Kurs Nr. 17271
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Dr Ingrid Walther, Pharma Consulting Walther, Germany
Mag. Bernhard Föger, AGES (Austrian Agency for Health and Food Safety), Austria
Dr Reinhard Kerker, GMP-Inspectorate, Germany
Savvas Koulouridas, Fagron, Netherlands
Silja du Mont, GDP/GCP -Inspectorate, Germany
Dirk Ohlenforst (invited), Bonn, Germany
Medical cannabis has been permitted for prescription in Germany since 2017, causing a need for producers supplying pharmacists and physicians with the newly "legalized" drug. But what qualifies as medical grade cannabis? This conference will give you an overview of all relevant regulatory and GMP/GDP requirements and aspects of medical cannabis.
In March 2017, the national German legislature expanded the options for prescribing medical cannabis products by passing a law amending provisions under the Narcotics Law and other regulations. These products, however, must comply with the relevant requirements laid down under Medicinal and Narcotics Law, including GMP and GDP. Therefore, the BfArM (the Federal Institute for Drugs and Medical Devices) has taken over new responsibilities by establishing the Cannabis Agency. This agency is meant to help in ensuring supplies for medical-quality cannabis.
Unlike AGES in Austria, though, where cultivation of medical cannabis has already been established, cannabis will not be cultivated by BfArM itself, but by commissioned companies. Cannabis is not meant to be stored directly at BfArM during any stage of the purchasing, harvesting or distribution process. These steps will be carried out by relevant producers or other commissioned companies (i.e. suppliers, importers). Hence, the agency will manage and monitor the cultivation, harvest, processing, quality assurance, storage, packaging and distribution of cannabis to wholesalers, chemists or manufacturers.
The GMP inspectorates are responsible for issuing manufacturing and import licenses or GMP Certificates. Thus, they will perform inspections at the sites of manufacturers who apply for these certificates and licenses.
The Cannabis Agency is responsible for ensuring that only medical grade cannabis is supplied,
The relevant requirements based on the underlying legal framework (including Pharmacopoeias) and the corresponding GMP, GDP and GACP guidelines must be complied with, and finally
Cannabis for medical purposes is also subject to the provisions of the German Narcotics Law.
This conference addresses specific GMP aspects to consider for Growers, Manufacturers, Start-Ups, Suppliers, Importers, QPs and QA personnel involved in Cannabis production. The topics provided are also of interest for GMP/GDP Inspectors responsible for issuing a GMP- certificate or manufacturers- / import license.
Welcome and Introduction
GMP for Cannabis: setting the scene
Production of Cannabis flos for medical purpose
Good Agricultural and Collection Practice, GACP
Cannabis Production / Infrastructure / Monitoring
GMP Certification / Manufacturing and Importation Authorization
Aspects to consider for applications for Manufacturing and Importation Authorizations
GMP certification: What you need to know
Inspections in Europe and beyond: Typical and recurrent compliance issues
Narcotic drugs - The regulations
Short overview of the German Narcotics Law ("Betäubungsmittelgesetz", BtMG)
Necessary documents for granting general licenses and import / export authorizations by the Federal Opium Agency (BfArM)
Reasons for refusal
GDP for Cannabis
Requirements for transport to pharmacies, veterinary dispensaries, hospitals
Requirements for distribution of cannabis through international distribution partners, wholesalers and 3PL partners
Launch of Cannabis products
Requirements to fulfil
Infrastructure, global marketing and distribution agreements
Medicinal cannabis products like oils and oil derivate products such as capsules, sublingual wafers and topical creams
Supplier qualification and handling after import
Experiences - Lessons learned
Application of GMP principles to Cannabis
Quality management System (QMS) including Qualification/Validation
DAB Monograph "Cannabis Flos": Points to consider