S.I. No. 309/1996:

MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL OF SUPPLY) (AMENDMENT) REGULATIONS, 1996.

MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL OF SUPPLY) (AMENDMENT) REGULATIONS, 1996.

In exercise of the powers conferred on the Minister for Health by section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), which said powers are delegated to me by the Health (Delegation of Ministerial Functions) Order, 1996 ( S.I. No. 24 of 1996 ), I, Brian O'Shea, Minister of State at the Department of Health, hereby make the following Regulations--

1. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 1996.

2. These Regulations shall be construed as one with the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 ( S.I. No. 256 of 1996 ).

3. The Medicinal Products (Prescription and Control of Supply) Regulations, 1996 are hereby amended by:-

(a) the insertion of the following sub-article in article 7-

"(9) Sub-article (4) shall not apply as respects a medicinal product which contains insulin.";

(b) the substitution in sub-article (1) of article 4 of the following definition for "health prescription"-

""health prescription" means a prescription issued in connection with arrangements made under section 59 or section 67 of the Health Act, 1970 (No. 1 of 1970 ), on a form supplied by or an behalf of a health board";

(c) the substitution of the following sub-article for sub-article (1) of article 16-

"(1) In any proceedings for an offence under section 32 of the Act in relation to these Regulations a certificate signed by--

(a) the State Chemist, or

(b) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875, or

(c) a chemist or analyst appointed by the Pharmaceutical Society of Ireland for that purpose,

stating the result of any test, examination or analysis of a sample shall, with regard to that sample, be evidence for all purposes of such result.";

(d) the substitution in the First Schedule of the word "à-Cyanobenzyl-ß-D-glucopyranosiduronic Acid" where it appears for the second time, by the word "α-Cyanobenzyl-6-O-ß-D-glucopyranosyl-ß-D-glucopyranoside";

(e) the deletion in First Schedule of the words "Sodium Hyaluronate";

(f) the substitution in the First Schedule of the words "Talampicillin Napsylateamoxifen" by the words "Talampicillin Napsylate";

(g) the substitution in Part I of the Third Schedule of the word "Oxethazine" by the word "Oxyethazaine".

Dated this 15th day of October, 1996

Brian O'Shea

Minister of State at the Department of Health.

Explanatory Memorandum

These Regulations clarify aspects of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 in regard to the classification of insulins, the recognition of dental prescriptions as health prescriptions and the nature of certificates to be given for the purpose of evidence. The Regulations also make certain technical adjustments to the First and Third Schedules..