Health Services Regulations, 2007

L.N. 165 of 2007

MEDICINES ACT

(CAP. 458)

Availability of Medicinal Products within the Government

Health Services Regulations, 2007

IN exercise of the powers conferred by article 106 (d) of the

Medicines Act, the Minister of Health, the Elderly and Community Care

has made the following regulations>-

The title of these regulations is the Availability of Medicinal Title.

Products within the Government Health Services Regulations, 2007.

Regulation 5(1)

Ref. No. __________________

Form T01

Application to the Superintendent of Public Health for the consideration of a

medicinal product to be covered by the Government Formulary List as per the

Government Health Services (Medicinal Products) Regulations, 2007.

This application is to be filled in clearly and completely, otherwise it will be returned and

will not be considered. The time lines for the decision specified in the legislation apply

once the application is validated and accepted.

1. Details of Applicant

1.1

Name of Marketing Authorisation Holder

1.2

Address

1.3

Telephone number

2. Details of Medicinal Product

2.1

Product Name

2.2

Active Ingredient

2.3

Pharmaceutical form

2.4

Strength

2.5

Method and Route of Administration

2.6

Proposed pack size/s to be placed on the Government Formulary List

2.7

Indications for which the product is being requested [indications should be covered by locally

approved Summary of Product Characteristics (SPC)].

2.8

Posology / Dosage regimen (as covered by SPC)

2.9

Duration of treatment course (where applicable)

2.10

Pharmacotherapeutic Group

ATC Code ____________________

Pharmacotherapeutic Group ____________________

3. Authorisation Status

3.1

Authorisation of the medicinal product in Malta (tick where applicable)

3.1.1

Authorisation in accordance with procedures laid down in Regulation (EC) No 726/2004 of the European

Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation

and supervision of medicinal products for human and veterinary use and establishing a European Medicines

Agency, as amended.



3.1.2

National Marketing Authorisation [also includes products approved through the Mutual Recognition

Procedure (MRP) and the Decentralised Procedure (DCP)]

3.2

Authorisation Number

3.3

Date of issue of Authorisation

3.4

Expiry Date of Authorisation

4. Costing

Lm

.

4.1

Estimated Unit Cost

Quote source of information on cost

Lm

.

4.2

Total Cost per Patient (Annually or per Treatment Course)

(Please explain how this figure was reached)

4.3

The estimated number of patients who would require the medicinal product

(state how this

information was derived).

4.4

Pharmaco-economic evaluation of the medicinal product (this is not mandatory and the

Superintendent of Public Health reserves the right to perform his evaluation)

5. Further Information regarding the Medicinal Product

5.1

Reasons for requesting the medicinal product to be considered for coverage by the Government

Formulary List

5.2

Comparison of this medicinal product to similar or alternative medicinal products or other

treatments available on the market

5.3

Comparison of this medicinal product to other medicines on the Government Formulary List in

terms of

•

Innovation

•

Therapeutic effectiveness/improvement

•

Cost and economic evaluation

•

Cost-effectiveness

•

Safety

•

Efficacy

•

Impact on quality of life

•

Availability and versatility of medicinal product

•

Other

List any information about the product which is being attached

Approved SPC

Authenticated copy of Marketing Authorisation

Literature to substantiate any information given

I, hereby confirm

That to the best of my knowledge and belief, all the particulars I have given in

this application form and all the documentation submitted, are correct and

complete.

I am fully aware that the list of medicines available within the Government Health

Services is by ATC classification and that the medicinal product will be

considered by its active ingredient and not as a proprietary/branded product.

I am aware of the criteria that apply through the legislation (Social Security Act,

Cap. 318, article 23; Availability of Medicinal Products within the Government

Health Services Regulations, 2007.).

Signature of Applicant

Name in BLOCK LETTERS

Date _______________________

In the case where the applicant, for the purpose of this application, would like to

nominate a person authorised to

a) communicate/sign on his behalf or

b) act fully on his behalf,

there shall be provided details of the nominee and the type of authorisation available..

Signature of Applicant

Name in BLOCK LETTERS

Date _______________________

Signature of Nominee

Name in BLOCK LETTERS

Date _______________________

For office use only: Application received on ___/___/___

(1) These regulations shall apply where the holder of a Scope.

marketing authorisation (hereinafter referred to as “the applicant”)

wishes to apply for the inclusion of a medicinal product on the list of

medicinal products covered by the Government Health Services,

hereinafter referred to as “The Government Formulary List”.

(2) These regulations shall not limit in any way the

Superintendent of Public Health from including any medicinal product

in The Government Formulary List.

Regulation 5(3)(a)

The Criteria which are taken into account by the Superintendent of Public Health,

the Committee and any experts with which they consult in deciding whether or not

to include a medicinal product on the Government Formulary List.

1. Entitlement to free medicines as specified in the Social Security Act, Cap. 318,

article 23 and the Fifth Schedule Part II to the same Act regarding Diseases and

Conditions in respect of which Free Medical Aid may be accorded. As well as

medicinal products required for the provision of care within Government

Institutions.

2. The registration status of the medicinal product in Malta.

3. A medicinal product or a category of medicinal products to treat conditions which

fall outside the scope of the Government Health Services may be entirely

excluded from the Government Formulary List.

4. The value, extent and relevance of the information and evidence available about

the medicinal product particularly in terms of cost-effectiveness, affordability by

the national health services, social and epidemiological impact, comparison to

other available medicines and other treatment modalities.

5. Diagnostic and other requirements for the prescription, use and monitoring of the

medicinal product particularly if additional costs are incurred.

6. The possibility for monitoring the use of the medicinal product and the outcome

of treatment.

7. Conditions for the supply, prescription, use and monitoring of the medicinal

product which determine the coverage of a medicinal product by the Government

Health Services.

8. The fact that patients were started on treatment or were part of a clinical trial does

not affect the decision for inclusion of a medicinal product on the Government

Formulary List.

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

Lm0.40 (€0.93)

(1) The Superintendent of Public Health shall be responsible Responsibilities.

for the implementation of these regulations and shall be assisted by a

Committee which may consult with experts as designated by himself.

He shall be supported by a secretariat which acts as secretariat to the

Committee and any sub-groups of experts.

(2) The Superintendent of Public Health, the members of

the Committee and any experts shall declare their interest, and the

Superintendent of Public Health will have the right to refuse any

committee members or experts on the basis of conflict of interest.

(1) The Government Formulary List shall include a list of The

Formulary List.

medicinal products by the International Non-proprietary Name (INN).

The products in this list shall be classified according to the Anatomical

Therapeutic Chemical (ATC) classification.

(2) The Government Formulary List shall not include

proprietary names of products, unless in exceptional circumstances

where patient safety may be compromised.

(3) The Government Formulary List shall include conditions

specific to coverage within the Government Health Services in terms

of entitlement to free medicines, supply within the Government Health

Services (primary and secondary care, use in specific clinics or

hospitals), prescriber criteria and use within the Government Health

Services (specific prescribers, conditions for prescribing, protocols,

therapeutic guidelines or clinical guidelines).

(4) Products which are not classified as medicinal products

in terms of the definition of the Medicines Act may be included on the

Government Formulary List.

(5) The method for determining the ratio to be used for

establishing equivalence, for different medicinal products within the

same therapeutic group, shall be communicated.

(1) An applicant may request that a medicinal product be

included in the Government Formulary List. In such cases the applicant

shall forward an application to the Superintendent of Public Health in

accordance with the requirements laid down by the said Superintendent,

as specified in the application form attached in Schedule I to these

regulations.

(2) The Superintendent of Public Health shall within 90 days

of receipt of the application, communicate the decision to the applicant.

If the information supporting the application is inadequate, the time-

limit shall be suspended and the applicant shall be notified of such

detailed additional information as may be required.

(3) Any decision not to include a medicinal product in the

Government Formulary List shall be communicated to the applicant

and it shall contain>

(a) a statement of reasons based upon the criteria in Schedule

II to these regulations, including, if appropriate, any expert opinions

or recommendations on which the decision is based<

(b) information about the remedies available to the applicant

under the laws in force and of the time limits allowed for applying

such remedies.

(1) Any decision to exclude a medicinal product from the

Decision to exclude.

Government Formulary List shall contain a statement of reasons based

on objective and verifiable criteria. Such decisions, including, if

appropriate, any expert opinions or recommendations on which the

decisions are based, shall be communicated to the person who is

responsible therefor.

(2) Any such person as may be responsible shall be informed

of the remedies available to him under the laws in force and the time-

limits allowed for applying such remedies.

Any decision to exclude a category of medicinal products from Exclusion of a

the Government Formulary List shall contain a statement of reasons category

medicinal products.

based on objective and verifiable criteria and shall be published in an

appropriate publication to be determined by the Superintendent of Public

Health.

Nothing in these regulations shall preclude the Superintendent Superintendent of

Public Health may

of Public Health from applying controls and conditions in the case of apply controls.

the procurement and supply of any medicinal product that is covered

by the Government Health Services.

These regulations revoke the Government Health Services (List Revokes L.N. 399

of 2003.

of Available Medicinal Products) Regulations, 2003.