Ireland

Policy

National policy, laws and related regulations for TM/CAM are in development.   However, there is no national office and work is carried out by the IMB.

Traditional herbal medicines are required to meet safety, quality and efficacy criteria in a similar manner to other licensed medicines as laid out in the new Traditional Herbal Medicinal Products Directive (2004/24/EC), amending Directive 2001/83/EC.

Contact

Irish Medicines Board

Website: http://www.imb.ie

 

Laws & Regulations

Nearly all food supplements are classified as medicines and must be registered with the IMB, Irish Medicines Board.  Any product which makes even mild claims or recommendations, has significant pharmacological effects, is packaged in tablet or capsule form, or is similar to another already registered medicinal product, must be registered.

Most botanicals must be registered with the IMB.  Some herbal supplements may not need to be registered depending on their production, and provided they make no claims or recommendations.  There are lists of medicinal herbs, herbs considered food, and herbs requiring prescription available from the IMB.  The European pharmacopoeia is legally binding.

Fortified and functional foods are generally not regulated so long as they are considered safe and the addition of botanicals to these foods is unregulated.

Post-marketing surveillance is in place for botanicals and is similar in nature to the plan used for drugs.

National policy, laws and related regulations for TM/CAM are in development.

Contact

Irish Medicines Board         

www.imb.ie

Standards & Guidelines

n Ireland, National policy on TM/CAM and laws of regulations for herbal medicine is currently being regulated. Unfortunately, there is no national program; national office and national research institute which working on TM, CAM or herbal medicines [1].

Herbal medicines in Ireland regulated under the law enforced in 1998. This is the same law applied for conventional medicine which regulated herbal medicines as prescription medicines, over the counter medicines, dietary supplements and medicines for self-medication purposes. Regarding to claim issues, by law, medical, health, nutrient content and structure/function claims possible to made for herbal medicines [1].

In Ireland, instead of national pharmacopoeia and national monograph, the European pharmacopoeia and European monograph are being used. Both of these documents are legally binding [1].

There are few requirements for manufacturing process of herbal medicines includes obedience to the information from pharmacopoeias and monograph, the GMP rules for conventional pharmaceuticals and special GMP rules. The successful of implementation of these requirements are measured through licensing of manufacturers and authorization of herbal products. In terms to safety and compliance requirements, both also applying the same requirements as for conventional pharmaceuticals [1].

Good Manufacturing Practice (GMP) is technical support issued by WHO in 2007 to assure the safety and quality of herbal medicines during the manufacturing process. However, it is advisable for other countries to develop their own national GMP for manufacturing herbal medicines which suits to the country's actual situation [2].

Currently, there is no registration system of herbal medicine existed in the country and the product is not listed in the national essential drug list. The system called post marketing surveillance system is used to monitor herbal medicines. Herbal medicine in Ireland is recognized as prescription and over the counter medicines. Products of herbal medicines are sold in the pharmacies and special outlet without regulated [1].

In terms of guidelines for agricultural and collection of herbal medicine's plants, this country obey to the documents by WHO title "WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants" [3].

Nowadays, herbal medicines are widely used as home remedies, over-the-counter drug products and raw materials for the pharmaceutical industry. A guideline to examine these quality of the herbal medicines for the safe use known as "Quality control methods for herbal materials" is produced by WHO in 1998 [4].

Ireland is an European Union (EU) and Organization for Economic Co-operation and Development (OECD) member countries which follows the simplified regulatory approval process on Traditional herbal medicinal products under the EU Directive on Traditional Herbal Medicinal Products (THMPD) formally known as The Directive 2004/24/EC [5][6].

Contact

Ministry of Health Ireland
Tel: 01 6354000, outside Ireland +353 1 6354000
Fax: 01 6354001, outside Ireland +353 1 6354001
Website: http://www.dohc.ie/

References

  1. WHO. National policy on traditional medicine and regulation of herbal medicines. Available from:http://apps.who.int/medicinedocs/pdf/s7916e/s7916e.pdf
  2. WHO. Guidelines on good manufacturing practices (GMP) for herbal medicines. Available from:http://apps.who.int/medicinedocs/documents/s14215e/s14215e.pdf
  3. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. Available from:http://whqlibdoc.who.int/publications/2003/9241546271.pdf
  4. WHO. Quality control methods for herbal medicines. Available fromhttp://apps.who.int/medicinedocs/documents/h1791e/h1791e.pdf
  5. Ireland. European Union (EU). Available from: http://europa.eu/about-eu/countries/member-countries/ireland/index_en.htm
  6. Ireland. Organization for Economic Co-operation and Development (OECD). Available from: http://www.oecd.org/ireland/