VETERINARY MEDICINAL PRODUCTS AND VETERINARY PHARMACIES (FEES) REGULATIONS

VETERINARY PHARMACIES (FEES)

SUBSIDIARY LEGISLATION 35.38

VETERINARY MEDICINAL PRODUCTS AND

VETERINARY PHARMACIES (FEES)

REGULATIONS

10th February, 2025

LEGAL NOTICE 336 of 2024.

The title of these regulations is the Veterinary Medicinal

Citation.

Products and Veterinary Pharmacies (Fees) Regulations.

(regulation 3)

Service

Validity

€

1. Authorisation

of

Veterinary

Medicinal Products

(a)

for the issuance and

5 years

renewal of an authorisation of

exemption

from

a

marketing

authorisation;

(b)

for the issuance and

3 years

renewal of an authorisation for

research and development purposes;

(c)

for the issuance and

1 year

renewal of an authorisation for

cascade use;

VETERINARY PHARMACIES (FEES)

(d)

for the issuance and

5 years

1,000

renewal of a 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

5 years

renewal of a 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

3 years

products in 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

5 years

products for parallel trade;

(d)

for the registration of

1 year

free

samples or demonstration packs.

3. For the notification of centrally

5 years

authorised Veterinary Medicinal Products.

In these regulations unless the context otherwise requires

Interpretation.

"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

Fees.

Director for services listed in the said Schedule.

Authorisations of activities

related with the manufacturing and

distribution of Veterinary Medicinal Products

and active substances

VETERINARY PHARMACIES (FEES)

(a)

for the issuance and

as

An

renewal

of

the

manufacturing determined annual

authorisation requiring a GMP

by the

fee of

inspection;

Director

25% on

following the total

an

payment

inspection requested

(maximum by the

3 years) contracto

r carrying

out the

GMP

inspectio

n

(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

as

Small

renewal

of

the

manufacturing determined (less than

authorisation not requiring a GMP

by the

inspection;

Director employee

following s) - 980

an

inspection Average

(maximum (15 to 75

3 years) employee

s) -1,500

Large (76

to 200

employee

s) - 1,960

Super

employee

(more

than 200

employee

s) - 2,910

Partial

manufact

ure - 290

VETERINARY PHARMACIES (FEES)

(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

as

renewal of wholesale distribution determined

authorisation in an activity that may

by the

include an inspection in Malta or Director

within the European Union or

after

European Economic Area, but does inspection

not include the costs of travel and (maximum

accommodation of inspectors, if 3 years)

applicable;

(i)

issuance of a new

465 for

authorisation

with

an

issuing a

inspection;

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 validity as

the brokering of veterinary medicinal determined

products which may or may not

by the

involve an inspection in Malta

Director

(maximum

3 years)

(i)

initial registration

with or without an inspection;

(ii)

renewal

of

a

registration;

VETERINARY PHARMACIES (FEES)

(b)

for

registration

for

as

importation and distribution of active determined

substances which may or may not

by the

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

as

as

conducted

outside

the

initial determined determine

inspection to grant the first GMP

by the

d by the

certificate

and

its

subsequent Director contracte

renewals, e.g. routine inspections and following a d party

other necessary inspections, to

GMP

conductin

investigate a complaint, following a inspection

g the

variation;

(maximum inspectio

3 years)

n + 25%

adminis-

trative fee

(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

as

as

pharmacovigilance inspection;

determined determine

by the

d by the

Director contracte

following

d party

an

conductin

inspection

g the

(maximum inspectio

3 years)

n + 25%

adminis-

trative fee

VETERINARY PHARMACIES (FEES)

(c)

pharmacovigilance

as

as

inspection as a routine inspection or determined determine

for other necessary inspections e.g. to

by the

d by the

investigate a complaint, following a Director contracte

variation;

following

d party

an

conductin

inspection

g the

(maximum inspectio

3 years)

n + 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

as

as

a GMP certificate after an inspection determined determine

with or without the issuance of a

by the

d by the

manufacturing authorisation;

Director contracte

following a d party

GMP

conductin

inspection

g the

(maximum inspectio

3 years)

n + 25%

adminis-

trative fee

(b)

issuance and renewal of 3 years

a certificate of veterinary medicinal

product, known as Free Sale

Certificate.

Licensing of activities related

with retail sale of Veterinary Medicinal

Products and active substances

VETERINARY PHARMACIES (FEES)

(a)

for the issuance and

as

renewal of a veterinary pharmacy determined

licence including an inspection in

by the

Malta;

Director

(maximum

5 years)

(i)

issuance of a new

licence with an inspection;

(ii)

renewal of a

licence.

Assessment of dossier for the

as

as

Marketing Authorisation of Veterinary determined determine

Medicinal Products with the scope of

by the

d by the

granting any type of authorisation for Director contracte

marketing.

prior to the d party

assessment conductin

g the

inspectio

n + 25%

adminis-

trative fee

For the testing (quality, safety,

as

as

efficacy or environmental safety) of determined determine

veterinary medicinal products alone or in feed,

by the

d by the

active substances or other products intended to Director contracte

be administered to or on animals or given as

d party

feed or with feed or water for control purposes

conductin

or enforcement.

g the

testing +

adminis-

trative

costs

according

to the

case

VETERINARY PHARMACIES (FEES)

For the destruction of veterinary

not

as

medicinal products alone or in feed, active applicable determine

substances or other products intended to be

d by the

administered to or on animals or given as feed

contracte

or with feed or water.

d party

carrying

out the

destructio

n +

adminis-

trative

costs

according

to the

case