Irish Medicines Board

The Irish Medicines Board

What does the Irish Medicines Board do?

A century or more ago, before the advent of modern mass pharmaceutical companies, a bewildering array of concoctions were available claiming to treat almost any ailment. Not every "miracle cure" advertised was snake oil, as many did contain active substances, but they were often at dangerous dosages. At the end of the nineteenth century, many commercially available "cure-alls" often included harmful levels of opium, cocaine or both.

Since that time, pharmacy has come a long way, and it is now possible to test substances in laboratory conditions to discover their precise reactions with the human body. This process of clinical trials for new drugs has led to a generation of medicines, purer, safer and more precise in their effects than ever before. Tragedies, such as the one caused by the drug thalidomide in the 1950s, are not acceptable to the public, who require that medicinal products should be tested beyond risk. Medicines must now pass rigorous clinical trials and assessment in order to be licensed and put on sale to the public.

The Irish Medicines Board (IMB) came into being in 1995 (replacing the National Drugs Advisory Board), and now licenses all medicines for human and animal treatment in Ireland. The board functions as a safeguard by protecting the public from sub-standard medical products, monitoring all clinical trials, and ensuring that advertisers do not make false medical claims for their products. The IMB regulates all aspects of medicine supply in Ireland, from manufacture to importation and distribution. Every product sold as medicine in Ireland must have an authorisation certificate that only the IMB can provide.

The IMB test all new medicines before giving them a license to be sold in Ireland. The board charges pharmaceutical companies a fee for this service, and aims to cover their running costs through such charges.

In the near future, the IMB will also take over regulatory responsibility for medical devices and controlled drugs. They already have the responsibility to control all clinical trials of drugs and treatments in Ireland. The IMB ethic committee examines all trial proposals and there are stringent guidelines on how such trials have to be conducted.

What counts as a medicine and what does not?

Usually, it is fairly clear what counts as a medicine and what does not. A product’s advertising or packaging will tell us in most cases. EU law defines a medicine as "any substance or combination of substances presented for treating or preventing disease in human beings or animals." Under this directive, the IMB is responsible for veterinary treatments as well as medicines intended for humans.

Increasingly, though, the line between medicine and non-medicine is being blurred by advertising that accentuates the health benefits, if any, of non-medicinal products. Some foods now require a medicinal authorisation because of the nutritional and vitamin additives they contain.

What about cosmetics and slimming products?

Because their primary aim is to maintain or improve the appearance of the body, cosmetics and slimming products are also licensed by the IMB, though not as medicines. There are stringent guidelines on how a cosmetic can be made, what it can contain, and how it can be used. If it contains hormones, antibiotics or certain other active substances, it can’t be considered as a cosmetic product. Equally, if it is to be swallowed, inhaled, injected or implanted into the body, it is a medicinal product, not a cosmetic.

Slimming products attempt to affect the body’s metabolism and digestive function, and have to be licensed by the IMB. Claims made by manufacturers about slimming products are carefully monitored by the IMB.

What about herbal medicines and homeopathic remedies?

There is more than one system of medical treatment, and increasingly people are turning to alternatives to conventional medicine such as homeopathy and Chinese medicine. These systems of medicine often work on quite different principles to conventional medicine.

All herbal medicines are considered as medicinal products, and some are only available on prescription. This is because many herbs have medicinal properties and it is important that the taking of such herbs be overseen by a trained physician. The herb St John’s Wort was one that the IMB decided to bring onto the prescription required list, as it may reactions when taken alongside other drugs.

Homeopathic remedies are covered by different legislation to medicines and herbs. The EU has passed the legislation that applies to all homeopathic treatments, and the IMB issues the certificates of registration to homeopathic treatments in Ireland.

How can I contact the IMB?

Irish Medicines Board,

Earlsfort Centre,

Earlsfort Terrace,

Dublin 2,

Ireland.

Tel: (01) 6764971

Fax: (01) 6767836

Email: foi@imb.ie

Website: www.imb.ie

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