PERMISSION FOR THE SUPPLY OF MEDICINES FOR USE IN THE NATIONAL HEALTH SERVICES IN EXCEPTIONAL CIRCUMSTANCES REGULATIONS

PERMISSION FOR THE SUPPLY OF MEDICINES FOR USE

IN THE NATIONAL HEALTH SERVICES IN EXCEPTIONAL

CIRCUMSTANCES

SUBSIDIARY LEGISLATION 458.63

PERMISSION FOR THE SUPPLY OF MEDICINES FOR

USE IN THE NATIONAL HEALTH SERVICES IN

EXCEPTIONAL CIRCUMSTANCES REGULATIONS

20th October, 2023

LEGAL NOTICE 249 of 2023.

The title of these regulations is the Permission for the

supply of medicines for use in the National Health Services in

exceptional circumstances Regulations.

(regulations 4 and 6)

For each application for

€4,000

the first year

For each application for

€6,000

subsequent years

In these regulations, unless the context otherwise requires

"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

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

PERMISSION FOR THE SUPPLY OF MEDICINES FOR USE

IN THE NATIONAL HEALTH SERVICES IN EXCEPTIONAL

CIRCUMSTANCES

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 of the permission, the permission holder shall

(a)

bear full responsibility of the medicinal product;

PERMISSION FOR THE SUPPLY OF MEDICINES FOR USE

IN THE NATIONAL HEALTH SERVICES IN EXCEPTIONAL

CIRCUMSTANCES

(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

amend, suspend or revoke the permission at any time

(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;

or

(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

time.