The Irish Medicines Board is the competent authority in this country for the authorisation, control and supervision of medicinal products placed on the market. Under the Medicinal Products (Licensing and Sale) Regulations, 1998, which give effect in this country to EU Council Directive 65/65/EEC, medicinal products, including vaccines, on the market in this country must be the subject of product authorisations granted by the Irish Medicines Board. Before the board will grant an authorisation, it must be satisfied as to the safety, quality and efficacy of the product concerned.
The Irish Medicines Board monitors the use of all authorised medicinal products on an on-going basis via a range of post authorisation mechanisms. With a view to minimising the risk of transmitting animal Spongiform Encephalopathy agents via medicinal products, the board required all authorisation holders to demonstrate that their medicinal products were manufactured in a manner which minimised that risk. This action was taken in harmony with the competent authorities in the other member states of the European Union on the basis of Commission Directive 1999/82/EC, which related to clinical standards and protocols in respect of the testing of medicinal products.
In view of the range of medicinal and other products that contain various substances derived from bovine origin the matter is by no means simple. The thrust of any action in this area is to minimise the risk of transmission of the infective agents rather than replacement of the materials used. This approach includes the sourcing of materials from countries with lower levels of BSE.