Irish Medicines Board announces 2007 performance outturn

05 June 2008

The Irish Medicines Board (IMB) today released details of its key activities and performance highlights for 2007. As part of its function to protect and enhance public health, the IMB licenses and monitors the safety of all medicines on the Irish market. In 2007, the number of new medicines licensed by the IMB increased by 28% from 848 in 2006 to 1,082. The IMB’s Enforcement Section also saw the number of cases initiated for breach of medicinal product legislation rise with the number almost trebling from 469 in 2006 to 1,397.

Highlights:

• Safety monitoring of medicines and medical devices continued as the core priority.
• Processed and evaluated 1,751 suspected adverse reactions reports associated with human medicines.
• Launched online reporting system for suspected adverse reactions and quality defects to further facilitate reporting by healthcare professionals and general public.
• The IMB initiated 1,397 enforcement cases for breaches of medicinal product legislation.
• The Veterinary Medicines Department received 1,058 applications for new and existing veterinary medicines
• 840 vigilance reports processed by the Medical Devices Department and 261 medical devices registered.
• The Human Medicines Department processed 16,595 applications for new and existing medicines.

The number of applications processed for human medicines, including new product authorisations, renewals and variations to product authorisations was 16,595 in 2007. 1,082 new products were licensed comprising both over the counter (OTC) and prescription only medicines (POM) compared to 848 in 2006. In addition, 114 clinical trials in Ireland were approved. One product was suspended from the Irish market in May 2007, when the IMB suspended the marketing authorisation for nimesulide containing products for oral use.

According to Pat O’Mahony, Chief Executive, IMB, 2007 was another significant year for the IMB with the safeguarding of public health the organisation’s core focus. 

        “To further safeguard public health, the IMB has now developed an online reporting mechanism which facilitates healthcare professionals and members of the public to report any suspected adverse reactions or quality defects associated with medicines directly to us. In 2007, we received 1,751 suspected adverse reaction reports and we urge all healthcare professionals to continue to report these to us. This information plays a vital role in our continuous assessment of the safety of medicines on the Irish market. 

        “In addition, in 2007 the IMB successfully brought prosecutions against a number of retailers and individuals for breaches of medicinal product legislations. These prosecutions act as a warning to retailers and individuals that the IMB will take the necessary regulatory action to seek to stop individuals and businesses operating outside the law and to protect public health,” states Mr O’Mahony.

The IMB’s Enforcement Section initiated a total of 1,397 cases involving breach of medicinal product legislation during 2007, compared to 469 in 2006. The number of enforcement cases closed in 2007 also increased by 8% with 866 cases compared to 797 in 2006. In 2007, the IMB seized a total of 88,279 tablets, 106,443 capsules, 22.5 litres of liquids and 40kg of creams. The active substances in these products covered a number of areas including Diazepam, Ephedrine, Sildenafil Citrate, prescription level vitamins, antibiotics and weight loss products.

The IMB successfully prosecuted six retail outlets for breaches in relation to the sale of Paracetemol containing products. In addition, following an IMB investigation, a conviction was recorded at Naas District Court for the unauthorised supply of anabolic steroids by mail order. The IMB also continued to work successfully with the Gardaí with a joint investigation resulting in a conviction on indictment being recorded at Dublin Circuit Court and a custodial sentence handed down for the supply of unauthorised medicinal products (anabolic steroids) by mail order.

In relation to medical devices, a total of 261 medical devices were registered during 2007, including 139 in vitro diagnostic devices. The Medical Devices Department received 840 vigilance reports. The principal issues encountered with medial devices during 2007 included software problems and concern surrounding the maintenance and management of devices particularly in the area of technical aids for disabled people.

The IMB’s veterinary department processed 1,058 license applications including new product authorisations, renewals and variations to product authorisations. In total 110 new medicines were licensed and 98 suspected adverse reaction reports were received. In addition the department introduced a new management structure and work-flow systems to improve efficiency.

The IMB continued to work at European and international level contributing to WHO and Council of Europe Group initiatives on Anti-Counterfeiting. IMB staff also participated in the WHO international drug monitoring programme and at the annual International Society of Pharmacovigilance (ISOP) conference. In addition, in December 2007, the IMB hosted an international summit of leaders of medicines regulatory authorities from around the world, which has led to increased cooperation in the areas of anti-counterfeiting and in the control of clinical trials. 

                                                                        ENDS

FOR FURTHER INFORMATION:
Siobhan Molloy /Angie Grant Tel: (01) 676 01 68
Weber Shandwick 086 817 5066 or 086 377 2791


About the IMB: The Irish Medicines Board (IMB) is the competent authority for the licensing of human and veterinary medicines and medical devices available in Ireland, or manufactured in Ireland for Irish or export markets. Its role is to protect and enhance public and animal health through ensuring the quality, safety, efficacy and effectiveness of medicinal products and medical devices available on the market.