STATUTORY INSTRUMENTS

S.I. NO. 150 OF 2001

MEDICINAL PRODUCTS (CONTROL OF PARACETAMOL) REGULATIONS, 2001

Dublin

Published by the Stationery Office

S.I. No. 150 of 2001

Medicinal Products (Control of Paracetamol) 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 (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 millilitres.

(2) Where a supply of a medicinal product is effected under this Regulation, the product concerned shall contain paracetamol as its only active analgesic ingredient and the supply shall be made in the circumstances that no more than one pack of a medicinal product shall be supplied in the course of any one retail transaction.

7.      A person shall not supply a medicinal product that contains paracetamol in solid unit dosage form unless each such unit dosage form is individually contained in a blister pack or in other such equivalent form of packaging as may be specified in the relevant product authorisation.

8.       (1)     The following statements shall appear clearly on the outer packaging of a medicinal product or, if there is no outer packaging, on its immediate packaging :-

(a)     “Contains Paracetamol”,

(b)     “Do not take any other paracetamol-containing products.”,

(c)     “Do not exceed the stated dose”

(d)     “Immediate medical advice should be sought in the event of overdosage, even if you feel well. Please read the enclosed leaflet carefully,” in cases where a package leaflet is supplied with the product and the product is intended mainly for use in adults,

(e)     “Immediate medical advice should be sought in the event of overdosage, even if the child seems well. Please read the enclosed leaflet carefully.” in cases where a package leaflet is supplied with the product and the product is intended mainly for use in children not over 12 years of age,

(f)     “Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage.” in cases where no package leaflet is supplied with the product.

(2) The following statements shall appear clearly on the package leaflet of a medicinal product :-

(a)     “Contains Paracetamol”,

(b)     “Do not take any other paracetamol-containing products.”,

(c)     “Do not exceed the stated dose”;

(d)     “Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage.”.

(3) The statements specified in paragraphs (1) and (2) as they apply to any particular medicinal product, may be varied with the prior written approval of the Board. Any such varied statement as may be approved by the Board shall not alter the effect of the information that was to have been conveyed by the original statement.

9.       A person shall not supply a medicinal product from an automatic vending machine or by means of any other mechanically or electronically controlled device of a self-service nature.

10.     (1)    The provisions of Regulations 5 and 6 shall not apply in the case of the supply by wholesale of a medicinal product by any person being either -

(a)  the holder of a wholesaler's licence under the Medical Preparations (Wholesale Licences) Regulations, 1993 (S.I.No.39 of 1993 ) (as amended), or

(b)  the holder of a manufacturer's licence under the Medical Preparations (Licensing of Manufacture) Regulations, 1993 (S.I.No.40 of 1993 ) (as amended) and under which licence the said medicinal product was manufactured,

to any person being either -

(i) the holder of a licence to which sub-paragraph (a) or (b) applies, or

(ii) a person who by virtue of these Regulations is lawfully entitled to supply such a product.

(2) The provisions of Regulation 7 shall not apply in the case of a medicinal product which is intended for supply solely on foot of a prescription.

(3) The provisions of these Regulations shall not apply in the case of a medicinal product which is intended for export.

11.     (1)      The enforcement and execution of these Regulations may be carried out by -

(a)  officers of the Board,

(b)  officers of the Minister,

(c)  health boards and their officers,

(d)  officers of the Pharmaceutical Society of Ireland.

(2)      Subject to paragraph (3), any such officer (with, in the case of an officer of the Board, a written authorisation of the Board, in the case of an officer of the Minister, a written authorisation of the Minister, in the case of an officer of a health board, a written authorisation of that board and, in the case of an officer of the Pharmaceutical Society of Ireland, a written authorisation of that Society), may, at all reasonable times and on production by him or her on request of his or her written authorisation, for the purposes of ascertaining whether or not there is or has been a contravention of these Regulations-

(a)  enter and search a premises of any class or description,

(b)  inspect any substance, preparation or article which is stored, kept or offered for supply at such premises,

(c)  require the production of, inspect and, if he or she thinks fit, take copies of any register, book, record, order, invoice or other document, or of any entry in any such book, record or other document at such premises, and

(d)  take (without payment) samples of any medicinal product, substance, preparation or article stored or offered or kept for supply at such premises for testing, examination or analysis.

(e) seize and detain any medicinal product, substance, preparation or article which he or she has reasonable cause to believe to be a product, substance, preparation or article in respect of which, or by means of which, an offence under section 32 of the Act in relation to these Regulations has or is being committed, and any document which he or she has reasonable cause to believe to be a document which may be required as evidence in proceedings under the Act.

(3)     Paragraph (2) shall not apply as respects any of the following premises-

(a)     such part of any premises (not being a shop) as is used by a registered medical practitioner or registered dentist for carrying on his or her practice, or

(b)     a premises used only as a private dwelling.

(4)     So much of paragraph (2) as enables officers of the Pharmaceutical Society of Ireland to enter premises of any class or description shall not apply as respects any of the following premises-

(a)  a hospital, nursing home, clinic or similar institution,

(b)  the premises of a manufacturer of a medicinal product.

(5)      Any person may, for the purpose of exercising any of the powers conferred on him or her by paragraph (2), require any other person, having authority so to do, to break open any package or container, or to open any vending machine, or to permit him or her to do so.

(6)     Where a person seizes any medicinal product, substance, article or document in the exercise of a power conferred on him or her by paragraph (2), he or she shall inform the person from whom it is seized, and, in the case of any medicinal product seized from a vending machine, the person whose name and address are stated on the machine, or if no name and address are so stated, the occupier of the premises on which the machine stands or to which it is affixed of that fact.

(7)     A person shall not wilfully obstruct or interfere with the exercise of a power by a person duly exercising such power as is specified in paragraph (2).

(8)     A person shall comply with a requirement duly made of him or her under paragraph (5).

12.     (1)     In any proceedings for an offence under section 32 of the Act relating to a contravention of 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 (38 & 39 VICT. c.63),

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

(2)      The certificate referred to in paragraph (1) shall be in the form set out in the Schedule to these Regulations.

13      The Medicinal Products (Prescription and Control of Supply) Regulations, 1996, are hereby amended in the First Schedule thereto and in Part 2 of the Third Schedule thereto, by the deletion of the references to paracetamol.

Schedule

(Regulation 12)

Medicinal Products (Control of Paracetamol) Regulations, 2001

( S.I.No 150 of 2001 )

Certificate stating results of tests, examination or analysis

This Certificate is issued by me, the undersigned, for the purposes of Regulation 11 of the Medicinal Products (Control of Paracetamol) Regulations, 2001

being⁽¹⁾ __________________________________________________________________

I hereby certify that I received on the ________ day of _______________________________ 19 ______

from⁽²⁾ ___________________________________ of ___________________________________

a sample of⁽³⁾ ___________________________________ for test, examination or analysis, which was

undamaged, duly sealed and marked⁽⁴⁾ _______________________________________________

I further certify that the said sample has been tested, examined or analysed by me or under my direction and that the results are as follows⁽⁵⁾ .

Results

Signature ________________________________ Date ________________________________

Explanatory Note

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

These Regulations impose further restrictions on the sale of medicinal products containing paracetamol.

In general, these Regulations

(i) Prescribe maximum pack sizes for products when sold in pharmacies and in non-pharmacies.

(ii) Prescribe cautionary and warning statements which must appear on all packs.

(iii) Prohibit the sale of paracetamol products in automatic vending machines.

(iv) Prohibit the sale of paracetamol products in non-pharmacy outlets when a second analgesic component is concerned.

(v) Prohibit the sale of multiple packs of paracetamol in the course of a single transaction.

(vi) Prohibit the sale of paracetamol products unless they are in blister packs or equivalent form of packaging.

Exemptions are provided in the case of prescription medicines and medicines intended for export.

⁽¹⁾ Here insert official title of analyst

⁽²⁾ Here insert the name of the sampling officer or agent who submitted the sample for analysis

⁽³⁾ Here insert the name or description of the product

⁽⁴⁾ Her insert the distinguishing mark on the sample and the date of the sample shown thereon

⁽⁵⁾ Here insert the relevant results as appropriate.