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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

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slide1
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 31st Oct 2005

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)
traditional herbal medicinal products directive thmpd1
The ‘herbal’ Directive – benefits for the customer & retailer?

Safeguard future supplies.

Confidence in the products & increased credibility.

Stronger marketing materials and promotions.

Direct medicalclaims.

Increased public & professional confidence in the products.

Traditional Herbal Medicinal Products Directive (THMPD)
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 Product classification.
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.
2003 developing provenance history the 30 year rule1
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.
2003 developing provenance history the 30 year rule2
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: Developing Provenance & History.The 30 year rule.
2003 2004 bioforce herbal directive priority list
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.

2003-2004: Bioforce ‘Herbal Directive’ priority list.
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

2004: Dossier planning in place.
how much does thmpd cost it depends where you are starting from
.How much does THMPD cost? -It depends where you are starting from

Marketing

Budgets?

Dossier application fees,

Licence maintenance fees,

Inspection fees, Staff costs,

Consultants fees?

Sub-contract

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

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
product registration activities 2005 20081
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.

Product registration activities 2005 - 2008
planning for the future
Bioforce: Registration planning in UK and Ireland.

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.
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.

Relationships with the Regulators.
traditional herbal medicinal products directive thmpd2
Time is running out.

The transition period ends April 2011.

IMB Information day February 2008.

Submit applications by:

Traditional Herbal Medicinal Products Directive (THMPD)

(1st January 2010)

planning ahead
Planning ahead

Portfolio ?

HERBAL MEDICINES

DIRECTIVE ?

FOOD

SUPPLEMENT ?

COSMETIC ?

HEALTH CLAIMS?

DO

NOTHING ?

FOOD ?

quo vadis with your herbals
Herbal Directive

A known entity

Can do business

since July 2007.

Less uncertainty.

Application

deadline 1 Jan 2010

Expensive

FSD & NHCR

Permitted botanicals not yet known.

EFSA Guidance Dec 2007.

Health claims not available until 2010.

Risky to wait?

Expense ?

Quo Vadis with your herbals ?
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.

Final Advice