§ Mrs. Ann WintertonTo ask the Secretary of State for Health what steps she has taken to satisfy herself that herbal products which do not require any licence under the terms of the Medicines Act 1968, rather than simply being exempt by sections 12 and 56 of that Act, will remain available under the provisions of the proposed new Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations; and if she will make a statement.
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§ Mr. SackvilleWe have looked carefully at all the circumstances in which herbal products are sold and supplied. Those herbal products which require no licence under the Medicines Act will remain available under the new regulations.
§ Mrs. Ann WintertonTo ask the Secretary of State for Health whether her recent announcement that herbal remedies currently exempt from licensing restrictions on their preparation under section 12 of the Medicines Act 1968 will remain exempt under the proposed new Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations also applies to their exemption under section 56 of that Act from restrictions on the supply of such herbal remedies; and if she will make a statement.
§ Mr. SackvilleThe exemptions and public health safeguards for herbal medicines under section 56 of the Medicines Act 1968 will continue to apply under the new regulations.
§ Mrs. Ann WintertonTo ask the Secretary of State for Health (1) what protection will be afforded by the proposed new Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations for those products which are sold only to herbalists and other practitioners for use in their preparations but not directly to the public; and if she will make a statement.
(2) what assumptions her Department has made of whether products sold directly to herbalists and other practitioners are considered to be placed on the market in the context of European directives; whether or not they therefore fall within the licensing requirements of relevant European directives; what steps she is seeking to guarantee their continued availability; how their continued availability will be protected by the proposed new Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations; and if she will make a statement.
§ Mr. SackvilleHerbal products supplied to herbalists and other practitioners for use in their preparations but not directly to the public, which are currently exempt from product licensing requirements under the Medicines Act 1968, will retain their exemption under the proposed new regulations. This will be the case whether or not these products can be regarded as placed on the market.
§ Mrs. Ann WintertonTo ask the Secretary of State for Health what consideration she has given to the proposals of the Natural Medicines Society for a simplified registration system for its preparations which would require the demonstration of safety and purity but not necessarily of efficacy; and if she will make a statement.
§ Mr. SackvilleHerbal medicines covered by exemptions from product licensing requirements under section 12 of the Medicines Act 1968 will remain exempt. The need for a simplified registration scheme for such products does not therefore arise.
§ Mrs. Ann WintertonTo ask the Secretary of State for Health how many representations her Department has received in total from individuals and from right hon. and hon. Members registering concern about the proposed new Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations; and how many of these representations welcomed the regulations in question.
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§ Mr. SackvilleThe Department has received about 3,500 letters from individuals and over 1,000 letters from right hon. and hon. Members who were concerned about the possible effect of the proposed new regulations on herbal medicines. Our confirmation that herbal medicines currently exempt from product licensing requirements will continue to enjoy this exemption when the new regulations come into force has been generally welcomed.
§ Mrs. Anne WintertonTo ask the Secretary of State for Health whether preparation of herbal products in the form of tinctures, extracts, powders and tablets falls outside the definition of industrial processes set by the European directive to be implemented through the proposed new Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations; and if she will make a statement.
§ Mr. SackvilleWe are satisfied that herbal preparations in the forms described, which are prepared by traditional processes, are not "industrially produced" when supplied in accordance with section 12 of the Medicines Act. They will therefore continue to be exempt from product licensing requirements.
§ Mrs. Ann WintertonTo ask the Secretary of State for Health if she will make available in the Library copies of all correspondence which she, her officials, and officials of the Medicines Control Agency have had with the European Commission in connection with the proposed new Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations and in connection with relevant European directives.
§ Mr. SackvilleSuch correspondence is regarded as confidential by the parties concerned. In my announcement of 11 November, I made clear our view in the position of herbal medicines under the relevant EC directive and the considerations that gave rise to that view.