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Herbal Medicine

Volume 479: debated on Monday 1 September 2008

To ask the Secretary of State for Health (1) how many applications under the provisions of the Traditional Herbal Medicinal Products Directive the Medicines and Healthcare products Regulatory Agency expects to receive for (a) single ingredient products and (b) more complex products; (221075)

(2) if he will list the principal quality and efficacy tests which must be met by manufacturers submitting products for registration under the Traditional Herbal Medicinal Products Directive; and if he will indicate in the case of each such test the costs of compliance assumed in the context of the regulatory impact assessment produced in connection with this legislation;

(3) what the requirements are under the Traditional Herbal Medicinal Products Directive for a qualified person to be employed to authorise the release of herbal products to the market; what purpose is served by this requirement; and what assessment he has made of the costs associated with this provision for a small manufacturer of specialist herbal remedies;

(4) what the outcome was of the recent review of the operation of the Traditional Herbal Medicinal Products Directive undertaken by the European Commission; what period was covered by the review; and whether he intends to make it his policy to press for the review to be repeated now that member states have had the opportunity to use the provisions of the Directive.

It is a commercial decision for individual companies whether to apply for a traditional herbal registration (THR) under the provisions flowing from directive 2004/24/EC. The Medicines and Healthcare products Regulatory Agency (MHRA) is not in a position to estimate how many applications will be submitted. So far, the MHRA has received 38 THR applications, of which 33 are for products containing a single active ingredient and five are for combination products. The MHRA expects that a high proportion of early applications will be for relatively simple products while companies become accustomed to meeting the regulatory requirements of the scheme.

There is normally no requirement for applicants to submit information on the efficacy of the product under the THR scheme. The quality requirements for herbal medicinal products and traditional herbal medicinal products are set out in detailed guidance documents following consultation with industry. The European Pharmacopoeia also sets out legally binding standards for herbal ingredients as well as excipients used in herbal medicinal products. The purpose of the quality tests is to ensure that the herbal medicinal product is safe for use and has a reproducible quality over its proposed shelf-life. Tests are required to ensure that the correct plant materials are used, free from potentially hazardous contaminants such as pesticide residues, fumigant residues, heavy metals/other toxic elements, mycotoxins, bacteria/fungi. Where herbal extracts are employed, tests are required on all materials used, including solvents and reagents used for extraction, to ensure that they are as intended and of acceptable quality. The herbal extract undergoes tests to ensure it is of reproducible quality and that it is free from hazardous levels of, for example, residual solvents, micro-organisms or potential contaminants from the starting plant materials. The finished dosage form is tested to ensure that it contains the declared amount of herbal ingredients and that it will remain of suitable quality throughout the proposed shelf-life.

European and United Kingdom medicines legislation requires manufacturers and/or importers of registered traditional herbal medicines for human use to hold a manufacturer’s licence. It is a condition of such a licence that the holder must have a Qualified Person (QP). The QP must either meet existing specific educational and vocational requirements or attain status through transitional arrangements. The QP has a personal responsibility for certifying that each batch of registered traditional herbal medicine, has undergone the appropriate tests, complies with its registered specification and has been manufactured in accordance with good manufacturing practice. The purpose of these requirements is to ensure that a safe quality traditional herbal medicine is placed on the market.

In its regulatory impact assessment of the THR scheme, the MHRA estimated that typically the costs of registering a product under the scheme could be several tens of thousands of 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.

The European Commission launched a public consultation in May 2007 on the review of the operation of directive 2004/24/EC. The consultation included data up to March 2007. It is the European Commission’s responsibility to report on the findings of that review and, pending that outcome, we have no present plans to press for an early second review.

To ask the Secretary of State for Health what the requirements are under the provisions of the Traditional Herbal Medicinal Products Directive for the certification of manufacturing premises; what charges are levied by the Medicines and Healthcare Products Regulatory Agency for inspections associated with such certification; and how many facilities have (a) been inspected and (b) been certified as meeting the necessary standards. (221078)

The Directive on Traditional Herbal Medicinal Products requires manufacturers of registered herbal medicines to be authorised by the national competent authority. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency authorises and inspects manufacturers. The inspection fee is currently £1,496 for a full day and £920 for half a day. Manufacturers must meet certain conditions and employ a qualified person in order to be authorised. A number of manufacturers were already authorised to manufacture herbal medicines before the Directive came into force. Since the implementation of the Directive all of the small number of manufacturers who have applied specifically to manufacture registered herbal medicines have been authorised.

To ask the Secretary of State for Health how many applications for product registrations under the provisions of the Traditional Herbal Medicinal Products Directive have been received by the Medicines and Healthcare Products Regulatory Agency to date; and how many of those applications have been approved. (221691)

The Medicines and Healthcare products Regulatory Agency has so far received 38 applications from 14 companies to register products under the traditional herbal registration scheme. To date 17 registrations have been granted and the remaining applications are under assessment.

To ask the Secretary of State for Health what assessment he has made of the regulatory impact of the Traditional Herbal Medicinal Products Directive on (a) small and medium-sized specialist manufacturers of herbal remedies, (b) specialist retailers and (c) consumer choice. (221692)

In its regulatory impact assessment of the traditional herbal registration (THR) scheme the Medicines and Healthcare products Regulatory Agency (MHRA) estimated that typically the 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. A steadily expanding THR scheme, alongside the availability of licensed herbal medicines, will offer consumers wide choice of over the counter herbal medicines made to assured standards of safety, quality and product information. The likelihood of increased consumer confidence in the standards of products, including the reliability of product information, could also be of benefit to responsible specialist manufacturers and retailers.

To ask the Secretary of State for Health what estimate he has made of the number of herbal products marketed under the provisions of Section 12(2) of the Medicines Act 1968 as medicines exempt from the need for a licence in the last 30 years; how many and what percentage of those products will need to secure registrations under the Traditional Herbal Medicinal Products Directive; and what steps he is taking to assist manufacturers with this process. (221693)

Companies are not required to notify the Medicines and Healthcare products Regulatory Agency (MHRA) of products marketed under section 12(2) of the Medicines Act 1968, therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under Directive 2004/24/EC manufactured herbal medicines placed on the market will require either a marketing authorisation or a traditional herbal registration (THR). As now there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.

The MHRA continues to provide a range of help to companies aimed at helping them to progress plans to register products including holding meetings with companies to discuss the progress of actual or prospective applications under the THR scheme and providing a range of detailed advice via the agency’s website.

To ask the Secretary of State for Health by what date herbal products marketed under the provisions of Section 12(2) of the Medicines Act 1968 as medicines exempt from the need for a licence will need to secure a registration under the provisions of the Traditional Herbal Medicinal Products Directive; and whether he plans to ask the European Union to extend that deadline. (221694)

From 30 April 2011 no herbal medicine within the scope of Directive 2004/24/EC may be placed on the market or distributed by way of wholesale dealing without a traditional herbal registration. As now there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation. We have no plans to ask the European Commission to propose legislation extending the deadline in Directive 2004/24/EC.

To ask the Secretary of State for Health what charges are levied by the Medicines and Healthcare Products Regulatory Agency for processing applications for product registrations under the Traditional Herbal Medicinal Products Directive for (a) single ingredient and (b) complex products. (221695)

The current fees for registering applications for products under the traditional herbal registration scheme range from £555 for single existing ingredient to £7,480 for complex new products. The fees charged by the Medicines and Healthcare products Regulatory Agency (MHRA) are set at a level to reflect fairly the cost related to each activity. These fee levels and costs are reviewed closely every year. This is in line with HM Treasury guidance.

MHRA fees for registering herbal products are significantly lower than those levied on pharmaceutical companies for the registration of other medicines. The fees are based on an estimate of the amount of time it takes to undertake each of the activities and the costs of the relevant staff required to undertake these activities. Applications that are more complex take longer to assess and can require staff with more experience to undertake the work. These costs are reflected in the fee charged. The fee of £7,480 for processing applications for registration of complex herbal products containing two or more ingredients not previously assessed by the agency reflects the additional work necessary when assessing ingredients for the first time.