MT
Production of Cannabis for Medicinal and Research Purposes
Table of Provisions (6)
Statutory Text (6 Articles)
L.N. 189 of 2025
PRODUCTION OF CANNABIS FOR MEDICINAL AND
RESEARCH PURPOSES ACT
(CAP. 578)
Production of Cannabis for Medicinal and Research Purposes
(Fees) (Amendment) Regulations, 2025
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 Citation.
for Medicinal and Research Purposes (Fees) (Amendment)
Regulations, 2025 and these regulations shall be read and construed as
one with the Production of Cannabis for Medicinal and Research S.L. 578.01.
Purposes (Fees) Regulations, hereinafter referred to as the "principal
regulations".
Regulation 2 of the principal regulations shall be amended Amends
regulation 2 of
as follows
the principal
regulations.
(a) immediately after the definition "Contribution" there
shall be added the following new definition
" "clock-stop" means any period during which the
Regulatory Authority is awaiting the applicant’s
submission of documents or information it has formally
requested";
(b) immediately after the definition "Licensing
Authority" there shall be added the following new definition
" "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;".
In the proviso to sub-regulation (2) of regulation 3 of the
principal regulations the words "upon the renewal of the licence every
three (3) years" shall be substituted by the words "upon the renewal of
the licence three (3) years after the granting of the licence".
Sub-regulation (2) of regulation 4 of the principal
regulations shall be substituted by the following new sub-regulation
"(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.".
Part I of the Schedule to the principal regulations shall be
substituted by the following new Part
"PART I
Fee/Contribution
Application or Renewal
Annual Fee
Fee
Production Licence for activities
€25,000 †
€25,000 †
related to cannabis for medicinal and
For manufacturing that
The annual fee
research purposes (covers all
includes
local
shall be waived
activities that may be authorised
cultivation,
the
when renewal
under article 4 of the Act)
following additional fee
fee is due †
per footprint allocated
If the licence
for cultivation applies*
holder fails to
m 2 up
*€5
per
to
prove that any
of the products
2,000m ;
listed on the
€20 per m 2 for part of
licence
have
been placed on
footprint
exceeding
the local market
2,000m 2
up
to
during
the
4,000m ;
preceding year,
subsequent
€40 per m 2 for part of
annual
fees
footprint
exceeding
shall be charged
4,000m 2
up
to
at €35,000
6,000m 2 ;
†With
effect
€100 per m 2 for part of
from 1 January
footprint
exceeding
2023. 6,000m 2
†With effect from 1
January 2023.
Licence for testing activities related
€5,000
€5,000
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
Fast-track application variation [10
€1000 per
variation
days]* to a licence related to
application
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 activities
€5,000
€1,000
related to cannabis for medicinal
purposes (involving an inspection in
Malta) **
GMP certificate related to cannabis
€25,000 in addition to
€15,000
for medicinal purposes (involving an
€600 per day, per
inspection, remotely or on-site, in a
inspector
and
per
third country outside the European
person deemed relevant
Union or European Economic
by the Regulatory
Area)***
Authority,
including
days for inspections
and
for
travel,
exclusive of travel and
accommodation
expenses
Additional inspections or audits
€5,000 per inspection or audit
related to data integrity, research,
security and EU-GMP
Consultation on scientific matters
€200 per person per hour
Research
and
educational
€1.00 per unit product distributed (in
contribution
to the
Regulatory
accordance with regulation 4(1), (2) and
Authority
(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.
** 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.
€0.36