We are living in a changing era. Just a couple of years ago, cannabis was a completely illegal product in most corners of the world. Nowadays, governments, pharmaceutical companies, cosmetic companies, and beverage companies are moving into this sector to fulfill new business opportunities in a US$75 billion market.
The emergence of this new industry, and its subsequent boom, is shaping the agriculture sector across borders. Canadian, European and American cannabis companies are looking to South American countries like Colombia and Peru to establish operations in order to lower production costs. With emerging markets comes new and evolving standards for production and exportation.
Cannabis legislation: Colombia and Peru
There are not only big multinational companies moving to Latin America to be part of the booming cannabis industry. Local cannabis businesses are surfacing daily in countries like Colombia, where local farmers are converting their tobacco crops into medical cannabis fields.
Colombia and Peru medical cannabis legislation is very clear: companies are only able to export derivative products; they are not able to export dry cannabis flowers.
International standards for cannabis
Based on the legislative restriction outlined above, there are a couple of questions that businesses and buyers may have in this space: Are local medical cannabis companies ready to export? Are they producing medical-grade cannabis derivatives? How can this be verified?
In order to enter an international market, medical cannabis producers must comply with certain international standards. Good Production Practices (GPP) is the standard guidance that licensed producers in Canada follow. Good Manufacturing Processes (GMP) is the equivalent standard American and European guidance.
How GMP is different from GPP
GPP and GMP require that the producers implement and demonstrate standard operating procedures, sanitation programs and systems to monitor products. They must also carry out product recalls if necessary.
Both systems are ways to ensure product safety, quality and environmental protection. However, GMP takes these steps a little further. Cannabis-specific GMP systems are also required to include more product testing for THC and CBD levels, as well as testing for microbial contamination and the presence of pesticides and heavy metals.
Getting certified under GPP or GMP
The first step to become certified is called a gap assessment. The mean of this assessment is to recognize what your quality management system currently involves and what else is necessary, depending on which type of certification you are thinking to obtain.
The goal of the gap assessment is to prepare an implementation timeline, and that can vary from company to company.
Other similar regulations
GPP and GMP are not the only regulations front-footed in the industry. Good Agricultural and Collection Practices (GACP) is a European standard that applies to herbal medicinal products such as cannabis. The American version of GACP is the Good Agricultural Practices (GAP), which is intended to serve the same purpose. GAP standards ensure that plants used for medicines are grown and harvested in such a way that harvested crops can be traced back to seeds or mother plants.
Which standards are the core components of a quality system?
No matter what regulatory guidance a product conforms to, they all have some common characteristics such as the use of a validated standard operating procedure, the existence of a sanitation program, monitoring of personnel, and ensuring that the installation is designed to minimize risks and is maintained in good condition. In order to organize these systems, a quality manual is usually used to define the scope of the corresponding programs and practices.
The Hazard Analysis and Critical Control Point (HACCP) plan is another common element in a quality system. The HACCP plan identifies which points in the manufacturing process present hazards, what those hazards are, how to prevent them, and how corrective actions will be handled if there is an error or abnormality at a control point. Both the HACCP plan and the quality manual are based on guidelines such as GPP or GMP.
Medical cannabis is intended to be used by patients with various kinds of ailments. For treatment, patients are using cannabis derivatives based on preliminary research of the plant’s health properties. Patients deserve access to safe cannabis products that have known potency and research-backed benefits.
Canada is probably the leading country establishing regulatory guidance that supports this need.
If you’re looking to provide accurate information about your medical cannabis product, or your company wants to enter international markets, like Europe, Canada, you will have to enter the certification world. The more widely-standardized these regulations are globally, the easier time businesses will have selling their goods to foreign markets, and the more confidence and security patients are afforded in using quality-assured products.
We offer streamlined licensing application processes
The Latin American cannabis sector is open for international investors on the lookout for new opportunities and early-mover advantages.
With increasingly stable legal regulations and more comprehensive information available about the industry, several countries in the region are forecasted to become key exporters of cannabis extracts and derivatives into the foreseeable future.
If you’re looking to enter the cannabis market and need some guidance, speak with us. At Biz Latin Hub, we ensure commercial success for those entering Latin American markets. Recently, we’ve established streamlined application processes for businesses obtaining licenses to grow and manufacture cannabis in Colombia.
Our teams of local and expatriate experts offer customized legal, financial and commercial back-office services that address the specific needs of our clients.
Contact us today via email at [email protected] for personalized business support.