The distinction between Good Agricultural and Collection Practice (GACP) and Good Manufacturing Practice (GMP), notably for the drying step of medical hashish flowers, has lately created some confusion in the hashish business.

Authored By: Peter Homberg, Dentons Europe LLP

 

The situation for importing medicinal hashish into Germany is that the flowers or extracts are manufactured in accordance with the relevant provisions on the manufacture and high quality assurance of medicinal merchandise of the European Union or in accordance with requirements equal to those.

These primary guidelines are specifically the guidelines on GACP and GMP. For the import of hashish from a rustic outdoors of the European Union, a nationwide certificates of the third nation have to be obtainable, which confirms the GMP conformity of the international manufacturing web site and which was accepted in precept inside the framework of a Mutual Recognition Agreement (MRA) between the third nation and the European Union.

If such an MRA doesn’t exist, the competent nationwide authority should itself examine the institution in the third nation in order to challenge its personal GMP certificates. This is usually a prolonged and pricey process.

In the pursuits of many corporations, methods are actually being sought to keep away from the lengthy and pricey strategy of GMP certification in third international locations. One of those methods is that medical hashish flowers are cultivated and harvested in conformity with GACP in a 3rd nation and then processed in conformity with GMP in the European Union. As such, solely the preliminary cultivation and processing steps can be carried out at the international manufacturing web site and no GMP certificates of the international manufacturing web site can be required since solely processing steps which don’t but fall below GMP can be carried on the market.

Whether that is attainable relies upon basically on which particular processing steps are carried out in the respective manufacturing web site and which guidelines of GACP and GMP apply to which processing steps. This is especially questionable for these elements the place GACP and GMP overlap: specifically reducing, drying and packaging.

In Germany, the answer relies upon largely on the interpretation of the GMP pointers by the competent authorities. The Düsseldorf district authorities, for instance, assumes that drying, reducing and packaging of hashish flowers is already lined by GMP and due to this fact an import certificates is required if these steps are carried out in a 3rd nation.

If as an alternative the flowers are first imported into one other Member State of the European Union and then shipped to Germany, the interpretation of the authorities of the respective Member State is decisive.

If they arrive to the conclusion {that a} GMP certificates was not needed, import to Germany is feasible even with no GMP certificates of the preliminary cultivation web site. Accordingly, flowers from Uruguay had been lately shipped to Germany from an organization with no GMP certificates through Portugal the place they had been additional processed below GMP circumstances.

It stays to be seen whether or not a clarifying standardization will happen in close to future.

 

 

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