S.I. No. 424/1986 -- Poisons (Amendment) Regulations, 1986.

S.I. No. 424/1986 -- Poisons (Amendment) Regulations, 1986. 1986 424

S.I. No. 424/1986:

POISONS (AMENDMENT) REGULATIONS, 1986.

The Minister for Health, in exercise of the powers conferred on him by section 14 of the Poisons Act, 1961 (No. 12 of 1961) as amended by section 33 of the Misuse of Drugs Act, 1977 (No. 12 of 1977) after consultation with Comhairle na Nimheanna, hereby makes the following Regulations:----

1. (1) These Regulations may be cited as the Poisons (Amendment) Regulations, 1986.

(2) These Regulations shall be construed as one with the Poisons Regulations, 1982 to 1984 and may be cited together with those Regulations as the Poisons Regulations, 1982 to 1986.

2. In these Regulations "the Principal Regulations" means the Poisons Regulations, 1982 ( S.I. No. 188 of 1982 ).

3. The Principal Regulations are hereby amended:----

( a ) by the insertion in article 2 after the definition of "local authority" of the following definition--

" "mastitis control programme" means a programme having as its primary objective the prevention and treatment of bovine mastitis, conducted by a Co-Operative Society registered under the Industrial and Provident Societies Acts, 1893 to 1978, engaged in the processing of milk, which includes the collection and dissemination of data on the organisms prevalent in bovine mastitis and their current sensitivity patterns and which is operated under the direction and control of an authorised person, registered druggist or registered veterinary surgeon."

( b ) by the substitution of the following article for article 6--

"6. (1) Subject to the provisions of these Regulations a person shall not in the course of a business sell or offer or keep for sale--

( a ) any poison set out in Part I of the First Schedule unless he is a person 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 and where the sale of any such poison is made it shall be effected by or under the supervision of an authorised person or a registered druggist, or

( b ) any poison set out in Part II of the First Schedule unless--

(i) he is a person 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 and where the sale of any such poison is made it shall be effected by or under the supervision of an authorised person or a registered druggist, or

(ii) he is a person licensed by a health board under article 14 in respect of the premises on which the said poison is sold or offered or kept for sale and where the sale of any such poison is made it shall be effected by that person.

(2) A person shall not sell or offer or keep for sale any poison from a travelling shop, vehicle or automatic vending machine."

( c ) by the substitution of the following article for article 8--

"8. (1) Subject to the provisions of articles 16 and 19 a poison set out in the Second Schedule shall not be sold to any person unless that person either--

( a ) is certified in writing by a householder in the manner described in sub-article (3), or

( b ) is known by the seller or by an authorised person or registered druggist in the employment of the seller at the premises where the sale is effected to be a person to whom the poison may properly be sold.

(2) Subject to the provisions of this article the seller of any poison set out in the Second Schedule shall not deliver it until--

( a ) he has entered or caused to be entered in a book kept for that purpose, in the form set out in the Fifth Schedule--

(i) the date of the sale;

(ii) the name and address of the purchaser;

(iii) the name and address of the person, if any, by whom the certificate required under sub-article (1) (a) was given;

(iv) the name and quantity of the poison sold;

(v) the purpose for which the poison is stated by the purchaser to be required;

and

( b ) the purchaser has signed his name to such entry.

(3) ( a ) A certificate given for the purposes of sub-article (1) (a) shall be in the form and shall contain the particulars set out in the Twelfth Schedule;

( b ) Such a certificate given by a householder who is not known to the seller of the poison to be a responsible person of good character shall not be a sufficient certificate for the said purposes unless it is endorsed in the manner specified in the Twelfth Schedule by a member of the Garda Siochana;

( c ) Any certificate given for the purposes of this article shall be retained by the seller on completion of the sale.

(4) Sub-articles (1) and (2) shall apply as respects the supply, otherwise than on sale, of any poison set out in the Second Schedule in like manner as if references in those sub-articles to the sale and seller of poisons respectively included references to the supply and the supplier of poisons.

(5) Subject to sub-article (6) so much of sub-article (2) as requires signature of an entry by a purchaser shall not apply as respects the sale of a poison to a person for the purpose of his trade, business or profession where--

( a ) the seller shall have obtained before the completion of the sale an order in writing signed by the purchaser stating the purchaser's name and address, trade, business or profession, the purpose for which the poison is required and the total quantity to be purchased, and

( b ) the seller is reasonably satisfied that the signature is that of the person purporting to have signed the order and that that person carries on the trade, business or profession stated in the order, being one in which the poison to be purchased is used, and

( c ) the seller inserts in the entry required to be made under sub-article (2) the words "signed order" and a reference number by which the order can be identified.

(6) Where a person represents that he urgently requires a poison set out in the Second Schedule for the purposes of his trade, business or profession, the seller may, if he is reasonably satisfied that the person so requires the poison and is, by reason of some emergency, unable before delivery either to furnish to the seller an order in writing duly signed or to attend and sign the entry in the book, deliver the poison to the purchaser on an undertaking by the purchaser to furnish such an order within twenty-four hours.

(7) All books kept for the purposes of sub-article (2) shall be preserved for a period of two years from the date on which the last entry was made therein and shall be kept readily available for inspection by any member of the Garda Siochana or a person holding a written authorisation for the purposes of article 20.

(8) The provisions of this article shall not apply as respects the sale or supply of any poison by the manufacturer or importer thereof or by a person carrying on a business in the course of which poisons are regularly sold by wholesale where--

( a ) the poison is sold or supplied to a person carrying on a business in the course of which poisons are regularly sold or are regularly used in the manufacture of other products, and

( b ) the seller or supplier is reasonably satisfied that the purchaser requires the poison for the purposes of that business.

(9) The provisions of this article shall not apply as respects the sale of any poison in the dispensing of a prescription issued by a registered medical practitioner or registered dentist.

(10) The provisions of this article set out in sub-article (2) (b) shall not apply in respect of compounds of Fentin."

( d ) by the addition to sub-article (8) of article 14 of the following paragraphs--

"(c) has not satisfied the Board on the level of direction and control to be exercised in accordance with the provisions of article 15(1) (d) (i), or

( d ) has not satisfied the Board in relation to the mastitis control programme and the availability to the licensee of the epidemiological data required under article 15 (1) (d) (iii).",

( e ) by the insertion of the words "or offer or keep for sale" after the word "sell" in sub-article 15(1) and of the words "or offered or kept for sale" after the word "sold" in paragraph (b) of the said sub-article.

( f ) by the substitution of the following paragraph for paragraph (d) of sub-article 15(1)--

"(d) any poison set out in Part III of the Fourth Schedule unless--

(i) the sale is effected under the general direction and control of the authorised person, registered druggist or registered veterinary surgeon having responsibility for a mastitis control programme and whose name is specified in the licence, and

(ii) the poison is an intra-mammary preparation for the prevention or treatment of bovine mastitis, and

(iii) the epidemiological data provided by the mastitis control programme is availed of in the case of each sale, and

(iv) the purchaser is engaged in the trade or business of agriculture and requires the poison for the prevention or treatment of bovine mastitis in the course of that trade or business."

( g ) by the substitution in sub-article (1) of article 18 of the words "the seller of any poison being an antibiotic substance set out in Part I or Part II of the First Schedule, or its salts, its esters, its derivatives or salts of its esters or salts of its derivatives" for the words "the seller of any poison set out in Part III of the Fourth Schedule".

( h ) by the substitution in article 18 of the following sub-article for sub-article (2)--

"2. So much of sub-article (1) as requires signature of an entry by a purchaser shall not apply where the sale is made--

( a ) on foot of a prescription issued by a registered veterinary surgeon and the seller has inserted in the entry required to be made under the said sub-article (1) the name of the veterinary surgeon who issued the prescription and an indication that the sale was made on foot of a prescription as aforesaid, or

( b ) otherwise than on foot of such a prescription provided that--

(i) the seller shall have obtained before the completion of the sale an order in writing signed by the purchaser stating the purchaser's name and address, the purpose for which the product is required and the form and total quantity of the product to be purchased, and

(ii) the seller is reasonably satisfied that the signature is that of the person purporting to have signed the order, and

(iii) the seller inserts in the entry required to be made under sub-article (1) the words "signed order" and a reference number by which the order can be identified."

(i) by the addition to article 19 of the following sub-articles--

"(5) The provisions of paragraphs (a), (b) and (c) of article 7(1), articles 7(2), (3) and (4), paragraph (a) of article 7(6), articles 7(7), 7(8), 10(1), 11, 12(1) and 13 shall not apply to any poison where--

( a ) it is a pesticide to which the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1985 ( S.I. No. 370 of 1985 ) apply, and

( b ) its packaging and labelling are in accordance with the provisions of those Regulations, and

( c ) it is not and does not contain either strychnine, its salts, its quaternary compounds or salts of paraquat.

(6) In this article the word "profession" shall be construed as not including the profession of farming."

( j ) by the substitution of the following sub-article for sub-article 20(1)--

"(1) The enforcement and execution of the provisions of these Regulations and the prosecution of offences under section 17 of the Act in relation to these Regulations may be carried out--

( a ) by officers of the Minister,

( b ) by the Society and its officers,

( c ) as respects the sale or keeping for sale of poisons by persons, not being persons 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, by health boards and their officers."

( k ) by the addition to sub-article 3 of article 20 of the following paragraph after paragraph (a)--

"(aa) enter any vehicle or travelling shop,"

( l ) by the addition to paragraphs (b), (c) and (d) of sub-article 3 of article 20 of the words "vehicle or travelling shop," after the word "premises".

( m ) by the insertion in Part 1 of the First Schedule of the words "Minoxidil; its salts" after the words "Mianserin; its salts".

( n ) by the insertion in Part I of the First Schedule of the words "Organochlorine compounds, the following; their isomers: --Aldrin, Dieldrin, DDT" after "Orciprenaline; its salts".

( o ) by the insertion in the Second Schedule of the words "Alpha-Chloralose other than preparations thereof specified in Part I of the Fourth Schedule" after the item beginning with the word "Alkaloids".

( p ) by the insertion in Part II of the Third Schedule of the word "Carbofuran" after the word "Bromomethane" in the column headed "Poison" and the insertion opposite to it of the words "Granular preparations" in the column headed "Substance or product in which exempted".

( q ) by the substitution of the application form set out in Schedule 1 to these Regulations for that set out in Part B of the Tenth Schedule.

( r ) by the substitution of the Certificate set out in Schedule 2 to these Regulatons for that set out in the Fifteenth Schedule.

4. The provisions of article 15(1) of the Principal Regulations shall apply, in respect of any person holding a licence under article 14 of the said Regulations, and which is in force on the date of coming into operation of these Regulations, until the date of expiry, cancellation or suspension of such licence, as if the amendment contained in article 3(f) of these Regulations had not been made.

5. The provisions of these Regulations other than article 3(i) shall come into operation on the 1st day of March, 1987.

6. Article 3(i) shall come into operation on the date of these Regulations.

SCHEDULE 1
Poisons Regulations, 1982 ( S.I. No. 188 of 1982 )
Application for a licence to sell poisons set out in Part II of the First Schedule to the Regulations
To the ............................................................ ............................................................ ....... Health Board.
I (1)............................................................ ...........trading as (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . hereby apply for a licence in respect of the following premises namely
(3)............................................................ ............................................................ ...................................
I hereby nominate (4)............................................................ ................................................. to act as my
responsible deputy(ies) for the purpose of article 14(6) of the said Regulations.
I hereby declare that I propose to sell poisons set out in Part III of the Fourth Schedule to the said Regulations in the form of intra-mammary preparations for the prevention and treatment of bovine mastitis.
I hereby declare that the above named premises is a recognised outlet of the co-operative society namely (2)............................................................ ............................................................ .................
which conducts a mastitis control programme and that I have made the necessary arrangements with
(5)............................................................ ......................................................, being a registered
(6)............................................................ ......................................................, for the purpose of compliance with article 15(1) (d) (i) of the said Regulations.
	Signature of applicant . . . . . . . . . . . . . . . . . . . .
	Date	. . . . . . . . . . . . . . . . . . .
I............................................................ ......................	of............................................................ ............
........................................................being a registered	(6)............................................................ ..........
having responsibility for the direction and control of the mastitis control programme referred to above, hereby consent to have my name entered in a licence granted pursuant to this application to sell under my general direction and control poisons set out in Part III of the Fourth Schedule to the said Regulations in the form of intra-mammary preparations for the prevention and treatment of bovine mastitis. I also declare that the epidemiological data will be available for the purpose of each sale of an intra-mammary preparation as required under article 15(1) (d) (iii) of the said Regulations.
	Signed............................................................
	Date............................................................ ...
(1) Here insert name of applicant.
(2) Here insert name of trading style of the business or enterprise.
(3) Here insert address of the premises in respect of which the licence is sought. A separate application and licence are required in respect of each premises.
(4) If so desired insert the name(s) of proposed deputy(ies) (not more than two).
(5) Here insert name and address of the person under whose general direction and control the sale of poisons set out in Part III of the Fourth Schedule to the Regulations is to be effected.
(6) Here insert the words "pharmaceutical chemist", "dispensing chemist and druggist", "druggist" or "veterinary surgeon", as the case may be.

SCHEDULE 2

Poisons Regulations, 1982 ( S.I. No. 188 of 1982 )
Certificate stating results of tests, examination or analysis
This Certificate is issued by me, the undersigned, for the purpose of article 21 of the Poisons Regulations, 1982, 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 under my direction and that the results are as follows:-- (5)
	Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
	Address. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(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 substance or product.
(4) Here insert the distinguishing mark on the sample and the date of sampling shown thereon.
(5) Here insert the relevant results as appropriate.

GIVEN under the Official Seal of the Minister for Health this 15th day

of December, 1986.

BARRY DESMOND,

Minister for Health.

EXPLANATORY MEMORANDUM

The Regulations amend the Poisons Regulations 1982 to 1984 to provide principally for the imposition of tighter restrictions on the retail sale of veterinary antibiotic preparations and to facilitate the enforcement of the controls over the sale of poisons generally. In addition, the Regulations provide for an exemption from the labelling, packaging and colouring requirements of the Poisons Regulations, 1982 in respect of those poisons, with the exception of paraquat and strychnine, to which the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1985 apply. Certain technical amendments to the Schedules to the '82 Regulations are also provided for.

Irish Statutory Instruments

S.I. No. 424/1986 -- Poisons (Amendment) Regulations, 1986.