Purposes (Fees) Regulations, 2018

L.N. 391 of 2018

L.N. 391 of 2018

PRODUCTION OF CANNABIS FOR MEDICINAL AND

RESEARCH PURPOSES ACT

(CAP. 578)

Production of Cannabis for Medicinal and Research

Purposes (Fees) Regulations, 2018

IN EXERCISE of the powers conferred by article 11(i) of the

Production of Cannabis for Medicinal and Research Purposes Act, the

Minister for Justice, Culture and Local Government, in consultation

with the Minister for Finance, has made the following regulations

The title of these regulations is the Production of Cannabis Citation.

for Medicinal and Research Purposes (Fees) Regulations, 2018.

(Regulation 3)

Fees and Contributions

PART I

Fee

Activity

Application/Renewal Fee

Annual

Fee

Manufacturing site licence

€35,000

related to cannabis for

For manufacturing that includes local

medicinal purposes

cultivation, the following additional

(involving an inspection in

contribution per footprint allocated for

Malta)

cultivation applies*

*€5 per m 2 up to 2000m 2 .

€20 per m 2 for part of footprint exceeding

2000m 2 up to 4000m 2 ;

€40 per m 2 for part of footprint exceeding

4000m 2 up to 6000m 2 ;

€100 per m 2 for part of footprint exceeding

6000m 2

€35,000

Licence for activities related

€10,000

to cannabis for research

purposes only (not

commercial)

€8,000

GMP certificate related to

€15,000

cannabis for medicinal

purposes (involving an

inspection in Malta or

within the

European Union/European

Economic Area) **

€5,000

GMP certificate related to

€25,000 plus €600 per day per inspector

including days for inspections and for

cannabis for medicinal

purposes (involving an

travel, exclusive of travel and

inspection in a third country

accommodation expenses

outside the European Union/

European Economic

Area)**

**The applicant must

additionally cover all travel

expenses, including flights

and accommodation of the

€15,000

inspectors.

Additional data integrity,

€5,000 per inspection/audit

research, and security

inspections/audits

Consultation on scientific

€200 per man/hour

matters

Research and education

€1.00 per unit product transacted

contribution to the

regulatory authority

B

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 authority

€1.00 per unit

product transacted

€0.36

In these regulations, unless the context otherwise requires –

Interpretation.

''the Act'' means the Production of Cannabis for Medicinal Cap. 578.

and Research Purposes Act;

''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) S.L. 458.46.

Regulations;

''Licensing Authority'' means the authority established by

article 3 of the Medicines Act;

''Regulatory Authority'' means the authority established by

article 4 of the Medicines Act; and

''Unit product'' means the product pack authorised for

dispensing to the patient.

(1) The Regulatory Authority shall receive the fees 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.

(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.

B

3577 B 3577