Irish Medicines Board (Miscellaneous Provisions) Act 2006

Amendment of section 9 of Irish Medicines Board Act 1995 (advisory committees).

14.— Section 9 of the Irish Medicines Board Act 1995 is amended—

(a) by substituting the following for subsections (8) and (9):

“(8) The Board shall not refuse to grant a licence or authorisation in respect of—

(a) a medicinal product or class of medicinal products, or

(b) the manufacture or wholesale of a medicinal product or class of medicinal products,

on any ground relating to the safety, quality or efficacy of the medicinal product or class of medicinal products, as the case may be, unless the Board has requested the advice of the appropriate committee in relation thereto and considered the advice given pursuant to the request.

(9) Whenever the Board grants, suspends, renews or revokes a licence or other authorisation in respect of a medicinal product, it shall notify the appropriate committee of such grant, suspension, renewal or revocation.”,

and

(b) by inserting the following after subsection (9):

“(10) In subsections (8) and (9), any reference to a medicinal product includes a reference to a medicinal product for animal use.”.