Law for more safety in the supply of medicines (Gesetz für mehr Sicherheit in der Arzneimittelversorgung, „GSAV“) came into force on Aug 16th 2019
"Patients must be able to rely on the fact that medicines help them and that they do not harm them. Therefore, we are strengthening the competences of the federal government" said Jens Spahn, Federal Minister of Health on 6th of June 2019, when the Bundestag passed the law.
The law is intended to increase protection against counterfeit medicines.
What will change for medicinal cannabis?
Adjustments have also been made regarding the treatment with cannabis that will allow an easier process of changing the type or dosage of medicine. If the public health insurance has granted cost coverage for the treatment with cannabis, the physicians will now be allowed to change the cannabis variety or the dosage without prior re-approval of the public health insurance..
It is also ruled that the top associations of pharmacies and public health insurances are obligated to negotiate fixed pharmacy surcharges for the supply of substances and preparations of substances in accordance with the German Medicines Act (AMG). It is intended that this will result in a price reduction of medical cannabis. Until now, the pharmacy selling price is calculated based on the pharmacy purchase price plus a pharmacy surcharge (90 t0 100%), which reflects the work in the pharmacy.
Cannabis flowers preparations (formula magistralis) cause a lot of work in the pharmacy. In particular, the identity testing by thin-layer chromatography (TLC), which is supposed to take around 90 minutes, is difficult for small pharmacies to perform alongside customer interaction.
[Frankfurt, 19. Aug 2019]
Cansativa became a member of the German Association of the Pharmaceutical Industry ["Bundesverband der Pharmazeutischen Industrie (BPI)"]
Cansativa is looking forward to working together with the members of the BPI to strive for an open and professional dialogue within politics and the pharmaceutical cannabis industry.
What does that mean? Cansativa stands for a proactive engagement in the action fields of the BPI, including i.a. the participation in political discussion of industry standards.
By joining the BPI, Cansativa is committed to promote the interests of its clients and international industry partners. Cannabis products have received an official right to existence with the change in the law in medicine. From responsible manufacturing to the delivery to the patient, Cansativa will support the cornerstones of this innovative industry.
We expect a successful cooperation with the BPI, which is constantly working on the clarification and improvement of industry standards. Cansativa played an active role in the preparation of an elaborated statement to the draft monograph of cannabis extracts.
[Frankfurt, 15. Jul 2019]
CANNABIS - ABC - A as for "Apothekenbetriebsordnung" (Ordinance on the Operation of Pharmacies)
Public pharmacies fall within the scope of the Apothekenbetriebsordnung (short ApBetrO). It was created in the 1980s in accordance with § 21 ApoG and sets requirements for the operation of pharmacies. The aim of ApBetrO is to ensure that the population is properly supplied with medicinal products and medical devices requiring the use of pharmacies.
As with other medicines, the handling of cannabis flowers in pharmacies must be carried out in compliance with the ApBetrO guidelines. The inspection obligations of pharmacies depend on the regulatory classification of cannabis flowers. Since the state authorities are entrusted with the monitoring of obligations of pharmaceutical law, the classification is not regulated uniformly throughout Germany. For the handling of cannabis flowers this means that, depending on the federal state, the requirements for the duties in the pharmacy business can diverge. The Federal Government already commented on the differences in January 2019. In case of ambiguities, the responsible drug authority should be contacted.
[Frankfurt, 5. Aug 2019]
CANNABIS - ABC - B as for Bioavailability
Bioavailability describes the degree and speed at which the active pharmaceutical ingredient (API) of a drug is released and absorbed. It therefore indicates the proportion that is metabolized in the organism. The active ingredient must be present at the site of action in the correct dosage. Bioavailability depends in particular on the form of consumption. For the intake of cannabis flowers, the application with a vaporizer is advantageous in order to absorb the main substances THC and CBD.
When properly applied with a vaporizer, the bioavailability of ingredients such as THC from cannabis flowers is relatively high at about 29-40 %. Smoking cannabis flowers, however, is not recommended for several reasons. As with the use of a vaporizer, the APIs are quickly released during smoking. However, the effect and bioavailability of THC is uneven over time. The bioavailability of THC is subject to large intra- and interindividual fluctuations with 2-56 %. The probably decisive disadvantage compared to the vaporizer is the damage to the respiratory tract caused by the addition of tobacco and the burning of plant material at high temperatures.
[Frankfurt, 14. Aug 2019]
CANNABIS - ABC - C as for Cansativa
Cansativa (lat. cannabis sativa) provides independent market access and extensive warehousing and distribution capacities.
Founded in 2017, Cansativa is a GDP-certified pharmaceutical wholesaler licensed for trade in controlled substances and headquartered in Frankfurt am Main, Germany. Cansativa is committed to the goal of professionalizing the medical cannabis market, eliminating stigmatization surrounding it, and reducing prices for patients.
Since the very beginning, Cansativa has operated its own distribution and fulfillment center, and as one of the “first movers” in the industry, it has become one of the largest importers and distributors of medical cannabis in Germany. From its location in Frankfurt am Main, the company supplies pharmacies and pharmaceutical wholesalers throughout Germany.
With the ongoing expansion of a second GMP/GDP site in the Rhine-Main area Cansativa creates even more import, distribution and warehousing capacities.
Cansativa’s founding team can build upon two generations of expertise in the fields of medicine, law, and strategy.
[Frankfurt, 21. Aug 2019]
CANNABIS - ABC - D as for "Darreichungsformen" (Dosage Forms)
The pharmaceutical variaties of medical cannabis available on the German market range from unprocessed flowers over to capsules, sprays and drops.
The active ingredients (cannabinoids and terpenes) in capsules and drops are ingested orally, travelling through the stomach to finally reach the liver, where they are absorbed into the bloodstream. Flowers in turn are inhaled by means of a vaporizer*. In this case, the active ingredients are absorbed directly into the bloodstream via the alveoli (pulmonary air sacs). Finally, sprays are applied into the oral cavity so that the active ingredients are primarily transferred directly into the bloodstream through the mucous membranes of the mouth. The onset of the effect, the effect progression as well as the duration of the effect depend on the dosage form and the concentration of the active ingredients in the medication.
When absorbed via the liver, the effect sets after 30-90 minutes and can last for 4-6 hours, depending on the concentration of the active substance. In contrast, the intake of the medicament through the alveoli or mucous membranes allows a much faster absorption of the active ingredients. In this case, the onset of the effect occurs only after 5-10 minutes lasting 2-3 hours.
*Unprocessed flowers can also be ingested in form of tea. In such case, the absorption of the active ingredients into the bloodstream occurs also through the liver. However, cannabinoids are poorly soluble in water. This means that the effective/optimal absorption is not guaranteed.
[Frankfurt, 27. Aug 2019]
CANNABIS - ABC - E as for Entourage-Effect
The "entourage effect" is often mentioned in the context of cannabis flowers. The term entourage is French and can be transelated as "environment" or „surrounding“. The entourage effect describes the potential interaction between the cannabinoids, terpenes and other components of the cannabis plant. Cannabis varieties contain hundreds of cannabinoids and chemical compounds such as terpenes and phenolic compounds. These can produce various medical effects such as modification of the action of cannabinoids. It is currently assumed that the combination of different cannabinoids with terpenes achieves an optimized effect. However, the exact effects of the synergy of different substances are still the subject of current research. 
 Nahler G, Jones TM, Russo EB (2019) Cannabidiol and Contributions of Major Hemp Phytocompounds to the “Entourage Effect”; Possible Mecha- nisms. J Altern Complement Integr Med 5: 070; Ethan B. Russo (2018) The Case for the Entourage Effect and Conventional Breeding of Clinical Cannabis: No “Strain,” No Gain; Front. Plant Sci., 09 January 2019
[Frankfurt, 3. Sep 2019]
CANNABIS - ABC - F as for Fibromyalgia Syndrome
The fibromyalgia syndrome (FMS) (ICD 10 No. M79.70) is described as a disorder characterized by widespread constant dull musculoskeletal pain that has lasted for at least 3 months, usually accompanied by fatigue, sleep, memory and mood issues that are not associated to another disorder (DGS Guidelines FMS, No. 2). Despite only little clinical evidence, FMS is in the field of pain a possible indication for the use of cannabinoids to manage symptoms (DGS Guidelines Cannabis, No. I.4; II.9).
(further references upon request)
[Frankfurt, 13. Sep 2019]
CANNABIS - ABC - G as for Golden Rules
[Frankfurt, 19. Sep 2019]
CANNABIS - ABC - H as for Hybrid
As the latin origin of „hybrid“ already lets anticipate, it concerns crosses of the cannabis plants. The typical differentiation of cannabis varieties is between the widely recognized main varieties Sativa, Ruderalis and Indica. The crossbreeding is possible within the respective variety, but also between Sativa, Ruderalis and Indica plants. Hybrid breeding takes place through selection from male and female cannabis plants of different species to produce the first hybrid generation.
The production of hybrids can influence various factors such as growth behavior, resistance, yield or active ingredient content. Hybrids open up adaptations for the medical sector that can be useful as examples for the treatment of various diseases. Most of the cannabis strains currently on the market are actually hybrids.
[Frankfurt, 2. Oct 2019]
CANNABIS - ABC - I as for Indica
In essence, a distinction is made between three types of cannabis: sativa, indica and ruderalis, as well as hybrids between the different varieties. The individual plant species differ among other things in their growth, their maturity and their ingredients.
In addition to the sativa plant, the indica plant is the second best known and the one with the higher CBD proportion. As the Indica plant has a high concentration of THC and CBD, the effect is sedating and relaxing and is used to treat tremor symptoms, multiple sclerosis, muscle spasms and Parkinson's disease. Due to the ingredient composition, the Indica variety rather influences physical symptoms.
The plant ripens in about 6-9 weeks and is characterized by a smaller and compact stature, with a thicker stem and broader leaves. Due to the origin of the first described plant samples from India this variety was named Indica.
Read a detailed article on the differences in plant species on the website of Leafly, the knowledge portal for Cannabis as medicine: https://www.leafly.de/indica-sativa-ruderalis-cannabis-sorten/
[Frankfurt, 10. Oct 2019]
CANNABIS - ABC - J as for Joint
Joints are conical tobacco cigarettes containing cannabis. The content, a mixture of tobacco and cannabis flowers, is twisted into paper. At the lower thin end, a mouthpiece, usually a filter, is inserted. Symbolic associations with cannabis are often made with joints, especially in the media. The recreational use of cannabis is also represented with joints in various musical styles, predominantly hip-hop and reggae culture.
These ideas should, however, be distinguished from their use in the medical field. The use of joints in this context belongs to the contemporary history of the 19th century: in the 1870s, cannabis cigarettes were marketed in the medical field by the manufacturer Simon Arzt. Today the use of joints should be rejected in the medical field, in particular because of the damage to the respiratory tract. In addition, smoking joints is not recommended because of the effects of tobacco combustion products. On the other hand, a gentle intake can be achieved by using a vaporizer, as this only heats up the ingredients up to the vaporization stage and thus prevents harmful oxidation products from forming.
[Frankfurt, 21. Oct 2019]
CANNABIS - ABC - K as for "Kräutermühle" (herbal grinder)
An herbal grinder is a technical device for grinding small dried plants. In the context of medicinal cannabis, this is an important utensil as the dried flowers must be crushed before a patient can consume them. The doctor determines with the recipe, whether the cannabis flowers should be crushed in the pharmacy or by the patients themselves.
Herb mills are made of different materials and usually consist of a substance container, two levels with sharp molars, a sieve and pollen compartment. By opposing movements, the filled in dried flowers are ground small by the sharp teeth. Some manufacturers offer herb mills with magnets, which prevent slipping of the individual levels of the utensil.
If you would like to buy a grinder for your patients, please contact us. We do have the herb mills of Storz and Bickel in stock.
[Frankfurt, 31. Oct 2019]
CANNABIS - ABC - L as for Latin America
With the legislative change in Germany in 2017, the first products being available on the German market for medical cannabis were Dutch products from the company Bedrocan. Subsequently, Canada was connected to the German market as the next exporting country. More countries will follow. In the past years, laws have been enacted in various countries across the globe which allow the production and export of medical cannabis.
In Latin America, Uruguay and Colombia as the most advanced already allow it, Mexico and Peru could follow. More constant hours of sunshine throughout the year and frost-free winters allow cultivation in greenhouses with a reduced supply of artificial light. This aspect, as well as lower wages, allows lower production costs to be achieved in these countries. These climatic and regulatory conditions attract international investors, who enable the financing of EU-GMP certified plants. This certification is necessary to meet the high quality requirements for cannabis as a medicinal product in Europe.
It remains to be seen which country will next dismantle regulatory hurdles for the local production of medicinal cannabis.
[Moerfelden-Walldorf, 07. Nov 2019]
CANNABIS - ABC - M as for Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nerve system that can affect both the brain and the spinal cord. The own immune system destroys parts of the nerve fibers, which is why paralysis, spasticity and disturbed sensory perceptions can occur. So far, there is no cure for multiple sclerosis, which is why it is the priority to reduce the inflammatory processes in those affected, to treat an acute episode and to relieve the symptoms.
Medicinal cannabis in various forms can be used to relieve pain. Because many MS patients experience severe pain as a result of inflamed nerve tissue or spasticity, the treating physician may prescribe medicinal cannabis at their discretion. Studies suggest that cannabis may relieve the symptoms of MS, presumably since the various cannabinoids influence acute inflammation.
[Moerfelden-Walldorf, 15. Nov 2019]
CANNABIS - ABC - N as for Neurology
Neurology is a discipline that deals with the structure and function of the (central) nervous system. The effect of cannabinoids extends to the whole body, but essentially emanates from the central nervous system: The body's own cannabinoid receptors transmit the cannabinoids of the medical cannabis plant to the central nervous system. As a result, coordination, body temperature or the hormone and immune systems are regulated.
Cannabis is of outstanding importance in the neurological medical practice in Germany. Many diseases affecting the nervous system have successfully been treated with cannabinoids for several years. This includes in particular multiple sclerosis (MS). This is an inflammatory disease of the myelin sheaths, a part of the nerve cell processes. MS is one of the few diseases for which there is an indication for cannabis.
Since physical pain is also transmitted to the brain via the nervous system, cannabis is an important drug also in pain medicine. According to the Federal Institute for Drugs and Medical Devices (BfArM), pain was the most common diagnosis for which cannabis was prescribed between March 2017 and March 2019.
[Moerfelden-Walldorf, 20. Nov 2019]
CANNABIS - ABC - O as Office of Medical Cannabis (OMC)
The OMC - Office of Medical Cannabis is the competent authority for the regulation of cannabis production and distribution in the Netherlands. According to the Single Convention on Narcotic Drugs of 1961, of the United Nations, each member country must establish a regulatory body to supervise narcotic drugs. For example, New Zealand is currently setting up a Medical Cannabis Agency in line with the implementation of its medical cannabis programme. In Germany, the “Cannabisagentur” was established with the amendment of the law in 2017. These government agencies award contracts for national cultivation, mostly through a tendering procedure. They are responsible for the further processing of cannabis, the monitoring of approvals and the pharmaceutical quality of the products as well as the distribution. The OMC is the point of contact for German wholesalers when purchasing Dutch cannabis products. There are clearly defined annual quantities for the production, as well as for the export to each country. The exported amount is distributed among pharmaceutical wholesalers through a clearly defined supply scheme.
[Moerfelden-Walldorf, 27. Nov 2019]
CANNABIS - ABC - P as of Patient
The patient is at the centre of legislation, quality control, research and distribution. For many patients, the use of cannabis to treat their diseases has become an integral part of everyday life. Over the past 21 years, the level of care in germany provided to promote patients' health has risen steadily.
Medical use has been possible in Germany since 1998. Since then dronabinol-containing medicine could be prescribed. By 2017, access had expanded so that today many patients can benefit from the possibility of prescribing cannabis flowers and standardised extracts. To ensure access and a high level of quality, manufacturers and distributors in particular are committed to a secure and smooth supply chain.
Before cannabis is delivered to the patient in a pharmacy, it is at least checked for identity and in certain cases also for quality. In addition, modern aids such as vaporisers are available to the patient for taking cannabis. Medical care also ensures that the medication always meets the needs of the individual and can also be changed between preparations. With the amendment to the law in March 2017, the legislator also wanted to secure access financially. Research also aims to gain new insights for the benefit of patients. To this end, the Federal Institute for Drugs and Medical Devices (BfArM) is currently commissioned to conduct a non-interventional survey on the use of cannabis drugs.
Other countries are also working to help patients gain access to medicinal cannabis. In the UK, the first patient registry for medical cannabis in Europe has now been launched. The aim is to collect sufficient information on seven different areas of application so that in future the costs of therapy may possibly also be borne by the National Health System in Great Britain.
[Moerfelden-Walldorf, 05. Dec 2019]
CANNABIS - ABC - Q as of "Qualitätsmanagementsystem" (Pharmaceutical Quality System)
The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by its distributors. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Pharmaceutical Quality System should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s).
Source: EU Guidelines for Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use, Part I, Chapter 1 (Pharmaceutical Quality System)
[Moerfelden-Walldorf, 10. Dec 2019]