S.I. No. 87/2015 - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2015.

1. The name of the person to be listed, and in the case of a registered retail pharmacy business, the name as it appears in the Register of Retail Pharmacy Businesses established under section 13(1) of the Pharmacy Act.

2. In the case of an application under Regulation 19A(4)(

b

), the name of the natural person who is responsible for ensuring compliance with these regulations.

3. The business name or trading style to be used by the person to be listed in connection with the supply of non-prescription medicinal products at a distance to the public by means of information society services, where that name is different to the name required to be provided by paragraph 1.

4. In the case of a corporate body controlled under the

Companies Act 1963

–

(

a

) the registered name of the body,

(

b

) the address of the registered office of the body, and

(

c

) the Companies Office Registration Number of the body.

5. The permanent address of the fixed premises at which the medicinal products are to be stored and from which they are to be supplied.

6. Where the premises is at a registered retail pharmacy business, the registration number of the retail pharmacy business concerned in the Register of Retail Pharmacy Businesses established under section 13(1) of the Pharmacy Act, or, where the premises is not such a business, a description and floor plan of the fixed premises.

7. The starting date of the activity of offering medicinal products for sale at a distance to the public by means of information society services.

8. The address of the website used for that activity and all relevant information necessary to identify that website.

9. The classification sub-category or sub-categories in accordance with Regulation 12(1)(

b

) of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (

S.I. No. 540 of 2007

) of the non-prescription medicinal products offered for sale at a distance to the public by means of information society services.

10. A statement that the supply of medicinal products to the public at a distance by means of information society services will be conducted in compliance with these Regulations.

GIVEN under my Official Seal,

12 March 2015.

LEO VARADKAR,

Minister for Health.

EXPLANATORY NOTE

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

These Regulations amend the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (

S.I. No. 540 of 2003

).

These Regulations give effect to Article 1(20) of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 which amended Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 by inserting new Articles 85c and 85d.

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

1 OJ No. L 174, 1.7.2011, p. 74.

2 OJ No. L 184, 25.6.2014, p. 5.

3 OJ No. L 178, 17.7.2000, p. 1.

4 OJ No. L 204, 21.7.1998, p. 37.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

17

th 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 2011

1

, hereby make the following regulations