Health Services in exceptional circumstances Regulations, 2023

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 21,136, 20 ta’ Ottubru, 2023

L.N. 249 of 2023

MEDICINES ACT

(CAP. 458)

Permission for the supply of medicines for use in the National

Health Services in exceptional circumstances Regulations, 2023

IN EXERCISE of the powers conferred by article 106 of the

Medicines Act, the Minister responsible for public health, after

consultation with the Licensing Authority, has made the following

regulations:-

The title of these regulations is the Permission for the Citation and

supply of medicines for use in the National Health Services in scope.

exceptional circumstances Regulations, 2023.

(regulations 4 and 6)

For each application for

€4,000

the first year

For each application for

€6,000

subsequent years

€0.18

In these regulations, unless the context otherwise requires

Interpretation.

"Act" means the Medicines Act;

"Licensing Authority" means the Licensing Authority

established in accordance with article 3 of the Act;

"Minister" means the Minister responsible for public

health;

"permission" means the permit to place medicinal products

on the market in Malta in accordance with the provisions of

article 20 of the Act and these regulations;

"permission holder" means the person holding a permission

issued under these regulations;

"importer" means any person who supplies medicinal

products within the National Health Services.

(1) When the Central Procurement and Supplies Unit Permission.

does not have access to any medicinal product, intended to be used in

the National Health Service, which is registered or may be registered

under the Act or any other legislation within the applicable time frame,

and subsequent to a request made under the first proviso of article 20

of the Act, it may request permission to the Licensing Authority to

procure and place an unauthorised medicinal product on the market

within the National Health Services in accordance with these

regulations.

(2) Permission to place an unauthorised medicinal product on

the market within the National Health Services may also be requested

by an importer.

(3) The Licensing Authority may grant permission to place

such unauthorised medicinal product on the market within the National

Health Services after an evaluation is carried out by the said Licensing

Authority, under exceptional circumstances of inherent public health

need.

(1) The Central Procurement and Supplies Unit and, or

an importer may, upon confirming that no medicinal product from

alternative sources is available, present to the Licensing Authority an

application in writing, requesting that the unauthorised medicinal

product is permitted to be procured and placed on the market within

the National Health Services.

(2) Each application shall be accompanied by the prescribed fee

in the Schedule and shall include

(a) the full name of the medicinal product, its active

ingredients, strength, dosage form and country of origin;

(b) the full name, address and contact details of the

supplier and the manufacturer;

(c)

the detailed reasons for the request;

(d) information, documentation, or evidence proving that

no offers were received for a registered medicinal product or a

medicinal product which may be registered within the applicable

time frame; and

(e) any other information, documentation, or evidence as

may be requested by the Licensing Authority

Provided that seventy-five percent (75%) of the prescribed

fee shall be refunded if the application is rejected.

(1) Any permission granted shall only apply to the

medicinal product listed on the application and shall not be

transferable to a similar product.

(2) Permission may be subject to conditions as may be

determined by the Licensing Authority.

(1) Permission shall be granted for a period of up to one

(1) year provided that all the conditions set out by the Licensing

Authority are satisfied.

(2) The application for permission shall be subject to the

payment of fees in the Schedule.

At the time of application and during the period of validity Responsibilities

of permission

of the permission, the permission holder shall

holder.

(a)

bear full responsibility of the medicinal product;

(b) declare that it does not have access to any equivalent

medicinal product which is registered or may be registered under

the Act or any other legislation within the applicable time frame;

(c) declare that the permission is being requested due to a

justified public health need and that the patient would remain

without the medicinal product if permission is not granted

Provided that a public health need includes but is not

limited to accessibility, excessive pricing, seriousness of the

circumstances of the case and product risk.

(1) The Licensing Authority shall have the right to Rights

pertaining to the

amend, suspend or revoke the permission at any time

Licensing

Authority.

(a) if any information in the application on which the

permission was granted is found to be either false or incomplete;

(b) if a material change of circumstances has occurred in

relation to the application which was not duly reported by the

applicant;

(c) if the permission holder does not adhere to all the

conditions as established by these regulations or under the Act;

(d) for any other circumstances which the Licensing

Authority considers fit.

(2) Furthermore, the Licensing Authority has the right to

request the applicant for any relevant additional information at any