Conversion of legislation and regulatory requirements into practice
In Denmark, according to the Act on the medicinal cannabis pilot programme and the development scheme, permission can be obtained for cultivation, manufacture of primary products, manufacture and import of primary products, manufacture of intermediate products, and sales and export of bulk and primary products. Medicinal cannabis is the designation of the processed flowers of the cannabis plant used for medical treatment. However, since it is neither categorized as a medicinal product or a dietary supplement, there are quite specific rules for cultivation and manufacture. Therefore the Danish Medicines Agency has established a specific legislation that aims to ensure control of cultivation and manufacture, in order to obtain a uniform product which is manufactured in a quality-correct manner, every time. Legislation and the rules within the field approach the requirements for the production of medicinal products, where the rules for good manufacturing practice, cultivation, transport and storage are applicable:
The production requirements for medicinal cannabis approach the rules of pharmaceutical production, where the rules of good manufacturing practice must be followed. GMP ensures that medicinal cannabis is manufactured according to current quality standards, in relation to the use of product.
To ensure the level of quality of the medicinal product, the rules of good distribution practice must be maintained throughout the distribution chain. This means that transport and storage must be controlled, and a traceability system must be established in order to identify any counterfeit products.
The company sends an application for company authorisation and/or product approval to the Danish Medicines Agency. The Danish Medicines Agency assesses the application and the submitted documentation in relation to applicable legal requirements, after which they come to the company for inspection before the final approval and company authorisation is given. The following example shows the application process for a company authorisation.
Since October 2017 we have supported a number of companies with counselling and specialist knowledge within both the development scheme and the pilot programme. We have extensive experience with the challenges that may arise in connection with the cultivation, manufacture, import and export of medicinal cannabis, and offer consultancy on company and product approval, including application to the Danish Medicines Agency.
We carry out GAP analyses and consultancy when establishing a quality management systems and preparing procedures. We offer competent feedback and support when establishing the production facility, commissioning testing of equipment and premises, including process risk analysis. We offer to perform auditing of suppliers and handle the contact with authorities, as well as affiliation of a competent person upon release to the market.
We offer education and training of employees in cannabis legislation, GMP, GACP, GDP and processes.
AlfaNordic's consultants have broad knowledge and experience within the various aspects of GxP regulated production environments. Our consultants in the cannabis team have extensive experience in advising about or resolving the challenges that may arise in cultivating, manufacturing, importing and exporting medicinal cannabis. We can you help interpret the rules and convert them into practice. This ensures an appropriate standard of quality from the beginning, so that a company authorisation will be obtained after a satisfactory inspection, and it ensures a satisfactory product application leading to the approval of the products. The starting point will usually be a GAP analysis. This is a controlled and systematic survey, in which requirements and milestones are defined in relation to standards on the basis of the company's current situation. The purpose of the GAP analysis is to identify the gaps that must be closed in order to achieve a solution that works in practice and, of course, meets the current legislation and standards.
If you want further knowledge about cultivation and the legislation within medicinal cannabis, we have prepared a table from which you can easily get an overview of different topics.
Here you can learn more about the Danish Medicines Agency's legislation on the pilot programme and development scheme for medicinal cannabis, the requirements for GMP – good manufacturing practice, cf. EU-GMP Eudralex vol. 4, documentation and rules for handling euphoriant substances. The cultivation requirements according to the GACP – Good Agricultural and Collection Practices and the distribution requirements – GDP, which describes the rules within good distribution practice.
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