S.I. No. 495/2008 - Pharmaceutical Society of Ireland (Retail Pharmacy Businesses) (Registration) Rules 2008

1. If the Council proposes to refuse an application for registration of a retail pharmacy business or for the continued registration of such a business, the Council shall notify the applicant accordingly.

2. Any notification given under paragraph (1) shall include

(

a

) a statement of the proposal of the Council,

(

b

) a statement setting out in detail the reasons on which the said proposal is based, and

(

c

) a statement that the applicant has the right to make representations to the Council in response to the notification.

3. A person to whom notification has been given under paragraph (1) may, within the time allowed after the notification was issued, give notice to the Council of his or her wish to do so, and make representations to the Council with respect to the proposal referred to in the notification.

4. The Council shall, after consideration of the representations, decide whether to grant the application for the registration of the retail pharmacy business or confirm or alter its proposal to refuse the application, as the case may be.

5. In this Schedule, “time allowed” means the period of 28 days or such extended period as the Council may in any particular case allow.

EXPLANATORY NOTE

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

These Rules set out the procedures that must be complied with by persons making application for the registration of retail pharmacy businesses under the

Pharmacy Act 2007

.

The Rules also set out the procedures for the examination of applications, for the notification of material changes to premises and of certain personnel, for the cancellation of registrations and for restorations to the Register.

6. The full postal address of the premises to which the application relates.

7. (1) Subject to subparagraph (2), a brief description of the premises including the internal layout of the premises as respects the areas where medicinal products are, or are intended to be, sold or supplied, prepared, dispensed, compounded or stored, together with—

(

a

) a site map to identify the location of the premises,

(

b

) a statement setting out the arrangements so as to enable—

(i) personal supervision to be exercised by a pharmacist of any preparation, dispensing or compounding and of the sale of medicinal products, at one and the same time,

(ii) a pharmacist to review and discuss in private with a person for whom a prescription has been issued, or with the carer of such a person, matters relating to the medicine therapy of the individual for whom the prescription was issued, and

(

c

) a sketch plan, drawn to scale, showing the areas and the layout to which this paragraph relates.

(2) Subparagraph (1)(

b

)(ii) of this paragraph shall not apply until 1 September 2010 in the case of retail pharmacy businesses that have been established by the pharmacy owner concerned in the relevant premises on the date on which these Rules came into force.

8. In the case of an application for the registration of a retail pharmacy business being made for the first time, a statement setting out the details of the ownership of that business including—

(

a

) the names of all the owners or co-owners of the retail pharmacy business, and

(

b

) in the case of a retail pharmacy business that is, or is to be, carried on by a corporate body, being a body controlled under the Companies Acts 1963 to 2006 and not being a public limited company, the legal and beneficial ownership of the body including a statement of the ownership of any shares issued in such body.

9. In the case of an application in relation to a retail pharmacy business in respect of which there has been, or is to be, a change in the ownership of the pharmacy, as defined in section 17(6) of the Act—

(

a

) a statement showing all of the owners or co-owners of the retail pharmacy business and, in the case of a retail pharmacy business that is or is to be carried on by a corporate body, being a body controlled under the Companies Acts 1963 to 2006 and not being a public limited company, a brief statement setting out the legal and beneficial ownership of the body including a statement of the ownership of any shares issued in such body,

(

b

) the name and address of the immediate former owner of that business,

(

c

) the date of such change of ownership, and

(

d

) the date or the intended date of opening of such business to the public.

10. In the case of an application in respect of the continued registration of a retail pharmacy business where no change in the ownership of the said business (as referred to in section 17 of the Act) has taken place since the provision of a statement under either of paragraphs 8 or 9, a statement that no such change has taken place in respect of the retail pharmacy business to which the application relates.

11. (1) Where the application relates to a retail pharmacy business which is a member of a group of such businesses having a common ownership, the name and address of each of those businesses and the relationship between those businesses including, in the case of any corporate body, being a body controlled under the Companies Acts 1963 to 2006 and not being a public limited company, that may be established for the conduct of one or more of the businesses concerned, the relationship between those bodies and any other body exercising a management or controlling role in the operation of the businesses concerned.

(2) A statement setting out the role of the superintendent pharmacist in the context of the retail pharmacy businesses referred to in subparagraph (1) and the manner in which such role is or will be discharged, having regard, in particular, to the role of the superintendent pharmacist as set out in Regulation 5 of the Regulation of Retail Pharmacy Businesses Regulations.

(3) In this paragraph the expression “common ownership” includes ownership as a pharmacy owner or as a director or shareholder of a corporate body which is a pharmacy owner.

12. A statement setting out the arrangements that the pharmacy owner has put in place in respect of all registered pharmacists employed or engaged in the retail pharmacy business so as to ensure that those pharmacists—

(

a

) obtain and maintain appropriate experience in the practice of pharmacy, and

(

b

) undertake appropriate continuing education and continuing professional development

with a view to protecting, maintaining and promoting the health and safety of the public.

13. A statement setting out the arrangements that the pharmacy owner has put in place in respect of the segregation, storage and disposal of any medicinal products, including veterinary medicinal products, that have expired or that have been accepted as a return under Regulation 6(3) of the Regulation of Retail Pharmacy Businesses Regulations.

14. A statement setting out the various services of a professional nature, which are provided or are to be provided by the retail pharmacy business.

15. A statement that the retail pharmacy business will be conducted in accordance with regulations under section 18 of the Act and that the applicant is satisfied as to the identity and current registration status of any person employed or engaged as a registered pharmacist in the business and that each such person is the person to whom the relevant certificate of registration as a registered pharmacist relates.

16. A statement setting out the details of any professional indemnity insurance cover or other means of personal or collective protection with regard to professional liability.

Rule 5(4)

SCHEDULE 2

Procedural provisions relating to proposals to refuse an application for registration

of a retail pharmacy business

The Council of the Pharmaceutical Society of Ireland, in exercise of the functions conferred on the said Society by

section 11

of the

Pharmacy Act 2007

(No. 20 of 2007), hereby makes the following rules.

Dated this 28 day of November 2008

BERNARD LEDDY

President

AMBROSE McLOUGHLIN

Registrar

I consent to the making of these Rules.

GIVEN under my Official Seal,

28 November 2008

MARY HARNEY,

Minister for Health and Children.

S.I. No. 495 of 2008

PHARMACEUTICAL SOCIETY OF IRELAND (RETAIL PHARMACY BUSINESSES) (REGISTRATION) RULES 2008

ARRANGEMENT OF RULES