Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 2002

• Jurisdiction: Ireland
• Citation: IR SI 627/2002
• Year: 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...