis and non-authorized cannabis extracts. Despite numerous publications, the amount of scientific data actually available is currently low. Therefore the attendance of the escort, which will be carried out in the Bundesopiumstelle, is of particular importance. Physicians report to the BfArM anonymized data for the therapy with cannabis medicines, which are collected over 5 years and then evaluated. Despite numerous publications, the amount of scientific data actually available is currently low. Therefore the attendance of the escort, which will be carried out in the Bundesopiumstelle, is of particular importance. Physicians report to the BfArM anonymized data for the therapy with cannabis medicines, which are collected over 5 years and then evaluated. Despite numerous publications, the amount of scientific data actually available is currently low. Therefore the attendance of the escort, which will be carried out in the Bundesopiumstelle, is of particular importance. Physicians report to the BfArM anonymized data for the therapy with cannabis medicines, which are collected over 5 years and then evaluated.

These data will then allow a general assessment to be made as to whether the use of cannabis medicinal products in unauthorized indications involves more opportunities than risks. They can be the basis for further clinical research with cannabis medicinal products, with the aim of achieving long-term approval of cannabis-based finished medicinal products.

 

http://www.bfarm.de/SharedDocs/Pressemitteilungen/DE/2017/pm7-2017.html?nlId=8664204

Advertisements

Author: Cenedella.de

Philip J. Cenedella IV - The 2-continent Cannabis Consultant. First and foremost, I am a Patient Advocate since 1977. I have also served as a Board of Director for the World Trade Center San Diego, as a Lead Consultant for Deutsche Telekom's Executive Board, Founded the Dayton Human Trafficking Accords and have been a C-Level Business Development Executive for over 3 decades. From California, now residing in Germany and providing professional business development services to firms from North America, Europe and worldwide. I support the work of United States Congressman Dana Rohrabacher (pictured below at ICBC Berlin) and the BERLIN PEACE ACCORDS which call for an end to the world war on Cannabis. https://cenedella.de/berlin-peace-accords Consulting Services: Sales and Business Development - all facets, C-level, ethical and professional Assist with Strategic Direction - but focused on its implementation Professionally represent your firm - at conventions, sales meetings, and events Research - licensing, compliance, distribution networks and qualify potential partners I am your resource, on the ground in Europe! Philip J. Cenedella IV Call +1.888.206.3264 USA / +49.0.151.720.16752 GERMANY Skype: philip.j.cenedella / eMail: phil@cenedella.de

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s