Important information about the "Sunset Clause" and marketing authorisations for herbal products

The MHRA is writing in May to all holders of marketing authorisations (MAs) asking them to submit to MHRA by 12 July a return about the marketing status of each of their authorised products for the purposes of a one-off Sunset Clause exercise. The letter reminded companies that if a medicinal product has not been on the market for 3 consecutive years since 30 October 2005, or was first authorised on or after 30 October 2005 but has never been placed on the market, and 3 consecutive years have elapsed, the MA automatically becomes invalid. MA holders will be required to continue to notify interruptions in supply in the future to ensure that MAs do not inadvertently become invalid because a product has not been on the market for 3 years. The letter also explained to companies that in certain exceptional circumstances it was possible to make a formal request to MHRA, as the competent authority, for an exemption on public h ealth grounds from the invalidation of their marketing authorisation.

Following a meeting between MHRA and representatives of the Herbal Forum on 19 May the MHRA wishes to highlight one additional circumstance in which it would be reasonable for a company to make a request for public health exemption for certain herbal products with MAs that are not currently on the market .

The MHRA initiated discussion with the Herbal Forum on 19 May about preparations for an MHRA programme, for implementation over a number of years, in which the regulatory status of existing herbal MAs would be reviewed to see whether a proportion may more appropriately come within the category of traditional herbal registration (THR). The main focus of this exercise will be on those products which around the early 1990s following review by the Committee on Review of Medicines, were given a marketing authorisation with a traditional use indication and any subsequent "piggy back" versions of these products. Full guidance on this programme will be discussed with the Herbal Forum and then posted on the MHRA website.

There may be certain herbal products with an existing MA that are not currently on the market which companies consider it may be feasible to return to the market under the THR scheme. Where a company considers there is a realistic possibility that they may want to move a currently non marketed herbal MA into THR status we would invite the company to request the public health exemption and to annotate the relevant form in the Sunset Clause exercise with the following words:

"We plan to have discussion with the MHRA about the regulatory status of this product as part of the MHRA programme to review the regulatory status of herbal products with an MA."

Where the MHRA receives such a request for a herbal product with an MA we are likely to agree that an exemption from the effect of the Sunset Clause should be given for three years. Any further extension beyond three years would be for consideration in the light of circumstances at the time. Potentially such an extension could be made if at that point a company was actively pursuing THR status for the product.

Please note that where companies request the public health exemption for a herbal product in this way this does not create an obligation to pursue THR status for the product in question, but rather an initial intention to consider this possibility: we recognise that companies will need to consider their plans carefully in the light of guidance to be issued about the arrangements enabling herbal MAs to transfer to THR status. Equally, companies are reminded of the guidance, already issued for the Sunset Clause one-off exercise, that it is the responsibility of the applicant seeking to make use of the public health exemption to inform the MHRA if any of the exceptional circumstances should change. Therefore, if a company having claimed the public health exemption in this way for a non marketed herbal MA subsequently decides not to pursue this route it should notify the MHRA accordingly.