AUTHORISATION FOR PREPARATION AND DISPENSING OF MEDICINAL PRODUCTS BY AUTOMATED MEANS FROM DESIGNATED

OF MEDICINAL PRODUCTS BY AUTOMATED MEANS

FROM DESIGNATED PREMISES AT CENTRAL

PROCUREMENT AND SUPPLIES UNIT (CPSU)

SUBSIDIARY LEGISLATION 458.62

AUTHORISATION FOR PREPARATION AND

DISPENSING OF MEDICINAL PRODUCTS BY

AUTOMATED MEANS FROM DESIGNATED

PREMISES AT CENTRAL PROCUREMENT AND

SUPPLIES UNIT (CPSU) RULES

24th December, 2021

LEGAL NOTICE 501 of 2021.

The title of these rules is the Authorisation for

Preparation and Dispensing of Medicinal Products by Automated

Means from Designated Premises at Central Procurement Services

Unit (CPSU) Rules.

In these rules, unless the context otherwise requires

"Act" means the Medicines Act;

"Authority" means the Licensing Authority established under

the Act;

"authorisation holder" means the Central Procurement and

Supplies Unit (CPSU) as holder of the authorisation to prepare and

dispense medicinal products by automated means granted under these

rules;

"designated premises" means premises designated by the license

holder from which the medicinal products shall be prepared and

dispensed;

"PIC/S" means The Pharmaceutical Inspection Co-operation

Scheme and the Pharmaceutical Inspection Convention.

The Central Procurement and Supplies Unit (CPSU)

shall only start preparing and dispensing medicinal products by

automated means upon authorisation granted by the Authority after the

requirements of these rules are satisfied and following satisfactory

completion of an inspection of the designated premises.

(1)

The Central Procurement and Supplies Unit

(CPSU) may present its application in writing to the Authority

requesting authorisation to prepare and dispense medicinal products

by automated means.

(2)

The application shall include

(a)

the name and address of applicant;

OF MEDICINAL PRODUCTS BY AUTOMATED MEANS

FROM DESIGNATED PREMISES AT CENTRAL

PROCUREMENT AND SUPPLIES UNIT (CPSU)

(b)

the address of the premises that is to be used for

such purpose, which shall be the designated premises;

(c)

the equipment and control facilities;

(d)

information, documentation or evidence to prove

that the premises are suitable and adequate, and that there are

suitable facilities, installations and equipment so as to ensure

proper preparation, conservation and dispensing of the

medicinal products, as well as cross contamination and mix-up

prevention;

(e)

the name and address of a managing pharmacist,

registered with the Pharmacy Council; and

(f)

any other information, documentation or evidence

as may be requested by the Authority.

(1)

The authorisation shall only be applicable to the

preparation and dispensing of medicinal products by automated means

from such designated premises.

(2)

Such authorisation shall not be transferable

Provided that Central Procurement and Supplies Unit

(CPSU) as authorisation holder may delegate the execution of its

functions emanating from this authorisation.

(1)

An authorisation shall be issued for a period of one

(1) year and shall be renewed for other periods of one (1) year each

provided that all conditions set out by the Authority are fulfilled.

(2)

The application for authorisation and the renewal thereof

shall be subject to the payment of the following fees to the Authority

(a)

two thousand three hundred thirty euro (€2,330)

for the initial inspection application;

(b)

one thousand one hundred and sixty-five euro

(€1,165) for annual renewal;

(c)

two hundred and fifty euro (€250) for variations to

authorisation requiring an on-site inspection;

(d)

fifty euro (€50) for each variation for all other

administrative variations.

(1)

The managing pharmacist shall be responsible for

(a)

the preparation and dispensing of the medicinal

OF MEDICINAL PRODUCTS BY AUTOMATED MEANS

FROM DESIGNATED PREMISES AT CENTRAL

PROCUREMENT AND SUPPLIES UNIT (CPSU)

products as provided by all applicable legislative and standard

requirements;

(b)

ensuring that products exposed to the ambient

(removed from their primary packaging) containing hormones

or hormone derivatives or analogues are prepared using isolator

technology;

(c)

ensuring that products exposed to the ambient

(removed from their primary packaging) containing cytotoxic

active ingredients, derivatives or analogues are not handled as

part of these authorised activities;

(d)

ensuring that all medicinal products used are

medicinal products authorised to be placed on the market in

Malta and must be sourced from authorised suppliers;

(e)

handling of products requiring refrigeration

should be adequately validated.

(2)

The managing pharmacist shall abide by all duties and

obligations pertaining to managing pharmacists in pharmacies, as

prescribed by the Act and any regulations or rules made thereunder,

and for standards and conditions issued by the Authority from time to

time in relation to pharmacies.

(3)

The managing pharmacist must ensure that all operations

and activities comply with PIC/S Guide to Good Practices for the

Preparation of Medicinal Products in Healthcare Establishments (PE

010), where applicable, as determined by the Authority.

The authorisation holder shall ensure that

(a)

a managing pharmacist is assigned to the

designated premises; and

(b)

the managing pharmacist is provided at all times

with all the required facilities, equipment and personnel

required for the managing pharmacist to execute the

responsibilities and perform the duties and obligations under

these rules and any other applicable standards and conditions

issued by the Authority from time to time in relation to

pharmacies and any conditions attached with the authorisation.

The Authority shall have the right to amend, suspend or

revoke the authorisation if

(a)

any matter stated in the application on which the

authorisation was issued is found to be either false or

incomplete;

OF MEDICINAL PRODUCTS BY AUTOMATED MEANS

FROM DESIGNATED PREMISES AT CENTRAL

PROCUREMENT AND SUPPLIES UNIT (CPSU)

(b)

a material change of circumstances has occurred in

relation to any of those matters mentioned in the application;

(c)

the provisions and conditions of the authorisation

have been contravened by the managing pharmacist or

authorisation holder;

(d)

operations are found not to be in line with the

applicable legislation, rules, regulations, conditions, guidelines

or standards;

(e)

the authoristion holder

did

not

address

satisfactorily any inspection findings; or

(f)

any other circumstance occurs as established by or

under the Act.

(1)

Each dispensed medicinal product must be

properly and adequately labelled.

(2)

The label must include

(a)

active pharmaceutical ingredient;

(b)

pharmaceutical form;

(c)

administration route;

(d)

pharmaceutical dose;

(e)

batch number; and

(f)

expiry date

Provided that the Central Procurement and Supplies Unit

(CPSU) may add further information that it may deem necessary from

time to time.

(3)

The labels must be in an indelible ink, in a format and

font which can be easily read by a person with a healthy unaided

eyesight without using any reading enabling devices or instruments.