Production of Cannabis for Medicinal and Research Purposes

L.N. 100 of 2023

PRODUCTION OF CANNABIS FOR MEDICINAL AND

RESEARCH PURPOSES ACT

(CAP. 578)

Production of Cannabis for Medicinal and Research Purposes

(Fees) (Amendment) Regulations, 2023

IN EXERCISE of the powers conferred by article 11 of the

Production of Cannabis for Medicinal and Research Purposes Act, the

Minister responsible for the Medicines Authority, has made the

following regulations:-

The title of these regulations is the Production of Cannabis

for Medicinal and Research Purposes (Fees) (Amendment)

Regulations, 2023 and these regulations shall be read and construed as

one with the Production of Cannabis for Medicinal and Research

Purposes (Fees) Regulations, hereinafter referred to as "the principal

regulations".

(REGULATIONS 3 and 4)

FEES AND CONTRIBUTIONS

PART I

Activity

Fee or Contribution

Application or Renewal Fee

Annual Fee

€25,000 †

€25,000 †

Manufacturing

site licence related to

† With effect from

For manufacturing that includes

cannabis for medicinal

local

cultivation,

the

following

the

January

2023;

purposes (involving

in additional fee per footprint allocated for

an

inspection

cultivation applies*

Malta)

*€5 per m 2 up to 2000m 2 ;

Should the licence

holder fail to prove that any

€20 per m 2 for part of footprint of the product listed on the

exceeding 2000m 2 up to 4000m 2 ;

licence has been placed on

the local market during the

€40 per m 2 for part of footprint preceding year, subsequent

exceeding 4000m 2 up to 6000m 2 ;

annual fees shall be charged

2 for part of footprint at €35,000

€100 per m

exceeding 6000m 2

† With effect from the 1 January

2023;

Should the licence holder fail to

prove that any of the product listed on

the licence has been placed on the local

market during the preceding year,

subsequent annual fees shall be charged

at €35,000

€500 per variation application †

Variation to a

manufacturing

site

licence related to

cannabis for medicinal

and research purposes

Licence

for

€10,000

€8,000

activities related to

cannabis for research

purposes only (not

commercial)

GMP

certificate

€15,000

€5,000

related to cannabis for

medicinal

purposes

(involving

an

inspection in Malta or

within the European

Union or European

Economic Area)**

GMP

€25,000 plus €600 per day per

€15,000

certificate related to inspector,

including

days

for

cannabis for medicinal inspections and for travel, exclusive of

purposes (involving travel and accommodation expenses

an inspection in a third

country outside the

European Union or

European Economic

Area)**

**The

applicant

must

additionally cover all

travel

expenses,

including flights and

accommodation of the

inspectors.

Additional data

€5,000 per inspection or audit

integrity,

research,

security and EU-GMP

inspections or audits

Consultation

€200 per person per hour

on scientific matters

Research and

€1 per unit product transacted (as per sub-regulations (1), (2)

educational

and (3) of regulation 4).

contribution to the

Regulatory Authority

€0.45

Regulation 2 of the principal regulations shall be amended

as follows

(a) immediately after the definition "the Act" thereof,

there shall be added the following new definition

" "Contribution" means a payment per unit product

marketed, made to the Regulatory Authority for

corresponding research and education activities;";

(b) the definition "Unit product" thereof shall be

substituted by the following new definition

" ''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.".

In sub-regulation (2) of regulation 3 of the principal

regulations, the words "regulatory authority, unless otherwise decided

by the regulatory authority.", shall be substituted by the words

"Regulatory Authority, unless otherwise decided by the Regulatory

Authority:" and immediately thereafter there shall be added the

following new proviso

"Provided that the application and renewal fee must

be paid on first application and upon the renewal of the licence

every three (3) years 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.".

Immediately after regulation 3 of the principal regulations Adds new

there shall be added the following new regulations

4. (1)

Contributions as specified in the

"Research and

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.

(2) The contribution shall not apply to

(a) products intended for export for the first

two (2) years, starting from the date the licence is

granted;

(b) start-up and small companies that meet

the applicable criteria for exclusion.

(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

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.".

5. Part I of the Schedule to the principal regulations shall be

substituted by the following new Schedule