Irish Health Trade Association Code of Practice
As a representative Association for manufacturers and distributors of health products*, the IHTA is concerned to establish that its members produce and market products to a uniformly high standard. This Code therefore identifies the common aspirations and standards of practice of members. As such it is an expression of the Ethos of the Health Trade.
It is a requirement of membership of the Association that members operate in conformance with the Code of Practice. Members are therefore expected to be fully conversant with the Code’s content and to raise issues that require clarification.
It is understood that this Code of Practice will need to be revised from time to time in the light of changing circumstances.
The Code is complementary to the Constitution of the Association.
The Code may not be construed in any way that is deemed to contradict statutory law, nor does it remove the obligation upon members to conduct their business in accordance with said law.
* The term ‘health product’ is defined in the Constitution of the Association as:
(1) Herbal, Homeopathic and Allied Products.
(2) Nutritional, Health Promotion and Food Supplements.
(3) Natural Cosmetics and Toiletries.
(4) Wholefoods including Organic Foods.
(5) Products or Services allied to or supportive of Categories (1) to (4).
2. GENERAL AIMS
The Association will endeavor to keep members informed on industry development at national, EU and international level providing also up dates on Association activity for and on behalf of members.
The aims and objectives of IHTA are to advance the role that health products play in the health of the individual and society at large. In particular IHTA:
(ii) Promotes a holistic approach to health care;
(ii) Encourages empirical and scientific research into the quality, safety and effectiveness of health products;
Encourages the application of such research in the production and marketing of the products of members;
(iii) Promotes and advances the commercial objectives of members.
(iv) Represents member companies/individuals at national and international level in their relationships with Governments and Statutory Agencies.
(v) Works co-operatively with similar organizations in Europe and the rest of the world with a view to furthering common interests;
(vi) Promotes sustainable patterns of production and distribution, which minimize the negative environmental impact of the industry.
Advises members of the requirements for placing Health product on the Irish Market:
- Statutory Instruments that apply;
- Classification of Products;
- Regulatory procedures that apply
- Novel Foods Procedure;
- Full medical licensing;
- Homoeopathic registration;
- Food supplement notification;
- Traditional medicine licensing.
3. STATUTORY REGULATIONS
The IHTA recognizes the difficulties imposed on members by the lack of appropriate regulations for Health Products. The Association is therefore actively involved in promoting the development of new regulations. In the meantime both the Association and its members are committed to working as far as possible within the existing statutory framework.
Where direct conflicts arise between the legitimate aspirations of members and inappropriate restrictions imposed by existing regulations, members are required to identify the problem to the Association and the Association will then formally raise the matter with the regulatory authority with a view to agreeing a way forward that is acceptable to all parties.
The above considerations aside, members who conduct their business in breach of statutory regulation are also in breach of the requirements of membership of the IHTA.
4. PUBLIC SAFETY
Members are concerned to ensure that products brought to the market are safe and create no threat to pubic health:
(i) Through the research work of its European Federation the IHTA publishes upper safety limits for essential micronutrients, which limits should not be exceeded in the products of members. These limits are continuously reviewed in the light of developing scientific understanding.
(ii) Prior to placing a product on the market, producers should carry out appropriate research on the safety of all ingredients both individually and together. Typically this research should have regard to:
- Industry upper safety levels for micronutrients;
- A review of formally recognized use (e.g. GRAS rating, Pharmacopoeia);
- A review of the actual use of the ingredients/product by volume and duration;
- A review of the published scientific literature
For Novel foods, the requirements of the EU Novel Foods procedure applies;
For medicinal products, the requirements of appropriate registration processes for medicinal products apply:
- Conventional medical licensing;
- Homoeopathic registration;
- Traditional medicine licensing (in development 2001).
(iii) Precise instructions for use are given in accordance with the requirements of the relevant medical, cosmetic or food regulations.
(iv) Quality assurance is established by adherence to statutory GMP for foods, cosmetics and medicinal products. Additional industry GMP standards are applied to Food Supplements as appropriate for preparations in unit dose form.
(v) Suppliers of medicinal products are required to operate to appropriate GMP and GDP standards which include adverse reaction reporting and the establishment of recall capabilities. This requirement is being recommended to all suppliers of products in unit dose form.
In order to ensure that the consumer is properly informed at point of sale, suppliers are selective about the channels of distribution. In particular pharmacy and health stores are treated as specialist retailers of health products and suppliers endeavour to ensure that the staff in these outlets receive appropriate training in the products supplied. This training consists of both product specific training by suppliers and independent training of retailers in good retailing practices (e.g. pharmacy courses, NAHS courses).
5. QUALITY ASSURANCE
Quality assurance is achieved by adherence to statutory requirements:
(i) Manufacture of homoeopathic and traditional medicinal products is carried out to pharmaceutical GMP by licensed pharmaceutical manufacturers;
(ii) Manufacture of food products adhere to food GMP;
(iii) Manufacture of body care products is carried out to appropriate GMP;
The following additional standards are being developed and implemented within the industry sector and members of the IHTA are expected to comply with all these standards.
(iv) Additional standards are applied to food supplements as is appropriate for foods in unit dose form (see CRN Guidelines);
(iv) Distributors ensure that products are manufactured in accordance with appropriate GMP in their country of origin, and take all practical steps to ensure that sub-suppliers conform to appropriate GMP.
(vi) Distributors will maintain adequate premises and facilities, and operate GDP (Good Distribution Practices).
(vii) Manufactures and Distributors should maintain finished product specification files in-house and have the capacity to support these specification with batch certificates of analysis on request.
6. LIABILITY INSURANCE
Members will at all times maintain adequate product liability insurance covering all products which they manufacture or supply.
7. HEALTH STATEMENTS
Health statements are used to market products and for the purposes of advising customers/consumers in the use of those products. In preparing and publishing claims members endeavour to comply with standard advertising codes of practice by ensuring that:
(i) Health statements are well-balanced, accurate and truthful;
(ii) Health statements are consistent with developing scientific and empirical knowledge as expressed in the product data file.
(iii) Health statements conform to developing statutory requirements.
(iv) Supporting literature such as manuals, text books, booklets and other clinical data, used for education, training and reference purposes, are not used in the public promotion of products.
Members of the Association understand that the Association is a voluntary organisation and members are asked to comply with the spirit and letter of the Associations Constitution and Code of Practice. In furtherance of this objective members will:
(i) Co-operate with the Associations General Secretary in any examination that he/she may make in relation to compliance by members.
(ii) Participate and raise matters of concern and contention for deliberation and debate.