João Nascimento, CEO of CANNPRISMA, spoke with MMJDaily about the importance of gaining the new authorization to grow, process, import, and export cannabis-based medicines, as well as, the success factors that make up the company and the plans for the future.

João Nascimento, CEO of CANNPRISMA

“Our main concern was to provide our plants with the best growing conditions possible, whether in winter or in summer”

CANNPRISMA is a Portuguese company that has recently been awarded the authorization to grow, process, import, and export cannabis-based medicines by the Public Security Police (PSP) and by INFARMED, the Portuguese medicine authority. Obtaining a license is not an easy endeavor, and it was no different for CANNPRISMA. “When it comes to licensing, the biggest challenge was COVID, which delayed the entire process,” says João Nascimento, CEO of CANNPRISMA. “Yet, INFARMED put an amazing amount of effort in attending all our requests promptly. I can’t stress enough how important it is to have a regulatory entity that is demanding yet fair, which can guide us to improve and to ensure that all companies comply with regulations.

More than a hybrid greenhouse
One of the most important assets of CANNPRISMA is their cultivation facility, which some would call a hybrid greenhouse, but that definition wouldn’t do justice to CANNPRISMA’s vision. “Our definition of the hybrid greenhouse is a little different,” he says. “We don’t consider ours hybrid. Our greenhouses are high quality, high-tech, and fully equipped so that we can adapt to each and every condition. This was our main concern: being able to provide our plants with the best growing conditions possible, whether in winter or in summer, with sunny or rainy weather. Fortunately, we have a team of experts that helped develop our facilities the way it is.”

It was exactly that team of experts that proved itself to be critical to overcome the cultivation challenges. “The biggest challenge of growing cannabis at scale is of course consistency,” he continues. “It is hard to provide the same potency levels in winter as in summer if you are not using supplemental lighting, for instance. On top of that, genetics play a huge role in guaranteeing that we can repeat our processes over and over without any fluctuation in potency, microbiologic counts, and even plant morphology. We are strict with all the processes. Of course, our infrastructures help to keep the risks low and to greatly reduce contaminations. But it’s not just because of the greenhouses. Our GACP processing facility in Castro Marim was built following the same rules of our future EU-GMP facility of Vila Real de Santo António. In so doing, standards stay high all the time.”

João takes care to point out that their consistently high quality is also a result of the people at CANNPRISMA. “The quality and consistency of our flowers is an outcome of the combination of qualified individuals that follow the vision of CANNPRISMA. This couldn’t be done without their willingness to go the extra mile every day, while meticulously following our SOPs. This, for sure, is the only way to deliver the best products.” Such results are also achieved because CANNPRISMA breeds its own genetics. “This was a must for us,” he says. “When it comes to cannabis genetics, there are so many interesting possibilities that we couldn’t get into this industry without doing it ourselves. It gives us an advantage as we have the right strains for our geography, allowing us to explore their potential and bring that up to its maximum. At the same time, having different and unique genetics allows us to enter markets with a diversified portfolio.” The last step to achieve high quality is the testing lab, which CANNPRISMA has built in-house. “It helps us to reduce the waiting times,” he points out. “But also gives us greater confidence in our rigorous quality control process.”

Support to the sector
CANNPRISMA set up its operation following these high standards also thanks to the regulatory framework in Portugal. “Portuguese legislation regarding cannabis is one of the most advanced in Europe,” he says. “The government and INFARMED are supporting the pharmaceutical cannabis sector. The commitment and rigor imposed by the institution are critical for this industry to thrive.” But of course, the true treasure is the land and the people of Portugal. “We have a highly qualified workforce in terms of agriculture and the pharma industries, in this country. Thus, with a clear regulatory framework and the agronomical advantage of large-scale, efficient production, Portugal has the potential to become a leading region for cannabinoid research as well as one of the largest exporters of medical cannabis in Europe. On top of that, Portugal can serve as a point of exchange between the North American and European markets.

Because of all the aforementioned reasons, the future of cannabis surely looks bright in Portugal and for CANNPRISMA. “The next 2/3 years will be full of innovation, discoveries, and knowledge,” he remarks. “We are talking about new methods for extraction, new formulations, gaining the trust of the medical community, patients, researchers. This is a sector that will grow very quickly, where technology and innovation will be key. This, together with the gradual opening of national legislation, will further promote the development of new medicines.”

“At CANNPRISMA, we aim to guide and support these actors the best we can, not only to promote the industry evolution but also, for us to establish as leaders in what we do best – producing premium medical cannabis to the people. So for the next 5 years, we aim to have the best GACP and GMP flower, extracts, oils, and APIs to deliver to pharmaceutical companies and have our own registered cannabis for medical preparations and marketing authorization (MA) for our medicines. But in the end, it all boils down to keeping up with the market, its evolution, and changes. And go on evolving and changing too. But one step ahead!”

Regulatory Affairs and Pharmacovigilance

Head of Regulatory Affairs and Pharmacovigilance

CANNPRISMA is recruiting a Head of Regulatory Affairs and Pharmacovigilance, full time.

RESPONSIBILITIES:

• Responsible for ensuring the correct management and approval of orders for new products and materials after document verification, proper registration in the market and materials, renew and keep up to date records and codifications, following the procedures established by the Competent Authorities and adopted by CANNPRISMA;

• Carry out all activities related to the registration of cannabis plant-based preparations, medicines, medical devices, cosmetic and body care products and food supplements, namely in the submission, management and filing of regulatory processes, in the monitoring and maintenance of the cycle of product life and ensuring regulatory compliance and compliance with applicable legislation throughout the process;

• Develop regulatory strategies, make contacts and collaborate with Competent Authorities and other Regulatory Entities, and carry out all activities within the scope of Pharmacovigilance and Surveillance of Health Products;

• Regulatory support and design of strategies for product registration in different markets/countries in accordance with local legislation and submission requirements in the exporting countries in which CANNPRISMA operate;

• Adaptation of the dossiers in accordance with the submission requirements of the exporting countries, their submission and maintenance of the respective marketing authorizations;

•Among others.

MAIN REQUIREMENTS:

• Consolidated experience in the area of ​​Pharmaceutical Regulation;

• Degree in Pharmaceutical Sciences, with specialization in Regulatory Affairs.

OTHER REQUIREMENTS:

• English language (proficient);

• Experience in using ERP system;

• Knowledge of GMP standards;

• Good communication and negotiation skills;

• Analytical capacity, organized and systematic;

PERSONAL CHARACTERISTICS:

• Team spirit;

• Be proactive;

• Ease of interpersonal relationships;

• Results oriented;

• Ethical at work and with a positive team attitude;

• Good communication skills;

• Good multitasking and supervision skills;

• Priority management.

To apply, send your Curriculum Vitae with the subject “Head of Regulatory Affairs and Pharmacovigilance” to the email: recursoshumanos@cannprisma.com

Doubts and questions, should be sent to the same email.

Only candidates selected for interview will be contacted.

CANNPRISMA is officially authorized to cultivate, export and import medical cannabis

The definitive authorization that allows the cultivation, import and export of medicinal cannabis was given after an on-site inspection by INFARMED and PSP and publication in Diário da República.

CANNPRISMA has, since today, the official authorization to cultivate, process, import and export cannabis-based products for medicinal purposes, by the Polícia de Segurança Pública (PSP – Public Security Police) and by INFARMED , the Portuguese government agency responsible to the Ministry of Health, which evaluates, authorizes, regulates and controls medicines for human use – including medical cannabis – as well as health products.

This means that the entire activity of this company from Algarve, complies with the Good Agricultural and Collection Practices (GACP).

The pandemic situation that has been going on since the beginning of last year, delayed the process of obtaining the definitive license, but which has now been concluded with the successful on-site inspection by INFARMED.

It should be noted that this licensing has already been subject to inspection by PSP, which confirmed compliance with all safety rules, in accordance with current legislation (Ministerial Ordinance nº83/2021)

The cultivation and processing unit of CANNPRISMA, with 10 hectares, is located in Castro Marim and includes about 3000 square meters of greenhouses and support infrastructure with the latest technology, respecting all the required quality standards (always following all the GMP requirements) which allows to obtain high quality flower.

By the end of 2021, the construction of the factory is expected to be completed, as well as its authorization for GMP operation by INFAMED.

This GMP manufacturing facilities, installed in Vila Real de Santo António, already has an aptitude decision from INFARMED.

These new facilities for the pharmaceutical industry, together with obtaining this definitive license, are in line with the company’s strategy of being present in the entire value chain of the medical cannabis business, as well as in the verticality of the company’s business (R&D, cultivation and harvesting, drying, packaging, processing, extracting, crystallizing API, medicine manufacturing, bottling and labeling).

Portugal currently has the best strategic conditions for the implementation of this new business area: climate, location, human resources, knowledge, policy, applicable legislation, among others.

There is great potential to become a leading country in research, production and one of the largest exporters of medicinal cannabis in Europe.

The rigor, quality, safety and clarity required by Portuguese licensing entities contribute in a definitive way so that Portugal becomes the best option for the cultivation and production of medicinal cannabis products for the whole world, fulfilling still all requirements in terms of business ethics.