S.I. No. 627/2002 - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 2002


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 (Prescription and Control of Supply) (Amendment) Regulations, 2002.

2.         These Regulations shall be construed as one with the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 to 1999 and may be cited together with those Regulations as the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 to 2002.

3          These Regulations shall come into force on the 18th day of December, 2002.

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

(a)  the insertion in Regulation 4(1) of the following definitions -

““European Pharmacopoeia” means the Pharmacopoeia referred to in subsection (3) of section 4 of the Pharmacopoeia Act, 1931 (No 22 of 1931) (as inserted by section 35 of the Misuse of Drugs Act, 1977 (No 12 of 1977)) and which is for the time being in force;

homeopathic medicinal product” means any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeia currently used officially in the Member States;”.

(b)  the insertion of the following paragraphs in Regulations 14-

“(3)  The provisions of Regulations 5 and 6 shall not apply to a homeopathic medicinal product which contains a substance specified in Part 3 of the Third Schedule at a level not exceeding one part per million, and which is the subject of an authorisation granted under regulation 7 of the Medicinal Products (Licensing and Sale) Regulations, 1998 ( S.I. No. 142 of 1998 ) or a certificate of registration granted under regulation 8 of the said Regulations.”

“(4)  The provisions of Regulations 5 and 6 shall not apply to the supply of a medicinal product which consists of or contains one or more of the herbal substances specified in Part 4 of the Third Schedule where the person making the supply is the occupier of the premises, not being a shop or other such retail outlet, on which the said medicinal product has been extemporaneously prepared and which the said person is able to close so as to exclude the public and the supply of the medicinal product concerned is made on those premises for administration to a particular person after being requested by or on behalf of that person and in that persons presence to use his or her own professional judgement as to the treatment required.”.

(c)  the substitution of the following for Regulation 15-

“Enforcement and Execution

15. (1) (i)   The Minister may appoint such and so many officers as he thinks fit to be authorised officers for the purposes of these Regulations.

(ii)      The Pharmaceutical Society of Ireland may appoint such and so many officers as it thinks fit to be authorised officers for the purposes of these Regulations.

(iii)     The Chief Executive Officer of each health board may appoint such and so many officers as it thinks fit to be authorised officers for the purposes of these Regulations.

(iv)     The Irish Medicines Board may appoint such and so many officers as it thinks fit to be authorised officers for the purposes of these Regulations.

(2) (a)      An authorised officer shall be furnished with a warrant of his appointment.

(b)      When exercising a power conferred on him under this regulation, an authorised officer shall, if required by a person thereby affected, produce the warrant to that person for inspection.

(3)  Subject to paragraphs (4) and (5) an authorised officer may for the purpose ensuring that these Regulations are being complied with -

(a)      at all reasonable times, enter and search a premises of any class or description,

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

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

(d)      inspect and copy or extract information from any data within the meaning of the Data Protection Act, 1988 ( No 25 of 1988 ),

(e)      take (without payment) samples of any medicinal product or substance stored, or offered or kept for supply at such premises for test, examination or analysis,

(f)       seize and detain any medicinal product, substance or article,

(g)      take any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings under the Act.

(4)  An authorised officer shall not other than with the consent of the occupier enter a private dwelling or such part of any premises (not being a shop) as is used by a registered medical practitioner or registered dentist for carrying on his professional practice unless he or she has obtained a warrant from the District Court under paragraph (8 authorising such entry.

(5)  So much of paragraph (3) 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;

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

(6)  An authorised officer, for the purpose of exercising any of the powers conferred on him by paragraph (3), may require any other person having authority to do so, to break open any container or package, or to open any vending machine, or to permit him to do so.

(7)  Where an authorised officer seizes any medicinal product, substance article or document in the exercise of a power conferred on him by paragraph (3), he 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.

(8)  If a judge of the District Court is satisfied, on the sworn information of an authorised officer, that there are reasonable grounds to authorise entry into any of those premises set out at paragraph (4)

(9)  herein, the judge may issue a warrant authorising such an authorised officer, accompanied, if appropriate, by other authorised officers and/or by a member or members of the Garda Síochána, at any time or times within one month from the date of issue of the warrant, on production of the warrant requested, to enter those premises or part thereof and to exercise any of the powers conferred on such an authorised officer under these Regulations.

(10) A person shall not wilfully obstruct or interfere with the exercise of a power by an authorised officer pursuant to these Regulations.

(11) A person shall not, without reasonable excuse, fail to comply with any request made by an authorised officer under these Regulations.”.

(d)  the substitution in the First Schedule thereto for the entries in respect of the various substances specified in Column 1 of Schedule II to these Regulations of the entries specified in the said Schedule II in respect of each such substance and of any entries that may appear in any of the Columns of the said Schedule II opposite the entry for each such substance;

(e)  the insertion in Part 1 of the Third Schedule thereto of the substances diclofenac sodium and flurbiprofen;

(f)   the insertion in Part 2 of the Third Schedule thereto of the substance Hypericum perforatum L.;

(g)  the insertion in the Third Schedule thereto of Parts 3 and 4 as contained in the Schedule I to these Regulations;

(h)  the insertion in Part 2 of the Fourth Schedule thereto of the substance cyproterone acetate;

(i)   the insertion of the following regulation after regulation 17:

“Amendment of Medicinal Products (Control of Paracetamol) Regulations, 2001

18. The Medicinal Products (Control of Paracetamol) Regulations 2001 ( S.I. No. 150 of 2001 ) are hereby amended by the substitution in paragraph (d) of regulation 5(2) and in paragraph (d) of regulation 6(2) of the words “use in children under six years of age” for the words “paediatric use”.”

Schedule I

“Part 3

(Regulation 14(3))

Substances which when contained in certain homeopathic medicinal products may be supplied without a prescription and in non-pharmacy outlets

Aconitum napellus L

Anamirta cocculus (L.) Wight & Arn.

Arsenic

Atropa belladonna L.

Caulophyllum thalictroides (L.) Mich.

Conium maculatum L.

Cytisus scoparium L.

Digitalis purpurea L.

Ephedra vulgaris Rich.

Gelsemium nitidum L.

Ginkgo biloba L.

Hypericum perforatum L.

Mandragora autumnalis Bertol.

Phytolacca species

Podophyllum species

Rauwolfia serpentina (L.) Benth. ex Kurtz

Schoenocaulon officinale (Schlect & Cham) A. Gray

Snake Venoms

Strychnos ignatii Berg.

Strychnos nux vomica L.

Symphytum species

Veratrum album L.

Viscum album L.

Part 4

Herbal substances which when contained in extemporaneously prepared medicinal products may be supplied without a prescription in certain limited circumstances

Ginkgo biloba L.

Hypericum perforatum L.”

Schedule II

 

 

Circumstances excluding products from prescription-only control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum strength, pack size or period of treatment

Use, pharmceutical form or manner of administration

Maximum Dose and Maximum Daily Dose

Diclofenac Sodium

B

Equivalent of 1.0% Diclofenac (MS)

30g (MPS)

7 days (MPT)

External: For the local symptomatic relief of pain and inflamation in the trauma of tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism.

For use in adults and children not under 12 years

Flurbiprofen

B

8.75mg (MS)

140mg (MPS)

Throat lozenges

For use in adults and children not under 12 years.

43.75mg (MDD)

Fluticasone Propionate

B

Container or package containing not more than 3000mcg of Fluticasone Propionate

6 months (MPT)

For the prevention and treatment of allergic rhinitis, including hay fever

In the form of a non-pressurised nasal spray.

For use in adults and children not under 12 years.

100mcg per nostril (MD)

200mcg per nostril (MDD

Ibuprofen

B

(1) 200mg (MS)

50(MPS)

(1)Internal:Rheumatic and muscular pain, backache, neuralgia, migrane, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.

(1) 400mg (MD)

1200mg (MDD)

(2) 400mg (MS)

25 (MPS)

(2) Internal: Muscular pain, backache, dental pain and dysmenorrhoea.

For use in adults and children not under 12 years.

(2) 400mg (MD) 1200mg (MDD

(3) 5.0%

30g (MPS)

7 days (MPT)

(3) External: For local symptomatic relief of pain and inflamation in the trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism.

For use in adults and children not under 12 years.

Lodoxamide Trometamol

B

Equivalent of 0.1% Lodoxamide (MS)

Eye Drops

For use in adults and children not under 4 years.

Terbinafine Hydrochloride

B

1.0% (MS)

15g (MPS)

14 days (MPT)

External: Products other than spray solutions.

For the treatment of tinea cruris (jock or dhobie itch) and tinea pedis (athlete's foot).

For use in adults and children not under 16 years.

 

GIVEN under my Official Seal

this 18th day of December, 2002.

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MICHE?L MARTIN T.D.

________________________

Minister for Health and Children

Explanatory Note

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

The main purpose of these Regulations is to update the controls applicable to the prescription and supply of medicinal products to the public.

The Regulations are also intended to give effect, on an on-going basis, to the various classification for the supply of medicinal products for human use that arise in connection with the authorisation of such products, in the context of Directive 2001/83/EC of the European Parliament and of the Council relating to medicinal products for human use and having particular regard to Title VI of this Directive which relates to the classification of medicinal products.

The Regulations also incorporate amendments to provide exemptions so as to enable certain homeopathic medicinal products to be supplied without a medical prescription and to enable the supply of certain prescription-only herbal medicinal products to be supplied in certain defined circumstances.