Cenedella.de

Philman's Pharm: "German Quality, California Ingenuity." Est. 1977


German cannabis lawyer KFN+ with good update on the German Cannabis As Medicine Cultivation, revised bid.

After the first award procedure for the cultivation of medical cannabis in Germany had been banned by the Higher Regional Court of Düsseldorf now the time has finally come and the Cannabis Agency has published the details of the new award procedure.

The Federal Republic of Germany, represented by the Federal Institute for Drugs and Medical Devices (BfArM) and the Cannabis Agency, continues to be the contracting authority for the award procedure for the cultivation, further processing, storage, packaging and supply of cannabis for medical purposes. This concerns the award of a public contract by way of an open procedure in accordance with §§ 97 et seqq. GWB (German Act against Restraint of Competition) and § 15 VgV (Regulations on the Award of Public Contracts and Procedures).

Prospective parties must prove their economic and financial capacity of the last 3 years when filing an application. Information must also be provided on sales in the cultivation, processing and supply of cannabis for medical purposes (THC content ≥ 1%) for the last 3 financial years, if available. Turnover in the cultivation, supply and processing of medicinal plants which have been placed on the market as medicinal products or active agents in a medicinal product after processing may also be considered as commendation now. The minimum condition for affirming suitability is then at least one cannabis reference for the cultivation of medical cannabis or one cultivation and processing reference for medicinal plants. The services provided must have been performed in accordance with both the GACP standard (Good Agricultural and Collection Practice) and the GMP standard (Good Manufacturing Standards), i.e. in accordance with the „Eudralex: Volume 4 Medicinal Products for Human and Veterany Use and Annex 7: Manufacture of Herbal Medicinal Products“, whereby approval for the manufacture of medicinal products must have been obtained from the competent authority ex ante.

If the contract is awarded Information must also be provided on how the financing of the contract is secured, and that the named land plot is available for the production site.

With regard to economic, financial, technical and professional capacity, a bidder may make use of the capacities of other companies within the framework of the so-called qualification hire. Thus, bidding consortia are also permitted, where the minimum conditions set must be fulfilled by at least one member of the bidding consortia.

The services are awarded by lot. The delivery quantity per batch is 200 kg per year. The following lots are set up:

Lot 1 to lot 8: cannabis flowers type 1

Lot 9 to lot 11: cannabis flowers type 2

Lot 12 and lot 13: cannabis flowers type 3

The cannabis flowers to be delivered must – depending on type respectively lot – contain the following concentration of tetrahydrocannabinol (THC) and cannabidiol (CBD):

type 1 with definition: THC between 18 and 22%, CBD < 1%

type 2 with definition: THC between 12 and 16%, CBD < 1%

type 3 with definition: THC between 5 and 9%, CBD between 5 and 9%.

Bidders may submit tenders for all lots, whereby one bidder may receive a maximum of 5 lots.

The delivery shall cover the following periods and quantities in total:

Delivery schedule of total quantity for the defined types

  1. Delivery year 2600 kg (type 1 1600 kg, type 2 600 kg, type 3  400 kg)
  2. Delivery year 2600 kg (type 1 1600 kg, type 2 600 kg, type 3  400 kg)
  3. Delivery year 2600 kg (type 1 1600 kg, type 2 600 kg, type 3  400 kg)
  4. Delivery year 2600 kg (type 1 1600 kg, type 2 600 kg, type 3  400 kg)

The award criteria are determined by a scoring system. The bidder with the lowest price offer for medical cannabis in the specified quality (detailed in euros per gram) receives 40 points. Another maximum of 5 points can be achieved by the quality of:

– the concept of technical facilities of the plant,

– the structural standards,

– the concept for GACP and GMP- standard,

– the concepts for cultivation, processing and delivery (e.g. with regard to prevention of failed harvests),

– the concept for production cycles,

– the concept for selection and training of personnel,

– safety and security concept.

When bidding, a concept for scheduling in the starting phase up to the first harvest with the respective intermediate steps must be submitted. The concept of the site and production must be described in detail for all stages to enable the cannabis agency to evaluate the award criteria. The origin and characteristics of the seed or plant material used must also be described in detail. The crucial technical facilities must also be particularised in concrete terms.

At the time of purchase capacity, the cannabis flowers must be appropriate for medical use. They must comply with the legal requirements of the current monography for cannabis flowers of the German Pharmacopoeia and the European Pharmacopoeia. With regard to heavy metal contamination certain limit values must be satisfied. The cultivation must also have been carried out according to the currently valid European GACP and GMP standards (see above) of course.

Conclusion: the new tender procedure slightly increases the quantities to be produced, which of course constitutes improvement. A cultivation and processing reference for medicinal plants is also sufficient to meet the minimum requirements. The quantities put out to tender however are still so meagre that it remains in doubt whether or not the production of medical cannabis in Germany can actually be of economic interest to interested companies. In view of the already approved import quantities of 21 tonnes in 2018 and a further increase in demand it remains cloudy why the German Federal Government is blocking the production of medical cannabis in their own country by tendering out such small quantities rather than giving a new and emerging industry in the country a chance.


German cultivation tender for medical marijuana stopped in its tracks…..and information on the GERMAN PATIENT ROUNDTABLE www.germanpatientroundtable.de

https://www.cannabisindustryjournal.com/news_article/german-court-stops-pending-cannabis-cultivation-bid-on-technical-fault/

German Patients are Going to be on the Front Lines of This Discussion

The difficulties that German patients have already faced in obtaining a drug that is now legal in their own country for medical use (and even for recreational purposes across an open border in Holland) are legion. While to a certain extent, German patients are in the same boat as patients elsewhere and their problems, in fact, there are still huge access issues that remain. For starters, the drug is much more expensive here, so those without health insurance approval face bills of about $3,000 per month. Why the eye-watering price? All medical grade cannabis is still imported, although increasingly this is now just via other EU countries, not just from Canada.

“One of the reasons we organized the national German Patient Roundtable is to give patients a voice in all of this supply and demand discussion and to help BfArM and others formulate workable solutions for all,” responded Philip Cenedella IV when reached for a response by CIJ. Cenedella, an American expat and the organizer of the Roundtable, a nationally focussed, umbrella group that is kicking off its campaign this year, spoke for many who are far from court and boardrooms where the decisions are being made.

Philip Cenedella
Philip Cenedella, pictured left, at the Deutsche Hanfverband (DHV) conference in Berlin last November.
Photo: @MedPayRx, Instagram

“While there are very talented firms who will now take up this discussion with the government and reissue a response for the tender, what we continue to see on the ground is that patients simply do not have the access granted them in the law which was passed over a year ago,” Cenedella says, with more than a note of frustration. “We again are calling on all government officials, industry executives and patient advocates to band together to immediately establish workable protocols that directly help the patients.”

Indeed, despite the frustration and delay, if not new costs and opportunities that this decision creates, one thing is very clear on the ground here. The current status quo is unacceptable. That alone should also put pressure on the powers that be to remedy the situation as quickly as possible. And via several routes, including widening import quotas or even issuing new licenses as a new solution to domestic cultivation is implemented.

“Patients are not being served and do not have access to a medicine that has been proven to improve lives,” says Cenedella. “Our simple request is for BfArM to finally invite patients into their discussions, to work with patients to formulate workable cultivation and distribution solutions, and we humbly request that this happen now before they go down another dead-end road, ending in another court defeat, and resulting in even more delays to the patients that are still lacking the care afforded them by the German Federal Court’s decision of 2017.”

 

For more info:

http://www.germanpatientroundtable.de

 


The State of Cannabusiness in Germany

The State of Cannabusiness in Germany

As a cannabis business executive, you undoubtedly have been following some of the significant events happening in Europe and you have asked yourself: “How does this affect my plans?”

It may be the German government establishing a nationwide medical marijuana program, or news about the Canadian companies buying or merging with their European counterparts that has your attention. But you know the times are a changin’ and you might want to benefit from this historic moment in our Industry.

For those companies that already have a strategic international plan in place, the opportunities are boundless.  Germany, a nation with 2.5 times the population of California, is leading the way with the a national, Federal-government approved, medical marijuana law already in place, and numerous regional efforts to establish recreational use are getting off the ground as I write this column.

Having been an advocate in California during the medical marijuana legalization push of 1990s, and now living here in Germany as they build their own regulated marketplace, it has been fun to be involved. I’d now like to share some of the organizations that may be able to help you and your company, if Europe is indeed on your radar.

Das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) is the German federal government’s  Institute for Drugs and Medical Devices and is lead by Professor Dr. Karl Broich. Their website is www.bfarm.de and they are basically the cannabis bureau of Germany, charged with implementing the medical marijuana law.  Interestingly, they will also be the sole purchaser of foreign-produced medical marijuana products, and then oversee the distribution exclusively though licensed pharmacies.

So Germans will be going to their local pharmacy to obtain their medicine, which officially should be paid by their insurance company.  Of course, the details are still being worked out, and I know of at least two lawsuits against insurance companies not paying for their clients medicine.

Last month, the BfArM put out a call for bids for the first ten authorized grow licenses in the history of Germany.  Negotiations are underway and the winning bidders should be announced shortly.  We will keep you updated on this, and all important details emanating from Europe, in future columns.

The Deutscher Hanfverband (DHV) is the German Hemp Association in Berlin and a fantastic resource and advocacy organization. They have been instrumental in getting the country to this point and their website is https://hanfverband.de I highly recommend signing up for their newsletter (which can easily be translated.)  Their next big event is the Hanf Parade in Berlin in August which will bring together over 10,000 advocates calling for open access.

For companies that want to get serious about being in Europe, the best organization I know of is the German Trade and Investment office located in Berlin which is part of the German Federal Ministry of Economic Affairs. Their website is www.gtai.de.

Their knowledge is vast, their connections incredible, and there is no charge for their services. They want to make it easy for international companies in our space to help Germany build their regulated marketplace. They provide advanced research, site-selection, tax information. And.. they are just an email or phone call away.

Of course, there are a total of 51 independent states that make up Europe and 28 of those make up the European Union.  To some degree all of these countries are changing the way they treat medical marijuana and CBD products.

If you are looking for some opportunities in this region, I would suggest looking not only at Germany, but also The Netherlands, Spain, United Kingdom, Switzerland, and the Czech Republic. Although Israel is not in the EU region, their expertise, leading edge research, products and capabilities are to be noted.

Before concluding, I need to give a shout out to Mr. Alex Rogers and his team at ICBC Berlin who put together one of the best industry events I have ever attended.  Back in April, in Berlin, almost 1000 attendees and exhibitors from throughout the world gathered to share information, make connections and close business deals.

Congressman Dana Rohrabacher, chairman of the Cannabis Caucus in the U.S. House of Representatives, was the keynote speaker and shared stories on his German ancestry, his first meeting with Ronald Reagan, and why legalizing our plant makes sense in so many ways.

Tommy Chong was also in attendance, was way coherent, and meeting him was definitely one of my personal highlights.  Yes, I admit it, I listened to his albums way back in 1971.

So I wish you a productive, successful and fun month ahead as we collectively take the next steps to “Make Cannabis Great Again” here in Europe, and wherever you are reading this in the world.

About The Author:


German researchers seek 25,000 marijuana users for study

http://www.ibtimes.co.uk/pot-smokers-wanted-german-researchers-seek-25000-marijuana-users-study-1618629

German researchers are hoping to get government backing for a new study that would see the recruitment of 25,000 recreational marijuana smokers.

The Research Initiative on Cannabis Consumption are seeking government approval to analyse the cannabis users in order to understand the effects of the drug after several years of use.

Their application is aimed at conducting a “Scientific Study on Cannabis Sequences for Mentally Healthy Adult Consumers” they say.

Germany legalised marijuana for medicinal purposes earlier in 2017 with new powers given to doctors to prescribe the drug to seriously ill patients at their discretion.

This, researchers say, paves the way for a new study analysing the longer-term effects of the drug.

Cannabis for recreational use is still illegal, but that hasn’t stopped 2,000 people already signing up for the study, say the researchers.

The group announced plans to begin the study in November 2016 saying it wanted to analyse the mental effects on those addicted to the drug.

“In Germany several million people regularly get high on cannabis,” wrote lawyer and chief executive of the project Marko Dörre in a statement released after the plans were submitted.

“It is time that science becomes more engaged with recreational use.”

Marijuana
German researchers are hunting for 25,000 cannabis smokers for a new study.Reuters/John Vizcaino

As part of the study, those selected would be permitted to pick up 30 grams of pharmaceutical cannabis, usually reserved for medical patients, on a monthly basis.

Researchers are prohibiting anyone under 18, first-time marijuana smokers, as well as candidates with high-risk of addiction or psychiatric problems, from taking part in the study.

Before the new act on the Amendment of Narcotics Regulations passed earlier this year, only around 1,000 people with serious medical conditions were permitted to use cannabis.

“With the law implemented in March changing controlled substance regulations, the German parliament took on a new risk assessment of cannabis,” said Dörre.

“The new assessment will also benefit science.”

The BfArM declined to comment to Tagesspiegel as to whether it had in fact received the application or the chances of it being approved.


The German government finally passed its legalization framework for medical cannabis consumption in March 2017. The country’s market is expected to record modest growth with its high 82 million population and a policy that allows prescriptions to be paid through health insurance plans, …MOTLEY FOOL article

Which Top Marijuana Company Will Capture Germany?

The German government finally passed its legalization framework for medical cannabis consumption in March 2017. The country’s market is expected to record modest growth with its high 82 million population and a policy that allows prescriptions to be paid through health insurance plans, thus potentially encouraging patients to explore medical cannabis health benefits.

Local marijuana producers with vast experience in mass growing of high quality product and hungry to capture the lucrative €12 – €15 a gram (roughly C$17 – C$21.75 per gram) German medical cannabis market, have been taking positions in growing their international business portfolios.

Some of the top local growers have already established footprints in Germany, but which among the local players is likely to gain significant traction in the new market?

Canopy Growth Corp

The local market leader, Canopy Growth Corp. (TSX:WEED) has already made a significant investment in Germany. The company acquired MedCann GmbH Pharma & Nutraceuticals (MedCann) back in November 2016. MedCann, a distributor, has successfully placed Canopy’s Tweed branded cannabis strains into German pharmacies.

The German distribution model strictly  confines cannabis sales to the pharmacy distribution model and no direct sales shall be allowed. Since all sales shall take the wholesale distribution channel, Canopy is already at a first mover advantage in this market.

Canopy has indicated that it is interested in producing cannabis locally in Germany with the expansion of the local program. With Germany expecting to launch a domestic cannabis cultivation initiative by 2019, Canopy is likely to try broadening its expansion program in the country.

Aphria Inc.

Aphria Inc. (TSX:APH) has recently announced an international expansion program that is currently focused on the United States market, and has committed $25 million to an investment in Florida. Its not yet clear whether it intends to make serious investments in the new German market, but it has been eyeing this market for some time.

Although it had not yet made any formal engagements in Germany by January 2017, the CEO Vic Neufeld, in an interview with the Midas Letter openly stated that Germany has been very much on Aphria’s radar, and the company once engaged in dialogue with two different organisations pertaining the German market.

However, Aphria has been very cautious in their Canada and U.S. expansion programs so far. It seems the company has a slow-but-sure approach to doing business as its Canadian operations have shown, so I do not expect an overly vigorous and aggressive German expansion program from them.

Aurora Cannabis Inc.

One of the fastest growing and most aggressive marijuana producers, Aurora Cannabis Inc.(TSXV:ACB), has recently announced a $75 million convertible debenture offering which is likely to close on April 26, 2017, with a clear intent of using the funds to “aggressively pursue international expansion opportunities,” says CEO Terry Booth.

The company believes the $185 million cash position gives them the strongest cash balance “in the global cannabis sector,” and Aurora wants to play a leading role “in multiple emerging global cannabis markets.” 

Its most likely Aurora may attempt a German expansion route. Given the company’s growth style, it goes big on ventures and seeks aggressive expansion. These traits have seen it emerging to become a serious top contender in the Canadian marijuana space in a very short time.

Most noteworthy, Aurora is already listed on the Frankfurt Stock Exchange in Germany and raising expansion funds locally may be relatively easier.

Investor takeaway.

Its not yet clear who among these top marijuana companies may become a serious investor in Germany, but Canopy already commands a serious lead.

There are other serious Canadian contenders to the German market, like the soon-to-be-listed Maricann Group Inc, which is already trying to acquire an 800,000 square foot facility and likely seeking a cultivation license in Germany, and  CanniMed Therapeutics and the Cronos Group who already have distribution relationships in the European country.

However, there will be competition from Netherlands entities too, but the market may not be that big enough to support massive investment as yet. Canadian growers who manage to capture the infant German market may be rewarded though, as they will gain first mover advantages into the opening European market.

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https://cenedella.de/ * Philip J. Cenedella IV * International Cannabis Consultant * Germany, Europe, USA and Canada markets * Medical Marijuana Patient Advocate since 1977 * Assist with Business Development, Licensing, Partnerships, and Strategic Direction.

Philip J. Cenedella IV

Bio

https://cenedella.de/
Philip J. Cenedella IV
International Cannabis Consultant
Medical Marijuana Patient Advocate since 1977.

First and foremost, Phil is a patient advocate for 4 decades having grown up in New York during the Rockefeller Drug Law years, then establishing himself in San Diego during the push for legalization there in the’ 90s.  Now he is situated in Germany during its historic transition into the leadership role of the European Cannabis industry.

Phil is uniquely qualified to help you establish your international business strategy having served as a Founding Board Member of the World Trade Center San Diego, a Lead Consultant for Deutsche Telekom, The California Trade and Investment Office, Deutsche Bank, IBM, San Diego Economic Development Board and many other entities.  He puts his years of business development, sales and distribution expertise to work for you in a highly professional, ethical and effective manner.

40 Years Experience:
Phil was born in Buffalo on the shores of the US/Canadian border, spent most of his life in San Diego overlooking the US/Mexico border, and now is living in Europe with its open borders and the opening of its legal Cannabis industry.

As a C-level business development executive in the technology and construction sectors, and a Founding Board of Director for the World Trade Center San Diego and San Diego Software Council, Phil has facilitated and closed sales and strategic partnerships worldwide.

Phil has also been Lead Consultant for the California Trade and Investment Office in Germany and catalyst for the CAL-IT Investment Forum in London.

He has served as a consultant for IBM, George Clinton, Deutsche Telekom, iSeeTV,  San Diego Convention Center, FINDLAW, Chaparral Computers and Networks, San Diego Economic Development Corporation, Deutsche Bank and many others in the Cannabis space (to remain confidential).

Phil is a USA citizen with an EU Work/Residence Permit.  He has exactly 40 years of firsthand knowledge of all aspects of our Industry and is a C-level International business development specialist who is highly professional yet very easy to work with.  He provides your firm with Strategic guidance and the ability to help you to increase your sales channels, distribution networks, and strategic partnerships.

Education:
1984, University of Dayton B.A. Psychology, Music minor-emphasis

Skill Level:
Sales 98%
Business Development 98%
International  trade 98%
Cannabis Industry 420%

Testimonials

 Who is Phil:
“Phil is an absolute professional. Flexible, hardworking and driven. His results were great and we highly recommend his services.” – BLF, NYC

“Phil has boundless enthusiasm and always applies 100% effort to all he does. Phil researched the US market for…. The USA became our best market by far, and I know that we would never have broken into that extremely tough market without Phil. His combination of broad based business knowledge, willingness to learn, team spirit and superb networking skills is very rare and extremely valuable. Always positive, he was a joy to work with. I thoroughly recommend him.” – GRB, UK

“Phil Cenedella has been my contact for several years and I have found him to be the consummate professional. He will always promptly return a call or provide me an answer to an inquiry. He is always “on-it” and truly treats a client as if they were part of his extended family. It’s very rare these days to find someone as dedicated to his business and his clients as Phil. Phil has all the characteristics of what I look for when I have occasion to be expanding my staff. He is honest to a fault, dedicated, sincere and is the paramount reason for my firm’s continuing…….” – DF ,USA

“Phil is the most personable, genuine, charismatic and effective business development manager I have had the pleasure to work with. He instills trust and confidence!”- JFL, EU

“Phil is family.” – George Clinton
Volunteer Positions:    Founder, Dayton and La Jolla Human Trafficking Accords, Founder, St. Vincent de Paul Christmas Caroling and Limo Party, Volunteer, Americans for Safe Access, Advisor, City of Hope – Dubai  Key accomplishments:  Assisted with the freeing from prison a child victim of human trafficking serving life without parole, initiated Goldman Sachs’ divestment of a human-trafficking related publication, assisted advocates on the frontlines in Dubai, Ohio, California and elsewhere.