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AUTHORISATION OF DISPENSING OF MEDICINAL GASES FROM PREMISES OTHER THAN A PHARMACY RULES

8 Articles / Provisions · Malta
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Laws of Malta — Subsidiary Legislation 458.45 — AUTHORISATION OF DISPENSING OF MEDICINAL GASES FROM PREMISES OTHER THAN A PHARMACY RULES

AUTHORISATION OF DISPENSING OF MEDICINAL

GASES FROM PREMISES OTHER THAN A PHARMACY

SUBSIDIARY LEGISLATION 458.45

AUTHORISATION OF DISPENSING OF

MEDICINAL GASES FROM PREMISES OTHER

THAN A PHARMACY RULES

24th August, 2007

LEGAL NOTICE 243 of 2007.

Laws of Malta — Subsidiary Legislation 458.45 — AUTHORISATION OF DISPENSING OF MEDICINAL GASES FROM PREMISES OTHER THAN A PHARMACY RULES

The title of these rules is the Authorization of Dispensing

of Medicinal Gases from Premises other than a Pharmacy Rules.

Laws of Malta — Subsidiary Legislation 458.45 — AUTHORISATION OF DISPENSING OF MEDICINAL GASES FROM PREMISES OTHER THAN A PHARMACY RULES

Medicinal gases shall not be dispensed from premises other

than a pharmacy unless there is an authorization issued by the

Licensing Authority and subject to such conditions set by the said

Authority.

Laws of Malta — Subsidiary Legislation 458.45 — AUTHORISATION OF DISPENSING OF MEDICINAL GASES FROM PREMISES OTHER THAN A PHARMACY RULES

(1) An authorization shall not be granted unless there is a

written request by the applicant addressed to the Licensing

Authority.

(2) All details of the intended operations must be submitted,

including

(a) the name and address of the applicant;

(b) the address of the premises that are to be used for such

purpose;

(c) the equipment and control facilities;

(d) information, documentation or evidence to prove that

the premises is suitable and adequate, and that there

are suitable facilities, installations and equipment so

as to ensure proper conservation and dispensing of the

product;

(e) the name and address of a managing pharmacist who

shall be professionally responsible for all activities;

(f)

any other information, documentation, or evidence as

may be requested by the Licensing Authority.

Laws of Malta — Subsidiary Legislation 458.45 — AUTHORISATION OF DISPENSING OF MEDICINAL GASES FROM PREMISES OTHER THAN A PHARMACY RULES

(1) The authorization shall only be applicable to the

dispensing of the medicinal gases from such site as is indicated

therein.

(2)

Such authorization shall not be transferable.

Laws of Malta — Subsidiary Legislation 458.45 — AUTHORISATION OF DISPENSING OF MEDICINAL GASES FROM PREMISES OTHER THAN A PHARMACY RULES

(1) An authorization shall be issued for a period of one

year and shall terminate to be applicable upon its expiry.

(2) The authorization can be renewed following a written

request to the Licensing Authority, to be submitted at least three

months before expiry of the validity period.

Laws of Malta — Subsidiary Legislation 458.45 — AUTHORISATION OF DISPENSING OF MEDICINAL GASES FROM PREMISES OTHER THAN A PHARMACY RULES

(1) A managing pharmacist shall be responsible for the

dispensing of the medicinal gases and shall do so against the

presentation of a prescription.

AUTHORISATION OF DISPENSING OF MEDICINAL

GASES FROM PREMISES OTHER THAN A PHARMACY

(2) The managing pharmacist shall follow any criteria and

conditions for the dispensing of medicinal gases as may be laid

down by the Licensing Authority from time to time.

Laws of Malta — Subsidiary Legislation 458.45 — AUTHORISATION OF DISPENSING OF MEDICINAL GASES FROM PREMISES OTHER THAN A PHARMACY RULES

The Licensing Authority shall have the right to amend,

suspend or revoke any authorization if

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

authorization was issued is found to be false or

incomplete;

(b) a material change of circumstances has occurred in

relation to any of those matters;

(c) the provisions of the authorization

have

been

contravened by the authorization holder;

(d) any other circumstance occurs as established by or

under the Act.

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