Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2015

• Jurisdiction: Ireland
• Citation: IR SI 87/2015

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 17th March, 2015.

I, LEO VARADKAR, Minister for Health, in exercise of the powers conferred on me by section 32 (as amended by section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006)) of the Irish Medicines Board Act 1995 (No. 29 of 1995) and for the purpose of giving effect to Article 1(20) of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 20111 , hereby make the following regulations:

1. (1) These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2015.

(2) The collective citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2015” includes these Regulations.

2. These Regulations shall come into operation on 24 June 2015.

3. In these Regulations—

“Regulations of 2005” means the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 ( S.I. No. 510 of 2005 );

“Regulations of 2011” means the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011 ( S.I. No. 525 of 2011 );

“Principal Regulations” means the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ).

4. Regulation 4(1) (as amended by Regulation 3 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2014 ( S.I No. 504 of 2014 )) of the Principal Regulations is amended—

(a) by substituting for the definition of “Act” the following definition:

“‘Act’ means the Irish Medicines Board Act 1995 , as amended by s. 197 of the Finance Act 1999 (No. 2 of 1999), Regulation 3 of the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ), Regulation 2 of the European Communities (Medical Devices) (Amendment) Regulations 2001 (S.I. 444 of 2001), Regulation 3 of the European Communities (Medical Devices) (Amendment) Regulations 2002 (S.I. 576 of 2002), the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006), the European Communities (Amendment of the Irish Medicines Board Act 1995 ) Regulations 2007 ( S.I. No. 542 of 2007 ) and the Health (Pricing and Supply of Medical Goods) Act 2013 (No. 14 of 2013);”,

(b) by substituting for the definition of “board” the following definition:

“‘Authority’ means the Health Products Regulatory Authority”;

(c) by inserting after the definition of “inhaler” the following definition:

‘manufacturer’s authorisation’ means an authorisation granted and in force in pursuance of the Medicinal Products (Control of Manufacture) Regulations 2007 ( S.I. No. 539 of 2007 );”,

(d) in the definition of “marketing authorisation”, by substituting “Authority” for “Board”,

(e) by inserting after the definition of “parenteral administration” the following definition:

“‘Pharmacy Act’ means the Pharmacy Act 2007 (No. 20 of 2007), as amended by the European Communities (Recognition of Professional Qualifications Relating to the Profession of Pharmacist) (No. 2) Regulations 2008 ( S.I. No. 489 of 2008 ), the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010 (No. 24 of 2010), the European Union (Recognition of Professional Qualifications relating to the Profession of Pharmacist) Regulations 2012 ( S.I. No. 235 of 2012 ), the Health (Pricing and Supply of Medical Goods) Act 2013 (No. 14 of 2013) and the European Union (Amendment of the Pharmacy Act 2007 ) Regulations 2015 ( S.I. No. 86 of 2015 );”,

(f) in the definition of “sampling officer”, by substituting “Authority” for “Board”,

(g) by inserting after the definition of “sampling officer” the following definition:

“‘Society’ means the Pharmaceutical Society of Ireland;”, and

(h) by substituting for the definition of “supply by way of wholesale dealing” the following definitions:

“‘supply by wholesale’ means the supply of a medicinal product to a person who obtains the product for one or more of the following purposes:

(a) supply in the course of a pharmaceutical business,

(b) administration in the course of a professional practice, or

(c) for or in connection with a service provided by a hospital;

‘wholesaler’s authorisation’ means an authorisation granted and in force in pursuance of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 ( S.I. No. 538 of 2007 ).”.

5. Regulation 10 (as amended by Regulation 3(g) of the Regulations of 2005) of the Principal Regulations is amended by substituting “supply by wholesale” for “by way of wholesale dealing” in both places where it occurs.

6. Regulation 16(3) of the Principal Regulations is amended by substituting “Authority” for “Board” in both places where it occurs.

7. Regulation 19 (as amended by Regulation 7 of the Regulations of 2011) of the Principal Regulations is amended by inserting after paragraph (4) the following paragraph:

“(5) The provisions of this Regulation shall also apply to the supply, by way of information society service, of medicinal products which by virtue of these Regulations may only be supplied on foot of a prescription.”

8. The Principal Regulations are amended by inserting after Regulation 19 (as amended by the Regulations of 2011) the following Regulations:

“Supply by information society services

19A.(1) Without prejudice to the provisions of the Pharmacy Act and the Regulations made under that Act, a person shall not supply a non-prescription medicinal product at a distance to the public in an EEA State by means of information society services, unless—

(a) he or she has been entered on the ISS supply list,

(b) he or she complies with these Regulations,

(c) the medicinal product is the subject of a marketing authorisation in the EEA State of destination, and

(d) the website offering the non-prescription medicinal products contains at least—

(i) the contact details of the Society,

(ii) a hyperlink to the website referred to in paragraph (13),

(iii) the common logo, established in accordance with Commission Implementing Regulation (EU) No. 699/2014 of 24 June 20142 and Article 85c(3) of the 2001 Directive, clearly displayed on every page of the website that relates to the offer for supply at a distance to the public of medicinal products and containing a hyperlink to the entry of the person in the ISS supply list,

(iv) a statement that a record of each transaction for the supply of medicinal products at a distance to the public by means of information society services will be retained for two years from the date of the transaction.

(2) The requirements of paragraph (1)(d) are without prejudice to the information requirements set out in Directive 2000/31/EC of the European Parliament and of the Council of 8 June 20003 .

(3) The Society shall establish and maintain a list, in accordance with paragraph (4), to be known as the “ISS supply list” of persons who have made valid applications in accordance with paragraph (5), in respect of the relevant 12 month period, to supply non-prescription medicinal products at a distance to the public by means of information society services.

(4) The ISS supply list referred to in paragraph (3) shall be divided into two Parts and the Society shall enter—

(a) in Part A of the list—

(i) the name of each pharmacy owner who has made a valid application in accordance with paragraph (5) in respect of the relevant 12 month period to supply, at a distance, to the public by means of information society services, non-prescription medicinal products,

(ii) the address of the registered retail pharmacy business from which such supply shall occur,

(iii) the address of the website used for the purposes of such supply (in URL form, rather than hypertext), and

(iv) the business name or trading style, if different from the name referred to in subparagraph (i), used in connection with such supply, and

(b) in Part B of the list—

(i) the name of every other person who has made a valid application in accordance with paragraph (5) in respect of the relevant 12 month period to supply, at a distance to the public by means of information society services, non-prescription medicinal products available on general sale under Regulation 12(1)(b)(ii) of the Medicinal Products (Control of Placing on the Market) Regulations 2007;

(ii) the address of the premises, which shall not be a dwelling, from which such supply shall occur,

(iii) the address of the website used for the purposes of such supply, and

(iv) the business name or trading style, if different to the name referred to in paragraph (i), used in...