Centre for the Promotion of Imports from developing countries

Market Access Requirements I Legislative Requirements for Natural Ingredients for Health Products

Session 8

03 May 2015

Centre for the Promotion of Imports from developing countries2

Content - What do we talk about?• Overview

– Nagoya Protocol– CITES– EU legislation – WHO Guidelines - GxP– SOPs

• Health industry– South African legislation– Herbal Medicine– Medical devices– Veterinary medication

• Food industry– Regulatory Framework– Novel Food– HACCP– RASFF

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Overview

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Overview - Market Access Requirements (MARs)

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health & safety

social

qualityenvironment

consumer

occupational

Buyers (MarketDriven)

Legis- lation

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Overview

Legal framework for Natural Ingredients for Health Products

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EU Legislation

– WHO Guidelines

(Public Health)

www.ec.europa.eu

www.who.org

Nagoya Protocol

(The Nagoya Protocol on

Access to Genetic Resources and

the Fair and Equitable Sharing

of Benefits Arising from their Utilization (ABS)

www.cbd.int/abs

CITES

(the Convention on International

Trade in Endangered

Species of Wild Flora and Fauna)

www.cites.org

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Nagoya Protocol

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS)

• Adopted by the Conference of the Parties to the Convention on Biological Diversity (tenth meeting on 29 October 2010)

• Entered into force on 12 October 2014• Objective:

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Appropriate access to genetic resources

Appropriate transfer of relevant technologies

Appropriate funding

fair and equitable sharing of the benefits arising from the utilization of genetic resources

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Implementation of the Nagoya Protocol in National Legislation

South Africa

• Regulation No 511/2014: demands guidance documents and implementing regulation

• Development of guidance documents (2015)

• Implementing regulation (2015)– Registered collection– Best practices– Monitoring of user

compliance

• http://www.icsu.org/freedom-responsibility/advisory-documentation/pdf-images/ABS_WS_Presentation_Crouch.pdf

EU

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CITES

The Convention on International Trade in Endangered Species of Wild Flora and Fauna

• Established in 1975• Agreement between governments• Ensures no species becomes/remains subject to

unsuitable exploitation because of international trade• Protects over 30,000 species (traded as live, dead, parts or

derivatives)• December 2014: 180 member countries (Parties)• South Africa member since 1975• Implemented by national legislation 2005: NEMA – National

Environmental Management: Biodiversity Act (10/2004)

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CITES – EU Wildlife Trade Legislation - Appendices

Three Appendices in CITES:

• Appendix I: species threatened with extinction: in general all international trade is banned (some trade may be allowed under exceptional circumstances)

• Appendix II: species that are not necessarily threatened with extinction, but may become so unless trade is closely controlled

• Appendix III: species subject to regulation within a particular member country and for which the co-operation of other member countries is needed to control international trade

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EU Legislation

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CITES – EU Wildlife Trade Legislation - Differences

• Stricter import conditions:Import permits not only required for species listed in Annex A but also for Annex B. Import notifications required for Annexes C and D.

• Different listings of plant species:Some species that are listed in Appendix II of CITES are listed in Annex A

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CITES – EU Wildlife Trade Legislation - Differences

• Trade regulations:The EU regulates trade with EU and between EU Member States - CITES regulates global trade

• Trade suspension:Regulation (EC) 338/97 authorises the EU Member States to suspend imports with regard to certain species and countries, even if trade is allowed under CITES

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Directorate General for Health and Food Safety

Covers following aspects:

• Public Health:– Medicinal products for human use– Medicinal products for veterinary use

• Food:– Supplements– Medical Food

http://ec.europa.eu/dgs/health_food-safety/index_en.htm

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WHO - Framework

1. The WHO framework• Sets global pharmaceutical legislation• Has increasingly levelled the playing field to allow DC ingredient

producers to comply with European requirements

2. European legislation for Pharmaceuticals• Marketing authorization – permitted on the market or not• Processing and compliance to good practice• Simplified regime for Traditional Herbal Medicinal Products

• Ensuring a high level of protection • Promoting the functioning of the internal market

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EU – South Africa - Good Agricultural and Collection Practices

• EU:– http://

ec.europa.eu/health/files/eudralex/vol-4/vol4_an7_2008_09_en.pdf– http://

www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003362.pdf

• South Africa:‒ MCC Medicines Control Council‒ http://

www.mccza.com/dynamism/default_dynamic.asp?grpID=29&doc=dynamic_generated_page.asp&categID=148&groupID=29

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WHO – Good Agricultural and Collection Practices (GACP)

http://apps.who.int/medicinedocs/en/d/Js4928e/

Objectives:• Quality assurance of MAPs as source for herbal

medicines• Sustainable cultivation and collection of MAPs

Covering following aspects:• Good agricultural practices for medicinal plants• Good collection practices for medicinal plants• Common technical aspects of these practices for

medicinal plants• Other relevant issues (e.g. ethical and legal

considerations and research needs)

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Good Agricultural Practices for Medicinal Plants

• Identification / authentication of cultivated medicinal plants:– Selection of medicinal plants, botanical identity, specimens

• Seeds and other propagation materials• Cultivation:

– Site selection; ecological, environment and social impact; climate; soil; irrigation and drainage; plant maintenance and protection

• Harvest• Personnel

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Good Collection Practices for Medicinal Plants

• Permission to collect• Technical planning• Selection of medicinal plants for collection• Collection • Personnel

Standard Operating Procedure (SOPs) and Work Instructions (WINs) for Resource Management and Resource Use

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Common Technical Aspects

• Post-harvest processing:– Inspection and sorting, primary processing, drying, specific

processing, processing facilities• Bulk packaging and labelling• Storage and transportation• Equipment:

– Materials, design, construction and installation, identification• Quality assurance• Documentation• Personnel (growers, collectors, producers, handlers, processors):

– General, health, hygiene and sanitation

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Other Relevant Issues

• Ethical and legal considerations:– Intellectual property rights and benefit-sharing– Threatened and endangered species

• Research needs

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Standard Operating Procedures – Procurement of Natural Ingredients• SOPs for:

– Resource management– Resource use– Domestication– Cultivation– Supplier audit

www.in2ni.com

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Health Products

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South Africa – Traditional Medicine and Legislation

• Health Products Association of Southern Africahttp://www.hpasa.co.za/

• Traditional Health Alliancehttp://www.naturalhealthalliance.co.za/index.htm#

• WHOhttp://apps.who.int/medicinedocs/en/d/Js7916e/9.1.html

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Herbal Medicine

• Simplified registration procedure– Proven use 30 years, 15 years in Europe many cannot!– Few products registered yet, might decrease future demand!

• Committee on Herbal Medicinal Products (HMPC)– Committee within European Medicines Agency– Herbal monographs: scientific opinion, non-binding– Community list: legally binding

Both mostly contain well-known, temperate species!EU Pharmacopoeia contains wider range of species

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Herbal Medicine

Good Manufacturing Practices – active substances

• GMP usually applied to intermediates after Active Substance is added to the process

• Increasing GMP requirements (from sourcing to manufacturing) for Medicinal and Aromatic Plants (MAPs) extracts, used as Active Pharmaceutical Ingredients (API).

• Additional requirements when producing APIs

• Next to GMP: implementation of UN guidelines on Good Agricultural Practice and Good Collection Practice (GACP) for MAPs

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API Application Matrix

Type of Manufacturing

Application of this Guide to steps (shown in grey) used in this type of manufacturing

Chemical Manufacturing

Production of the API Starting Material

Introduction of the API Starting Material into process

Production of Intermediates(s)

Isolation and purification

Physical processing, and packaging

API derived from animal sources

Collection of organ, fluid, or tissue

Cutting, mixing, and/or initial processing

Introduction of the API Starting Material into process

Isolation and purification

Physical processing, and packaging

API extracted from plant sources

Collection of plant

Cutting and initial extraction(s)

Introduction of the API Starting Material into process

Isolation and purification

Physical processing, and packaging

Herbal extracts used as API

Collection of plants

Cutting and initial extraction

 Further extraction

Physical processing, and packaging

API consisting of comminuted or powdered herbs

Collection of plants and/or cultivation and harvesting

Cutting/ comminuting

   Physical processing, and packaging

Biotechnology: fermentation/ cell culture

Establishment of master cell bank and working cell bank

Maintenance of working cell bank

Cell culture and/or fermentation

Isolation and purification

Physical processing, and packaging

“Classical” Fermentation to produce an AOI

Establishment of cell bank

Maintenance of the cell bank

Introduction of the cells into fermentation

Isolation and purification

Physical processing, and packaging

Increasing GMP requirements

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EU Basic Requirements for Active Substances used as Starting Materials

Objectives: • Product quality and purity• To include guidelines from the receipt of materials until the

distribution

Recommendations that are:• expected to be applied • modified in any relevant annexes• replaced by an alternative

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EU GMP Basic Requirements for Medicinal Products

EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines

http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

Commission Directive 2003/94/EC: • Pharmaceutical Quality Systems• Personnel• Premise and Equipment• Documentation• Production• Quality Control• Outsourced Activities / Contract Manufacture and Analysis• Complaints and Product Recall• Self Inspection

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Pharmaceuticals

• Medicinal products entering the EU market must be approved!– Importing authorisation– Marketing authorisation– Labelling and packaging provisions– Control of each batch– Pharmacovigilance system

• Required for final products

• Rules include detailed quality and traceability standards for natural ingredients

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Pharmaceuticals – Herbal Medicine

• Simplified authorisation procedure for homeopathic and herbal medicinal products (Directive 2004/24/EC): – List of herbal substances, preparation and combinations thereof

for use in traditional herbal medicinal products (Commission Decision 2008/911/EC of 21.11.2008)

• Procedure information under:http://ec.europa.eu/health/human-use/herbal-medicines/index_en.htm

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Medical Devices

• Legislative framework:– Core legal framework consists of three directives and

amendments:› Directive 90/385/EEC active implantable medicinal devices› Directive 93/42/EEC medical devices› Directive 98/79/EC vitro diagnostic medical devices

• Guidelines for implementation:http://ec.europa.eu/growth/sectors/medical-devices/documents/guidelines/index_en.htm

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Veterinary Use

• Medicinal products for veterinary use must be authorised at member state level

• Legislative framework:– Directive 2001/82/EC– Regulation (EC) No 726/2004

• Objective:– Protect public and animal health– Particular protection from residue limits from pharmacologically

active substances used in food-producing animals (Regulation (EC) No 470/2009)

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Health Food

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Regulatory Framework

• General Food Law:– Regulation (EC) No 178/2002– General requirements:

› Safety requirements› Traceability› Operators’ responsibility

• Guidance document for implementation:http://ec.europa.eu/food/safety/docs/gfl_req_guidance_rev_8_en.pdf

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Food Supplements

• What are food supplements?

• Directive 2002/46/EC:– Rules for the labelling of food supplements– Specific rules on vitamins and minerals in food supplements

• Annex II of directive 2002/46/EC positive list allowed substances in tradehttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:183:0051:0057:EN:PDF

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Medical Food

• What is medical food?

• Regulation (EC) No 953/2009:– Rules for composition and labelling of medical foods– Specific rules on vitamins and minerals in food supplements

• Annex of Regulation positive list allowed substances in trade

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:269:0009:0019:EN:PDF

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National Positive Lists

• Positive lists of botanicals per country:– BELFRIT: Belgium, France, Italy– Stoffliste des Bundes und der Bundesländer Kategorie „Pflanzen

und Pflanzenteile”: Germany– Draft Royal Decree 2015/162/B (03.04.2015): Belgium

› 1019 plants with potential application conditions› Implementation of existing BELFRIT list

Difficult to introduce new species

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Novel Food

• No significant consumption in EU before 1997• Legislative barrier in EU

– Time– Costs– Documentation

http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm

• What about Switzerland?

• Upcoming regulatory Changes

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What are the Approval Requirements?

Novel food: Must be safe for consumers and properly labelled • Risk assessment• Authorisations• Simplified procedure – notification• Labelling• Safeguard measure

Find information:http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm

The Novel food catalogue to check your ingredients:http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/

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HACCP

Hazard Analysis Critical Control Points

• Mandatory to all processed food: since 2006

• Emphasis: prevention!

7 Steps for implementing HACCP1. Potential Hazards

2. Control Points

3. Lowest and Highest Limits

4. Responsibilities

5. Correct responses

6. Checking Tools and devices

7. Documentation

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RASFF Notifications and Negative List

• Rapid Alert System for Food and Feed (RASFF) alters and notifications through RASFF Portal

https://webgate.ec.europa.eu/rasff-window/portal/index.cfm?event=SearchForm&cleanSearch=1

• Negative list of novel foods based on RASFF alerts (since 2009) of USDA

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Questions & Answers

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