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Ir. Theo van Rooijwww.rivendell.eu
Regulatory aspects of Herbal Medicinal Products
and Supplements in EU / the Netherlands
Definitions 1 Medicinal
Categories of Herbal Medicinal Products:- Traditional Herbal Medicinal Products –
traditionele kruidengeneesmiddelen (Article 16a(1) of Directive 2001/83/EC)
2002/24/EU - Well Established Use (Article 10a of Directive 2001/83/EC )- Full registration – own data
(Article 8(3) of Directive 2001/83/EC )- Medical devices (topical + physical action)
Definitions 2 - Food Law Categories of Herbal products within Food Law:- Herbal or botanical supplements /
botanicals (in Dutch kruidenpreparaat) –Category food supplement
- Herbal teas (food) - Spices- Cosmetic products with herbal
extracts
Traditional Herbal Medicinal Products – THMP - 1
- 2004/24- Sufficient safety data and plausible
efficacy- Involves assessment of mostly
bibliographic safety and efficacy data- At least 30 years on the market, including
at least 15 years within the EU- Use without the supervision of a medical
practitioner; not administered by injection- Quality as medicinal products /
Pharmaceutical - GMP
Traditional Herbal Medicinal Products–THMP- 2
- EMA community monographs (if available) basis for registration file
- UK, Germany, Poland, Austria, Spain, have a lot of THMP registrations
- Netherlands: submission dossier to CBG (43 approvals untill end 2015)
- National - not harmonised
Well Estbalished Use – WEU- Scientific literature- well-established medicinal use within
the EU for at least ten years- with recognised efficacy and an
acceptable level of safety- Submission to: National competent
authority of a Member State for national, mutual recognition and decentralised procedures”. (CBG)
- EMA if centralised procedure applies
Granted registrations by EU member states 2004-2015
Granted registrations per EU member state until end 2015
Traditional Use: none in DK, LI, LU, MT
Well Established Use:none in CY, IT, LI, LU, MT
Germany 263 278
UK 344 1
Austria 195 51
Poland 197 24
France 23 22
Italy 10 0
Spain 90 27
Sweden 69 41
Netherlands 43 18
Amount of registrations in the EU 2004-2015
All over EU Traditonal Use Well Established Use
Registrations since 2004
1577 768
Mono preparations ± 70 % ± 80 %
Combination products
± 30 % ± 20 %
Per year average 140 90
Community Herbal monographs
- EU community herbal monographs can be found on the EMA website
- Monographs are divided into two sections:Well-established use (marketing authorisation)Traditional use (simplified registration)
Process of community monographs by HMPC / EMA
Herbal medicinal Products Committee- 1. Rapporteur: 0- 2. On going call for scientific data: 0- 3. Draft under discussion: 6- 4. Draft published:6- 5. Assessment close to finalisation =
pre-final: 6- 6. Assessment finalised: 167
Structure Community monograph - 1
- 1 NAME- 2 QUALITATIVE AND QUANTITATIVE
COMPOSITION- 3 PHARMACEUTICAL FORM - 4. CLINICAL PARTICULARS- 4.1. Therapeutic indications- 4.2. Posology and method of administration- 4.3. Contraindications- 4.4. Special warnings and precautions for use- 4.5. Interactions with other medicinal products
and other forms of interaction
Structure Community monograph - 2
- 4.6. Pregnancy and lactation- 4.7. Effects on ability to drive and use machines- 4.8. Undesirable effects- 4.9. Overdose- 5. PHARMACOLOGICAL PROPERTIES- 5.1. Pharmacodynamic properties- 5.2. Pharmacokinetic properties- 5.3. Preclinical safety data- 6. PHARMACEUTICAL PARTICULARS- 7. DATE OF COMPILATION/LAST REVISION
Approved registrations per herb in EU until end 2015 (top 10)
Traditional use Well Established
Harpagophytum 60 Ginkgo biloba 104
Pelargonium sidoides 59 Hedera helix 81
Valeriana officinalis 52 Hypericum perforatum 49
Hypericum perforatum 44 Valeriana officinalis 41
Thymus 39 Silybum marianum 31
Passiflora 37 Echinacea herba 27
Echinacea radix 25 Cimicifuga 25
Panax ginseng 25 Glycine max (lecithin) 19
Salvia officinalis 25 Pelargonium sidoides 18
Crataegus 23 Vitis vinifera 18
No harmonisation for several herbs in EU
Country Ginkgo St-Johns wort
Belgium Medicinal product + Food supplement: max 21,6 mg flavonolglycosid + 5,4 mg terpeenlacton + warning statements
Medicinal prodduct + Food supplement: max 700 μg hypericin + warning statements
Germany Only medicinal law Only medicinal law
Netherlands Medicinal + Food supplement: some warning statements indicated but not mandatory; no maximum
Medicinal + Food supplement no restrictions; warning statements by self-regulation, no maximum
Food Law- Responsibility for compliance with all
regulations regarding safety, quality, efficacy (health claims) completely by the producer / importer
- In a lot of EU countries there is an obligation to notify or authorise the product before bringing on the market
- Netherlands, UK, Austria, Sweden do not require notification / authorisation
Important aspects for herbal preparations as food supplements
1. Is the herb allowed within Food Law: mainly national situations + Novel Food Catalogue?
2. Are health claims possible?
3. Quality issues: HACCPpurity, identity, contamination
Is the herbal ingredient allowed in EU in a food supplement?
- Novel Food directives (258/97+ 2015/2283)
- EU Novel Food Catalogue: beware: not complete!
- BELFRIT list, legal value outside of Belgium low(incorporated in latest Royal Decree for plants 24-01-2017), France, Italy, but very good information
- Practice: in some EU member states a herb is a Medicinal product, in others within Food Law, with certain restrictions
Herbal ingredients food supplements – Netherlands - 1
1. NL Warenwetregeling kruidenpreparaten 2001 + additions: a. List of forbidden, unsafe herbsb. Max. toxic Pyrrolizidine Alkaloids: 1 μg per kg /liter.c. No Aristolochia acids
Herbal ingredients food supplements – Netherlands - 2
2. Proof of history of use before May 1997 (Novel Food – 258/07) in at least one EU member state – significant ?- Equivalence : extracts – bio-technology- BELFRIT – Belgian KB Plant list- practice: is it already in the market as a food supplement (a website is no proof!) and is it safe?
Is a health claim allowed?
- 1924/2006: nutrition & health claims- For botanical ingredients > 1000 dossiers
were submitted to EC/EFSA- Just a few are evaluted by EFSA: all
negative: dossier too weak, trials with patients + medical claims were rejected
- Result: all botanical claims are ON HOLD untill EC takes a final decision (end 2017?) how the evaluation by EFSA should be done: based on tradition or on science???
Requirements ON HOLD claims
- National practice per EU country can be different
- In general: Health claim is possible if:1. the claim has the same meaning as in the dossier2. Is an allowed health claim3. If the daily amount and specifications of the herb is in line with the condition of use as in the dossier(s)
Quality aspects
- Identity – Purity- ABC Adulteration program – website
ABC-Herbalgram- HACCP obligation -Import outside EU- Daily dosage, extract.- Contamination with PA (max 1 ppb:
EFSA/BfR) and PAH / 4 PAH (2015/1933: 10 / 50 ppb)
- Safety – interactions – warning statements.
Useful websites
- EFSA PA: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/859e.pdf
- EU Novel Food Catalogue: http://ec.europa.eu/food/safety/novel_food/catalogue/search/public/index.cfm
- EMA - herbal community monographs - http://www.ema.europa.eu/ema
- ESCOP http://escop.com- ABC - American Botanical Council + magazine Herbalgram –
Adulterants program – www.herbalgram.org- AHPA – American Herbal Products Association – www.ahpa.org- Medlineplus https://medlineplus.gov/druginfo/herb_All.html
Thanks for your attention!
Questions?
Voor informatie: Ir. Theo van [email protected]
www.rivendell.eu