TCM granules are medicines

Granules of Traditional Chinese Medicine require import permit

05/03/2011

Traditional Chinese Medicine (TCM) offers a variety of alternative treatments, with acupuncture being one of the best-known uses of TCM in this country. According to a ruling of the Federal Administrative Court in Leipzig granules are so-called presentation drugs.

However, the TCM also includes a variety of active ingredients based on herbs and spices, which are often supplied in the form of granules to Germany and processed here by pharmacies. At the Federal Administrative Court in Leipzig, the legal classification of these TCM granules was decided on Thursday. According to the judgment of the Federal Administrative Court, the granules are presentation medicines and their import therefore requires official approval.

TCM granules require import license according to pharmaceutical legislation
In the proceedings at the Federal Administrative Court in Leipzig was to decide on the action of a company that sells industrially processed standardized extracts of herbs and spices of Traditional Chinese Medicine. The granules are needed for the preparation of formulations and are usually delivered directly to pharmacies. However, the competent authority in Bavaria had argued that an official permit under the Medicinal Products Act is required for the import of TCM granules. The applicant company was prohibited from passing on the granules imported without such permission. After the company had already failed with its request at the Administrative Court, the Federal Administrative Court has now accepted as the last instance of the authority's position and required a license under the German Drug Law for the import of TCM granules.

TCM granules are to be evaluated as presentation medicinal products
According to the judgment of the Federal Administrative Court, the granules of Traditional Chinese Medicine are to be judged according to the German Medicines Act. After all, pharmaceutical legislation covers not only medicines whose pharmacological action for restoring or influencing bodily functions is actually proven (functional medicines), but also preparations which serve to heal or alleviate human diseases and thus give the impression of a medicinal product (so-called presentation medicines). In order to protect consumers from potentially ineffective or at worst harmful substances, presentation medications must also be treated in accordance with pharmaceutical legislation, according to the judgment of the Federal Administrative Court. The imported granules for TCM are to be considered as presentation medications and therefore require a corresponding permit upon importation.

Importer responsible for quality and safety
The reasoning of the importing company was not to be followed because the granules of Traditional Chinese Medicine were designated and introduced as remedies for use in pharmacies. It does not matter that the granules were delivered only to pharmacies and not to end consumers, so the judgment of the court. As a presentation drug must also be available for the granules an import license under pharmaceutical law to ensure that no potentially harmful to health agents are used for the treatment of human diseases. As an importing company, the applicant, like a manufacturer, should be responsible for the safety and quality of the granules it distributes. This was to ensure that no questionable preparations were handed over to end customers in Germany. In addition, the TCM granules are not mere precursors, which are first processed by the pharmacists into medicines, but the granules are already essentially produced and usable in their imported form. The supplied pharmacists would only put together the individual mixtures for the patients, said the Federal Administrative Court. (Ref .: BVerwG 3 C 8.10 - Judgment of 3 March 2011)

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