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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. Adopted March 2004 - Implementation 31 st Oct 2005
Experience of working with the
Traditional Herbal Medicinal Products Directive
A company point of view
Irish Health Trade Association
AGM April 2008
Bioforce (UK) Ltd.
Passed into law in Ireland July 2007
Simplified route to a medicines licence (registration).
Requirements (The dossier)
Traditional Use : Indications justified from ‘history’.
Safety: For intended use, bibliographic reviews
Quality: Pharmaceutical standards apply (GMP).
Indications: Minor and Self-limiting without intervention of a healthcare professional, i.e. OTC type indications.Traditional Herbal Medicinal Products Directive (THMPD)
Safeguard future supplies.
Confidence in the products & increased credibility.
Stronger marketing materials and promotions.
Increased public & professional confidence in the products.Traditional Herbal Medicinal Products Directive (THMPD)
- British Herbal Pharmacopoeia
- British Pharmaceutical Codex
- Martindale Extra Pharmacopoeia.
2. Other authoritative bibliographic references.
- World Health Organisation.
- 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
- France ‘ Avis aux fabricants’ 1990 & 1998.
- Germany ‘Rote’ list.2003: Developing Provenance & History.The 30 year rule.
- 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.
- 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: Developing Provenance & History.The 30 year rule.
Assessing the chances for each product
with the herbal directive.
2) Organising the Product List - Prioritising.
Product popularity and sales value.
Ease of dossier compilation.2003-2004: Bioforce ‘Herbal Directive’ priority list.
Dossier application fees,
Licence maintenance fees,
Inspection fees, Staff costs,
Regulatory Affairs Dept.
Create dossiers, Administrate
applications, Maintain licences,
Working electronically & e-CTD.
Pharmacovigilance systems. QPPV.
GMP licences, Active ingredients, Manufacture,
Packaging & Distribution. QC Labs, Qualified Person.
Product stability studies.
Herb suppliers, GACP, Quality & Continuity
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
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.Product registration activities 2005 - 2008
Several applications in assessment with the UK Authority.
Full programme of dossiers in planning up to and beyond 2010.
Atrogel submitted to Irish Medicines Board Dec 2007.
All products registered in the UK will also be registered in Ireland.Planning for the future.
Meetings with UK Trade Associations.
Publication of guidance documents.
Conferences & seminars.
MHRA Internet site.
Meetings with Bioforce.
Communication during assessment process.
Pre-registration notification scheme.
Meeting with Bioforce.
IMB internet site – Question & Answers.
Information meeting Feb 2008.
e-mail exchanges.Relationships with the Regulators.
The transition period ends April 2011.
IMB Information day February 2008.
Submit applications by:Traditional Herbal Medicinal Products Directive (THMPD)
(1st January 2010)
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.Final Advice