The classification of botanical (herbal) products – A UK ...

The classification of botanical (herbal) products – A UK perspective

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This presentation will cover

• The MHRA and the work of the Medicines Borderline Section

• The classification of botanical products

Safeguarding public health

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What we do

• The work of the Medicines Borderline Section is to investigate the status of products which do not have marketing authorisations and to determine whether or not they fall within the definition of a medicinal product.

• Products can fall on the borderline with foods, cosmetics, biocides, medical devices and the General Products Safety Directive.


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Classification

The MHRA reaches a determination on whether a product is or is not a medicinal product on a case by case basis, in the light of:

• the definition set out in the Directive;

• relevant ECJ and domestic Court precedents and

• following an assessment of all the available evidence.

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The Definition of a Medicinal ProductArticle 1.2 Council Directive 2001/83/EEC

“Any substance or combination of substances presented as having properties for treating or preventing disease in human beings;

Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”

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Deciding the Status of a Product

• Claims• The context of those claims, and the overall

presentation• How a product appears to the public• The labelling, packaging and package inserts• Promotional literature• Advertisements• Product form• Target group

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Deciding the Status of a Product

• Pharmacological properties of the ingredients• Product promotional literature• Product form• Target group• Similar licensed products

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Deciding the Status of a Product Recent relevant ECJ cases

C-319/05 Garlic CapsulesC-147/07 HechtPharmaC-27/08 BiosNaturproduckt GmbH

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Classification of medicinal products

•Systematic approach

•Need to give full reasons for our classification

•In a formal compliance investigation we need all the relevant information about a product before we can come to a view of its status

•If we conclude that a product is a medicinal product, a Provisional Determination Notice (PDN) is issued to the company giving the reasons for the determination

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•The PDN offers the company the opportunity to challenge the determination, in writing or orally before the Review Panel for Borderline Products

•If the company accept the PDN or the challenge is unsuccessful, a Final Determination Notice is issued

•Penalties for non-compliance

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•An Urgent Notice may be issued for an unlicensed medicinal product.

•Medicines legislation takes precedence over other legislation.

•Because medicines legislation is ‘harmonised’ a medicinal product is not necessarily subject to the mutual recognition procedures which apply to (for example) food supplements.

Botanical (Herbal) products

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•Since 30 April 2011 only herbal medicinal products with a marketing authorisation or certificate of registration can be sold or supplied; but

•Unlicensed herbal remedies which were legal under the previous exemptions and which were already on the market at that date, could, until 30 April 2014, be “sold through” by retailers.

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Previous arrangements:

•The product had to be a ‘herbal remedy’ (i.e. plant or plants only)

•The product had to be named after the plant(s) it contained - no brand name

•No written recommendations or claims were permitted on the label or in a leaflet

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Registration Scheme for Traditional Herbal Medicines

• Product must have a history of use of 30 years, at least 15 of which must be within the EU

• Product has to meet standards of safety and quality

• Combination products have to be plausible

• Products have to be made to relevant standards of GMP

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Registration Scheme for Traditional Herbal Medicines

• Possible to have indications for herbal medicines

• Proper quality controls on products and their labels & leaflets

• Possibility of including vitamins and minerals in the formulation

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MHRA is encouraging companies to use this logo to tell consumers that the product has a certificate of registration

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The THR Scheme

•Approval is based on traditional use and not on pharmacological properties

•No means of assessing complex combination herbals as yet – and this includes Chinese and Ayurvedic remedies

•HMPC monographs incomplete

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The THR Scheme

•Approved remedies can be more expensive

•Unresolved resolved the question of practitioner exemptions

•Companies are known to be putting their unlicensed remedies back on the market labelled as “food supplements”

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•Herbal products that are used to treat an underlying clinical condition are medicinal products

•The regulatory status of the unlicensed herbal remedies which were legal under previous exemptions has not changed = they are medicines .

•Only herbal medicinal products with a marketing authorisation or certificate of registration can be sold

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Herbal ‘List’

•Herbal ‘aid memoire’ published in 2005 & lists known uses of a large number of herbal products

•MHRA worked with key stakeholders

•List is for information only – no legal status.

•Case-by-case approach still applies.

•If not a medicinal products legality needs to be checked by a relevant regulatory body

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The list gives the following information:

•Botanical name•Common name•Any recorded medicinal uses•Any recorded food uses (relevance?)•Recorded use in aromatherapy•Recorded use in cosmetic products•General comments•The part(s) of the plant used medicinally

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The Legislation

• Pharmaceutical Directive 2001/83/EEC

• Human Medicines Regulations 2012(S.I. 2012/1916)

Regulation 46 (1) – Requirement for medicinal products to have a marketing authorisation before being placed on the market

Regulation 279 – No person may publish an advertisement for an unlicensed medicinal product

Part 7 – Herbal medicinal products

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Where can I go for advice?

• Guidance Note 8 A guide to what is a medicinal product – isdownloadable from

• The Borderline Products page of the MHRA website at www.mhra.gov.uk

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