Veterinary Pharmacies (Fees) Regulations, 2024

L.N. 336 of 2024

FEES ORDINANCE

(CAP. 35)

Veterinary Medicinal Products and

Veterinary Pharmacies (Fees) Regulations, 2024

IN EXERCISE of the powers conferred by article 2 of the Fees

Ordinance, the Minister responsible for veterinary services, with the

concurrence of the Minister responsible for finance, has made the

following regulations:-

(1) The title of these regulations is the Veterinary

Medicinal Products and Veterinary Pharmacies (Fees) Regulations,

2024. (2) These regulations shall come into force within two (2)

months from their publication in the Gazette.

(regulation 3)

Service

Validity

€

1. Authorisation of Veterinary Medicinal

(a)

for the issuance and renewal of an

5 years

authorisation of exemption from a marketing

authorisation;

(b)

for the issuance and renewal of an

3 years

authorisation for research and development

purposes;

(c)

for the issuance and renewal of an

1 year

authorisation for cascade use;

(d)

for the issuance and renewal of a

5 years

1,000

marketing authorisation of veterinary medicinal

products authorised in accordance with the

national procedure, decentralised procedure and

mutual recognition procedure, but does not

include the cost of assessment of the dossier;

(e)

for the issuance and renewal of a

5 years

marketing authorisation of veterinary medicinal

products in accordance with

subsequent

recognition procedure, but does not include the

cost of assessment of the dossier.

2. Registration of Veterinary Medicinal

Products

(a)

for the registration of products in

3 years

accordance with regulation 8(1) of the

Veterinary Medicinal Products Regulations

(S.L. 437. 115);

(b)

for the registration of a

5 years

homeopathic product;

(c)

for the registration of products for

5 years

parallel trade;

(d)

for the registration of samples or

1 year

free

demonstration packs.

3. For the notification of centrally

5 years

authorised Veterinary Medicinal Products.

In these regulations unless the context otherwise requires

"Director" means the Director for Veterinary Services;

"GMP" means good manufacturing practice as defined in

the Good Manufacturing Practice for Veterinary Medicinal

Products Rules.

The fees specified in the Schedule shall be payable to the

Director for services listed in the said Schedule.

Authorisations of activities related with

the manufacturing and distribution of Veterinary

Medicinal Products and active substances

(a)

for the issuance and renewal of as determined An annual

the manufacturing authorisation requiring a

by the

fee of 25%

GMP inspection;

Director

on the total

following an

payment

inspection

requested

(maximum 3

by the

years)

contractor

carrying out

the GMP

inspection

(i)

for

changes

in

manufacturing authorisations that do not

require any inspection. Changes may be

grouped if they are submitted at the same

time and are related to each other.

(b)

for the issuance and renewal of as determined Small (less

the manufacturing authorisation not requiring a

by the

than 15

GMP inspection;

Director

employees)

following an

- 980

inspection

(maximum 3 Average (15

to 75

years)

employees)

-1,500

Large (76 to

employees)

- 1,960

Super

employee

(more than

employees)

- 2,910

Partial

manufactur

e - 290

(i)

for

changes

to

the

manufacturing authorisation that do not

require any inspection. Changes may be

grouped if they are submitted at the same

time and are related to each other.

(c)

for the issuance and renewal of as determined

wholesale distribution authorisation in an

by the

activity that may include an inspection in Malta Director after

or within the European Union or European inspection

Economic Area, but does not include the costs (maximum 3

of travel and accommodation of inspectors, if

years)

applicable;

(i)

issuance

of

a

new

465 for

authorisation with an inspection;

issuing a

new

authori-

sation

(ii)

renewal

of

an

authorisation;

(iii) to vary the conditions of

authorisation

without

inspection.

Changes may be grouped if they are

submitted at the same time and are

related to each other;

(iv)

to vary the conditions of

the authorisation by inspection.

Registration of activities related with

brokering of veterinary medicinal products and

distribution of active substances

(a)

for the registration for the validity as

brokering of veterinary medicinal products determined by

which may or may not involve an inspection in the Director

Malta

(maximum 3

years)

(i)

initial registration with or

without an inspection;

(ii)

renewal of a registration;

(b)

for registration for importation as determined

and distribution of active substances which may

by the

or may not involve an inspection in Malta;

Director

(maximum 3

years)

(i)

initial registration with or

without an inspection;

(ii)

renewal of a registration.

Inspections or supervision of activities

related with veterinary medicinal products for which

an authorisation, certificate, licence or registration is

not issued, although existing ones may be varied

(a)

for inspections conducted outside as determined

the initial inspection to grant the first GMP

by the

determined

certificate and its subsequent renewals, e.g.

Director

routine inspections and other necessary following a

inspections, to investigate a complaint,

GMP

following a variation;

inspection

(maximum 3

years)

(i)

for changes to the GMP

certificate that do not require any

inspection. Changes may be grouped if

they are submitted at the same time and

are related to each other;

(b)

for

the

pharmacovigilance as determined

inspection;

by the

determined

Director

following an contracted

inspection

(maximum 3 conducting

years)

(c)

pharmacovigilance inspection as a as determined

as

routine inspection or for other necessary

by the

determined

inspections e.g. to investigate a complaint,

Director

by the

following a variation;

following an contracted

inspection

party

(maximum 3 conducting

years)

the

inspection

+ 25%

adminis-

trative fee

(d)

for the supervision of destruction

of veterinary medicinal products alone or in

feed, active substances or other products

intended to be administered to or on animals or

given as feed or with feed or water but does not

include the cost of destruction as determined by

the entity which shall be carrying out the

destruction. Covers all the period from the

beginning until the end of the destruction.

Certifications

related

with

the

manufacture or marketing of veterinary medicinal

products and active substances

(a)

issuance and renewal of a GMP as determined

as

certificate after an inspection with or without

by the

determined

the issuance of a manufacturing authorisation;

Director

by the

following a

contracted

GMP

party

inspection

conducting

(maximum 3

the

years)

inspection

+ 25%

adminis-

trative fee

(b)

issuance and renewal of a

3 years

certificate of veterinary medicinal product,

known as Free Sale Certificate.

Licensing of activities related with retail

sale of Veterinary Medicinal Products and active

substances

(a)

for the issuance and renewal of a as determined

veterinary pharmacy licence including an

by the

inspection in Malta;

Director

(maximum 5

years)

(i)

issuance of a new licence

with an inspection;

(ii)

renewal of a licence.

Assessment of dossier for the Marketing as determined

as

Authorisation of Veterinary Medicinal Products with

by the

determined

the scope of granting any type of authorisation for

Director

by the

marketing.

prior to the

contracted

assessment

party

conducting

the

inspection

+ 25%

adminis-

trative fee

For the testing (quality, safety, efficacy or as determined

as

environmental safety) of veterinary medicinal products

by the

determined

alone or in feed, active substances or other products

Director

by the

intended to be administered to or on animals or given as

contracted

feed or with feed or water for control purposes or

party

enforcement.

conducting

the testing

+ adminis-

trative costs

according

to the case

For the destruction of veterinary not applicable

as

medicinal products alone or in feed, active substances or

determined

other products intended to be administered to or on

by the

animals or given as feed or with feed or water.

contracted

party

carrying out

the

destruction

+ adminis-

trative costs

according

to the case

€0.63