Transcript Document
Bioforce (UK) Ltd.
Experience of working with the Traditional Herbal Medicinal Products Directive (THMPD)
A company point of view
Irish Health Trade Association AGM April 2008 D. Belshaw Bioforce (UK) Ltd.
April 2008
Traditional Herbal Medicinal Products Directive (THMPD) Adopted March 2004 - Implementation 31 st Oct 2005
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Passed into law in Ireland July 2007 Simplified route to a medicines licence (registration).
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Requirements (The dossier) Traditional Use : Indications justified from ‘history’.
Safety: For intended use, bibliographic reviews Quality: Pharmaceutical standards apply (GMP).
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Indications: Minor and Self-limiting without intervention of a healthcare professional, i.e. OTC type indications.
Traditional Herbal Medicinal Products Directive (THMPD) • • • • •
The ‘herbal’ Directive – benefits for the customer & retailer?
Safeguard future supplies.
Confidence in the products & increased credibility.
Stronger marketing materials and promotions.
Direct medical claims.
Increased public & professional confidence in the products.
Started looking at THMPD ~2002-2003
2003 Product classification.
Products
Regulators IMB Herbal Medicines Project Directives Regulations Guidance Experience Strategic Trade groups planning
Herbal Directive Cosmetic Food Supplement Medical device Homeopathic Food
2003: Developing Provenance & History.
The 30 year rule.
1. Pharmacopoeial evidence.
- British Herbal Pharmacopoeia - British Pharmaceutical Codex - Martindale Extra Pharmacopoeia.
2. Other authoritative bibliographic references.
- World Health Organisation.
- ESCOP monographs, - Commission E monographs - Physicians Desk Reference for Herbal Medicines, - Potters Herbal Cyclopaedia, - Other books by recognised Phytotherapy experts.
3. EU Member state schemes.
UK, MHRA Briefing note, 2004, ‘Sources of evidence & prospects for 30 years use.
France ‘ Avis aux fabricants’ 1990 & 1998.
Germany ‘Rote’ list.
2003: Developing Provenance & History.
The 30 year rule.
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Company Archives.
- Bioforce UK / Switzerland & Other EU based Bioforce partners.
- Old price lists.
- Product manuals.
- Sales records (International) - Sales invoices (UK).
Dose & Route of administration
- Do products fit the pattern of recommended use?
- If not, can they be made to fit?
2003: Developing Provenance & History.
The 30 year rule.
Corresponding products.
- Internet searches for similar products with or without a marketing authorisation.
- Information from MHRA.
- Products with a marketing authorisation.
- Date(s) of granting marketing authorisations.
- Products registered elsewhere in the EU.
Literature search references.
On line searching for ‘old’ papers.
2003 2004: Bioforce ‘Herbal Directive’ priority list.
1) Compiling the first Bioforce ‘Product list’.
Assessing the chances for each product with the herbal directive.
2) Organising the Product List - Prioritising.
Product –potential.
Product popularity and sales value.
Ease of dossier compilation.
2004: Dossier planning in place.
Bioforce AG Bioforce UK Cultivation Quality & Manufacturing Clinical & Non-clinical Expert reports Expert reports Sales records/ Data support Traditional use
How much does THMPD cost?
-It depends where you are starting from
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Marketing Budgets?
Dossier application fees, Licence maintenance fees, Inspection fees, Staff costs, Consultants fees?
Regulatory Affairs Dept. Create dossiers, Administrate applications, Maintain licences, Regulatory enquiries.
Working electronically & e-CTD.
Pharmacovigilance systems. QPPV. PSUR maintenance.
GMP licences, Active ingredients, Manufacture, Packaging & Distribution. QC Labs, Qualified Person.
Product stability studies.
Herb suppliers, GACP, Quality & Continuity Sub contract
Product registration activities 2005 - 2008
UK Atrogel: Registered Oct 2006.
A traditional herbal medicinal product for the symptomatic relief of muscular aches, pains and stiffness, sprains, bruises and swelling after contusions, exclusively based on long-standing use.
Prostasan: Registered Sept 2007 Traditional herbal medicinal product used for the relief of lower urinary tract symptoms in men who have a confirmed diagnosis of benign prostatic hypertrophy (BPH), based on traditional use only. Prior to treatment other serious conditions should have been ruled out by a doctor.
Product registration activities 2005 - 2008 Atrosan: Registered Jan 2008.
A traditional herbal medicinal product used for the relief of backache, rheumatic or muscular pain, and general aches and pains in the muscles and joints, based on traditional use only.
Venaforce: Registered Feb 2008.
A traditional herbal medicinal product that has been used for the relief of symptoms associated with chronic venous insufficiency and varicose veins, such as tired heavy legs, pain, cramps and swelling, based on traditional use only .
Planning for the future.
Bioforce: Registration planning in UK and Ireland.
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Several applications in assessment with the UK Authority.
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Full programme of dossiers in planning up to and beyond 2010.
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Atrogel submitted to Irish Medicines Board Dec 2007.
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All products registered in the UK will also be registered in Ireland.
Relationships with the Regulators .
UK: MHRA.
Meetings with UK Trade Associations.
Publication of guidance documents.
Providing advice.
Conferences & seminars.
MHRA Internet site.
Meetings with Bioforce.
Communication during assessment process.
IRL: IMB.
Pre-registration notification scheme.
Meeting with Bioforce.
IMB internet site – Question & Answers.
Information meeting Feb 2008.
e-mail exchanges.
Traditional Herbal Medicinal Products Directive (THMPD)
Time is running out.
The transition period ends April 2011.
• IMB Information day February 2008. Submit applications by:
(
1st January 2010)
FOOD SUPPLEMENT ?
Planning ahead
Portfolio ?
HERBAL MEDICINES DIRECTIVE ?
HEALTH CLAIMS?
COSMETIC ?
DO NOTHING ?
FOOD ?
Quo Vadis with your herbals ?
Herbal Directive
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A known entity
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Can do business since July 2007.
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Less uncertainty.
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Application deadline 1 Jan 2010
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Expensive FSD & NHCR
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Permitted botanicals not yet known.
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EFSA Guidance Dec 2007.
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Health claims not available until 2010.
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Risky to wait?
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Expense ?
Final Advice
• Look at the herbal products in your portfolio • Organise the herbal product portfolio according to importance to your business. • Talk to the suppliers & manufacturers of your most important herbal products.
• What are their plans?
• Take steps to safeguard the important products.
• Make friends with your regulators in the IMB and FSAI.
– talk to them and ask for advice.