Our mission 
 The
principal aim of the Irish Health Trade Association is to promote the
wellness of all people in Ireland and to ensure they have freedom to access
traditional medicines and natural health products of their choice that
are safe, efficacious and of high quality.
The Irish Health Trade Association is pleased to announce the
appointment
of Dr. Alan Ruth as Chief Executive Officer.
Alan has worked in the healthcare industry for over 30 years, both in
Ireland and the UK. His experience embraces prescription medicines, medical
devices, surgical products and consumer healthcare products.
Prior to his appointment with the IHTA, Alan worked as an independent
management consultant in the healthcare industry. Before this, he was
Director and General Manager (Ireland) for a multi-national pharmaceutical
company (Searle Pharmaceuticals).
 Alan's qualifications include a BSc in Psychology & Physiology, a
prize-winning MBA, an MA Marketing (with distinction) and a PhD in
Organizational Psychology. He is a Chartered Biologist, a Member of the
Institute of Biology (UK), a Member of the European Health Psychology
Society and a Fellow of the Royal Society of Health.
Alan's numerous articles have appeared in such publications as: 'Modern
Medicine: The Irish Journal of Clinical Medicine', 'Irish Psychiatrist', and
'Irish Pharmacist.'
Industry Submissions
Latest News
FOOD SUPPLEMENT DIRECTIVE.
 Food Supplement Regulations 2007
Directive 2002 46 EC
St. Instrument no 539 2003
Latest News
TRADITIONAL HERBAL MEDICINAL PRODUCTS DIRECTIVE.
Implementation of the Traditional Herbal Medicinal Products Directive
[2004/24/EC] and the establishment of the Traditional Herbal Medicinal
Products Registration Scheme 31/08/2007
The national regulations required to implement the Traditional Herbal
Medicinal Products Directive [2004/24/EC] are now in place. The Medicinal
Products (Control of Placing on the Market) Regulations 2007 [SI No. 540 of
2007] came into force on the 23rd July 2007. Following on from this the IMB
is pleased to announce that the Traditional Herbal Medicinal Products
Registration Scheme is now available for applicants to apply for
certificates of traditional-use for relevant herbal medicinal products.
Applications to the Traditional Herbal Medicinal Products Registration
Scheme
Information and guidance on making an application to the scheme is now
published in the Publications section of the IMB website [www.imb.ie]
Timeframe for implementation of the Traditional Herbal Medicinal products
registration Scheme
According to the Medicinal Products (Control of Placing on the Market)
Regulations 2007 (SI 540 of 2007), on the coming into force of the
regulations no medicinal product can be placed on the market without a prior
marketing authorisation or certificate of traditional-use registration.
However, the regulations provide an exemption from this requirement until
30th April 2011 for traditional herbal medicinal products that were on the
market in the State on the coming into force of the regulations.
Notwithstanding the above and in order to ensure that relevant products hold
either a marketing authorisation or a certificate of traditional-use
registration by the 30th April 2011, potential applicants should be aware
that the new regulations also include a provision for the IMB to establish
dates by which applications for traditional-use registration must be
submitted.
Further information on the legislation and registration scheme are available
in the form of a FAQ documents available on the IMB website. Any further
queries on the above can be put in writing to Dr. Cora Nestor at the below
address or sent via e-mail to herbalmedicines@imb.ie.
Medical Products (control of placing on the market) Regulations 2007
The Traditional
Herbal Medicinal Products Directive (2004/24/EC) was
published in the 'Official Journal of the European Union' on Friday 30
April 2004.
Paragraph 1 of article 2 states that: 'the Member State shall take the
necessary measures to comply with this Directive by 30 October 2005…
This could lead to the introduction of a simplified registration scheme
for manufactured over-the-counter (OTC) traditional herbal remedies in
the second half of 2005. There would then be a further 'transitional'
period of 5 ½ years to allow all existing herbal medicines to
gain a Traditional Registration. The Dept of Health & Children have
yet to outline to industry their considerations in this regard.
 IMB Pre Application
Notification
Directive 2004/24 on Traditional Herbal
Medicinal Products was published on the 30th of April in the EU official
Journal.
Up dates available in the member's only section.
Latest News
CONTAMINANTS.
There has been much activity at a European Union level to develop legislation
covering a wide range of chemical contaminants in foods. Most of these
laws relate to food supplements.
A number of contaminants subject to legal control are listed in EU Regulation
(EC) No466/2001 and amendments.
This Regulation gives maximum levels for the following contaminants in
a large number of commodities and foods.
The list includes :
Lead
Cadmium
Mercury
3-MCPD
Dioxins
Nitrate
Aflatoxins
Ochratoxin A
The most complex part of the regulation is that dealing with mycotoxins
(toxic substances produced by fungi or moulds on plant material). The
requirements
for aflatoxins have already been expanded by Regulation (EC) No.257/2002,
an amending regulation to 466/2001.
More details available in the member's only
section.
Latest News
NOVEL FOODS:
Up dated information on Novel Food Catalogue listing is available from
the Food Safety Authority of Ireland,
phone; 353(0)1 8171300
fax; 353(0)1 8171207
www.fsai.ie
Latest News
HOMEOPATHY:
The Irish Medicines Board has recently published the Medicinal Products (Licensing and Sale) Regulations, Statutory Instrument Number 142 of 1998:
Simplified Registration Scheme for Homeopathic Medicinal Products for Human use.
Companies who wish to market Homeopathic Medicinal Products, which qualify for the Simplified Registration Scheme, as provided for in the above regulations and in accordance with EU Directives for Human Medicines, 92/73/EEC and 2001/83/EC; are hereby notified that applications for such registration can be submitted to the Irish Medicines Board with effect from the 1st of October 2003.
Applications will be considered sequentially by the IMB, in the following five categories:
1. Mineral, single substance products.
2. Plant, single plant products.
3. Animal, single animal products.
4. Complex, products that contain more that one homeopathic stock.
5. Other, any homeopathic medicinal product not included in categories 1 – 4.
All applications for products containing single mineral substances, in homeopathic dilution, must be submitted to the IMB by 31/1/2004, in order that such products may lawfully remain on the market.
The remaining categories should be submitted during 2004/2005 and companies will be notified in due course of the appropriate dates.
Any product in the single mineral category for which an application has not been submitted by the date above must be removed from the market by 31/3/2004.
Guidance Notes and Application Forms for the scheme are available directly from the IMB or on the web site at www.imb.ie.
Latest News
NUTRITIONAL AND HEALTH CLAIMS MADE ON FOODS:
Regulation EC No 1924/2006 on nutrition and health claims made on
foods came into force on
19th January 2007 and will apply from 1st July 2007.
Corrigendum to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December
2006 on nutrition and health claims made on foods.
Foods placed on the market or labelled prior to 1st July 2007 which do not
comply with the requirements of this Regulation may be marketed until their
expiry date but not later than 31st July 2009 . With regard to nutrient
profiles, foods may be marketed until 12 months following the adoption of
the relevant nutrient profiles and their conditions of use.
In addition, health claims describing or referring to the role of a nutrient
or other substance in the growth, development and the functions of the body
may be made from 19th January 2007 until the adoption of the list of health
claims referred to in Article 13(3), under the responsibility of the food
business operator, provided that they comply with this Regulation.
The Food Safety Authority of Ireland will be compiling the Irish list of
Article 13 claims. This has immediate implications for Irish food business
operators (FBOs) who make claims about their food products and who wish to
continue to use these claims. These FBOs must ensure that their claim, and
all relevant scientific substantiation and information for its use, is
submitted to the FSAI before 28th September 2007. Check www.fsai.ie
The FSAI is accepting submission of health claims under Article 14 of
Regulation 1924/2006/EC. These are reduction of disease risk claims and
claims referring to children's development and health.
EFSA recently published a guidance document to assist all FBOs in preparing and presenting their applications for
authorisation of Article 14 claims.
The guidance presents a common format to assist the applicant in the
preparation of a well-structured application. This will also help EFSA to
deliver its scientific advice in an effective and consistent way.
Guidance document available from the secretariat or check; www.efsa.europa.eu/en/science/nda/nda_opinions/claims/ej530_guidance_health_
claims.html
The FSAI have in their web site advised FBOs to use this document in the
preparation and presentation of Article 14 applications.
Two paper copies and two electronic copies (e.g. CD) of the dossier are
required to comply with the requirements of Article 15(2)(a)(iii), to
circulate the dossier to EFSA.
The paper copies will be considered the formal application.
Electronic copies should use common electronic formats, such as MS Office
type documents or Adobe Acrobat Reader. The files should be searchable using
the search facilities of standard software packages.
Submissions should be addressed to Health Claims, Public Health Nutrition,
Food Safety Authority of Ireland, Abbey Court, Lower Abbey Street, Dublin 1.
Check www.fsai.ie
Proposal for a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods July 2003.
This proposal regulates the information about a food product and its nutritional value that appears on its label. Only nutrition and health claims that are in conformity with the provisions of this Regulation will be allowed on the labelling, presentation and advertising of foods placed on the market.
Nutrition Claims
A “nutrition claim” means any claim which states, suggests or implies that a food has particular nutrition properties due to:
(a) the energy (calorific value) it – provides,
– provides at a reduced or increased rate, or
– does not provide, and/or
(b) the nutrients or other substances it
– contains,
– contains in reduced or increased proportions, or
– does not contain;
The proposed Regulation aims to harmonise the use of nutritional claims for example products claiming to be low in fat, may only make such a claim where the product contains no more than 3g of fat per 100g or 1.5g of fat per 100ml. Only nutrition and health claims that are in conformity with the proposed provisions will be allowed on the labelling, presentation and advertising of foods placed on the market within the Community. See the attached Annex from the Directive which lists permitted nutritional claims and the conditions applying to them.
Health claims
A “health claim” means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health;
Within three years of the Regulation entering into force, a ‘positive list’ of well established claims which describe the role of a nutrient or of another substance in
growth, development and the normal functions of the body which are based on generally accepted scientific data and well understood by the average consumer will be drawn up e.g. health claims regarding the role of a nutrient in the body which is well established such as the claim that calcium plays an important role in the strengthening teeth and bones would be permitted. For more novel claims scientific evaluation and premarketing approval will be required.
Implied health claims shall not be allowed for e.g. claims which make reference to general non-specific benefits of the nutrient or food for overall good health, or claims which make reference to the advice of doctors or other health professionals or their professional associations or charities, or suggest that health could be affected by not consuming the food will not be permitted.
Futher information available on the members only section.
Our objective
- Click here to view the IHTA Constitution and the IHTA Code of Practice
- The Irish Health Trade Association was established to represent the interests of manufacturers, importers and distributors of Natural Health Care products on the Irish market.
- These products include herbal preparations, homeopathic products, vitamin and mineral supplements, flower remedies and also natural body care products, health foods and food supplements.
- A principal aim of the Association is to gain
wide spread recognition for the valuable role that these natural health
care products can play in improving the health status of the population.
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