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The Irish Medicines Board (IMB) is the Irish government agency which is responsible for regulating medicines and medical devices on the Irish market.

It was established under Statutory Instrument (S.I.) No. 143/1998 — Irish Medicines Board (Competent Authority) Order, 1998, which states:

"The Minister for Health and Children, in exercise of the powers conferred on him under subsection (4) of section 4 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), hereby orders that the Irish Medicines Board be appointed as the competent authority for the purposes of Council Directive No. 65/65/EEC of 26 January, 1965, (Official Journal No. 22 of 9 February 1965), as amended, and for the purposes of any regulations under the Health Act, 1947 (No. 28 of 1947) and the Irish Medicines Board Act, 1995, giving effect to that Directive, as amended."

The fundamental role of the IMB is to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products.

Roles of the IMB

 * 1) Licensing of medicines for human use
 * 2) Licensing of veterinary products
 * 3) Licensing of wholesalers and manufacturers of human and veterinary medicines
 * 4) Pharmacovigilance & Drugs safety monitoring
 * 5) Clinical Trial Licensing
 * 6) Inspection of wholesale and manufacturing sites