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L.S. 458.52 Regoli dwar l-Għoti ta’ Prodotti Mediċinali mill-Fondazzjoni għal Servizzi ta’ Ħarsien Soċjali.

DISPENSING OF MEDICINAL PRODUCTS ( FO U N D AT IO N F O R S O CIA L W EL FA RE S ERVI CE S ) [ S.L.458.52 1 SUBSIDIARY LEGISLATION 458.52 DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES 26th September, 2008 LEGAL NOTICE 235 of

  1. The title of these rules is the Dispensing of Medicinal Products (Foundation for Social Welfare Services) Rules. Title.
  2. For the purpose of these rules and unless the context otherwise requires - Interpretation. "the Act" means the Medicines Act; Cap.
  3. "the Foundation" means the Foundation for Social Welfare Services; "the Licensing Authority" means the authority established under the Act; "designated premises" means premises designated by the Foundation from which the medicinal products listed in the Schedule shall be dispensed. 3.

(1)Only the medicinal products, or class or classes of medicinal products listed in the Schedule shall be dispensed from the designated premises. Dispensing of medicinal products by Foundation.
(2)The Foundation shall inform the Authority of the address of the designated premises and shall only start dispensing such medicinals once the Licensing Authority approves the designated premises. 4.
(1)The Foundation shall only dispense the medicinal products listed in the Schedule after an authorization is granted by the Licensing Authority. Authorization.
(2)Such authorization shall not be transferred to any person and it shall only be applicable to the dispensing of the medicinal products listed in the Schedule from the designated premises.
(3)The Foundation shall immediately notify the Licensing Authority of any medicinal product which is no longer required to be dispensed.
(4)The Foundation shall, when any medicinal product other than those listed in the Schedule are required to be dispensed from the designated premises, in writing request the Authority to effect an amendment in the Schedule. 5.
(1)The authorization shall be valid for a period of one year and it may be renewed following a written request by the Foundation to the Authority. Validity and renewal of authorization. 2 [ S.L.458.52 D IS P E N S I N G O F M E D IC I N A L P R O D U C T S ( FO U N D AT I O N F O R S O CI AL W EL FA RE S ERV ICE S )
(2)The request shall be submitted at least three months before the expiry of the validity period.
(3)There shall be payable, in respect of such authorization, the pharmacy fees applicable to pharmacy licences. Dispensing. 6.
(1)The dispensing of the scheduled medicinal products shall only be made from the designated premises to patients entitled to the services provided by the Foundation.
(2)The Foundation shall not dispense or supply in any manner whatsoever any of the scheduled medicinal products to the general public. Narcotic and psychotropic substances. Responsibilities of the managing pharmacist. 7. The storage and dispensing of narcotics and psychotropic drugs shall be subject to the same conditions as are applicable to pharmacies. 8. A managing pharmacist shall be responsible for: (
  1. a)the dispensing of the medicinal products in the designated premises and shall do so against the presentation of a prescription; (
  2. b)all duties and obligations pertaining to managing pharmacists in pharmacies as listed under the Act and any regulations or rules made there under, and for standards and conditions issued by the Authority from time to time in relation to pharmacies. Responsibilities of the Foundation. 9. For the purpose of this authorization, the Foundation shall be responsible for all duties and obligations pertaining to pharmacy licence holders, as listed under the Act and any regulations or rules made thereunder, including standards and conditions issued by the Authority from time to time in relation to pharmacies. Rights pertaining to the Authority. 10. The Authority shall have the right to amend, suspend or revoke the authorization if: (
  3. a)any matter stated in the application on which the authorization was issued is found to be either false or incomplete; (
  4. b)a material change of circumstances has occurred in relation to any of those matters; (
  5. c)any of the provisions of the authorization have been breached by the Foundation. DISPENSING OF MEDICINAL PRODUCTS ( FO U N D AT IO N F O R S O CIA L W EL FA RE S ERVI CE S ) [ S.L.458.52 SCHEDULE (Rule 3) List of medicinal products authorized for the purpose of these rules ANTIDEPRESSANTS TCAs Amitriptylline 10mg Amitriptylline 25mg Imipramine 10mg Imipramine 25mg Clomipramine 10mg Clomipramine 25mg Nortriptyline 10mg Nortriptyline 25mg Trimipramine 25mg Trimipramine 50mg SSRIs Fluvoxamine 100mg Paroxetine 20mg Fluoxetine 20mg SNRIs Venlafaxine 37.5mg Fluanxol 0.5mg Related-Antidepressants Mianserin 10mg Mianserin 30mg ANTIPSYCHOTICS Chlorpromazine 25mg Chlorpromazine 100mg Promazine 25mg Trifluoperazine 1mg Trifluoperazine 5mg Sulpiride 50mg Haloperidol 0.5mg Haloperidol 1.5mg Haloperidol 5mg Atypical-Antipsychotics Risperidone 1mg Risperidone 2mg Quetiapine 25mg Quetiapine 100mg Quetiapine 200mg Olanzepine 5mg 3 4 [ S.L.458.52 D IS P E N S I N G O F M E D IC I N A L P R O D U C T S ( FO U N D AT I O N F O R S O CI AL W EL FA RE S ERV ICE S ) Olanzepine 10mg ANTIMANICS Sod. Valproate 200mg Sod. Valproate 500mg Carbamazepine 200mg Lithium carbonate 400mg ANTIEPILEPTICS Phenytoin 50mg Phenytoin 100mg BETA-BLOCKERS Propranolol 10mg Propranalol 40mg REVERSIBLE MAOIs Moclobemide 150mg CNS STIMULANTS Dexamphetamine 5mg Methyphenidate 10mg OPIOID ANALGESICS Dihydrocodeine 30mg Methadone mixture 1mg/ml BENZODIAZEPINES Diazepam 2mg, 5mg Lorazepam 1mg, 2mg Nitrazepam 5mg Bromazepam 1.5mg, 3mg, 6mg Clonazepam 0.5mg, 2mg COMPOUND ANALGESICS Co-proxamol ANALGESICS Paracetamol 500mg ANTI-INFLAMMATORY DRUGS Diclofenac 25mg Mefenamic Acid 250mg ANTIBIOTICS / SKIN DISINFECTION / TOPICAL CREAMS Augmentin 375mg Povidone-Iodine solution Hydrocortisone cream DISPENSING OF MEDICINAL PRODUCTS ( FO U N D AT IO N F O R S O CIA L W EL FA RE S ERVI CE S ) Fusidic cream DRUGS USED IN TREMOR Benzhexol 2mg ANTIHISTAMINES Hydroxyzine 25mg Promethazine 10mg, 25mg DRUGS USE IN SUBSTANCE ABUSE Disulfiram 200mg INTRAMUSCULAR INJECTIONS Hyoscine Metoclopramide Haloperidol Fluphentixol Zuclopenthixol Procyclidine [ S.L.458.52 5

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