Regulatory aspects of Herbal Medicinal Products. and Supplements in EU / the Netherlands. Ir. Theo van Rooij

Transcription

1 Regulatory aspects of Herbal Medicinal Products and Supplements in EU / the Netherlands Ir. Theo van Rooij

2 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)

3 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

4 Traditional Herbal Medicinal Products THMP /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

5 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

6 Well Estbalished Use WEU Scientific literature wellestablished 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

7 Granted registrations by EU member states 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 UK Austria Poland France Italy 10 0 Spain Sweden Netherlands 43 18

8 Amount of registrations in the EU All over EU Traditonal Use Well Established Use Registrations since Mono preparations ± 70 % ± 80 % Combination products ± 30 % ± 20 % Per year average

9 Community Herbal monographs EU community herbal monographs can be found on the EMA website Monographs are divided into two sections: Wellestablished use (marketing authorisation) Traditional use (simplified registration)

10 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 = prefinal: 6 6. Assessment finalised: 167

11 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

12 Structure Community monograph 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

13 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

14 No harmonisation for several herbs in EU Country Ginkgo StJohns 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 selfregulation, no maximum

15 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

16 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: HACCP purity, identity, contamination

17 Is the herbal ingredient allowed in EU in a food supplement? Novel Food directives (258/ /2283) EU Novel Food Catalogue: beware: not complete! BELFRIT list, legal value outside of Belgium low(incorporated in latest Royal Decree for plants ), 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

18 Herbal ingredients food supplements Netherlands 1 1. NL Warenwetregeling kruidenpreparaten additions: a. List of forbidden, unsafe herbs b. Max. toxic Pyrrolizidine Alkaloids: 1 μg per kg /liter. c. No Aristolochia acids

19 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 biotechnology 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?

20 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???

21 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 dossier 2. Is an allowed health claim 3. If the daily amount and specifications of the herb is in line with the condition of use as in the dossier(s)

22 Identity Purity Quality aspects ABC Adulteration program website ABCHerbalgram 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.

23 Useful websites EFSA PA: EU Novel Food Catalogue: EMA herbal community monographs ESCOP ABC American Botanical Council + magazine Herbalgram Adulterants program AHPA American Herbal Products Association Medlineplus

24 Thanks for your attention! Questions? Voor informatie: Ir. Theo van Rooij