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, August 19th, 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, July 15th, 2019]
CANNABIS - ABC - A like 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, August 5th, 2019]
CANNABIS - ABC - B like 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, August 14th, 2019]
CANNABIS - ABC - C like 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, August 21st, 2019]
CANNABIS - ABC - D like 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.
[August 27th, 2019]
CANNABIS - ABC - E like 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, September 3rd, 2019]
CANNABIS - ABC - F like 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, September 13th, 2019]
CANNABIS - ABC - G like Golden Rules
[Frankfurt, September 19th, 2019]
CANNABIS - ABC - H like 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, October 2nd, 2019]
CANNABIS - ABC - I like 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, October 10th, 2019]
CANNABIS - ABC - J like 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, October 21, 2019]