In order to directly enter the German pharmaceutical market, a German entity with a Managing Director (MD) is required. As the German regulatory regime is made up of a federal system consisting of different local autonomous regulatory bodies and agencies, the location of the company office defines the authority responsible for the processing of permits and licenses. While all federal states (Bundesländer) are abiding by the same rules and regulations, the legal interpretation and actual execution might differ from state to state.
The MD’s role has to be complemented with in-house company committed Quality Manager, who is upholding the Quality Management System (QMS). This system clearly defines roles, responsibilities and processes ensuring that the product that is imported, released and distributed is complying to EU-harmonized Good Distribution Practices (GDP), a guidelines regime outlined: European Commission on Good Distribution Practice of medicinal products for human use
Setting up a Quality Management System
When relying on service providers for your supply chain, it is crucial that all delegated responsibilities are properly documented and described in your QMS. It has to be mutually agreed upon in writing and communicated to the relevant authorities.
For instance, the manufacturer for cannabis flowers or extracts might hand over its produce to a company treating it with ionizing radiation packager to reduce bacteria and fungi count, who then sends sample to a test lab for confirming contents and bacteria count. Another company might be responsible for packaging. Another company might be then responsible for transport, storage and distribution. Nevertheless, the final quality responsibility rests with the MD of the German entity.
Once the wholesale entity is setup, quality agreements and service provisions are in place, the location of the manufacturer stipulates the local regulatory activities. For instance, if the cultivation is outside the EU, the German entity is the importer of goods and must hold an import license according to §72 AMG (Medicinal Products Act, Arzneimittelgesetz).
Once a Qualified Person based in the EU has released the product on relevant specifications and testing results, it can be sold in Germany and the wider EU market.
The aforementioned details are relevant for the following four permits and licenses, as they are required for introducing cannabis products to the German pharmaceutical market and navigating through the respective main regulatory challenges.
1) The wholesale company is required to import and distribute the cannabis product to German pharmacies, according to §52a AMG (Medical Product Act).
2) The narcotic license is necessary for any entity handling cannabis produce if there is an intention to sell and distribute medical cannabis with a THC-content > 0.2% according to §3 BtMG (Narcotics Act)
3) The AMRadV license is required if the cannabis flower is treated with ionizing radiation to reduce germ count. Any such produce has to comply with the the Order on radioactive medicinal products and medicinal products treated with ionising radiation (German designation: AMRAdV, Irradiation Decree)
4) The Import License is necessary for importing cannabis produce from non-EU countries, according to §72 AMG.