Licensing of Medicines: Policy on Herbal Medicines in European Union and UK (Sun Ten Journal, No. 3, Sept 2004, Page 99-100)

The Medicines and Healthcare products Regulatory Agency (MHRA) formed from a merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) on April 1, 2003.  MHRA is responsible for improving regulatory arrangements for herbal medicines in order to further protect public health.

To provide the public with access to a wide range of safe, high quality herbal remedies with appropriate information about the safe use of the product.

Current regimes
There are two alternative regulatory routes for herbal medicines:

  1. Licensed herbal medicines:
    To receive a product licence (market authori-zation), herbal medicine are required to meet safety, quality and efficacy criteria in a similar manner to any other licensed medicines.
  2. Herbal remedies exempt from licensing:
    The exemption applies where herbal remedies are "special" designed by Doctors for specific patients.

Problems with current regimes
Many companies have difficulty meeting conventional requirements to prove product efficacy when seeking a licence for herbal medicines. This arrangement protects the public but tends to restrict choice.

For unlicensed herbal remedies, there are no specific safeguards on the quality and safety, and there`s not enough information for the public about the safe use of unlicensed products. This arrangement gives the public choice, but not enough protection.

The MHRA reached a wide measure of agreement with the UK natural health sector on the need to improve the regulatory position, and is engaged in ongoing dialogue with around 50 interest groups which represent consumers, practitioners, manufacturers, suppliers, retailers, and healthcare professionals. Helpful contributions have been made by these and other groups.

European development
The European Commission has recognized that a number of Member States have difficulties with current European law in the existed regulations of herbal medicinal products. Two recent initiatives cover:

  1. Well established` medicines: Commission Directive 99/83EC in principle gives greater flexibility in the use of bibliographic data for this category of medicines to meet the requirements to demonstrate safety and efficacy.
  2. Traditional use` medicines: In September 1999 the European Pharmaceutical Committee set up a working group of Member States to investigate the possibility of a directive for traditionally used medicines. The MHRA, representing the UK, was asked to act as rapporteur for the group, developing ideas on the possible contents of a directive.

The Traditional Herbal Medicinal Products Directive
In January 2002, the Commission adopted formal Proposals for a Directive on traditional herbal medicinal products. The MHRA held a full public consultation during the summer of 2002. This is extended for greater dialogue between the Agency and the herbal sector.  During this period, a range of products ingredients were noted as potentially not meeting the terms of the Directive by stakeholders. A meeting was held on May 30, 2003 and November 25, 2003 between the Agency and representative of herbal sector to discuss the amendments to the proposed Directive which was issued by the Commission in April 2003.

Progress of negotiations on the Directive
The Directive is subject to the co-decision procedure that involves discussion and agreement within and between the Council of Ministers and the European Parliament. The European Parliament completed the first reading of the proposal in November, 2002. The European Commission brought out amended proposals of the Directive on April 9, 2003 after taking into account the European Parliament amendments and earlier negotiations in the Council of Ministers working group.
The European Parliament supported the Directive during its second readings in a plenary session on December 17, 2003. The Directive was formally adopted at a Council of Ministers meeting on March 11, 2004.

The Traditional Herbal Medicinal Products Directive was published in the "Official Journal of the European Union" on April 30, 2004. Paragraph 1 of article 2 stated that: "the Member State shall take the necessary measures to comply with this Directive by October 30, 2005......".

UK Government must take measures to implement the Directive into UK law within 18 months (October 30, 2005) of the Directive coming into force.  This could lead to the introduction of a simplified registration scheme for manufactured over-the-counter (OTC) traditional herbal remedies in the second half of 2005.  There would be a further "transitional" period of 51/2 years to allow all existing herbal medicines to gain a Traditional Registration.

Information came from the Medicines and Healthcare products Regulatory Agency (MHRA), Licensing of medicines: Policy on herbal medicines.

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