Oct. 31, 2019 | Business Insider
The pharmaceutical company Panaxia Israel, the largest manufacturer and distributor of pharmaceutical cannabis in Israel, announced today, that the audit of the regulatory body of the EU which was conducted at the plant in the past weeks, was successfully completed, and subject to a number of completions which will be conducted in the next few weeks, it is expected to receive the EU standard (EU-GMP) to manufacture pharmaceutical cannabis products.
The EU-GMP standard is a binding quality assurance standard to manufacture drugs marketed in the EU. The comprehensive audit included, among other things, an inspection of the manufacturing facilities, the manufacturing conditions, quality assurance, quality control, and an analytical laboratory, all according to EU-GMP standards.
The EU-GMP standard is necessary in order to export medical cannabis products to most of the EU countries, including Germany, Poland, Italy, Denmark, Greece, and more. Since these countries do not recognize the Israeli standard (IMC-GMP), it is impossible to market products manufacturedin Israel in these countries, without complying with the European EU-GMP standard. The regulation requirements compel all plants and companies which manufacture, store, use, and manage drugs of any kind in Europe. It should be noted that there are a few medical cannabis companies around the world, estimated at less than 10, with extraction plants which comply with the rigorous European standard requirements.
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