from Premises other than a Pharmacy Rules, 2012

L.N. 222 of 2012

MEDICINES ACT

(CAP. 458)

Authorisation for Dispensing and Delivery to Patients of Total

Parenteral Nutrition Solutions and Ambulatory Dialysis Solutions

from Premises other than a Pharmacy Rules, 2012

IN exercise of the powers conferred by means of article 79(2) of

the Medicines Act, hereinafter referred to as "the Act", the Licensing

Authority has made the following rules:-

The title of these rules is the Authorisation for Dispensing

and Delivery to Patients of Total Parenteral Nutrition Solutions and

Ambulatory Dialysis Solutions from Premises other than a Pharmacy

Rules, 2012.

Total Parenteral Nutrition Solutions and Ambulatory

Dialysis Solutions, which are classified as medicinal products,

hereafter referred to as infusion solutions, shall not be dispensed from

premises other than a pharmacy unless there is an authorisation issued

by the Licensing Authority and subject to such conditions set by the

said Authority.

(1) An authorisation shall not be granted unless there is

a written request by the applicant addressed to the Licensing

Authority.

(2) All details of the intended operations shall be submitted,

including

(a)

the name and address of the applicant;

(b) the address of the premises that are to be used for

such purpose and the details of the means of transportation to be

used to deliver these infusion solutions up to patient level;

(c)

the equipment and control facilities, both in the

premises and in the transport systems used particularly if cold

storage is needed;

(d) information, documentation or evidence to prove

that the premises and transport systems used are suitable and

adequate, and that there are suitable facilities, installations and

equipment so as to ensure proper conservation, particularly if

cold storage is needed, and dispensing of the infusion solutions;

(e)

the name and address of a managing pharmacist who

shall be professionally responsible for all activities including

storage, transportation and delivery up to patient;

(f)

any other information, documentation or evidence as

may be requested by the Licensing Authority.

The authorisation shall only cover the dispensing and Dispensing and

delivery of these infusion solutions together with other infusion fluids delivery.

and ancillary medical equipment and devices used in total parenteral

nutrition and dialysis, herein after referred to as "ancillary items",

from such site as is indicated therein.

Such authorisation shall

Conditions of

authorisation.

(a)

not be transferable;

(b)

be issued for a period of one year unless renewed.

(1)

It shall be duty of the managing pharmacist to Duty of the

managing

ensure

pharmacist.

(a)

the procuring and sourcing of these infusion

solutions together with their ancillary items from licensed

wholesale dealers, and their adequate storage, dispensing and

delivery to the patient; and

(b) that the dispensing and where applicable, delivery to

the patient of these infusion solutions together with their

ancillary items, shall always be against a valid prescription

Provided that in those cases where delivery is

effected by a person other than the managing pharmacist, the

responsibility shall still vest with such managing pharmacist,

unless such a delivery is contracted out to a wholesale dealer in

which case the responsible person of the wholesale dealer shall

be responsible for the integrity of these products during their

delivery to the patient.

(2) The managing pharmacist shall follow any criteria and

conditions for the dispensing and transportation of these infusion

solutions as may be laid down by the Licensing Authority from time

to time.

The Licensing Authority shall have the right to amend, Powers of the

Licensing

suspend or revoke any authorisation if

Authority.

(a)

any matter stated in the application on which the

authorisation was issued is found to be false or incomplete;

(b) a material change of circumstances has occurred in

relation to any of those matters;

(c)

any provision or condition of the authorisation have

been contravened by the authorisation holder or by the

managing pharmacist;

(d) any other circumstance occurs as established by or

under the Act.

€0.36