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

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


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CBD Innovator and Supplier Isodiol Hosts “Cannabis vs. Opiates” Panel at the California Cannabis Business Expo

CARLSBAD, CA / ACCESSWIRE / March 8, 2017 / As Southern California’s most innovative hemp cannabinoid product manufacturer, Isodiol is proud to be associated with pro athletes and doctors at the California Cannabis Business Expo in San Diego on March 5th through March 8th. In addition to presenting innovative pharmaceutical grade and full-spectrum CBD finished products, Isodiol is sponsoring a panel titled “Cannabis vs. Opiates,” discussing the wellness benefits of phytocannabinoids. While the Company is consistently expanding its role in the global cannabis marketplace, it is also committed to educating and informing people on the science behind the hemp plant. Derived from organic certified hemp, Isodiol’s products contain no THC and can be shipped anywhere in the world.

Isodiol has brought together two celebrated NFL athletes and a respected medical doctor to discuss “Cannabis vs. Opiates” at the CCBExpo, Wednesday, March 8 from 2-3:00pm. Marvin Washington played eleven seasons in the NFL and won a Super Bowl ring with the Broncos. Eddie “Boo” Williams played seven years for the New Orleans Saints. Both men have since steeped themselves in the medical cannabis industry and have become strong forces and important voices for the efficacy of medical cannabis – including non-psychotropic hemp cannabidiol/CBD – as an alternative to opiates. Dr. Jeffrey Ostriker, M.D., has been in practice in Los Angeles county for over 25 years. For the last seven years, he has lectured and held seminars on medical cannabis. He is a member of ICRS/International Cannabis Research Society and is a Board Member of Society of Cannabis Clinicians and its research committee. He remains actively involved in ASA/Americans for Safe Access and Patients Out of Time and has consulted on Hawaii’s development of its Medical Cannabis regulations.

“We work tirelessly not only as product innovators, but also as educators within this growing wellness sphere. To partner with credible voices like Marvin, Eddie, and Dr. Ostriker is a true privilege. I look forward to the wisdom they will share about the benefits of phytocannabinoids in the face of a growing Opioid addiction epidemic. We are certainly proud to support this movement,” says Isodiol CEO, Jared Berry. “This Company was started out of a passion for helping people. We realize that to do so effectively means more than just developing the best products. It is also incumbent upon us to stay at the forefront of knowledge and science and to openly share that information at every opportunity.”

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Five good reasons for Cannabis as Medicine

From DHV ….by The Editors

Cannabis against common diseases

The “Cannabis as Medicine” law currently allows the use of cannabinoids as medicine for seriously ill patients. A variety of ailments can be treated successfully with cannabis and increasing scientific studies on the subject deal with the therapeutic efficacy of cannabinoids. Therefore, we have for you the five most common diseases in which cannabis could be used.

1. Back Pain

In Germany statistically currently 32-49% of people back pain. Approximately 70% have pain at least once a year and about 80% complain at least once in a lifetime of backache ( Source: Robert Koch Institute ).

In the majority of patients, this is not due to unique causes. Spasms and inflammation caused by faults within the complex working of the muscles, joints and ligaments of the back.

Studies on the use of cannabinoids in chronic pain show a possible application in pain medicine. Interesting for the pain therapy in this context are the two best known cannabinoids, the psychoactive THC (tetrahydrocannabinol), and the little psychoactive CBD (cannabidiol). Cannabinoids are to alleviate the situation, back pain and muscle spasms. Loosen cramps in the muscles, acting analgesic and anti-inflammatory.

The endocannabinoid system is a part of the nervous system and consists of receptors that control, among other things, the mood, appetite, digestion and pain. At these receptors dock at the cannabinoids of the cannabis plant. THC binds to the two known cannabinoid receptors CB1 and CB2. The CB1 receptor is one of the most common receptors in the brain and also occurs in most other tissues and organs of the body. If the CB1 receptor is activated by THC, so it causes, in addition to numerous other effects, pain relief and muscle relaxation. Excessive activity in the pain circuits of the brain is inhibited, thereby alleviating the pain. The CB2 receptor is found mainly on the immune cells. Activation of the CB2 receptor by THC inhibits inter alia inflammation.

2. insomnia

According to the Robert Koch Institute about suffering 25 percent of the German population from insomnia.

“The possible sleep-inducing effects of cannabis have been known for a long time. Dr. Bernhard Fronmüller, doctor at the hospital in Fürth and royal Bavarian district physician, reported in 1869 in his acclaimed work “Clinical studies on the sleep-making effect of the narcotic drug” about his experiences at exactly one thousand patients suffering from different causes of severe insomnia and had been treated by him with various medications. After cannabis was in 53 percent of cases, good effect, little or no effect in 21.5 percent partially and 25.5 percent “(Dr. Franjo Grotenhermen:.. Cannabis and THC in severe insomnia )

THC has on the body an artery widening effect. The enlargement of the blood vessels, the blood pressure is lowered and as a result also reduces the body temperature. It comes to a feeling of relaxation and stress reduction. This can, of course, conducive to sleep depth and duration of effect.

3. allergies

In Germany 20-25% of the population suffers from allergic disease. 86% of all allergies have a pollen allergy, 41% are allergic to dog or cat, 38% of house dust and 14% to molds (source: German Society for Allergology and Clinical Immunology ).

A study by the University of Bonn from 2007 has shown that cannabinoids have anti-inflammatory properties. In the experiment with mice applying reduced a THC solution allergic skin reaction demonstrably. The endocannabinoid system plays an important role in the regulation of inflammatory processes in the body. The cannabinoid THC bind to cannabinoid receptors and activates them. Characterized the allergic response is reduced. For example, contact allergies with hemp ointment can be treated successfully. Even patients with allergic asthma have reported relief from their symptoms through medication with cannabis.

4. migraine

Migraine is one of the most common forms of headache, around 10 percent of the adult population in Germany suffers from migraine attacks (Source: German Society of Neurology ).

Medical marijuana may successful in the treatment of migraine may be used. A study by the University of Colorado has researched the effects of medical marijuana on the frequency of migraine attacks. But were 121 adults, in which migraine headaches were diagnosed and where medical marijuana by a doctor had prescribed, examined in the period from January 2010 to September 2014. The effects were significant. In 85 percent of cases, the patients experienced a decrease in headaches from an average of 10.4 to 4.6 times a month. With 12 percent of the participants the complaints heard even on quite.

The causes of migraine are varied and still controversial. Thus previous studies have chronic migraines with a malfunction in the endocannabinoid system brought the persons concerned in relation. It is understood in this context the fact that cannabinoids reduce the pain associated with migraine, by controlling the penetration of the pain signals to the brain through the receptors of the endocannabinoid system.

Another effect of cannabis on the body is the already mentioned expansion of blood vessels. As a possible cause of migraines and circulatory disorders in the brain play a role cannabis may also help alleviate. So let the vasodilator effects that acts cannabis on meninges, subside a migraine attack. Migraine attacks are also often accompanied by severe nausea. Cannabis helps not least here, too. Cannabinoids attributed a sickness and nausea-suppressing effect.

5. depression

According to the Foundation German Depression Help about 5% of the population suffers aged 18-65 years in Germany develops major depression. Almost one in five ill at least once in their lives from depression. (18 percent of the population). Thus, depression is one of the largest common diseases.

One of the best known properties of cannabis is its antidepressant effects, which may suffering from depression people benefit. In particularly interesting therapeutic point here is the mode of action of cannabidiol (CBD shortly). These writes Dr. Franjo Grothenhermen : “Animal studies with rats and mice do not support previously published patient experience that CBD has antidepressant properties. So researchers at the University of Cantabria (Spain) found in two studies of a mouse model of depression found that “CBD could represent a new, fast-acting drug by both signaling pathways in the cerebral cortex that respond to serotonin or glutamate, by a 5 -HT1A receptor dependent mechanism strengthened. “

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Overweight and obesity

Slightly more than half of women (53%) and two thirds of men (67%) in Germany are overweight . About a quarter of adults is even very overweight (obese). Overweight and obesity are mainly responsible for a variety of complications.  

Cannabis contains a variety of different cannabinoids, including not only the known appetizing ingredients. The cannabinoid CBD could assist in combating obesity help. Thus CBD plays a role in the so-called browning white fat cells. In the human body there are two different types of fat cells. Firstly, the so-called “white fat cells”, which contribute substantially to the formation of fatty deposits and secondly, the “brown fat cells”, which are able to convert excess energy into heat. The conversion of white adipocytes to brown adipocytes (tanning) and the activation of existing brown fat cells are currently investigated as ways to combat obesity.

“The scientists showed that CBD might have a role in the browning of white fat cells, in enhancing the fat burning in heat production and in reducing the fat production. They wrote that “CBD could be explored as a potential promising therapeutic agent for the prevention of obesity” (Franjo Grotenhermen: new in science to the treatment with CBD ) “Here the research is still at its infancy and we are excited. , how it goes on.

 

This post may be considered in no way intended to replace professional medical care by a qualified practitioner. The information should not be used to independently provide diagnosis or treatment.

 


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Isodiol CBDExtreme and NANOtechnology

A key component to Isodiol’s continually growing relationships with consumers, wholesalers, and manufacturers is the quality and consistency of their pharmaceutical grade CBD finished products and bulk goods. Featured products appeal to these markets.

Nanotechnology powers several of Isodiol’s products. CBD NaturalsTM bottled nano-amplified hemp CBD water contains cellular nutrients and cannabidiol for powerful hydration. VitaDots CBD gummies deliver HeneplexTM, a full spectrum hemp essential oil complex with naturally occurring, non-psychoactive phyto­cannbinoids like Cannabidiol (CBD) and over 75 botanical terpenes. They come in two formulas/flavors, one for immune and bone health and one for digestive support. NanoDrops Beverage Enhancer is also powered by HeneplexTMand is a convenient way to add cannabinoid support to any liquid.

CBDXtremeTM delivers TruSpectrumTM full-spectrum hemp oil in a variety of innovative delivery systems. VAPEIt formulas combine phytocannabinoids and adaptogenic herbs in tasty blends. DABIt Crumble, Distillate, and Isolate formulas provide options for full-spectrum phytocannabinoid and extreme CBD benefits. The versatile ADDit hemp oils deliver the full-spectrum of phytocannabinoids. CHEWIt provides vitamins and pre/probiotic support in these all-natural CBD gummies.

Isodiol’s bulk products are impacting the international market. Pure CBD Isolate is refined 99%+ pure CBD in a crystalline formula for consumer and manufacturing needs. Labeled as CBD99TM, it is the first hemp-derived Isolate to enter the marketplace. Its reputation as the highest quality crystalline available placed it in demand as the most widely used naturally sourced CBD for medical studies. Derived from the industrial parts of the hemp plant and available for distribution through the USA and internationally, this Isolate is Kosher certified and produced in a GMP and ISO 9001 certified facility. It is sourced completely from ECO certified (European Organic Certification) Hemp.

Nano Concentrates are also powerful options for nanoemulsified Cannabidiol delivery. CebidiolTM revolutionizes skin delivery technology with microencapsulated CBD. The microscopic spheres release layer by layer for time-released delivery. HeneplexTM is a universal, water-based additive. Its unique synergistic blend of over 75 botanical terpenes and 25,000mg/liter of non-psychoactive Cannabidiol (CBD) can be easily incorporated into a wide array of formulations, offering manufacturers competitive advantage when it comes to cost and product efficacy. CBDNanoUltraTM contains 20,000mg/liter of Cannabidiol and is also a water-soluble additive.

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Germany – 1 March 2017 update – Cannabis legislation has not yet been published in the Federal Gazette

Cannabisgesetz noch nicht im Bundesanzeiger veröffentlicht

Even if the Bundestag and the Federal Council have decided to make it easier for patients who are seriously ill in future to gain access to medicine from cannabis blossoms and extracts , the cannabis legislation has not yet been published in the Federal Gazette. Thus, contrary to the reports of different news portals, probably no marijuana from today will give on prescription in pharmacies for patients without exception permission.

 

The last February day offered some new laws and legal changes in the Federal Law Gazette , but no publication of the cannabis as a medical law can be found in the table of contents of the first part of the publication of 28.02.2017, which provides information on the federal laws now in force. As a result, the right to prescribe the cost of cannabis medicines by health insurance companies from March 1 is as little the same as the state license, which may be allowed to be licensed to the medical profession, which may have recently been prescribed by a doctor. On the other hand, however, first steps can be found in publications of 17.02.2017,

 

The fact that a publication in the Federal Chancellor is always imperative before the coming into effect of a law , but nevertheless urbayrian media gave their local audience conscientiously before the first day of the month of March, before these also have to get used to the changed circumstances in dealing with the demonized drug .

 

As soon as it is in the Federal Court, the law applies to all.


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H.R.975 – Respect State Marijuana Laws Act of 2017 – Rohrabacher

There is 1 version of this bill. View text

Summary (0)

A summary is in progress.


Actions Overview (1)

Date
02/07/2017 Introduced in House

All Actions (5)

Date
02/07/2017 Referred to House Energy and Commerce
Action By: House of Representatives
02/07/2017 Referred to House Judiciary
Action By: House of Representatives
02/07/2017 Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Action By: House of Representatives
02/07/2017 Sponsor introductory remarks on measure. (CR H1075-1078)
Action By: House of Representatives
02/07/2017 Introduced in House
Action By: House of Representatives

Titles (2)

Short Titles:

Short Titles – House of Representatives

Short Titles as Introduced:

Respect State Marijuana Laws Act of 2017

Official Titles:

Official Titles – House of Representatives

Official Title as Introduced:

To amend the Controlled Substances Act to provide for a new rule regarding the application of the Act to marihuana, and for other purposes.


Subjects (5)

Subject — Policy Area:

One Policy Area term, which best describes an entire measure, is assigned to every public bill or resolution.

  • Alternative treatments
  • Drug trafficking and controlled substances
  • Drug, alcohol, tobacco use
  • State and local government operations

Cosponsors (14)


Committees (2)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Judiciary 02/07/2017 Referred to
House Energy and Commerce 02/07/2017 Referred to

Related Bills (0)

As of 02/28/2017 no related bill information has been received for H.R.975 – Respect State Marijuana Laws Act of 2017.


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Isodiol NanoMIST products announced

Published on Feb 27, 2017

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About our company

Isodiol and its team of collaborators own exclusive technological and production capacity rights that cannot be found anywhere else in the world. The team has worked tirelessly to bring together the most talented technological minds to breed and cultivate hemp. This team of staff has extensive experience in planting, development, research and CBD production. These experts have created a process that allows them to extract pure CBD oil from the mature stalks of the hemp plant. This proprietary extraction method is unique and ensures that Isodiol’s pure CBD products are the highest quality available anywhere in the world.

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Isodiol’s team of collaborators operate facilities located in close proximity to hemp fields and skilled human resources. This proximity optimizes industrial cannabinoid oil production and increases the efficacy of operating costs. This enables CBD oil to be offered wholesale to large manufacturers and CBD oil products to individual consumers at affordable rates. The goal is to create a mutually beneficial relationship with the pharmaceutical, cosmetic and nutraceutical markets that depend on consistent supply.

Isodiol is committed to the continuing development of cannabinoid oil for the benefit of individuals worldwide. It can be used by those suffering from non­-life threatening and critical ailments, including a variety of skin conditions. To learn more about the uses of CBD oil, please visit the ‘Trials/Studies’ section of our website located at the top of the page. There, you can peruse a variety of clinical trials and medical studies detailing the effects of CBD use.