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Health: Herbal Products

Answer

The Medicines and Healthcare products Regulatory Agency (MHRA) would expect some rationalisation in the manufacturing of herbal medicines reflecting the fact that to carry out this activity safely to systematic standards within a regulated environment requires specialist expertise. It is likely that some manufacturers lacking such specialist expertise may withdraw from the market. However, there is no basis on which to make specific estimates. Feedback to the agency from individual companies suggests that many are still developing their plans for registering products under the traditional herbal registration (THR) scheme. So far 14 companies have submitted applications to register one or more products in the UK under the scheme and we therefore anticipate that there will be a competitive market. It is not possible to estimate the impact of the THR scheme on retailers. One factor is likely to be improved consumer confidence in products made to assured standards. The guidelines on the quality of herbal medicinal products prepared by the European Medicines Agency largely reflect good practice identified by the herbal industry. In its regulatory impact assessment of the THR scheme the MHRA estimated that typically the overall costs of registering a product under the scheme could be several tens of thousand pounds but that the figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed.

Secondary information

Type

Written question

Reference

5063; 703 c364-5WA

Session

2007-08

Notes

Answer received between Tuesday 19 August and Tuesday 26 August 2008

Subjects

Costs EU law Registration Herbal medicine

Contains statistics

Yes

Link

View this Written question on www.publications.parliament.uk