STATUTORY INSTRUMENT

S.I. No. 512 of 2001

Medicinal Products (Licensing and Sale) (Amendment) Regulations, 2001

DUBLIN

PUBLISHED BY THE STATIONERY OFFICE

S.I. No. 512 of 2001

Medicinal Products (Licensing and Sale) (Amendment) Regulations, 2001

I, Micheál Martin, Minister for Health and Children, in exercise of the powers conferred on me by Section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995 ), as adapted by the Health (Alteration of Name of Department and Title of Minister) Order, 1997, (S.I. No. 308 of 1997 ) hereby make the following Regulations:-

1.       These Regulations may be cited as the Medicinal Products (Licensing and Sale) (Amendment) Regulations, 2001.

2.       These Regulations shall be construed as one with the Medicinal Products (Licensing and Sale) Regulations, 1998 (S.I.No. 142 of 1998 ) and may be cited together with those Regulations as the Medicinal Products (Licensing and Sale) Regulations, 1998 and 2001.

3.       The Medicinal Products (Licensing and Sale) Regulations, 1998 are amended as follows:-

(a)  in article 2(1) by inserting the following after the definition of “certificate of registration”:

“health board” means a health board established under section 4(1) of the Health Act, 1970 (No. 1 of 1970 ) and includes each Area Health Board established by section 14 of the Health (Eastern Regional Health Authority) Act, 1999 (No. 13 of 1999 ).”;

(b)  in article 4 by inserting the following after paragraph (e):

“(f) the importation or sale of a medicinal product by or on behalf of a health board, at the request of the Minister for Health and Children, to meet the needs of a national emergency or other circumstances of extreme urgency where the medicinal product is intended for use exclusively in such emergency or circumstances of extreme urgency.”.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation).

These Regulations amend the Medicinal Products (Licensing and Sale) Regulations, 1998 (which requires persons importing and selling (which includes distributing) medicinal products to hold product authorisations in respect of those products) to facilitate the obtaining and making available of such medicinal products that have not been authorised in this country, to meet the needs of a national emergency or other circumstances of extreme urgency.