other than a Pharmacy Rules, 2007

L.N. 243 of 2007

MEDICINES ACT

(CAP. 458)

Authorization of Dispensing of Medicinal Gases from Premises

other than a Pharmacy Rules, 2007

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

Medicines Act, hereinafter referred to as “the Act”, the Licensing

Authority has made the following rules>-

The title of these rules is the Authorization of Dispensing of

Medicinal Gases from Premises other than a Pharmacy Rules, 2007.

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.

(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.

(1) The authorization shall only be applicable to the Conditions of

dispensing of the medicinal gases from such site as is indicated therein. authorizations.

(2) Such authorization shall not be transferable.

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

renewal of

and shall terminate to be applicable upon its expiry.

authorization.

(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.

(1) A managing pharmacist shall be responsible for the Responsibility of

managing

dispensing of the medicinal gases and shall do so against the presentation pharmacist.

of a prescription.

(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.

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

Licensing

or revoke any authorization if>

Authority.

(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.

The Authorization of Dispensing of Medicinal Oxygen from Repeals L.N. 398 of

2005. Premises other than a Pharmacy Rules, 2005 are hereby being repealed.

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

Lm0.12 (€0.28)