AUTHORISATION FOR PREPARATION AND DISPENSING OF MEDICINAL PRODUCTS BY AUTOMATED MEANS FROM DESIGNATED PREMISES AT CENTRAL PROCUREMENT AND SUPPLIES UNIT (CPSU) [ S.L. 458.62 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
- 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; Citation. Interpretation. Cap.
- "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. Authorisation. 4.
(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. Application for authorisation.
(2)The application shall include: (
- a)the name and address of applicant; 1 2 AUTHORISATION FOR PREPARATION AND DISPENSING OF MEDICINAL PRODUCTS BY AUTOMATED MEANS FROM DESIGNATED PREMISES AT CENTRAL PROCUREMENT AND SUPPLIES UNIT (CPSU) [ S.L. 458.62 (
- 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. Conditions of authorisation. 5.
(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. Validity and renewal of authorisation. 6.
(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. Responsibilities of managing pharmacist. 7.
(1)The managing pharmacist shall be responsible for: (
- a)the preparation and dispensing of the medicinal AUTHORISATION FOR PREPARATION AND DISPENSING OF MEDICINAL PRODUCTS BY AUTOMATED MEANS FROM DESIGNATED PREMISES AT CENTRAL PROCUREMENT AND SUPPLIES UNIT (CPSU) [ S.L. 458.62 3 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. 8. The authorisation holder shall ensure that: (
- a)a managing pharmacist is assigned to the designated premises; and Responsibilities of authorisation holder. (
- 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. 9. 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; Rights pertaining tothe Authority. 4 [ S.L. 458.62 AUTHORISATION FOR PREPARATION AND DISPENSING 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 satisfactorily any inspection findings; or did not address (
- f)any other circumstance occurs as established by or under the Act. Labelling requirements. 10.
(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.