S.I. No. 71/1993:

THE MEDICAL PREPARATIONS (LABELLING & PACKAGE LEAFLETS) REGULATIONS, 1993.

THE MEDICAL PREPARATIONS (LABELLING & PACKAGE LEAFLETS) REGULATIONS, 1993.

The Minister for Health in exercise of the powers conferred on him by sections 5 and 65 of the Health Act, 1947 (No. 28 of 1947) as amended by Section 39 of the Health Act, 1953 (No. 26 of 1953) and by Section 36 of the Misuse of Drugs Act, 1977 (No. 12 of 1977) hereby makes the following Regulations:--

1. These Regulations may be cited as the The Medical Preparations (Labelling and Package Leaflets) Regulations, 1993.

2. (1) In these Regulations:--

"common name" means the international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name.

"immediate packaging" means the container or other form of packaging immediately in contact with the medical preparation.

"labelling" means information on the immediate or outer packaging.

"the Minister" means the Minister for Health.

"name of the medical preparation" means the name given to a medical preparation, which may be either an invented name or a common or scientific name, together with a trade mark or the name of the manufacturer; the invented name shall not be liable to confusion with the common name.

"outer packaging" means the packaging into which is placed the immediate packaging.

"package leaflet" means a leaflet containing information for the user which accompanies the medical preparation.

"product authorisation" means a licence granted or renewed by the Minister under Article 6 of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ), as amended.

"strength of the medical preparation" means the content of the active ingredient expressed quantitatively per dosage unit, per unit of volume or weight, according to the dosage form.

(2) In these Regulations any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto, any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article and any reference in a Schedule to a paragraph shall be construed as a reference to a paragraph of that Schedule.

3. (1) Subject to sub-article (2) a person shall not in the course of a business carried on by him sell or offer or keep for sale a medical preparation which does not conform to the provisions of these Regulations.

(2) Sub-article (1) shall not apply to a medical preparation which is

( a ) prepared or dispensed by or in accordance with a prescription issued by a registered medical practitioner or registered dentist.

( b ) sold or supplied by a registered medical practitioner or registered dentist for or to a patient under his care.

( c ) sold or supplied by a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons in accordance with the Pharmacy Acts, 1875 to 1977 where such sale or supply is carried out by or under the supervision of a pharmacist and is manufactured by that pharmacist--

(i) in accordance with a specification furnished by the person to whom the preparation is to be sold, or

(ii) in circumstances where the person under whose supervision the preparation is sold or supplied exercises his own judgement as to the treatment required.

4. (1) The particulars which shall appear on the outer packaging of medical preparations shall be as listed in Schedule I.

(2) Except in the case of immediate packaging referred to in sub-articles (3) and (4) the particulars laid down in Schedule I shall appear on the immediate packaging.

(3) The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging:

-- the name of the medical preparation,

-- the name of the holder of the authorisation for placing the product on the market,

-- the expiry date,

-- the batch number.

(4) The following particulars at least shall appear on small immediate packaging on which it is not feasible to display the particulars laid down in Schedule 1:

-- the name of the medical preparation and, if necessary, the strength and the route of administration.

-- the method of administration,

-- the expiry date,

-- the batch number,

-- the contents by weight, by volume or by unit.

5. The outer packaging of a medical preparation may include--

(i) symbols or pictorgrams designed to clarify particulars which appear on the packaging, and

(ii) other information compatible with the summary of product characteristics incorporated in the product authorisation granted in respect of the medical preparation in question which is useful for health education, to the exclusion of any element of a promotional nature.

6. The particulars referred to in articles 4 and 5 shall--

(i) be easily legible, clearly comprehensible and indelible,

(ii) appear in the Irish or in the English language but this shall not prevent the said particulars from also being indicated in other languages provided the same information appears in all the languages used.

7. A package leaflet shall be included in the packaging of a medical preparation unless all the information required by article 8 is directly conveyed on the outer packaging or on the immediate packaging.

8. (1) The package leaflet shall be drawn up in accordance with the summary of product characteristics incorporated in the product authorisation granted in respect of the medical preparation in question.

(2) The details specified in Schedule 2 shall appear on the package leaflet and in the same order as they appear in the Schedule.

9. (1) The package leaflet in respect of a medical preparation shall be written in terms which are clear and understandable to a patient and be clearly legible and it may include:--

(i) symbols or pictograms designed to clarify certain information specified in Schedule 2 and

(ii) other information, compatible with the summary of product characteristics incorporated in the product authorisation granted in respect of the medical preparation in question which is useful for health education, to the exclusion of any element of a promotional nature.

(2) The particulars appearing on a package leaflet shall be in the Irish or English language but this shall not prevent the said particulars from also being indicated in other languages and provided the same information appears in all the languages used.

10. A product authorisation granted or renewed by the Minister under Article 6 of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, ( S.I. No. 210 of 1984 ), as amended, may provide for exemption from any of the requirements of these Regulations as regards the particulars which should appear on labels and package leaflets where the Minister is of opinion that the product is not intended to be delivered to a patient for self-administration.

11. (1) Subject to the provisions of sub-article (2), these Regulations shall come into effect on 1st January 1994.

(2) Notwithstanding the provisions of sub-article (1), the provisions of these Regulations shall come into effect, as respects a medical preparation for which a product authorisation was granted before 1st January, 1994, not later than two years after the date of the renewal of that product authorisation.

12. (1) The Medical Preparations (Advertisement and Sale) Regulations, 1958 ( S.I. No. 135 of 1958 ) are hereby revoked except insofar as is necessary to give effect to the provisions of sub-article (2).

(2) The provisions of article 6 of the Medical Preparations (Advertisement and Sale) Regulations, 1958 ( S.I. No. 135 of 1958 ), as amended, shall continue to apply to any medical preparation as referred to in sub-article (2) of article 11 until such time as the provisions of these Regulations come into effect in respect of that medical preparation.

13. The enforcement and execution of the provisions of these Regulations may be carried out by

(i) Officers of the Minister,

(ii) Health boards and their officers,

(iii) insofar as persons involved in the retail sale of medical preparations are concerned, the Pharmaceutical Society of Ireland and its officers.

SCHEDULE 1

Particulars required to appear on the outer packaging of medical preparations or, where there is no outer packaging, on the immediate packaging.

( a ) the name of the medical preparation followed by the common name where the preparation contains only one active ingredient and if its name is an invented name; where a medical preparation is available in several pharmaceutical forms and/or the strength (baby, child or adult as appropriate) must be included in the name of the medical preparation;

( b ) a statement of the active ingredients expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;

( c ) the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;

( d ) a list of those excipients known to have a recognised action or effect. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;

( e ) the method and, if necessary, the route of administration;

( f ) a special warning that the medical preparation must be stored out of reach of children;

( g ) a special warning, if this is necessary for the medical preparation concerned;

( h ) the expiry date in clear terms (month/year);

( i ) special storage precautions, if any;

( j ) special precautions for disposal of unused medical preparations or waste materials derived from such preparations, if appropriate;

( k ) the name and address of the holder of the authorisation for placing the medical preparation on the market;

( l ) the number of the authorisation for placing the medical preparation on the market;

( m ) the manufacturer's batch number;

( n ) in the case of self-medication, instructions on the use of the medical preparations.

SCHEDULE 2

Particulars required to appear on the package leaflet.

( a ) For the identification of the medical preparation:

--the name of the medical preparation, followed by the common name if the preparation contains only one active ingredient and if its name is an invented name; where a medical preparation is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (for example, baby, child, adult) must be included in the name of the medical preparation,

--a full statement of the active ingredients and excipients expressed qualitatively and a statement of the active ingredients expressed quantitatively, using their common names, in the case of each presentation of the preparation,

--the pharmaceutical form and the contents by weight, by volume or by number of doses of the product, in the case of each presentation of the preparation,

--the pharmaco-therapeutic group, or type of activity in terms easily comprehensible for the patient,

--the name and address of the holder of the authorisation for placing the medical preparation on the market and of the manufacturer;

( b ) the therapeutic indications except where it is a condition of the product authorisation that this information should not be specified.

( c ) a list of information which is necessary before taking the medical preparation,

--contra-indications,

--appropriate precautions for use,

--forms of interaction with other medical preparations and other forms of interaction (for example, alcohol, tobacco, foodstuffs) which may affect the action of the medical preparation,

--special warnings.

this list must:

--take into account the particular condition of certain categories of users (e.g. children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions),

--mention, if appropriate, potential effects on the ability to drive vehicles or to operate machinery,

--detail those excipients, knowledge of which is important for the safe and effective use of the medical preparation and included in the guidelines published by the EC Commission;

( d ) the necessary and usual instructions for proper use, in particular:

--the dosage,

--the method and, if necessary, route of administration,

--the frequency of administration, specifying if necessary the appropriate time at which the medical preparation may or must be administered,

and, as appropriate, depending on the nature of the preparation:

--the duration of treatment, where it shold be limited,

--the action to be taken in the case of an overdose (for example, symptoms, emergency procedures),

--the course of action to take when one or more doses have not been taken,

-- indication, if necessary, of the risk of withdrawal effects;

( e ) a description of the undesirable effects which can occur under normal use of the medical preparation and, if necessary, the action to be taken in such a case; the patient should be expressly invited to communicate any undesirable effect which is not mentioned in the leaflet to his doctor or to his pharmacist;

( f ) a reference to the expiry date indicated on the label, with:

--a warning against using the preparation after this date,

--where appropriate, special storage precautions,

--if necessary, a warning against certain visible signs of deterioration;

( g ) the date on which the package leaflet was last revised.

GIVEN under Official Seal of the Minister for Health, this 12th day of March, 1993.

BRENDAN HOWLIN,

Minister for Health.

EXPLANATORY NOTE.

These Regulations give effect to EC Council Directive 92/27 of 31st March, 1992 on the labelling of medicinal products for human use and on package leaflets (O.J. No. L. 113, 30.4.92 p. 8).