We are experts in comprehensive solutions for medical cannabis projects
We design and build comprehensive solutions tailored to the specific requirements of each project.
With Labsom, you can be sure that your medical cannabis facility will comply with regulations, and we will provide you with the necessary support at every stage of the project through specialist professionals in each key area.
We design a plan tailored to each specific situation, always ensuring compliance with the minimum requirements so that your project can obtain AEMPS certification.
We design a plan tailored to each specific situation, always ensuring compliance with the minimum requirements so that your project can obtain AEMPS certification.
We verify and document that the facilities comply with the established standards, ensuring they operate correctly and are validated in accordance with regulations.
We provide guidance on compliance with GMP and ISO standards and regulatory requirements, ensuring that every project is carried out in accordance with the required standards.
We train and support technical teams in the proper operation and maintenance of cleanrooms, providing specialist, practical expertise.
We implement control and monitoring systems to ensure stable environmental conditions and ongoing compliance with critical parameters.
On 27 June, the Congress’s Health and Consumer Affairs Committee gave the green light to legalising the substance, provided it is used for therapeutic purposes. The proposal approved calls for the substance to be regulated so that it can be used to relieve pain and mitigate the side effects of medical treatments, such as the pain caused by chemotherapy.
GMP regulations, which refer to Good Manufacturing Practice, are a system designed to ensure that products meet a set of quality standards. They were established to minimise the risks associated with any type of pharmaceutical production, such as contamination, incorrect labelling of packaging, or excessive or insufficient levels of the active ingredient. It covers every aspect of production, from materials, equipment and premises to hygiene and staff training.
For its part, GACP consists of a set of guidelines on good agricultural and collection practices. It was developed by the World Health Organisation (WHO) in 2003 to improve the quality of the cultivation and production of medicinal plants used in herbal medicines. Its aim is to ensure that plant-based raw materials can be consistently reproduced to a standard, which requires an appropriate quality system.
If you have a medical cannabis project, it is crucial to comply with both sets of regulations to ensure consumer safety. At Labsom, we help you interpret the requirements, produce the necessary documentation and prepare your facilities to comply with the legislation and pass the AEMPS assessment.
Medical cannabis is indicated for people suffering from the following*:
*It may be applicable to other therapeutic conditions where studies provide a body of evidence deemed consistent.
Treatments using standardised extracts of cannabis or medical marijuana will have a controlled, pre-defined duration. The specialists administering such treatment may continue the treatment depending on the results and if they deem it appropriate.
Only specialist doctors or healthcare professionals will be authorised to issue prescriptions. It was also noted that training in the use of medical cannabis or marijuana should be promoted amongst healthcare professionals.
The regulation of medical cannabis in Spain involves legalising the substance for purely therapeutic purposes. It will be used to relieve pain and the symptoms caused by certain medical conditions.
Medical cannabis is regulated by the Health and Consumer Affairs Committee of Parliament, which on 27 June 2022 gave the go-ahead for the legalisation of the substance for therapeutic purposes.
It is expected that medical cannabis could be available in Spanish pharmacies by the end of the year. A medical prescription will always be required.
We’re here to listen to you and look forward to learning about your project.
We handle the design, installation, management, and maintenance of cleanrooms, prioritizing safety and offering customized solutions. We’ll also contact you to discuss your project and provide a quote tailored to your needs.
