PRODUCTION OF CANNABIS FOR MEDICINAL AND RESEARCH PURPOSES (FEES) REGULATIONS

RESEARCH PURPOSES (FEES)

SUBSIDIARY LEGISLATION 578.01

PRODUCTION OF CANNABIS FOR MEDICINAL AND

RESEARCH PURPOSES (FEES) REGULATIONS

23rd November, 2018

LEGAL NOTICE 391 of 2018, as amended by Legal Notices 100 of

2023 and 189 of 2025.

The title of these regulations is the Production of

Cannabis for Medicinal and Research Purposes (Fees) Regulations.

L.N. 100 of 2023; 

(REGULATIONS 3 and 4)

L.N. 189 of 2025.

FEES AND CONTRIBUTIONS

PART I

Activity

Fee/Contribution

Application

or

Annual Fee

Renewal Fee

RESEARCH PURPOSES (FEES)

Production

Licence

for

€25,000 †

€25,000 †

activities related to cannabis

For manufacturing

The annual

for medicinal and research

that includes local

fee shall be

purposes (covers all activities

cultivation,

the

waived when

that may be authorised under

following

renewal fee

article 4 of the Act)

additional fee per

is due †

footprint allocated

If the licence

for

cultivation

holder fails

applies*

to prove that

*€5 per m 2 up to

any of the

2,000m 2 ;

products

listed on the

€20 per m 2 for part

licence have

been placed

of

footprint

on the local

exceeding 2,000m 2

market

up to 4,000m 2 ;

during

the

preceding

€40 per m 2 for part

year,

of

footprint

subsequent

exceeding 4,000m 2

annual fees

up to 6,000m 2 ;

shall

be

charged

at

€100 per m 2 for

€35,000

part of footprint

exceeding 6,000m 2

†With effect

from

†With effect from 1

January

January 2023.

2023. Licence for testing activities

€5,000

€5,000

related

to

cannabis

for

medicinal

and

research

purposes

Licence for activities related to

€10,000

€8,000

cannabis for research purposes

(not commercial)

Variation to a licence related to

€500 per variation

cannabis for medicinal and, or

application

research purposes

RESEARCH PURPOSES (FEES)

Fast-track application variation

€1000 per variation

[10 days]* to a licence related

application

to cannabis for medicinal and,

or research purposes (not

requiring an inspection and, or

third-party involvement)

GMP certificate related to a

€15,000

€5,000

Production

Licence

for

activities related to cannabis

for

medicinal

purposes

(involving an inspection in

Malta) **

GMP certificate for testing

€5,000

€1,000

activities related to cannabis

for

medicinal

purposes

(involving an inspection in

Malta) **

GMP certificate related to

€25,000 in addition

€15,000

cannabis

for

medicinal

to €600 per day, per

purposes

(involving

an

inspector and per

inspection, remotely or on-site,

person

deemed

in a third country outside the

relevant by the

European Union or European

Regulatory

Economic Area)***

Authority,

including days for

inspections and for

travel, exclusive of

travel

and

accommodation

expenses

Additional

inspections

or

€5,000 per inspection or audit

audits related to data integrity,

research, security and EU-

GMP

Consultation

on

scientific

€200 per person per hour

matters

Research and educational

€1.00 per unit product distributed

contribution to the Regulatory

(in accordance with regulation 4(1),

Authority

(2) and (3))

* The timeline commences upon acceptance of the application

for assessment and excludes any clock-stops. The Medicines Authority

may extend the timeline in exceptional circumstances.

RESEARCH PURPOSES (FEES)

** Should the applicant engage in GMP activities falling within

the scope of the Medicines Act (Cap. 458), and where the fees under

these regulations differ from those applicable under the Medicines

Authority (Fees) Regulations (S.L. 458.46), the applicant shall pay the

fee applicable under these regulations in addition to the difference

between that fee and the fee under the Medicines Authority (Fees)

Regulations (S.L. 458.46). This is to ensure that the total amount paid

corresponds to the higher applicable fee. Administrative GMP

variations not requiring an inspection shall be subject to the fees

established in the Medicines Authority (Fees) Regulations (S.L.

458.46).

*** The applicant shall additionally cover all travel expenses,

including flights and accommodation of the inspectors and personnel

deemed relevant by Regulatory Authority.

All fees and contributions payable in accordance with these

regulations shall be non-refundable.

PART II

Importation and/or wholesale distribution of cannabis based products or

synthetic cannabinoid products in accordance with the Medicines Act

and the Drug Dependence (Treatment not Imprisonment) Act

€450

Application / renewal # (for each form and strength)

# Renewal must be submitted 3 months before expiry.

€3,000

Fast track application [15 working days] * (for each form

and strength)

* Timeline applies from the validation of the application

and excludes clock-stops. The Medicines Authority

may extend the timeline in exceptional circumstances.

Annual maintenance fee (for each form and strength)

€275

Research and education contribution to the regulatory

€1.00 per unit

authority

product transacted

In these regulations, unless the context otherwise

requires –

''the Act'' means the Production of Cannabis for

Medicinal and Research Purposes Act;

"Contribution" means a payment per unit product

marketed, made to the Regulatory Authority for corresponding

research and education activities;

"clock-stop" means any period during which the

Regulatory Authority is awaiting the applicant’s submission of

documents or information it has formally requested

''distribution'' includes activities consisting of procuring,

holding or supplying, apart from distributing to the public,

medicinal preparations of cannabis in the authorised product

pack size;

''GMP certificate'' has the same meaning as ''GMP

certificate'' in article 2 of the Medicines Authority (Fees)

Regulations;

''Licensing Authority'' means the authority established by

article 3 of the Medicines Act;

"preceding year" means the period of twelve (12)

consecutive months commencing on the date an annual fee

becomes due and ends on the day immediately preceding the

next annual fee due date

Provided that for the purpose of calculating the

first annual fee, the twelve (12) month period shall be deemed

to commence on the date on which the license is officially

granted in accordance with the Act and these regulations;

''Regulatory Authority'' means the authority established

by article 4 of the Medicines Act; and

RESEARCH PURPOSES (FEES)

''Unit product'' means the final product pack as authorised

for release, which pack shall in any case not exceed one (100)

hundred grams in weight or four (400) hundred millilitres in

volume, or as otherwise approved by the Regulatory Authority

taking into consideration composition and intended market.

(1)

The Regulatory Authority shall receive the fees

specified in the Schedule of these regulations from persons intending to

carry out importation, wholesale distribution, cultivation and

processing, and/or production of cannabis, and any other activity

related to cannabis for medicinal use and/or research purposes as

determined by the Regulatory Authority.

(2)

The validation and processing of applications submitted

for the approval, renewal, authorisation, licence, and/or permit, shall

only start once the relevant fees have been paid in full by the applicant

to the Regulatory Authority, unless otherwise decided by the

Regulatory Authority

Provided that the application and renewal fee must be

paid on first application and upon the renewal of the licence three (3)

years after the granting of the licence or as determined by the

Regulatory Authority from time to time. The annual fee shall be

payable upon the licence being granted and is due every twelve (12)

months thereafter.

(3)

The fees are exclusive of any additional fees that may be

charged by other competent authorities for ancillary and supporting

documentation, reports, or other services that may be required by the

regulatory authority to process the application and issue the requisite

licences, certificates, or permits.

(4)

Any additional expenses incurred by the Regulatory

Authority shall be charged to the applicant separately.

(5)

The Regulatory Authority shall be exempt from any

liability for the payment of any tax on income or duty on documents in

force in Malta.

(6)

The Licensing Authority may suspend or revoke licences,

certificates, or permits granted or issued if the fees stipulated in these

regulations are not paid in full and on time

Provided that the Regulatory Authority may charge

interest for late payment at a rate of six percent (6%) per annum.

(1)

Contributions as specified in the Schedule shall be

made by any licence holder to the Regulatory Authority in connection

with research and education and shall be capped at three hundred

thousand Euro (€300,000) per annum.

RESEARCH PURPOSES (FEES)

(2)

The contribution shall not apply to products intended for

export for the first two (2) years, commencing from the date of the first

commercial export.

(3)

Whilst the contributions by licence holders shall be capped

or are exempt from these contributions in accordance with sub-

regulations (1) and (2), all other provisions as may be prescribed and

applicable under all relevant legislation and, or set out in guidelines as

issued or as may be issued by the Regulatory Authority in force at the

time, shall still apply.

(4)

These contributions shall be directed towards the funding

of innovative projects, the provision of resources that enhance scientific

research endeavours, educational development, exposures and

programmes that mitigate skills mismatch, the creation of awareness,

promoting responsibility and alignment with the regulations, and other

initiatives ancillary thereto.

(1)

The administration and management of the

contributions shall be entrusted to a board appointed by the Minister

called the Contributions Management Board (hereinafter referred to as

"the Board"). The Board, in the exercise of its functions, shall regulate

its own procedures and meetings as it deems appropriate, and act

within a reasonbable time with impartiality in accordance with the

principles of fair hearing. In its deliberations, the Board shall have the

right of access to all relevant information and may request appropriate

expertise from, or collaboration with third parties, as it may consider

necessary.

(2)

The Minister shall designate a competent person to act as

secretary for the Board.

(3)

The members of the Board shall be appointed by the

Minister for a term of three (3) years under such terms and conditions as

may be specified in their appointment. Members so appointed may be

re-appointed on the expiration of their term of office.

(4)

Where any member of the Board is unable to act, the

substitute member having the same qualifications shall act in his stead.

(5)

A person shall cease to be a member of the Board at the

expiration of his term of office.

(6)

A member of the Board may be removed from office by

the Minister if, in his opinion, such member is no longer fit to continue

in office or has become incapable of properly performing his duties as a

member.

The Regulatory Authority shall have the discretion to

exempt research activities carried out solely for academic purposes,

from any or all licence requirements, fees and, or contributions

RESEARCH PURPOSES (FEES)

Provided that the Regulatory Authority may, where and to

the extent it deems fit, establish regulatory conditions and measures, in

relation to exempt academic cannabis research practices, and require

the enforcement of such regulatory conditions and compliance thereto.

Amended by: 