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Development Consulting. Offshore Wind. 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. 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. 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. 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:. 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. 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. 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. 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. Search Search. GAP analysis, quality management and procedures Our experts perform GAP analysis and consultancy when quality management systems and development of procedures are being established. Experts in GAP analysis Our consultants have a broad knowledge and experience in the various aspects of GxP-regulated production environments. 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. 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. 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. How does the application process work? The example below shows the application process for a business license. Legislation on narcotics. GMP-Eudralex vol. Validation and qualification: Including commissioning tests of equipment and premises. Assistance in identifying potential CMOs and other relevant partner. 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. 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. Guidance and help to solve specific challenges afterwards to make the company ready for the Danish Medicines Agency's inspection.

Medical cannabis

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The data was collected as part of my master's thesis. In order to be able to carry out my master's thesis, I received a scholarship from fiat panis. Christoph Schunko does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment. The use of herbicides — substances that control unwanted plants — is on the rise across Africa. Also, rural wages have risen due to rural-urban migration and structural transformation. Herbicides may help to raise yields, thereby contributing to food security. They also reduce the large labour burden associated with manual weeding, which is often done by women and children. A study in Zambia suggests that herbicide can reduce labour use for weeding from up to 70 to 10 days per hectare. However, herbicides may also have negative effects on environmental and human health, particularly when substances are not carefully handled and no protective equipment is used. Unintentional pesticide poisoning kills 11, people every year, according to a global study. In the quest to assess these trade-offs one aspect has received limited attention: the role of edible weeds, which can be key elements of rural food baskets, yet are targeted by herbicides. In a new study , we explored the role of edible weeds in rural diets in Zambia and how herbicides affect their consumption. But informed decisions should be made acknowledging all potential trade-offs, including those regarding edible weeds and food and nutrition security. For our study we surveyed or interviewed randomly selected households in rural parts of eastern and southern Zambia where most families depend of farming. We also used qualitative methods such as field walks, focus group discussions, and stakeholder interviews. All the households collected edible weeds from their fields. The most important species were spiny amaranth, nalta jute and plants from the aster family. Edible weeds provide important nutrients. Bidens pilosa or black-jack is frequently used in Zambia to treat anaemia. Read more: Kenya's push to promote traditional food is good for nutrition and cultural heritage. Edible weeds are mostly eaten fresh but also preserved through drying. Nearly all of the households that preserved edible weeds did so to ensure future food security. Herbicide use in Zambia is slowly but steadily climbing. Herbicides are specifically designed to eradicate weeds. We found that the rise of herbicides, as measured by the share of plots sprayed, has not yet affected consumption of weeds. Households using herbicides can still access edible weeds from non-sprayed plots and from outside their farms. However, households that have already been using herbicides for some time consume fewer edible weeds and many households themselves perceived trade-offs between herbicide use and edible weed availability. In the coming years, households will have to manoeuvre the trade-offs between herbicides and edible weeds. It is possible, for instance, that herbicides may contribute to higher agricultural production for these families — and that the additional revenues from increased harvests may be used to buy nutritious food and counterbalance the loss of edible weeds. Edition: Available editions Europe. Become an author Sign up as a reader Sign in. Events More events.

Lusaka buying weed