TCM: Granules are drugs

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Granules of traditional Chinese medicine require an import permit

Traditional Chinese Medicine (TCM) offers a variety of alternative treatment methods, whereby acupuncture is probably one of the best-known areas of application of TCM in Germany. According to a judgment of the Federal Administrative Court in Leipzig, granules are so-called presentation medicines.

However, the TCM also includes a large number of active ingredients based on herbs and spices, which are often delivered to Germany in the form of granules and processed here by the 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 medicinal products and their import therefore requires official approval.

TCM granules require import license according to pharmaceutical law In the proceedings at the Federal Administrative Court in Leipzig, a decision had to be made about the lawsuit of a company that sells industrially processed standardized extracts from herbs and spices of traditional Chinese medicine. The granules are required for the production of prescriptions and are usually delivered directly to pharmacies. However, the competent authority in Bavaria had argued that an official license under the Medicinal Products Act is required to import the TCM granules. The plaintiff was prohibited from passing on the granules imported without such permission. After the company had already failed with the matter at the administrative court, the Federal Administrative Court, as the last instance of the authority position, has now also approved and required a license under the Medicinal Products Act for the import of TCM granules.

TCM granules are to be assessed as presentation medicinal products According to the judgment of the Federal Administrative Court, the granules of traditional Chinese medicine are to be assessed according to the Medicinal Products Act. This is because pharmaceutical law does not only cover medications whose pharmacological effects for restoring or influencing bodily functions have actually been proven (functional medicinal products), but also preparations that serve to cure or alleviate human diseases and thereby give the impression of a medicinal product (so-called presentation medicinal products). In order to protect consumers from potentially ineffective or at worst health-endangering substances, the presentation medicinal products must also be treated according to pharmaceutical law, according to the ruling of the Federal Administrative Court. The imported granules for the TCM are to be assessed as such presentation medicinal products and therefore require a corresponding permit when they are imported.

Importer responsible for quality and safety The reasoning given by the importing company should not be followed, since the granules of traditional Chinese medicine were described and introduced as remedies for use in pharmacies. It does not matter that the granules were only delivered to pharmacies and not to end users, the court ruled. As a presentation medicine, an import license according to pharmaceutical law must also be available for the granules to ensure that no potentially health-endangering agents are used for the treatment of human diseases. As an importing company, the applicant, like a manufacturer, must be responsible for the safety and quality of the granules it sells. This is to ensure that no questionable preparations are sold to end customers in Germany. In addition, the TCM granules are not mere preliminary products that are only further processed into medicines by pharmacists, but the granules are essentially already manufactured and usable in their imported form. The supplied pharmacists would only put together the individual mixtures for the patients, the Federal Administrative Court said. (Ref .: BVerwG 3 C 8.10 - judgment of March 3, 2011)

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