We have extensive experience with the challenges that manufacturers and importers may face, and we offer advice on both company and product approval, including applications to the Danish Medicines Agency.
GAP analysis, quality management and procedures
Our experts perform GAP analysis and consultancy when quality management systems and development of procedures are being established. We offer sparring and support in the establishment of production facilities, as well as commissioning tests of equipment and premises, including process risk analysis.
We offer audits of suppliers and we handle the authority contract, as well as attaching a professional person upon release to the market.
We offer education and training of employees in cannabis legislation, GMP, GACP, GDP and procedures.
Experts in GAP analysis
Our consultants have a broad knowledge and experience in the various aspects of GxP-regulated production environments.
Our medical cannabis team has extensive experience in advising on the challenges that may arise within the cultivation, manufacturing, import and export of medical cannabis.
We can help interpret the rules and put them into practice. This ensures an appropriate quality level from the beginning which will ensure a satisfactory inspection that can lead to a company permit being obtained afterwards, as well as ensuring a satisfactory product application that will lead to approval of the products.
The starting point will most often be a GAP analysis. This is a controlled and systematic mapping, where requirements and milestones are defined in relation to standards based on the company's current situation. The purpose of the GAP analysis is to identify the gaps that need to be closed in order to achieve a solution that works in practice while complying with current legislation and standards.
Medical cannabis consultancy
In Denmark it is possible to obtain permissions for cultivation, production and import of starting products, production of intermediate products, and sale and export of the bulk and initial products.
Medical cannabis is the term for the processed flowers from the cannabis plant that are used for medical treatment. However, medical cannabis is not categorized as a medical drug or a dietary supplement, so very special rules apply for cultivation and production of medical cannabis.
The Danish Medicines Agency has thus set up specific legislation that aims to ensure control of cultivation and production of medical cannabis in order to achieve a uniform product that is always manufactured in accordance with specific terms of quality.
The legislation and the rules for medical cannabis are based on the requirements for the production of medicines, where the rules for good manufacturing practice, cultivation, transport and storage apply:
Good Manufacturing Practices - GMP
The production requirements for medical cannabis are based on the rules for production of medicine, where the rules for good manufacturing practice must be followed. GMP ensures that medical cannabis is manufactured in accordance with the quality standards that are applicable to the product’s use.
Good Agriculture Collection Practices - GACP
The rules of good agricultural collection practices (GACP) are followed when growing medical cannabis plants.
GACP is a set of rules that regulates the cultivation, harvesting, and the subsequent handling and processing of the plant material, in order to ensure a sufficient quality of the plant material.
Good Distribution Practices - GDP
To ensure the quality level of the medical product, the rules of good distribution practice must be observed throughout the distribution chain.
This means that it is necessary to carry out control of transportation and stocks, and a traceability system must also be established in order to be able to identify any possible counterfeit products.
How does the application process work?
The company sends an application for a company permit and / or product approval to the Danish Medicines Agency. The Danish Medicines Agency assesses the application and the documentation in relation to current legal requirements, and subsequently they will make an inspection of the company before the final approval and company permit is granted.
The example below shows the application process for a business license.
NIRAS’s expertise in medical cannabis
We can advise and provide assistance within these areas:
- Compliance: Legislation on medical cannabis. Legislation on narcotics. GMP-Eudralex vol. 4, GACP & GDP.
- Validation and qualification: Including commissioning tests of equipment and premises.
- Assistance in identifying potential CMOs and other relevant partner.
- Audit of suppliers: NIRAS represents the customer during the audit. We prepare, implement and conclude with an audit report. We follow-up according to the customer's wishes.
- Business case and consulting: GAP analysis, consulting on the preparation of quality management systems and procedures.
- Process risk analysis: Performed on the company's own processes to identify all critical processes in cultivation and production of medical cannabis
- Analysis and optimization of processes including mapping of flow
- Process validation
- Upscaling from pilot scale to full scale production
- Authority contact and expert:Advice on company and product approval, including application to the Danish Medicines Agency and handling of contact with authorities. Affiliation of an expert upon release to the market.
- Education and training: Courses for employees in GMP, GACP, GDP, customer-specific courses, and ‘on-the-job’ training in processes.
NIRAS’s practical experience from the medical cannabis industry
We have solved the following tasks for companies in the medical cannabis industry:
- Sparring and business development including GAP analysis of where the company is positioned in relation to the ambitions, as well as advice on how the company can progress in order to achieve its goals.
- Clarification of issues concerning the import and export of medical cannabis
- Design and set-up of production facilities that match the requirements of the authorities.
- Establishment and / or optimization of quality systems and production processes that ensure high and consistent production quality.
- Preparation before inspection: Our cannabis consultants review the companies’ processes to identify the challenges that are critical in order to obtain the necessary approvals and permits. Guidance and help to solve specific challenges afterwards to make the company ready for the Danish Medicines Agency's inspection.
- Assistance during the inspection itself: Our experienced cannabis consultants can support the company’s management as representative of the company when receiving inspectors, answering questions, and following up on the subsequent reporting.
- Courses that strengthen the company’s knowledge and understanding of how the company can apply and adapt the documentation and quality requirements in the legislation on medical cannabis to the company’s specific processes.