THCA Therapeutics received written confirmation from the German Federal Institute for Drugs and Medical Devices, BfArM, regarding the regulatory classification of pure THCA-A intended for importation into Germany.

Following the submission of detailed chemical information, BfArM confirmed that the substance was clearly identified as:

(-)-trans-Δ9-tetrahydrocannabinolic acid A — THCA-A
CAS No. 23978-85-0

According to BfArM, the pure substance THCA-A does not fall under the provisions of the German Medical Cannabis Act, MedCanG.

BfArM therefore confirmed that the importation of pure THCA-A into Germany does not require:

• an authorization under Section 4 MedCanG; or
• an import permit under Sections 12 et seq. MedCanG.

The authority additionally clarified that a MedCanG authorization may become necessary if THCA-A is converted into Δ9-tetrahydrocannabinol, including dronabinol, for medical or scientific purposes.

THCA Therapeutics intends to develop stabilization, manufacturing and storage processes designed to preserve THCA-A in its acidic form and minimize decarboxylation into Δ9-THC. Any potential conversion or manufacturing activity will be assessed separately and conducted in accordance with the applicable regulatory requirements.

This confirmation represents an important regulatory milestone for the project and provides greater clarity for the planned sourcing and importation of pure THCA-A for future pharmaceutical research and development.

Status: Regulatory identity confirmed and pure THCA-A import requirements clarified by BfArM.