EU legislative requirements in relation to medicinal products are covered by Council Directive 65/65/EEC, as amended, which lays down special provisions for medicinal products derived from human blood or plasma i.e. blood products. The Irish Medicines Board (IMB) is the competent authority for the purposes of this directive. The IMB was established under the Irish Medicines Board Act, 1995, to licence the manufacture, preparation, importation, distribution and sale of medicinal products in Ireland. The remit also includes the regulation of medicinal products, including blood products, used in Ireland. The board also has responsibility for the supervision and control of medicinal products placed on the market in this country. All medicinal products, including blood products, used in Ireland are licensed and monitored by the IMB which is a guarantee of their compliance with Council Directive 65/65/EEC. However, Council Directive 65/65/EEC, as amended, specifically excludes blood components such as whole blood, plasma and blood cells of human origin.
The IMB is also the regulatory authority for the collection, screening, processing and quality control facilities in respect of human blood, blood components and blood products. The lMB inspects the IBTS by conducting two full inspections and investigations each year, and reports annually to the Minister on these inspections. The IMB apply the following EU directives and guidelines in their inspections of the IBTS:
–EC Directive No. 91/356/EEC dated 13 July 1991 which lays down the principles and guidelines of good manufacturing practice for medicinal products for human use;
–European Community Guide to Good Manufacturing Practice for Medicinal Products (vol. IV of the Rules Governing Medicinal Products in the European Community);
–Guide to the Preparation, Use and Quality Assurance of Blood Components (5th edition, 1999) Council of Europe.
Three annual reports have been presented and published to date which outline the significant progress made by the IBTS in ensuring compliance, nevertheless, specific instances of non-compliance have been reported which are being addressed.