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we will expand further on how International Cannabis Producers must navigate the regulatory landscape to launch their products in the German Medical Cannabis market.
The Regulatory Landscape in Germany
In Germany, the production of pharmaceuticals is regulated in the German Medicines Act (AMG) as well as in the legally binding drug and active ingredient manufacturing regulation (AMWHV). At European level, however, Directive 91/356 / EEC derives from the EC GMP Guide (GMP Foundations of the European Union). Many detailed topics are also governed by further guidelines in the form of appendices to the EU GMP Guide.
Of central importance in Europe is the current EU Directive 2004/27 / EC. This concerns the creation of a Community code for manufacturers of medicinal products for human use.
Cannabis in Germany then, is covered by all these directives and is classified as an Appendix III drug requiring GMP compliances to the EC GMP Guide.
Yet, outside the EU economic area, the intergovernmental agreement called PICS (Pharmaceutical Inspection Convention Scheme) regulates the GMP regulations.
A Key Consideration – the QC Test Point
Cannabis products derived within the European Union do not require an analysis / retest before being dispensed to pharmacies. Quality assurance is ensured through the selection and monitoring of suppliers in the context of the company quality management system.
However, non-EU cannabis products do require an analysis / retest of each batch as part of import and batch release process. The authority has no regular quality checks on the medicinal products themselves and therefore the import and batch release process are heavily regulated by law. The participation of the pharmacists (Ie: “Qualified Person”) is required and they are responsible for the proper testing and documentation to ensure Quality Assurance.
Violations of this can jeopardize the drug-legal permissions. Regulators oversee drug importers / wholesalers through regular inspections, typically every 3 years, reviewing documentation regarding the individual batches, the quality and risk management system. Depending on the occasion, for example, if counterfeit medicines or faulty batches of products are on the market, the authorities have extensive powers of intervention to prevent them.
Currently, pharmacies in Germany can only deliver cannabis flowers imported from the Netherlands and Canada to patients. In these countries, cannabis flowers are not approved finished medicinal products. So, if pharmacists buy cannabis flowers, they are classified as “starting materials”, the quality of which must be proven by a test certificate. Pursuant to Section 11 (2) of the Pharmacies Act, the pharmacist must at least establish the identity.
As you go deeper into identity verification, it gets more complicated. Pharmacies are subject to various rules, the understanding of which requires the extensive training of pharmaceutical staff working in pharmacies.
The methods for identity verification are described in the monograph “Cannabis Flowers” of the German Pharmacopoeia (DAB), which came into force in May 2017. In addition, reference is made to the method of identity verification described in the section entitled “Alternative Methods for Identifying DAC / NRF Precursors” for cannabis flowers.
The test certificates for cannabis imported from the Netherlands, including, among other things, the exact content of THC and CBD in each batch, are available on the homepage of the Dutch cannabis agency.
Note: The DAB is a ring binder that exists in every pharmacy. The contents of the DAB are protected by copyright and are not visible to non-pharmacists. The same applies to the monographs of the DAC / NRF. A few explanations can only be found here.
An actual quality inspection does not take place at the pharmacies. Pharmacists only determine the identity based on the test certificates. Likewise, no content determination of the THC and CBD shares is performed.
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Bridging the gap to EU GMP Compliance and Testing
The cannabis agency in Germany (a separate department formed within BfArM) or BfArM, is not responsible for conducting quality control on checks on medical cannabis being imported into Germany by medical cannabis wholesalers. The responsibility lies with the importer into Germany.
Unlike the Danish regulations, Canadian ACMPR regulations are only Good Production Practice (GPP) compliant, not GMP, and Health Canada’s OMC (Office of Medical Cannabis) maintains no such tests.
Therefore, for a Canadian company to export to Germany, they must demonstrate compliance by getting GMP certification of their Canadian facilities through European regulators or regulators from countries part of the MRA (Mutual Recognition Agreement) pertaining to GMP. There are the only groups that can issue a certification to EC GMP Guide.
Continue at: https://www.cannabiscomplianceinc.com/germany-part-2/
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