Achieving EU GMP (European Union Good Manufacturing Practices) compliance is crucial for exporting cannabis to Europe. Preparations for successfully achieving EU approval for export take a significant amount of effort and knowledge, but can pay off with a very lucrative business opportunity. dicentra can help you with the regulatory requirements that you need to comply with, including helping prepare for inspection.
A great first step is to conduct mock GMP inspections, to prepare in advance of an official inspection by an actual audit by an EU competent authority. A mock inspection would verify GMP compliance, finding any deficiencies and eliminating them.
The German government legalized cannabis in 2017 for medical purposes, and allowed government insurance reimbursement for patients who qualified. Cannabis cultivation in Germany is estimated to begin in 2019; until then, the supply of medicinal cannabis into the German market would highly depend on importing from other countries.
GMP is an integral part of quality management that applies to all the phases of a product life cycle. In European Union countries, inspections are held by the national competent authorities of the member states. These national authorities work toward ensuring public health protection. Products intended for the EU medical cannabis market are required to comply with EU GMP, ensuring that the medicines are of high quality and are consistently produced. Manufacturers should comply with GMP standards right from the moment the raw materials enter the facility until the finished product is released for sale.
GMP is incorporated in the pharmaceutical quality system along with quality risk management that includes risk assessment, risk control and risk communication. Maintaining the quality, safety and efficacy is the main focus, ensuring delivery of consistent medicinal product to patients. Major steps in the cannabis product life cycle are cultivation, harvesting, post-harvest processing, finished product processing, packaging, labelling and distribution. EU GMP guidelines are provided in EudraLex Volume 4.
GMP applies at each step of the supply chain. The basic requirements of GMP in the European Union include careful consideration to all the aspects that can potentially affect the quality of the product. They constitute all the steps from premises, manufacturing controls including validation, specifications, and quality control, along with all other requirements to the proper recall system and pharmacovigilance practices.
GMP compliance is of great importance to safeguarding public health and enabling traceability in case of recall or complaint. If you are thinking of exporting cannabis to Europe, we are here to help.
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dicentra Cannabis Consulting has the knowledge and experience to help you navigate through the regulatory framework to get your product to the European market. We offer the inspection preparation & strategic services to acquire EU GMP certification. Contact us today for any further questions.