THCA Therapeutics received a written response from the German Federal Institute for Drugs and Medical Devices, BfArM, regarding the potential importation of pure THCA-A for medical and scientific research purposes.

According to the preliminary assessment provided by BfArM, the pure substance (-)-trans-Δ9-tetrahydrocannabinolic acid A, also referred to as THCA-A, does not fall under the provisions of the German Medical Cannabis Act, MedCanG. On this basis, the importation of the pure substance would not require an authorization under Section 4 MedCanG or an import permit under Sections 12 et seq. MedCanG.

BfArM also clarified that the regulatory treatment may differ when THCA-A is contained in a preparation, mixture or formulated product that falls within the legal definitions of the MedCanG.

Because the structural formula included in the initial project documentation did not fully correspond with the substance known to BfArM as THCA-A, the authority was not able to provide a final and binding classification for the intended material.

THCA Therapeutics is therefore preparing a detailed clarification of the exact substance identity, including:

• the full chemical and IUPAC name,
• structural and molecular formula,
• molecular weight,
• CAS number,
• Certificate of Analysis,
• product specification,
• purity profile, and
• information regarding Δ9-THC and other possible impurities.

The next step is to determine whether a formal substance classification request is required for the specific THCA-A isolate intended for importation.

This correspondence represents an important regulatory milestone for THCA Therapeutics. It provides an initial indication that chemically pure THCA-A may be treated differently from medical cannabis preparations under German law, while confirming that the exact chemical identity and composition of the intended product must be verified before importation.

Status: Regulatory clarification received; substance-specific confirmation pending.