Dispensing of Medicinal Products

L.N. 235 of 2008

MEDICINES ACT

(CAP. 458)

Dispensing of Medicinal Products

(Foundation for Social Welfare Services) Rules, 2008

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

Medicines Act, the Minister for Social Policy has made the following

rules>-

The title of these rules is the Dispensing of Medicinal Products Title.

(Foundation for Social Welfare Services) Rules, 2008.

(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-

Mianserin 10mg

Antidepressants

Mianserin 30mg

ANTIPSYCHOTICS

Chlorpromazine 25mg

Chlorpromazine 100mg

Promazine 25mg

Trifluoperazine 1mg

Trifluoperazine 5mg

Sulpiride 50mg

Haloperidol 0.5mg

Haloperidol 1.5mg

Haloperidol 5mg

Atypical-

Risperidone 1mg

Antipsychotics

Risperidone 2mg

Quetiapine 25mg

Quetiapine 100mg

Quetiapine 200mg

Olanzepine 5mg

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

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

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

€0.56

For the purpose of these rules and unless the context otherwise Interpretation.

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 Medicines Act<

“designated premises” means premises designated by the

Foundation from which the medicinal products listed in the

Schedule to these rules shall be dispensed.

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

medicinal products

medicinal products listed in the Schedule to these rules, shall be by Foundation.

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.

(1) The Foundation shall only dispense the medicinal Authorization.

products listed in the Schedule to these rules 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 to these rules 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.

(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.

(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.

(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.

The storage and dispensing of narcotics and psychotropic drugs

shall be subject to the same conditions as are applicable to pharmacies.

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.

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 there

under, including standards and conditions issued by the Authority from

time to time in relation to pharmacies.

The Authority shall have the right to amend, suspend or Rights pertaining to

the Authority.

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.