Competent advice inCannabis Law
Do you have questions about the trade in medicinal cannabis?
- In-house and contract manufacturing
- GMP certification
- Import and export
- AMRadV applications
- Wholesale trade permit
- Narcotics trade permit
- Distribution and pricing law
We are happy to help!
If you have any questions about cannabis law, we welcome you to contact us by email at:
Of course, you can also reach us by phone at +49 (40) 33443690.
Since 10 March 2017, medical cannabis may be prescribed in Germany as dried flowers or as an extract with the active ingredients dronabinol or nabilone at the expense of the health insurance under certain conditions. However, only medicinal cannabis from cultivation under state control or approved finished medicinal products containing cannabis can be prescribed.
According to § 31 para. 6 of the German Social Code Book V (SGB V), doctors can prescribe medical cannabis if there is a serious illness and a "generally recognised service corresponding to the medical standard" is either not available or "cannot be used according to the justified assessment of the treating panel doctor, weighing up the expected side effects and taking into account the state of illness of the insured person". In addition, there must be a "not entirely remote prospect" that the course of the disease or serious symptoms will be "noticeably positively" influenced.
The way cannabis is prescribed is regulated in the Narcotic Prescription Regulation (Betäubungsmittel-Verschreibungsverordnung, BtMVV).
In order to be allowed to trade in medicinal cannabis in Germany, one needs, on the one hand, a wholesale medicinal product licence according to § 52a of the German Medicinal Products Act (AMG) and, on the other hand, a narcotics trade licence according to § 3 of the German Narcotics Act (BtMG).
If the cannabis products in question have been treated with ionising radiation to reduce the germ count (§ 7 AMG and § 1 AMRadV), it is also necessary to apply to the Federal Office for Drugs and Medical Devices (BfArM) for authorisation of these products.
If you also want to cultivate, store, import, trade, distribute and/or promote medicinal cannabis, we will be happy to advise you.
We are happy to support you in these areas, among others:
Setting up a company
- Finding a location and land
- Registration of trademarks and other protective rights
- Application for a wholesale licence according to § 52a AMG (German Drug Law)
- Application for a narcotics trade licence according to § 3 BtMG
- Filing AMRadV applications
- Conclusion of contracts with growers, contract manufacturers and storage service providers
- Conclusion of contracts with transport service providers
- Site selection and site analysis
- GMP requirements (conformity)
- GDP requirements (conformity)
- Import and export permits
- Examination of the marketability of the goods
- Examination of advertising to consumers and professionals
- Application for a PZN number
- Price law
- Conclusion of supply contracts with wholesalers and pharmacies
PharmSec Internattional GmbH, founded in cooperation with the law firm DIEKMANN Rechtsanwälte, advises companies in particular in the areas of medicinal products and narcotics (BtM) and supports them in applying for and maintaining permits (e.g. for wholesale trade in medicinal products pursuant to § 52a of the German Medicinal Products Act (AMG) or for trade in narcotics pursuant to § 3 of the German Narcotics Act (BtMG)).
The brains behind the company are, in addition to Dr. Fabinne Diekmann, Mr. Stefan Heinz, who has many years of experience in QA/GMP/GDP - most recently as head of quality assurance at Mundipharma GmbH in Limburg (Lahn). In addition, he has many years of experience in conducting quality audits (3rd party audits) and inspections by authorities in the national and international environment.
In addition, PharmSec offers its own training courses and acts as a speaker on various platforms.