Irish Medicines Board
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.
counts as a medicine and what does not?
Usually, it is
fairly clear what counts as a medicine and what does not. A products 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.
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.
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 cant 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
attempt to affect the bodys 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.
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 Johns
Wort was one that the IMB decided to bring onto the prescription required list,
as it may reactions when taken alongside other drugs.
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.
can I contact the IMB?
Tel: (01) 6764971
Fax: (01) 6767836
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