Tag Archives: cultivation

April 5, 2019

German Cultivation Bid Appears To Have Three Finalists

By Marguerite Arnold

The Frankfurt-based newspaper Handelsblatt Zeitung is reporting that three Canadian firms (actually two Canadians and a German start-up cofounded by another Canadian company) have now been selected as the first cannabis cultivation bid finalists, however insiders on the ground say that this is not necessarily a final decision.

A Berlin-based subsidiary of Wayland in Germany called Demecan, along with Aphria and Aurora have all been named as bid finalists pending a normal review period.

However, there are other complications still looming. This is far from over.

The first issuance of the bid in 2017 went down in court over a technical fault on the part of the issuing agency. The current iteration was posted last summer and saw its application moved several times because of further legal challenges.

As Peter Homburg, partner and head of the European Cannabis Group at Dentons said when contacted by Cannabis Industry Journal, “This is of course not an official announcement. I have a tendency to believe that others involved in the tender process historically may well challenge this decision.”

BfArM, the federal German agency in charge of the cannabis cultivation tender process, did not respond to a request for a comment as of press time.

The Decision Is Far From Over

Here are the basic challenges still ahead:

There is a lawsuit pending against the bid itself from applicants that has yet to be decided. The Klage (formal hearing in court) is due next week. If that does not derail the process, here are the next considerations.

While all three firms named in the bid have international reputations, there are some pending questions.

Wayland is far ahead of the other two firms in terms of production capability in the country. Their facility in eastern Germany has just been certified GMP standard – which means they are qualified to produce the quality of flower required for medical consumption. This news is also far from a surprise.

As Ben Ward, CEO of Wayland Group, commented when contacted by CIJ for a response via email: “At Wayland, we believe in meaningful partnerships, investing in Germany from day one, demonstrating a long-term commitment to the market,” says Ward. “Wayland GmbH is a German company, operated by Germans, existing in Dresden and Munich and is committed to this market. The companies awarded lots received the allocation based on a rigorous application process, not media sensation.”

Of all the Canadian firms, in fact, despite its lack of high-flying stock price, Wayland has made the most concerted effort to show its commitment to producing in Germany by a large investment of capital and expertise. Further, the firm has shown itself to be the most culturally sensitive to German culture, including hiring a female member to the board (a hot topic far from the cannabis industry). However, there are other issues looming. On the same day that Wayland issued a press release announcing its position in the bid, it also issued one announcing the merger talks with ICC had failed.

The second is that Aphria’s main cultivation center in Canada is not EU-GMP certified although they have applied for the same and now also own one of Germany’s largest distributors (with approximately a 6% market share).

Other firms not only kicked off the entire cannabis discussion in Germany, but have established GMP-compliant facilities both in Canada and across Europe, namely Canopy Growth, which was widely believed to have also applied to the second tender. However prevailing rumours about a Canadian “crop failure” in British Columbia (described by the company as a deliberate destruction of plants created by delays in the licensing process) last fall may have also played a role in the German decision.

Aurora is also in interesting waters. Having distinguished itself as Canopy’s closest rival across Europe, winning significant kudos in Denmark, Italy, Poland and Luxembourg last year, the company is also clearly not “just” a medical cannabis company and apparently was refused an opportunity to go public on the Deutsche Börse last fall. The selection of the firm by BfArm for the bid in a situation where the company is on a watch list created by the stock market regulatory agency in Frankfurt is also an intriguing one. Especially given the company’s announcement of its Polish success on the same day as the decision to import was announced, and the fact that so far it is the only Canadian cannabis company to successfully import to Luxembourg.

And The Import Game Is Just Getting Hot…

The unsurprising news that the bid appears to be moving forward is actually not the hottest news in Europe right now. The reality on the ground is already shifting. Several weeks ago, a Frankfurt-based distribution start-up announced that they had successfully imported cannabis into the country from Macedonian-based Nysk Holdings via Poland.

At the International Cannabis Business Conference (ICBC) in Berlin last weekend, Australian producers (for one) were also reporting a German demand for their product that was greater than they could fill. And there were many Israelis present for what is expected to be an official opening of their import ability by the third quarter of this year.

Price Wars Are Looming

The bid itself is going to have a powerful impact on pricing in both the German and European market beyond that. It represents the first time in any country that a government has attempted to pre-negotiate prices for the drug as a narcotic beyond Israel and in this case, it will have at least regional implications.

At the same time, it is also clear that producers like Nysk and beyond them, Israeli and Australian firms (in particular) are actively finding ways to have their product enter the country- and further at prices that are catching the Canadians on the hop. Indeed Aurora is reporting that it actually lowered its “usual” prices to win European contracts which have been reported as being 3.2 euros a gram in Italy and 2.5 euros a gram in Luxembourg.

To put this in perspective, this is a range of about CA$3-5 a gram of flower which is also well below what Canopy (for one) has reported selling its product even to recreational users in Canada and significantly below medical export prices as reported by recent company corporate reports.

Wayland in contrast, is reporting that its production price in Germany will be at least a euro-per-gram cheaper than this. Or in other words, more in line with prices expected to be generated from both the bid itself and the cannabis now entering the country from other sources.

And of course, this is only the first of what is expected to be a series of new tenders. The original amount, itself increased in the two years the issue has been pending, is clearly not enough to even begin to meet demand as proved by the levels of competitively priced imports now entering the country.

Beyond questions about whether this time the tender will actually stand, are those now pending about new ones potentially in the offing – and not just in Germany but across Europe as cannabis continues to see a very green spring.

April 1, 2019

Soapbox

Third-Party Cannabis Safety Audits & How to Prepare in 7 Steps

By Tyler Williams

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Unlike the food industry, the cannabis industry is still in its infancy. Which means there is not a push from retailers demanding cannabis farmers, extractors or manufacturers to get third-party audits. In fact, most grow operations supply into their own dispensaries. So why should a cannabis farmer, extractor or manufacturer get a third-party audit? Third-party audits are crucial to maintaining product safety and quality by providing a third set of eyes to verify what is working and what is not. Besides regulatory requirements and customers requiring your facility to get a third-party audit, there are numerous other benefits to receiving an audit. Some of these benefits include:

Improvement to product safety
Improvement to product quality and consistency
Meeting regulatory compliance
Eliminating potential risks and possible recalls
Marketing advantages over competitors who are not audited by a third-party
Improvement to consumer confidence and an increase to brand loyalty

How to Prepare for a Third-Party Audit

Working for a certification body, I am in the unique position to see numerous sites go through the certification process. In this position I have seen both extremes: Sites that spend 6-8 months and a lot of resources preparing for an audit, as well as sites that wait until the day before to even look at the audit standard. Unfortunately, the latter is almost always going to fail the audit. Here are seven steps for preparing for your next third-party audit.“By failing to prepare, you are preparing to fail.”– Benjamin Franklin

Start Preparing Early

Think of your third-party audit as a college exam one month away. You could start studying for the exam now and get a real understanding of the material or you could wait until the day before to start your no-sleep, energy drink-fueled, 24-hour cram session. We all know which preparation method will get a better score on the exam. Now let’s apply that same strategy to your third-party audit. Once you have decided what audit is best for your site and have those specific standards in your hand, the clock starts ticking and you should already be preparing for the audit, whether it is one month or six months away.

Get Management Commitment

It is essential to the entire cannabis safety and quality system to have commitment from top down. Without this, the site will not get the resources (people, equipment, money, time, etc.) they need to pass a third-party audit. Management commitment is so important that it is often seen as its own section in most modern audit standards. It is very easy for third-party auditors to identify when there is a lack of management commitment in a site. Therefore, if you don’t get management commitment, then you are already starting off the audit on a bad note.

Create a To-Do-List

Think of the entire audit checklist or standard as your long to-do list. Some things, like attaining a certificate of analysis (COA) from a supplier, may only need to be done annually. While other things, such as ensuring employees are following Good Manufacturing Practices (GMPs), will need to be done continuously throughout day to day operations. Go through the audit checklist and separate what needs to be done annually, semiannually, quarterly, monthly and continuously throughout day to day operations. This will give you a list with all of the frequencies of each different requirement.

Teamwork“Teamwork makes the dream work, but a vision becomes a nightmare when the leader has a big dream and a bad team.” – John C. Maxwell

The preparation of an audit should never rest on the shoulders of one person. Yet this is something I tend to see too often in both food and cannabis facilities alike. Your site should establish a cannabis safety and quality team of multidiscipline personnel that have an impact on product safety and quality. Once the team is established, various tasks from the to-do-list can be disbursed among all the members of the team. Collaboration is key to successfully preparing for a third-party audit, especially when the timelines are very stringent.

Training

Training is essential to preparing for your third-party audit. This is what closes the gaps between what the safety and quality department have developed and what your front-line employees are applying. All employees should know what part of the audit standard applies to them. Additionally, employees should be trained on interview questions that the auditor might ask them during the audit. Helping them prepare for these types of questions will help ease their nerves and allow them to answer the questions with self-assurance when it comes time to the actual audit.

Conduct Internal Audits

Conducting internal audits is not only a great way to prepare for your third-party audit, it’s a requirement. You should always use the audit checklist to observe your documents and facility to see where there are gaps. If possible, the person or team conducting the internal audit should never review their own work. Additionally, all issues or non-conformances should be noted, evaluated, corrected and closed out.

Third-Party Pre-Assessment or Mock Audit (Optional)

A third-party pre-assessment or mock audit is the closest thing you can get to an actual audit. This is where a company would come in and evaluate your site to the specific standards and give a formal report over any deficiencies found during the assessment and how to fix them. This is a great way to test your preparedness before the actual audit.

March 28, 2019

Farmako Inks Deal To Import 50 Tonnes of Polish Cannabis Into Germany

By Marguerite Arnold

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The ex-im cannabis map of Europe has been promising to get interesting for some time. And in March, it’s long promised potential just bloomed a little more as Frankfurt-based Farmako announced a first-of-its kind import deal of 50 tonnes of medical cannabis (and from Poland no less) over the next four years.

Farmako was just founded in September 2018. They began distribution to German pharmacies this month. They also have an office in London and cross-European aspirations.

While Farmako is the first to announce such a unique cross-border production and distribution agreement, however, they are far from the only ones planning the same. In fact at least Tilray is expected to announce that their newly-minted Portuguese crop is being processed into oil bound for German pharmacies any day now. It is also not unrealistic to expect that (at least) Canopy Growth, of the big Canadian producers at least, will soon announce the same situation for their crops in countries across the continent, starting with Spain.

Outside Germany of course, this kind of entrepreneurial endeavour is already underway. In the UK, a new import group just announced the first bulk shipment of Dutch medical cannabis into the country, distributed directly to over 1,000 pharmacies nationwide.

There still are a couple of jaw-dropping things to consider about this new German development. Namely, that the amount of just this deal over the next four years between two (relatively new, non-Canadian) companies is approximately five times the amount currently called for in the still pending domestic cultivation bid in Germany.

The second, of course, is that the Polish company on the other side of the border and this ex-im deal, PharmaCann Polska, is a uniquely positioned conglomeration of individuals with apparently Canadian and Israeli market experience. This means that they are already positioned to access the biggest two production markets in the world and are certain to be looking to exploit other Eastern European connections (at minimum). If not ones further afield than that.

One thing is absolutely certain far beyond the particulars of this one deal. The current import limitations from Canada and the Netherlands into the German market appear to be a thing of the past. And the cross-border trade for medical cannabis is now clearly entering a new phase.

Implications

Farmako clearly intends to go after the existing Canadians in the market on price, which means both Canopy Growth and Tilray. But it also means Wayland, at this point is the largest domestic certified producer (albeit with Canadian roots and partners) and an entire licensed facility in eastern Germany ready to go. That is not an insignificant threat and sets up another looming question: Which will actually be cheaper in the long run? Domestically grown German cannabis, or that imported from adjacent countries with lower paying labor markets?

This announcement also means that the “cannabis shortage” in the country is officially over as of this spring. And that won’t just come from Farmako but others already in the market and those angling now to get in via other creative means.

Regardless, what that will do to overall sales, patient numbers and overall speed is another matter.

British Barristers Take On Cannabis “Novel Food” Regulation In Brussels

By Marguerite Arnold

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The first thing to understand about the significance of the British barristers now challenging the EU’s classification of hemp extracts as a novel food is that this is like jumping into the middle of an action adventure by coming in at the second act. In other words, you miss the introduction and the first couple of car chases.

That said, this action movie also features a cannabis-flavored plot. Those used to the maddening hair splitting now going on just about everywhere as the industry gains legitimacy, in other words, are familiar with the larger story line.

Here are the “CBD Cliff’s Notes.”

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

It is highly significant that a major British cannabis trade organization, the Cannabis Trades Association, hired a leading law firm in London to go sue the EU over its recent decision to lump all CBD extracts into the same “novel” distinction. Up until now, only CBD sourced from cannabis had fallen prey to this strange regulation. Thus, the lawsuit. No Brexit themes involved. Yet. Although that too will play a role in all of this.

What Is This Really About?

If those in the CBD business are honest with themselves, the real reason for this segmented part of the cannabis industry to even exist in the first place is the race, desire and need to actually be allowed to operate in relative regulatory peace. No matter what the battles are on the THC front. CBD has been seen as a result, pretty much since the beginning of the new age of legalization, as the “safer” political and market entry choice by those in regions such as U.S. southern states and the burgeoning, can’t-wait-to-be-off-to-the-races, market in Europe. See the new federal hemp legalization bill in the United States as Exhibit A.

However, in Europe this has run into more than a few problems since the Swiss put “low THC” or “Cannabis Lite” on the map more locally. Starting with the whole discussion about licensing in general. And then, even more confusingly, about what to actually classify the plant. Especially when it is used in food and cosmetics as opposed to “medicine.”

Specifically, where does the cannabis plant in general, let alone its individual components, really fall when it comes to regulated human consumption?

european union states — Member states of the European Union

For the time being- read last year when the industry in Spain was facing police busts over CBD cookies on the shelves at health stores- the conventional industry wisdom was that this whole furore was “just” over the use of concentrates, tinctures and other products made from cannabis-sourced CBD. However, given the noise that Austria managed to make over Christmas about the entire “licensing” issue (namely who has the right to produce, sell and package even CBD as a cannabinoid no matter where it is sourced), the EU also moved all CBD products and tinctures- even those made from good old hemp- into the novel food category.

This means in effect, that even CBD extracts produced from the hemp plant (which is actually the majority of such product in Europe) must now be regulated as a “novel food” too. Even though in poor old hemp’s case, it is certainly the case that health food nuts have been consuming the same in Europe long before (and certainly after) standing EU “novel food” regulations were put into place back in the late 90’s.

Thus, the lawsuit, launched from a country unsure of whether it will even be in the EU post-May (either the month or the current PM).

According to the EU at least for now, CBD itself is a “novel food” no matter from where it is sourced. And that, according to not only science but food history is an absolute fallacy.consumer safety, from factory to pharmacy or farm to table, is never far from the discussion

Likely Outcomes

Those who were hoping that CBD would remain unregulated in the EU should think again. It is highly likely that what will happen is that CBD production licensing is in the cards and just about everywhere. Think GMPs but with a consumer-food twist.

While indie producers might groan at the prospect of fees and licensing procedures, remember this is Europe. And consumer safety, from factory to pharmacy or farm to table, is never far from the discussion.

While this lawsuit, in other words, is likely to make the EU think more closely about regulating CBD in general, what is most likely to happen is that entire enchilada will be lumped under a regime to insure that high quality production, particularly of crops bound for consumption, is also extended to anything that ends up in either a food or cosmetic product.

CBD Producers Have To Keep Current On Regs

Given the current murkiness that exists, in other words at this point across Europe, in every country and for every CBD product, exports here from other places are still not a great idea.

There are labeling, licensing and of course, ultimately legislative issues that are all still in flux. And while the outcome of the lawsuit might eventually regulate and standardize things, the idea that a license-free CBD production industry is clearly now dead in the water.

March 26, 2019

Stratos: Quality, Expansion & Growth in Multiple Markets

By Aaron G. Biros

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Jason Neely founded Stratos in 2014, when he and a small group of people left the pharmaceutical industry in search of a new endeavor in the cannabis marketplace. The concept was straightforward: Apply pharmaceutical methodologyof production to cannabis products. Back then, Stratos offered a range of THC-infused tablets in the Colorado market.

Brenda Verghese, vice president of research & development, was one of five people on staff when Stratos launched. Now they have about 30 team members. Consumers were looking for a cannabis product that would be consistent and reliable every time, taking the guesswork out of infused products dosage. That’s where Brenda Verghese found her skillset useful.

Transitioning to the pharmaceutical industry right out of college, Verghese started her career as a chemist and worked her way up to the R&D business development sector. “I specializedin formulations and taking a product from concept to commercialization in the pharmaceutical space,” says Verghese. “Jason Neely approached me with the idea of a cannabis company and focusing on making products as effective and consistent as possible, so really bringing pharmaceutical science into the cannabis space. In the matter of 4 years we grew substantially, mainly focusing on the efficacy of products.”

Behind the scenes at packaging and labeling Image credit: Lucy Beaugard

Soon after the success of their THC products became apparent, Stratos launched a CBD line, quickly growing their portfolio to include things like tinctures and topicals as well. According to Verghese, they are hoping that what’s been established on the THC side of their business as far as reproducibility and consistency is something that consumers will also experience on the CBD side. “Quality and consistency have definitely driven our growth,” says Verghese. “That is what consumers appreciate most- the fact that every tablet, tincture or swipe of a topical product is going to be consistent and the same dose every time.” This is what speaks to their background in the pharmaceutical sciences, FDA regulation has taught the Stratos team to create really robust and consistent formulations.

Quality in manufacturing starts at the source for Stratos: their suppliers. They take a hard look at their supply of raw materials and active ingredients, making sure it meets their standards. “The supplier needs to allow us to do an initial audit and periodic audits,” says Verghese. “We require documentation to verify the purity and quality of oil. We also do internal testing upon receipt of the materials, verifying that the COAs [certificates of analysis] match their claims.”

Process validation in action at the Stratos facility
(image credit: Lucy Beaugard)

Verghese says maintaining that attention to detail as their company grows is crucial. They implement robust SOPs and in-process quality checks in addition to process testing. They test their products 5-6 times within one production batch. Much of that is thanks to Amy Davison, director of operations and compliance, and her 15 years of experience in quality and regulatory compliance in the pharmaceutical industry.

Back in August of 2018, Amy Davison wrote an article on safety and dosing accuracy for Cannabis Industry Journal. Take a look at this excerpt to get an idea of their quality controls:

Product testing alone cannot assess quality for an entire lot or batch of product; therefore, each step of the manufacturing process must be controlled through Good Manufacturing Practices (GMP). Process validation is an aspect of GMPs used by the pharmaceutical industry to create consistency in a product’s quality, safety and efficacy. There are three main stages to process validation: process design, process qualification and continued process verification. Implementing these stages ensures that quality, including dosing accuracy, is maintained for each manufactured batch of product.

Fast forward to today and Stratos is looking at expanding their CBD products line significantly. While their THC-infused products might have a stronger brand presence in Colorado, the CBD line offers substantial growth potential, given their ability to ship nationwide as well as online ordering. “We are always evaluating different markets and looking for what suits Stratos and our consumer base,”says Verghese.

March 25, 2019

How a Cloud QMS Can Get Cannabis Startups ISO 9001-Certified

By Mike Hansen

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When it comes to compliance for cannabis startups, the ISO 9000 family of standards reigns supreme. Providing the guidelines for the concepts that make up a quality management system (QMS), the ISO family is composed of five standards: ISO 9000, 9001, 9002, 9003 and 9004. Outside of ISO 9001, ISO 9000 is the most important because it creates the foundation that guides all of the other standards.

ISO 9000 is split into two sections: fundamentals and vocabulary. Fundamentals covers the basic principles of quality management and the vocabulary section is a dictionary of quality management terminology. ISO 9000 is crucial because it provides direction on proper QMS implementation that will lead to achieving an ISO 9001 certification.

While the entire ISO 9000 family is focused on quality management systems that aim to help organizations “ensure that their products and services consistently meet customer’s requirements and that quality is consistently improved,” ISO 9001 is the only standard that lists actual requirements and requires certification.Cloud-based quality management software provides the flexibility and scalability, that cannabis startups need to comply with ISO 9001

Quality Management Systems (QMS)

When conceptualizing “quality management,” it is best to think of it as an organization’s definition of how it will meet the quality requirements of customers and other stakeholders who are affected by its work. Implementing this requires an extensive alignment of company processes and procedural governance.

It’s easiest to think of a QMS as the facilitator of outlined processes that are required to fulfill ISO 9001 requirements. For example, if an organization has defined a change request process, it could use a cloud-based QMS to put that process in place. However, the benefits of a cloud-based QMS don’t have to end at ISO 9001. It can also help organizations comply with other regulations like GxP.

ISO 9001 Requirements

ISO 9001 requirements can sound very generic because they’re meant to be applied to any organization, big or small, in any industry. The key to ISO 9001 is the concept of continuous improvement, which is why specific requirements for what “quality” is are not defined. Rather, companies must create objectives and work toward improving processes to meet those objectives. That said, a certified QMS still must do the following:

Meet the requirements of other stakeholders, for example, customer requirements and regulatory standards
Ensure that employees receive training outlining the quality requirements
Determine and document the processes, their interactions and their results
Be able to produce records to prove that system requirements have been met
Constantly monitor quality management software performance
Address any risks that could result from changes
Perform internal audits and correct any issues
Continuously improve the QMS

From creation to disposal, document protocols must be clear and properly followed.With that in mind, ISO 9001’s purpose is to evaluate whether or not a QMS does a good job of managing processes while also being able to help organizations identify areas that need improvement. In simple terms, ISO 9001 helps companies who were making an excellent product most of the time, make an excellent product every time.

How can cloud quality management software help you get your ISO 9001 certification? Once you create processes that adhere to ISO 9001 quality management standards, you have to put them into practice. Enter: quality management software. But, how exactly does it help?

Optimal Time to Value

First, cloud-based software is the most cost-efficient to implement. Secondly, since a QMS needs to be accessible to every employee regardless of whether they work at HQ or on-site, cloud QMS are built to be mobile-friendly and easily accessed from any location.

Automated Document Lifecycles & Version Control

From creation to disposal, document protocols must be clear and properly followed. As up-to-date documents are an important factor in maintaining high levels of quality, the most recent versions of approved documents should be readily available while previous editions should be hidden away.

With cloud quality management software, workflows can automate the review and approval processes by automatically sharing documents with the right reviewers. Then, after the document has been approved, the changes will automatically be applied to the master document while the obsolete version is archived, helping to remove any chance of it being accidentally used after the update.

Easy Document Location & Metadata

According to ISO 9001, searching through an organization’s documents should be as easy as searching with Google. It’s an added bonus when the quality management software enables users to add custom metadata to documents. Metadata is just extra information that helps to define a document (like file size, type, date modified). With certain cloud-based QMS’, you can add custom metadata fields to make documents easier to find. For example, you can add an “expiration date” field that allows you to look up policies based on when they are set to expire.With the growing number of data breaches happening every year, it’s important to address the security components of a QMS.

Document Traceability

In order to pass any ISO 9001 audit, there needs to be a complete audit trail for every document, including active documents and the earlier archived versions. While this might seem like a big ask, cloud quality management software helps make this simple. Every single change to a document, regardless of whether it’s the current or past version, is tracked. When combined with automated workflows, you’re able to produce a precise log of every change made by every user.

Advanced User Permissions & Central File Ownership

With the growing number of data breaches happening every year, it’s important to address the security components of a QMS. Many of these issues can be resolved with user permissions, which is generally related to managing users’ editing and sharing access. The proper view, edit, and approval rights go a long way to reducing the risk of human error.

Another feature that may seem like common sense is central file ownership. When the organization owns all of its documents, there’s no need to worry that important files will be lost or deleted. With one owner, the damage that can be inflicted by malicious third-parties is also limited.

Cloud-based quality management software provides the flexibility and scalability, that cannabis startups need to comply with ISO 9001. With the cloud as a foundation, these systems will continue to be assets for the cannabis industry as it gains momentum and expands more.

March 19, 2019

Health Canada Issues Voluntary Cannabis Recall Guide

By Marguerite Arnold

1 Comment

Last month, Health Canada published a Voluntary Recall Guide to help producers not only stay in compliance but run their operations better. While it will certainly prove to be a critically useful guide for Canadian LPs who are now subject to domestic regulations, it is also a highly useful document for others. Namely, newly legalizing U.S. states and even European countries now looking for guidance on how to shape, structure and regulate their own burgeoning domestic cultivation markets either underway now or about to start.

What Is Of Particular Interest?

While it may sound like a no-brainer, the guide lays out, albeit in very broad strokes, the kinds of procedures all licensed producers should be implementing anyway to efficiently run a compliant business.

It could be considered, on one level, a critical start-up business guide for those still looking for guidance in Canada (as well as elsewhere). Domestically, the document is clearly a handy template, if not something to create checklists from, in setting up a vital and at this point, mandatory part of a compliant cultivation facility in Canada.

The guide also covers not only domestically distributed product but that bound for export.

One of the more intriguing aspects of the guide is also how low tech it is. For example, the guide suggests that a license holder responsible for recall notices, plan on quick response methods that include everything from a self-addressed postcard to an email acknowledgement link.

That said, recalls must be reported to the government exclusively via an email address (no mail drop is listed). And suggestions about media outlets to which to submit recall notices are noticeably digitally heavy. Websites and social media platforms are suggested as the first two options of posting a recall. Posters at retailers is listed dead last.

What is also notable, not to mention commendable, is the inclusion of how to include supply chain partners in recall notices, as well as the mandate to do it in the first place.

Also Of Note

Also excellent is the attempt to begin to set a checklist and process about evaluating both the process of the recall itself and further identification of future best practices.Health Canada also expects companies to show proof of follow up efforts to reach non-responders all along the supply chain.

For example, the report suggests that LPs obtain not only feedback from both their supply chain and consumers involved, but elicit information on how such entities and individuals received the information in the first place. Further, the volume of responses (especially from end consumers) or lack thereof should be examined specifically to understand how effective the outreach effort actually was in reaching its target audience.

This is especially important because Health Canada also expects companies to show proof of follow up efforts to reach non-responders all along the supply chain.

Regulatory Reporting Guidelines

One of the reasons that this guide is so useful is that Health Canada also expects to receive full written reports touching upon all of the issues it lays out within 30 days of the recall announcement itself.

In turn, this is also a clear attempt to begin to start to document quality controls and attempts to correct the same quickly in an industry still plagued by product quality issues, particularly at home, but with an eye to overseas markets.

As such, it will also prove invaluable to other entities, far beyond Canadian LPs involved in the process this document lays out. Namely, it is a good comprehensive, but easy to follow and generally applicable guide for new states (in the case of the US) if not national governments in Europe and beyond who are now starting to look at regulating their own burgeoning industries from the ground up.

March 15, 2019

How To Choose The Right Cannabis Consultant For Your Company

By Martha Ostergar

3 Comments

The cannabis industry is growing fast as more states implement legislation to legalize cannabis in different ways. If you’re trying to break in or keep your place in this new market, it can be difficult to understand and comply with ever-changing government regulations as you try and scale your business.

Cannabis businesses need to comply with a range of new local, state and federal regulations related to cannabis specifically, in addition to regulations already in place for the pharmaceutical and food industries to ensure their products are safe for public consumption. On top of that, there are the complexities of managing a supply chain, including growing, warehousing, transportation, food safety requirements, product labeling, business plans, marketing, selling and any other necessities that come with running a businesses.

This is a lot of new information when you’re vying for your place in the cannabis industry. That’s why some businesses are turning to consultants to help. Consultancy is a great and time-tested way to grow your businesses and keep a competitive edge. But just like every other industry, when you choose a consultant, there are specific things to look for and avoid.each party will have work to do in order to communicate clearly, define responsibilities and execute on a plan.

Understand the Role of Consultants

The expertise of cannabis consultants can vary widely. Usually there’s no “one stop shop” for everything you need to run your business, meaning consultants often specialize in a specific area. Consultant expertise includes specialties such as cultivation, manufacturing, food safety, dispensary, transportation, legal, accountants, human resources and more, all within different regulatory compliance wrappers.

It’s important to remember that consultants are usually not responsible for setting goals for you, but the right consultant can help you refine, meet and even exceed your goals. However, each party will have work to do in order to communicate clearly, define responsibilities and execute on a plan.

Focus on Your Specific Needs

Identifying your specific needs and understanding what success looks like for you is a critical step to take before contacting any consultant. This prep work helps you identify what kind of consulting you actually need and what you’re willing to spend to get it. Some consultants can help you tackle more than one area, but most will specialize. In fact, choosing several specialized consultants (if you have many needs), may feel like it costs more up front, but it will likely save you frustration, headaches and money in the long run. Additionally, if a consultant claims they can do everything in several areas of expertise, they may be overpromising on what they can actually deliver to you as a customer.

Ask the Right Questions

When vetting a consultant, it’s your job to ask probing questions. Don’t hold back and don’t be put off by vague answers. If a consultancy avoids questions or can’t give clear answers, they may be overpromising or being less than honest about their skillset. Here are some general areas of discussion to help you get started when interviewing consultants:

Consultants can help you get through unfamiliar territory or help you to manage your team’s workload.

The consultant’s relevant experience.
Past or current client references.
Detailed discussion of your specific needs as a business.
How much time can the consultant dedicate to you as a client.
Detailed outline of the consultation plan, including a clear timeline.
Responsibilities of each party, deliverables and what success looks like for customer sign off.
Certifications and credentials if relevant to your consultation needs (e.g. legal, accounting, regulatory).
What is and is not included with their quoted fee, and what you may be charged for as an “add on” to your contract.
Any possible conflicts of interest, including how consultants separate work for clients who are competitors.

Avoid Red Flags

As with any burgeoning market, there will be consultants who get into the cannabis space that are more interested in making money than helping you as an individual client as businesses work to legitimize the industry as a whole. Doing your research and asking for referrals helps, but there are also red flags to look for. Some of these red flags may pop up due to inexperience and some may be a sign of bad actors in the consultant market.

Asking for equity as payment.
Refusing to provide references.
Avoiding questions or giving unclear answers.
Unwilling to track time and itemize costs on bills.
Overpromising AKA “this sounds too good to be true.”
Dominating the process instead of treating you like a partner.

Build a Strong Relationship

To get the most out of a consultancy experience, it’s important for both parties to work at building a strong business relationship. You know you’re hitting the sweet spot in business relationships when you have well-oiled communication and feedback loops, including honesty around expectations and frustrations from both parties. A great consultant wants feedback so they can improve their process, therefore they will actively listen to and address your concerns. Additionally, it’s important for you as a client to also be open to feedback and ready to make changes to your process to get the best return on your investment.

March 13, 2019

Legalization & Regulation Recap: This Week’s News

By Aaron G. Biros

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Across the country, a handful of states are expected to move forward with a number of bills making their way each state’s legislature. Here is a quick recap on some of the more newsworthy bills from this week.

Arizona

When Arizona legalized medical cannabis use, there was no provision in the legislation that required laboratory testing to insure the safety of cannabis products. To this day, Arizona is one of the few states left that has legalized medical cannabis, but does not require lab testing. A bill, SB 1494, that just passed through the state’s Senate could very well change that. According to azmarijuana.com, the bill passed unanimously through the Arizona Senate and would require the Arizona Department of Health Services (ADHS) to implement regulations for laboratories to test for contaminates like pesticides.

They need at least 75% of the House to vote in favor in order for it to pass. If that happens, testing could be required as soon as June 1, 2020.

New Hampshire

In the Northeast, New Hampshire and Vermont have bills related to cannabis making their way through the state legislatures. A committee in the New Hampshire House of Representatives just backed a bill to legalize recreational cannabis.

The House Criminal Justice and Public Safety Committee voted 10-9 to recommend HB 481, which would legalize recreational cannabis, including growing up to 12 plants, imposing a tax of $30 per ounce on cannabis sold through retail. It would also set up a regulatory agency in charge of licensing and regulating the industry.

New Jersey

Governor Phil Murphy met with lawmakers earlier this week to discuss the legalization of recreational cannabis. According to CBS New York, the Governor reached a deal with Senate President Steve Sweeney, Assembly Speaker Craig Coughlin, Sen. Nicholas Scutari and Assemblywoman Annette Quijano to introduce a bill that he would sign into law.

The deal would legalize and regulate recreational cannabis, expunge previous cannabis-related convictions, levy a $42 tax per ounce of cannabis sold, along with setting up a commission to issue licenses and regulate the market. When Governor Murphy ran for office, his campaign included a pledge to legalize recreational cannabis, A previous attempt to get a bill through the legislature failed to get enough votes last year.

Vermont

Back in February, the Vermont Senate passed a bill to regulate and tax recreational cannabis with a veto-proof majority. SB 54 is now in committee review in the House, where it is expected to see more hurdles, according to Burlington Free Press.

Another bill was introduced in the Vermont Senate, SB 117,which would reportedly open up more access to the medical cannabis program, including increasing possession limits, allowing patients to grow more plants at a time and set up a lab testing program as well.

Wyoming

Last week, Governor Mark Gordon signed a bill into law that legalizes and regulates the cultivation and sales of hemp-derived CBD. The state is now working with the WY Department of Agriculture to submit plans to the federal government for regulating the industry.

March 12, 2019

Countries Take Lessons From Others On Legalizing Cannabis

By Marguerite Arnold

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As the German bid fiasco proves, and in spades, there is no easy transition out of prohibition. As of this April, it will be two years since the German Cannabis Agency issued its first cultivation bid. Since then, the first attempt went down in legal flames (in court) and the agency in charge, BfArM took an embarrassing hit for committing a “technical fault.” As of April, the second issuance gets its day in court. And then presumably, hopefully, cultivation can start to get going.

However, the German cultivation bid is far from the only time that government officials and regulators have created canna Frankensteins. In every legalizing market so far, in fact, from Colorado’s recreational start in 2014 to Canada, lawsuits, flubs and mistakes have been the order of the day.

There is a growing debate in Europe over how the cannabis industry should be allowed to flourish.States throughout the US continue to model their legalization frameworks off of states that have already done so. No wonder, then that as legalization rolls on, other countries are beginning to study the early movers- for tips on what to do and what to avoid.

New Zealand Takes A Look At Portugal

New Zealand is widely expected to become either the “next” country (or the one after that) to fully legalize recreational cannabis. Further it plans to do so during a national election (presumably ahead of the U.S. but that will be interesting to watch). New Zealand has jumped the gun already and put it on the electoral agenda.

That leaves the Kiwis with at least another 18 months to consider how they might pull it off. Don’t forget, it took the Canadians that long, with one failed initiation date last summer that was pushed to the fall. And that was with a medical market that was already three years old.

As of this month at least, New Zealanders are looking at several options, Portugal being one of them. Portugal gained distinction by decriminalizing all drugs at the turn of the century and has not looked back.

The country has seen a steady decline in all the bad stuff associated with the black market. Overdoses, drug crime, teen use and HIV infections have all dropped dramatically.

That said, for all Portugal’s forward motion, nobody else, yet, has quite followed suit.

Decriminalization, it should be pointed out, is also only one of the many issues facing a national change in policy. As Canada knows well.

Luxembourg Takes A Look At Canada

The Greens in Luxembourg certainly made news last year when they announced that recreational cannabis legalization was on their five-year legislative plan. In a tip to both U.S. and Canadian discussions about how legalization can increase tax revenues, Luxembourgers are also clearly looking at how to follow suit.

Aurora cannabis so far has the only distribution agreement inked with the country to provide medical supplies, but it is unknown at this point whether Luxembourg will be content to merely import or grow its own.

One of the biggest problems Europeans will encounter immediately in looking at the Canadian transition to recreational use is that the government literally had to mandate an additional five-year period for medical use after the beginning of the recreational market. So far, at least, Luxembourgians appear to want to do this the other way around. They have already created a multi year test and study program for medical uses of the drug.

A Big Difference In Approaches

There is a growing debate in Europe over how the cannabis industry should be allowed to flourish. On one end of the discussion who see no issues with the North American model of public companies, in particular, having the greatest influence over the shape of the industry. But this is not the only discussion in the room at this point, particularly given the huge head start the Canadian public companies now have in the rest of the world.

In places like Spain and Thailand, for example, politicians are also starting to bring other models to the fore- including protectionist policies around domestic cannabis production.

Regardless, compare and contrast is a trend that is still in its infancy as the market leaders struggle with the implications of half-baked policies and those who follow seek to emulate the successes but avoid the mistakes.

The Decision Is Far From Over

And The Import Game Is Just Getting Hot…

Price Wars Are Looming

How to Prepare for a Third-Party Audit

Implications

Other Looming Problems

What Is This Really About?

Likely Outcomes

CBD Producers Have To Keep Current On Regs

Quality Management Systems (QMS)

ISO 9001 Requirements

Optimal Time to Value

Automated Document Lifecycles & Version Control

Easy Document Location & Metadata

Document Traceability

Advanced User Permissions & Central File Ownership

What Is Of Particular Interest?

Also Of Note

Regulatory Reporting Guidelines

Understand the Role of Consultants

Focus on Your Specific Needs

Ask the Right Questions

Avoid Red Flags

Build a Strong Relationship

Arizona

New Hampshire

New Jersey

Vermont

Wyoming

New Zealand Takes A Look At Portugal

Luxembourg Takes A Look At Canada

A Big Difference In Approaches