Costs

The MCA also briefly discussed its preliminary thinking re DTHMP registration costs. The MCA thinks that simple herbal teas (marketed with some indications) and tinctures sold OTC will attract a low level of registration fee, the MCA says on a par with that required for homeopathic registration fees. This might also apply to any product that was on the European Medicines Evaluation Agency centralised list when all an applicant would have to do is to refer to already existing data. Combination products and more complex, "sophisticated" extracts (by which I assume the MCA might mean extracts standardised on perceived actives) are likely to attract a higher registration fee. The MCA say they charge a fee based on the in-house work they have to do to process a registration. Since little data is held by the MCA on Chinese or Indian herbs, these too will in the first instance be likely to be registered at a higher than standard rate. The MCA made the point that the more work the Industry can do itself to assemble data, the cheaper the process is likely to be. The MCA says that it will be holding workshops around the UK on the DTHMP for manufacturers and importers in the coming months. It is also doing trial site visits to companies to see what needs to be done to achieve an acceptable standard of GMP.

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