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DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

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Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

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 )

SUBSIDIARY LEGISLATION 458.52

DISPENSING OF MEDICINAL PRODUCTS

(FOUNDATION FOR SOCIAL WELFARE SERVICES)

RULES

26th September, 2008

LEGAL NOTICE 235 of 2008.

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

The title of these rules is the Dispensing of Medicinal

Products (Foundation for Social Welfare Services) Rules.

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

(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

( 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

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

For the purpose of these rules and unless the context

otherwise requires -

"the Act" means the Medicines Act;

"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.

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

(1) Only the medicinal products, or class or classes of

medicinal products listed in the Schedule shall be dispensed from

the designated premises.

(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.

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

(1) The Foundation shall only dispense the medicinal

products listed in the Schedule after an authorization is granted by

the Licensing Authority.

(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.

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

(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.

( 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.

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

(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.

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

The storage and dispensing of narcotics and psychotropic

drugs shall be subject to the same conditions as are applicable to

pharmacies.

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

A managing pharmacist shall be responsible for

(a) the dispensing of the medicinal products in the

designated premises and shall do so against the

presentation of a prescription;

(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.

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

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.

Laws of Malta — Subsidiary Legislation 458.52 — DISPENSING OF MEDICINAL PRODUCTS (FOUNDATION FOR SOCIAL WELFARE SERVICES) RULES

The Authority shall have the right to amend, suspend or

revoke the authorization if

(a) any matter stated in the application on which the

authorization was issued is found to be either false or

incomplete;

(b) a material change of circumstances has occurred in

relation to any of those matters;

(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 )

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