2006 Significant Year of Growth at Irish Medicines Board
27 November 2007
The Irish Medicines Board (IMB) today released details of its key activities and performance highlights for 2006. It was a successful year for the IMB across all departments and functions.
- Safety monitoring of medicines and medical devices continued as the core priority
- Processed and evaluated over 1,900 nationally occurring suspected adverse reaction reports associated with use of human medicines notified by healthcare professionals and pharmaceutical companies
- The IMB initiated 469 enforcement cases for breaches of legislation
- The Medical Devices Department handled 993 vigilance reports
- The Human Medicines Department processed almost 18,000 applications for new and existing medicines whilst concurrently eliminating the backlog of applications for the first time ever Medical Devices Department registered 343 new medical devices
The number of applications processed for human medicines, including new product authorisations, renewals and variations to product authorisations was 17,725 in 2006. 848 new products were licensed comprising both over the counter (OTC) and prescription only medicines (POM). The historical backlog of licensing applications was eliminated in 2006. In addition, 122 clinical trials in Ireland were approved.
A total of 58 recalls of medicinal products were requested by the IMB during 2006. 56 related to human medicines and two related to veterinary medicines. Packaging and labelling defect issues, as well as the distribution of unlicensed products were the largest contributors to these recalls.
The IMB’s Enforcement Section initiated 469 cases involving breaches of medicinal product legislation during 2006 compared to 561 cases in 2005. The number of enforcement cases closed during the year increased significantly to 797 as compared to 430 cases in 2005. In total the IMB seized 96,487 tablets, 41,361 capsules, 52,873ml of liquids and 5,652g of creams. The active substances contained in the products seized covered a number of areas including antibiotics, antidepressants, corticosteroids and products for erectile dysfunction.
One of the main features of 2006 was the continued development of co-operation with other enforcement agencies in Ireland and abroad. A number of joint operations with the Gardaí and the Revenue Customs Service resulted in the initiation by the Director of Public Prosecutions (DPP) of a prosecution by indictment in a case involving the supply of anabolic steroids, along with the referral of other files to the DPP for consideration. Joint operations were carried out at a number of pharmacies along with authorised officers of the Health Service Executive and the Pharmaceutical Society of Ireland to ensure compliance with the wide range of legislation that applies to pharmacies.
The focus on the threat posed by counterfeit medicines was maintained during 2006 and the IMB contributed to the efforts of the Council of Europe and the World Health Organisation towards the development of anti-counterfeiting strategies.
In relation to medical devices, a total of 343 medical devices were registered during 2006 including 172 in-vitro diagnostic medical devices. 2006 also saw a number of major recalls of medical devices including a recall of a contact lens solution which was thought to be associated with an increased incidence of a serious eye infection, and the recall of three automatic external defibrillators due to component problems. A critical issue also arose in relation to the sale of illegitimate diagnostic test kits via internet sources. In total there were 122 recalls during the year. In all instances the IMB had considerable involvement with overseeing the manufacturers’ recalls.
According to Pat O’Mahony, Chief Executive, IMB, 2006 was a significant year of progress across all areas of activity.
“We recorded an increase in reporting of adverse reactions and we would again urge all healthcare professionals to continue to be vigilant and to report suspected adverse reactions to the IMB as they are a key component in our continued assessment of the safety of medicines on the market in Ireland. We have further expanded our remit to incorporate regulation of Tissues and Cells. This in effect, designates the IMB as the Competent Authority for tissues and cells in Ireland and requires our organisation to licence establishments to ensure standards of quality and safety for the donation, procurement, testing, storage and distribution of human tissues and cells. While maintaining our core focus on protecting public and animal health, a significant milestone was also reached in 2006 with the elimination of the historical backlog of licensing applications in human medicines.”
Output in the Veterinary Medicines Department was the highest on record in 2006 with 1,026 applications processed, and 70 suspected adverse drug reaction (ADRs) reports were received. The Veterinary Department also developed new initiatives in relation to the licensing of immunological veterinary medicinal products as well as publishing a pharmacovigilance guide to reporting ADRs in animals.
The IMB become the competent authority for the regulation of Tissues and Cells on the 7th April 2006 and by the end of 2006, the IMB had received 17 applications for Tissue Establishment Authorisation. The IMB continued to work at a European and international level contributing to the WHO Organisation Committee for the International Conference on Medicines Counterfeiting as well as attending Council of Europe Seminars relating to counterfeiting of medicinal products and a Council of Europe Anti Doping Conference. In addition, the IMB continued its participation in the WHO’s Advisory Committee on Safety of Medicines and at the EU’s Pharmacovigilance Working Party where issues relating to the safety of medicinal products were reviewed and evaluated.
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.