Medicinal Products (Control of Paracetamol) Regulations. 2001

• Jurisdiction: Ireland
• Year: 2001
• Citation: IR SI 150/2001

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 (Control of Paracetamol) Regulations, 2001.

2. These Regulations shall come into force on the 1st day of October, 2001.

3. (1) In these Regulations:-

“the Act” means the Irish Medicines Board Act, 1995 ;

“authorised person” has the meaning assigned to it by section 2 of the Pharmacy Act, 1962 (No. 14 of 1962) as amended by section 34 of the Misuse of Drugs Act, 1977 (No. 12 of 1977) and by regulation 4 of the European Communities (Recognition of Qualifications in Pharmacy) Regulations, 1991 ( S.I.No. 330 of 1991 );

“active ingredient”, in respect of a medicinal product, means a substance which contributes to the pharmacological action of the medicinal product and cognate expressions shall be construed accordingly;

“the Board” means the Irish Medicines Board;

“dosage unit” means-

(a) where a medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, or

(b) where a medicinal product is not in any such form, that quantity of the product which is used as the unit by reference to which the dose is measured;

“export”, in respect of a medicinal product, means the physical departure of the product from the State to a territory that is not part of the State;

“pack size” means the quantity of a medicinal product by weight, volume or number of dosage units contained in the pack presentation intended for supply;

“package leaflet” means a leaflet containing information for the user which accompanies the medicinal product;

“prescription” means a prescription issued by a registered medical practitioner or a registered dentist;

“product authorisation” means a licence granted or renewed under the Medicinal Products (Licensing and Sale) Regulations, 1998 ( S.I. No. 142 of 1998 );

“supply” includes sell, distribute and offer and keep for sale or distribution.

(2) In these Regulations any reference to a regulation shall be construed as a reference to a regulation contained in these Regulations and any reference in a regulation to a paragraph or sub-paragraph shall be construed as a reference to a paragraph or sub-paragraph of that regulation.

4. These Regulations shall apply to a medicinal product that consists of or contains paracetamol.

5. (1) Subject to paragraphs (2) and (3) and to Regulation 6, a person shall not supply a medicinal product except in accordance with a prescription.

(2) Notwithstanding paragraph (1), a person keeping open shop for the dispensing or compounding of medical prescriptions under the Pharmacy Acts, 1875 to 1977 may, otherwise than in accordance with a prescription, supply a medicinal product provided that -

(a) in the case of dosage units each of which contains more that 120mg of paracetamol but not more than 500mg of paracetamol, the pack size does not exceed 24 such units;

(b) in the case of dosage units each of which contains more than 500mg of paracetamol but not more than 600mg of paracetamol, the pack size does not exceed 20 such units;

(c) in the case of dosage units each of which contains more than 600mg of paracetamol but not more than 1000mg of paracetamol, the pack size does not exceed 12 such units;

(d) in the case of a medicinal product intended for paediatric use and each dosage unit of which contains not more than 120mg of paracetamol, the pack size does not exceed 24 such units, or in the case of a liquid form of the said product in which the said quantity of paracetamol is contained in 5 millilitres, the pack size does not exceed 140 millilitres; or

(e) in the case of a medicinal product in liquid form in which each 5 millilitre dosage unit contains not more than 250mg of paracetamol other than a product to which sub-paragraph (d) applies, the pack size does not exceed 70 millilitres;

and provided that such supply is effected by, or under the personal supervision, of an authorised person.

(3) Notwithstanding paragraph (1), a person keeping open shop for the dispensing or compounding of medical prescriptions under the Pharmacy Acts, 1875 to 1977 may supply a medicinal product provided that -

(a) an authorised person at such shop has interviewed the person requesting the product and has satisfied himself or herself that it is safe in the circumstances to supply the product, and

(b) the total quantity supplied does not exceed fifty dosage units or, in the case of a medicinal product which is not in the form of a tablet or capsule or is not an article in some other similar pharmaceutical form, two packs.

(4) A medicinal product which by virtue of this Regulation may only be supplied in accordance with a prescription shall be subject to the requirements of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 ( S.I.No.256 of 1996 ) (as amended) in the same manner as medicinal products specified in Part B of the First Schedule to those Regulations are so subject.

6. (1) Notwithstanding Regulation 5, a person, who is not a person keeping open shop for the dispensing or compounding of medical prescriptions under the Pharmacy Acts, 1875 to 1977, may supply a medicinal product which is intended for oral use, provided that -

(a) in the case of dosage units each of which contains more than 120mg of paracetamol but not more than 500mg of paracetamol, the pack size does not exceed 12 such units;

(b) in the case of dosage units each of which contains more than 500mg of paracetamol but not more than 600mg of paracetamol, the pack size does not exceed 10 such units;

(c) in the case of dosage units each of which contains more than 600mg of paracetamol but not more than 1000mg of paracetamol, the pack size does not exceed 6 such units; or

(d) in the case of a medicinal product intended for paediatric use each dosage unit of which contains not more than 120mg of paracetamol, the pack size does not exceed 12 such units, or in the case of a liquid form of the said product in which the said quantity of paracetamol is contained in 5 millilitres, the pack size does not exceed 60...