GACP and GMP: Cannabis in Switzerland

Swiss lawmakers and public authorities are currently discussing relief for the growing and production of pharmaceutical cannabis (THC content ≥ 1%). To date, only growing cannabis with a lower THC content is legal. Growing medical cannabis is already possible today for scientific research purposes, medical applications or pharmaceutical product development, but only with corresponding Swissmedic licenses. Since pharmaceutical cannabis is covered by the Narcotics Act, licenses for growing and production would remain mandatory even after the liberalisation that is being sought.

If liberalisation is officially supported in Switzerland, a corresponding run on growing and production is expected. Obtaining certification from Swissmedic early on can therefore represent an important advantage in the highly competitive cannabis market. After all, pharmaceutical companies and pharmacies are only permitted to procure their active substances and pharmaceutical products from companies with a Swissmedic license. It serves as proof that the GACP and GMP rules are consistently followed. But what takes effect when?

Cannabis growing is subject to compliance with the GACP requirements, the good agricultural and collection practices. These GACP requirements form the basis for implementing a quality assurance system for growing and ensure the flawless quality of the plant raw material.

In the production of medical cannabis products in turn, the GMP rules apply for manufacturing finished pharmaceutical products and active substances according to the EU GMP guidelines, part I (pharmaceutical products) and/or part II (active pharmaceutical ingredients).

Obtaining a Swissmedic approval for the production of medical cannabis in compliance with the GMP rules is certainly complex and requires a structured approach. The GMP experts at gempex have prepared a typical, ideal plan of procedures for the construction or conversion of medical cannabis production operations, which has already been successfully used several times. A unique full-service package is brought to bear here, allowing companies to obtain a GMP production license for plant-based pharmaceutical products in a reasonable time starting with initial planning. Companies who are among the first with a corresponding Swissmedic approval generally have a competitive advantage. After all, cannabis has become far more than just a trending topic in the meantime!

You will find further information on the topic of GMP for cannabis – growing and production and a direct contact person for all GACP and GMP matters under this link.