The translation of this document is outdated.
Translation validity: 01.01.2020.–31.03.2022.
Amendments not included:
29.03.2022.,
13.02.2024.
Republic
of Latvia
Cabinet
Regulation No. 681 Adopted 17 December 2019
|
Regulations Regarding the
Procedures for Calculating and Making Payments for the Activities
of State Supervision and Control and Paid Services of the Food
and Veterinary Service
Issued pursuant to
Section 21.1, Paragraph nine of the Law
on the Supervision of the Handling of Food,
Section 12 of the Veterinary Medicine Law,
Section 19.1 of the Law on Circulation
of Animal Feedingstuffs, Section 26.1,
Paragraph five of the Animal Protection Law,
Section 12, Paragraph two of the Pharmaceutical Law,
and Section 5, Paragraph nine of the Law
on Budget and Financial Management
1. The Regulation prescribes:
1.1. the procedures for calculating a charge and making a
payment for the activities of State supervision and control
carried out by the Food and Veterinary Service (hereinafter - the
Service) laid down in Regulation (EU) 2017/625 of the European
Parliament and of the Council of 15 March 2017 on official
controls and other official activities performed to ensure the
application of food and feed law, rules on animal health and
welfare, plant health and plant protection products, amending
Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No
1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European
Parliament and of the Council, Council Regulations (EC) No 1/2005
and (EC) No 1099/2009 and Council Directives 98/58/EC,
1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and
repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of
the European Parliament and of the Council, Council Directives
89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC,
96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official
Controls Regulation) (hereinafter - Regulation No 2017/625), and
in the Law on the Supervision of the Handling of Food, the
Veterinary Medicine Law, the Law on Circulation of Animal
Feedingstuffs, and the Pharmaceutical Law;
1.2. the amount of the charge and the procedures for paying
it:
1.2.1. for the issuing of a permit for the use of an animal in
an experimental project procedure, and also for amending and
renewing the abovementioned permit;
1.2.2. for the hiring of experts (researchers) necessary for
assessing the experimental project;
1.3. the types of paid services provided by the Service and
the price list.
2. The charge for the activities of State supervision and
control to which the charge specified in Annex IV to Regulation
No 2017/625 is not applied shall be determined in such an amount
as to cover the expenditures of the Service in accordance with
Articles 81 and 82 of Regulation No 2017/625.
3. The Service shall collect the charge for the activities of
State supervision and control in meat cutting plants and
game-processing plants in the amount specified in Chapter II,
Parts II and III of Annex IV to Regulation No 2017/625.
4. The Service shall collect the charge for the implemented
activities of State supervision and control (except for
activities pertaining to the border control of animals and goods)
specified in the laws and regulations regarding the circulation
of food and animal feedingstuffs, animal health and protection in
the amount specified in Annex 1 to this Regulation.
5. The charge for the paid services provided by the Service
shall be collected in the amount specified in Annex 2 to this
Regulation.
6. The charge for the activities of State supervision and
control pertaining to the border control of animals and goods
shall be collected in the amount specified in:
6.1. Chapter I, Parts I, II, III, IV, V, VI, and VII of Annex
IV to Regulation No 2017/625 - for the importation of
consignments (cargoes) containing live animals and meat,
including meat products, containing poultry, game meat, rabbit
meat and farmed game meat, animal by-products, animal
feedingstuffs of animal origin, fishery products and other
products of animal origin intended for the use as food that are
not meat products from third countries, and also for the
consignments (cargoes) of such animals and goods from third
countries which are carried in transit or transhipped;
6.2. Annex 3 to this Regulation - for the consignments
(cargoes) of goods not referred to in Sub-paragraph 6.1 of this
Regulation.
7. The charge for the border control of consignments shall be
calculated according to the net weight and number of consignments
(cargoes).
8. The charge for paid services provided in the circulation of
veterinary medicinal products shall be collected by the Service
in accordance with Annex 4 to this Regulation.
9. The party receiving the service shall cover the charge for
the activities of State supervision and control and the paid
services referred to in this Regulation:
9.1. by using a payment card at the Service;
9.2. by transferring the payment to the account of the Service
with the intermediation of such payment institution which has the
right to provide payment services within the meaning of the Law
on Payment Services and Electronic Money.
10. The party receiving the service shall pay for the
activities of State supervision and control and the paid services
referred to in this Regulation according to an invoice prepared
by the Service.
11. If, upon request of the party receiving the service, the
Service sends the invoice for the services provided, the
marketing authorisation, or another document by post, a charge
for the postal services according to the rates of the postal
merchant shall be collected from the party receiving the
service.
12. On the basis of an application by the party receiving the
service, the Service and the party receiving the service may
agree on the transfer of the financial resources to the account
of the Service before performance of the activities of State
supervision and control and provision of services, and also
before receipt of the relevant invoice.
13. Cabinet Regulation No. 1083 of 8 October 2013, Procedures
for Making Payment for the Activities of State Supervision and
Control and Paid Services of the Food and Veterinary Service
(Latvijas Vēstnesis, 2013, No. 199, 250; 2015, No. 178;
2016, No. 107; 2017, No. 26; 2018, No. 96), is repealed.
14. The Regulation shall come into force on 1 January
2020.
Prime Minister A. K. Kariņš
Minister for Agriculture K. Gerhards
Annex 1
Cabinet
Regulation No. 681
17 December 2019
Charge for the Activities of State
Supervision and Control of the Food and Veterinary Service
Specified in the Laws and Regulations Regarding the Circulation
of Food and Animal Feedingstuffs, Animal Health and
Protection
No. |
Supervision
and control activity |
Unit of measurement |
Price (in
EUR)1 |
I. Preparation and issuing of a veterinary (health)
certificate2 |
1. |
Preparation and
issuing of a veterinary (health) certificate of animals,
including inspection of animals before and during quarantine
(according to the actual time of control per working
hour): |
1.1. |
during standard working
hours |
hour |
17.60 |
1.2. |
outside working hours on
working days and on weekends |
hour |
23.63 |
1.3. |
during night hours |
hour |
26.65 |
2. |
Veterinary (health)
certificate for pets - preparation and issuing |
certificate |
7.50 |
3. |
Veterinary
(health) certificate for products of animal origin,
reproductive products, and animal by-products and derived
products not intended for human consumption - preparation and
issuing: |
3.1. |
during standard working
hours |
consignment |
31.60 |
3.2. |
outside working hours on
working days and on weekends |
consignment |
42.46 |
3.3. |
during night hours |
consignment |
47.89 |
4. |
Veterinary
(health) certificate for animal feedingstuffs of animal and
plant origin (according to the actual time of control per
working hour) - preparation and issuing: |
4.1. |
during standard working
hours |
hour |
17.60 |
4.2. |
outside working hours on
working days and on weekends |
hour |
23.63 |
4.3. |
during night hours |
hour |
26.65 |
II.
Preparation and issuing of a certificate of conformity, a
control authorisation, and other attestations, certificates,
and statements related to supervision and
control2 |
5. |
Preparation and
issuing of a plant-care product certificate of
conformity: |
5.1. |
grain and
consignment of processed grain products without
packaging: |
5.1.1. |
weighing up to 60 tonnes |
consignment |
19.92 |
5.1.2. |
weighing 61 to 1000
tonnes |
tonne |
0.33 |
5.1.3. |
weighing 1001 to 5000
tonnes |
tonne |
0.30 |
5.1.4. |
weighing 5001 to 10 000
tonnes |
tonne |
0.23 |
5.1.5. |
for a batch weighing more
than 10 001 tonnes |
tonne |
0.20 |
5.2. |
grain and
consignment of processed grain products in packaging: |
5.2.1. |
for a batch weighing up to 60
tonnes |
consignment |
24.19 |
5.2.2. |
for a batch weighing 61 to
1000 tonnes |
tonne |
0.40 |
5.2.3. |
for a batch weighing 1001 to
5000 tonnes |
tonne |
0.36 |
5.2.4. |
for a batch weighing 5001 to
10 000 tonnes |
tonne |
0.28 |
5.2.5. |
for a batch weighing more
than 10 001 tonnes |
tonne |
0.21 |
5.3. |
for other plant-care
products |
consignment |
11.65 |
6. |
Preparation and issuing of a
mushroom and wild berry certificate |
consignment |
23.30 |
7. |
Preparation of a
certificate of conformity or a control authorisation for the
compliance of imported or exported fresh fruit and vegetables
with the trade standards specified in Parts A and B of Annex
I to Commission Implementing Regulation (EU) No 543/2011 of 7
June 2011 laying down detailed rules for the application of
Council Regulation (EC) No 1234/2007 in respect of the fruit
and vegetables and processed fruit and vegetables sectors
(hereinafter - Regulation No 543/2011), and issuing thereof
for a consignment: |
7.1. |
weighing up to 1000 kg (per
cargo) |
consignment |
11.65 |
7.2. |
weighing more than 1001 kg
(for every subsequent 1000 kg over the first 1000 kg) |
1000 kg |
0.90 |
8. |
Preparation of a
control authorisation for a repeat conformity assessment of
fresh fruit and vegetables with the trade standards specified
in Parts A and B of Annex I to Regulation No 543/2011 (on the
non-conforming consignment), and issuing thereof for a
consignment weighing: |
8.1. |
up to 100 kg |
consignment |
17.40 |
8.2. |
from 101 to 1000 kg |
consignment |
26.20 |
8.3. |
from 1001 to 10 000 kg |
consignment |
34.90 |
8.4. |
from 10 001 to 25 000 kg |
consignment |
43.60 |
8.5. |
25 001 kg and more |
consignment |
52.30 |
9. |
Preparation of a certificate
of conformity and a special certificate for agricultural and
processed agricultural products that are eligible for export
refunds (according to the actual costs of control per working
hour), and issuing thereof |
hour |
17.60 |
10. |
Preparation and
issuing of an attestation or a certificate related to control
and supervision, including intervention measures (per working
hour): |
10.1. |
during standard working
hours |
hour |
17.60 |
10.2. |
outside working hours on
working days and on weekends |
hour |
23.63 |
10.3. |
during night hours |
hour |
26.65 |
11. |
Preparation and issuing of an
attestation or a certificate related to border control of
animals and goods, or approval of an extract from the
certificate |
consignment |
23.30 |
12. |
Preparation and issuing of
various attestations, certificates, extracts from an
inspection protocol, and statements related to supervision
and control (if no special inspection of the facility under
supervision or other activities (laboratory tests) are
necessary) |
document |
2.95 |
III. Assessment (inspection) and recognition of a
facility under supervision specified in laws and regulations
and approval of a control authority (in the food and
veterinary field) |
13. |
Preparation and
issuing of an authorisation of recognition or approval: |
13.1. |
entry and updating of
information in databases |
entirety of information |
9.96 |
13.2. |
preparation and issuing of an
authorisation |
authorisation |
2.50 |
14. |
Making of
variations in an authorisation of recognition or an
authorisation of approval of a control authority: |
14.1. |
entry and updating of
information in databases |
entirety of information |
5.69 |
14.2. |
preparation and issuing of an
authorisation |
authorisation |
2.50 |
15. |
Costs of one working hour of
the inspector for an assessment (inspection) before
recognition, registration or before approval of a control
authority (in the food and veterinary field), and for a
repeat assessment (inspection) if a non-compliance is
found |
hour |
17.60 |
16. |
Preparation and issuing of a
marketing authorisation |
authorisation |
2.50 |
17. |
Costs of one working hour
(not including lodging costs) of the inspector (expert) for
inspecting an establishment (object) or documents for the
receipt of various attestations or for lifting restrictions,
and also for taking of samples (upon a written request by the
client) |
hour |
17.60 |
18. |
Recognition of an
establishment for export to third countries |
according to
corroborative documents or according to the expert conditions
and rates set by the consigning country |
IV. Inspection of fishery products |
19. |
Inspection of fishery
products at landing sites |
tonne |
3.27 |
V. Activities
of State supervision and control in
slaughterhouses3, 4, 5 |
20. |
Charge for the
control of slaughtered animals (per animal), except for the
case referred to in Paragraph 21 of this Annex: |
20.1. |
beef: |
20.1.1. |
adult cattle |
unit |
5.70 |
20.1.2. |
young cattle |
unit |
2.28 |
20.2. |
equine animal meat |
unit |
3.42 |
20.3. |
pork - animals of
a slaughter weight of: |
20.3.1. |
up to 25 kg |
unit |
0.57 |
20.3.2. |
25 kg or more |
unit |
1.14 |
20.4. |
lamb and goat
meat - animals of a slaughter weight of: |
20.4.1. |
up to 12 kg |
unit |
0.17 |
20.4.2. |
12 kg or more |
unit |
0.29 |
20.5. |
poultry
meat: |
20.5.1. |
poultry of the Gallus
genus, and guineafowl |
unit |
0.006 |
20.5.2. |
ducks and geese |
unit |
0.012 |
20.5.3. |
turkeys |
unit |
0.029 |
20.5.4. |
quails and partridges |
unit |
0.002 |
20.6. |
farmed rabbit meat |
unit |
0.006 |
21. |
Charge for the time of
control if the payment per animal specified in Paragraph 20
of this Annex does not cover the actual costs (according to
the actual time of control per working hour) |
hour |
11.77 |
22. |
Charge for idle time if the
idle time exceeds one hour (according to the actual time per
hour) |
hour |
11.77 |
VI.
Assessment of the activities of an organic farming control
authority in a third country |
23. |
Inspection of the submitted
documents and preparation of a report after assessment of the
activities of the control authority |
report |
557.77 |
24. |
Assessment of the
activities of the control authority in a third country
(according to the actual working time) |
hour |
17.60 |
daily allowance of
a business trip, travel expenditures, lodging, and other
expenditures according to the corroborative documents and set
rates |
VII. Supervision of food quality schemes |
25. |
Certification of products in
food quality scheme, annual inspection and repeat inspection
if non-compliance is found in Latvia (according to the actual
working time) |
hour |
17.60 |
26. |
Certification of
products in food quality scheme, annual inspection and repeat
inspection if non-compliance is found in another European
Union Member State (according to the actual working
time) |
hour |
17.60 |
daily allowance of
a business trip, travel expenditures, lodging, and other
expenditures according to the corroborative documents and set
rates |
VIII. Issuing of an experimental project permit for
the use of an animal in a procedure |
27. |
Assessment of an experimental
project and the documents related thereto and issuing of an
experimental project permit (if no additional documents are
necessary for the assessment) |
project |
57.79 |
28. |
Assessment of additionally
submitted documents necessary for the experimental
project |
entirety of documents |
36.12 |
29. |
Remuneration of the expert
(researcher) involved in the assessment of the experimental
project (per project) |
one expert |
180.07 |
30. |
Amending of an experimental
project permit |
permit |
21.67 |
31. |
Renewal of an experimental
project permit |
permit |
36.12 |
IX. Unscheduled activities of State supervision and
control in case of non-compliance (in accordance with Article
79(2)(c) of Regulation No 2017/625) |
32. |
Costs of one working hour of
the inspector when performing unscheduled control and
implementing measures in case of non-compliance |
hour |
17.60 |
33. |
Laboratory testing when
performing unscheduled control and implementing measures in
case of non-compliance |
according to the
actual costs of laboratory testing |
Notes.
1 Value added tax shall not be imposed in
accordance with Section 3, Paragraph eight of the Value Added Tax
Law.
2 The charge shall include taking of official
samples.
3 The charge shall include diagnostics of
trichinellosis at the slaughterhouse laboratory.
4 The control costs are partially covered in the
support measure 'Support for partial covering of veterinary
expert-examination costs' specified in the laws and regulations
regarding annual State support to agriculture and the procedures
for the granting of such support.
5 Upon calculating the costs, in addition to the
charge specified, a charge shall be calculated for any work
carried out outside the stated working hours, on official
holidays, and during night hours, in accordance with the laws and
regulations governing employment relationships.
Minister for Agriculture K. Gerhards
Annex 2
Cabinet
Regulation No. 681
17 December 2019
Price List of Paid Services of the
Food and Veterinary Service
No. |
Type of service |
Unit of measurement |
Price without VAT (in
EUR) |
VAT (in EUR) |
Price with VAT (in EUR) |
1. |
Report on measurement and
testing results |
report |
17.48 |
3.67 |
21.15 |
2. |
Distribution of
forms of the documents involved in the circulation of
veterinary supervision: |
2.1. |
pet passport |
passport
form |
0.92 |
0.19 |
1.11 |
2.2. |
veterinary prescriptions |
set of
forms |
0.08 |
0.02 |
0.10 |
2.3. |
requests for medicated
feedingstuffs |
set of
forms |
0.08 |
0.02 |
0.10 |
2.4. |
special veterinary
prescriptions |
set of
forms |
0.21 |
0.05 |
0.26 |
3. |
Copying: |
3.1. |
A4 format |
page |
0.19 |
0.04 |
0.23 |
3.2. |
A3 format |
page |
0.25 |
0.05 |
0.30 |
4. |
Rental of equipment, devices
(for example, a projector) |
hour |
4.39 |
0.92 |
5.31 |
5. |
Rental of a meeting room at a
territorial unit |
hour |
7.17 |
1.51 |
8.68 |
Minister for Agriculture K. Gerhards
Annex 3
Cabinet
Regulation No. 681
17 December 2019
Charge for the Activities of State
Supervision and Control in the Border Control of Goods
No. |
Type of supervision and
control |
Unit of measurement |
Price (in
EUR)1 |
1. |
Food safety control
(except for the food the payment for the control of which is
specified in Regulation No. 2017/625): |
1.1. |
consignment transported in one
road vehicle/automobile or container, weighing up to 5000 kg
(except for the food referred to in Sub-paragraph 1.5 of this
Annex) |
consignment |
19.45 |
1.2. |
consignment
transported in one road vehicle/automobile or container,
weighing 5001 kg or more (except for the food referred to in
Sub-paragraph 1.5 of this Annex): |
1.2.1. |
for 5000 kg |
consignment |
19.45 |
1.2.2. |
for every additional 1000 kg
(over 5001 kg) |
1000 kg |
5.84 |
1.3. |
consignment in one
or multiple containers on the same ship (one customs
clearance document), per consignment (except for the food
referred to in Sub-paragraph 1.5 of this Annex): |
1.3.1. |
for 5000 kg |
consignment |
19.45 |
1.3.2. |
for every additional 1000 kg
(over 5001 kg) |
1000 kg |
3.57 |
1.4. |
consignment in one
or multiple railway wagons within the same train (one customs
clearance document), per consignment (except for the food
referred to in Sub-paragraph 1.5 of this Annex): |
1.4.1. |
for 10 000 kg |
consignment |
19.45 |
1.4.2. |
for every additional 10 000 kg
(over 10 001 kg) |
10 000 kg |
5.84 |
1.4.3. |
maximum charge for the
consignment referred to in Sub-paragraphs 1.4.1 and
1.4.2 |
consignment |
118.73 |
1.5. |
salt consignment regardless of
the type of vehicle |
consignment |
19.45 |
2. |
Safety control for a
consignment of materials and articles intended to come into
contact with food: |
2.1. |
weighing up to 5000 kg |
consignment |
19.45 |
2.2. |
weighing 5001 kg or
more: |
2.2.1. |
for 5000 kg |
consignment |
19.45 |
2.2.2. |
for every additional 1000 kg
(over 5001 kg) |
1000 kg |
1.95 |
2.2.3. |
maximum charge for the
consignment referred to in Sub-paragraphs 2.2.1 and
2.2.2 |
consignment |
126.70 |
3. |
Safety control of
non-food products for a consignment of medicinal products and
plant protection products: |
3.1. |
for cargo weighing up to 5000
kg |
consignment |
19.45 |
3.2. |
for cargo weighing
5001 kg or more: |
3.2.1. |
for 5000 kg |
consignment |
19.45 |
3.2.2. |
for every additional 1000 kg
(over 5001 kg) |
1000 kg |
1.95 |
3.2.3. |
maximum charge for the
consignment referred to in Sub-paragraphs 3.2.1 and
3.2.2 |
consignment |
126.70 |
4. |
Control of animal
feedingstuffs (except for feedingstuffs of animal origin the
payment for the control of which is specified in Regulation
No 2017/625) for a consignment: |
4.1. |
weighing up to 10 000 kg |
consignment |
19.45 |
4.2. |
for cargo weighing
10 001 kg or more: |
4.2.1. |
for 10 000 kg |
consignment |
19.45 |
4.2.2. |
for every additional 10 000 kg
(over 10 001 kg) |
10 000 kg |
5.84 |
4.3. |
maximum charge for the
consignment referred to in Sub-paragraphs 4.2.1 and
4.2.2 |
consignment |
118.73 |
5. |
Control of a consignment of
reproductive products (semen intended for artificial
insemination, ova and embryos, eggs for hatching) (except for
the reproductive products the payment for the control of
which is specified in Regulation No 2017/625) |
consignment |
19.45 |
6. |
Control of the goods referred to
in Paragraphs 1, 2, 3, and 4 of this Annex in international
postal consignments, weighing up to 30 kg |
consignment |
19.45 |
7. |
Costs of one working hour of the
inspector (expert) for taking samples and sending samples for
laboratory testing upon request of the owner (authorised
representative) of the consignment |
hour |
19.45 |
Note. 1 Value added tax shall not be imposed in
accordance with Section 3, Paragraph eight of the Value Added Tax
Law.
Minister for Agriculture K. Gerhards
Annex 4
Cabinet
Regulation No. 681
17 December 2019
Paid Services of the Food and
Veterinary Service in the Circulation of Veterinary Medicinal
Products
No. |
Item of expenditures |
Unit of measurement |
Price (in
EUR)1 |
I.
Registration, re-registration, and supervision of
registration of veterinary medicinal products |
1.
National registration procedure |
1.1. |
Expert
examination of the application and attached documentation for
the registration of veterinary medicinal products: |
1.1.1. |
for the first pharmaceutical
form and strength submitted |
application |
750.00 |
1.1.1.1. |
for every additional
pharmaceutical form2 |
application |
320.00 |
1.1.1.2. |
for every additional strength
of the medicinal product2 |
application |
235.00 |
1.1.2. |
for homeopathic medicinal
products |
application |
160.00 |
1.2. |
Expert
examination of the application and attached documentation for
the re-registration of veterinary medicinal products: |
1.2.1. |
for one pharmaceutical form
and strength |
application |
320.00 |
1.2.1.1. |
for every additional
pharmaceutical form2 |
application |
160.00 |
1.2.1.2. |
for every additional strength
of the medicinal product2 |
application |
96.00 |
1.2.2. |
for homeopathic medicinal
products |
application |
96.00 |
2.
Mutual recognition procedure |
2.1. |
Expert
examination of the application and attached documentation for
the registration of veterinary medicinal products: |
2.1.1. |
for the first pharmaceutical
form and strength submitted |
application |
1565.00 |
2.1.2. |
for every additional
pharmaceutical form2 |
application |
785.00 |
2.1.3. |
for every additional strength
of the medicinal products or for every application for
medicinal products with identical registration documentation,
but different names of medicinal products, and with an
identical or different owner of registration (for an
iterative application), if submitted at the same
time2 |
application |
525.00 |
2.1.4. |
for the reference Member
State procedure, per application (in addition to the expert
examinations referred to in Sub-paragraphs 2.1.1, 2.1.2, and
2.1.3 of this Annex) |
number of the
procedure |
1955.00 |
2.2. |
Expert
examination of the application and attached documentation for
the re-registration of veterinary medicinal products: |
2.2.1. |
for the first pharmaceutical
form and strength submitted |
application |
1045.00 |
2.2.2. |
for every additional
pharmaceutical form2 |
application |
655.00 |
2.2.3. |
for every additional strength
of the medicinal product or sales packaging or for every
application for medicinal products with identical
registration documentation, but different names of medicinal
products, and with an identical or different owner of
registration (for an iterate application), if submitted at
the same time2 |
application |
265.00 |
2.2.4. |
for the reference Member
State procedure, per application (in addition to the expert
examinations referred to in Sub-paragraphs 2.2.1, 2.2.2, and
2.2.3 of this Annex) |
number of the
procedure |
1955.00 |
3.
Decentralised registration procedure |
3.1. |
Expert
examination of the application and attached documentation for
the registration of veterinary medicinal products in the
decentralised procedure: |
3.1.1. |
for the first pharmaceutical
form and strength submitted |
application |
1565.00 |
3.1.2. |
for every additional
pharmaceutical form2 |
application |
785.00 |
3.1.3. |
for every additional strength
of the medicinal products or for every application for
medicinal products with identical registration documentation,
but different names of medicinal products, and with an
identical or different owner of registration (for an
iterative application), if submitted at the same
time2 |
application |
525.00 |
3.1.4. |
for the reference Member
State procedure, per application (in addition to the expert
examinations referred to in Sub-paragraphs 3.1.1, 3.1.2, and
3.1.3 of this Annex) |
number of the
procedure |
1955.00 |
3.2. |
Expert
examination of the application and attached documentation for
the re-registration of veterinary medicinal products: |
3.2.1. |
for the first pharmaceutical
form and strength submitted |
application |
1045.00 |
3.2.2. |
for every additional
pharmaceutical form2 |
application |
655.00 |
3.2.3. |
for every additional strength
of the medicinal product or sales packaging or for every
application for medicinal products with identical
registration documentation, but different names of medicinal
products, and with an identical or different owner of
registration (for an iterate application), if submitted at
the same time2 |
application |
265.00 |
3.2.4. |
for the reference Member
State procedure, per application (in addition to the expert
examinations referred to in Sub-paragraphs 3.2.1, 3.2.2, and
3.2.3 of this Annex) |
number of the
procedure |
1955.00 |
4.
Issuing of authorisations and certificates |
4.1. |
Issuing of a marketing
authorisation of veterinary medicinal products in paper
form |
authorisation |
15.00 |
4.2. |
Issuing of an export
certificate of a product (veterinary medicinal product) |
certificate |
140.00 |
4.3. |
Issuing of an abbreviated
certificate of a product (veterinary medicinal product)
(certificate of free trade or statement on the registration
status of the veterinary medicinal product) |
certificate |
41.50 |
5.
Post-registration supervision |
5.1. |
Annual charge4
or: |
|
235.00 |
5.1.1. |
annual charge if the total
turnover from the relevant veterinary medicinal products
distributed in Latvia in the previous calendar year exceeds
EUR 2000.00 |
registration
number |
235.00 |
5.1.2. |
annual charge if the total
turnover from the relevant veterinary medicinal products
distributed in Latvia in the previous calendar year is EUR
1000.01 to EUR 2000.00 |
registration
number |
100.00 |
5.2. |
Analysis of the periodic
safety report - in-depth expert examination5 |
report |
275.00 |
5.3. |
Review of the periodic safety
report without an in-depth expert examination |
report |
75.00 |
6. Making of variations in
the registration documents of veterinary medicinal
products (for each product) |
6.1. |
Minor variations of Type I
A |
one
variation |
132.50 |
6.2. |
Minor variations of Type I
B |
one
variation |
199.50 |
6.3. |
Major variations of Type II
if an in-depth scientific assessment of the documents or an
expansion of the registration is necessary |
one
variation |
391.50 |
6.4. |
Major variations of Type II
if an in-depth scientific assessment of the documents is not
necessary |
one
variation |
229.00 |
6.5. |
Major variations of Type II
related to the change of the owner of the marketing
authorisation (the new owner of the marketing authorisation
is not the same person) |
one
variation |
132.50 |
6.6. |
Approval of the uniform
labelling of veterinary medicinal products of the Baltic
States |
expert
examination |
132.50 |
6.7. |
Approval of the labelling
mock-up |
expert
examination |
135.50 |
6.8. |
Variations in the labelling
mock-up |
expert
examination |
41.50 |
II.
Issuing of permits in the circulation of veterinary medicinal
products |
7.
Parallel-imported veterinary medicinal products |
7.1. |
Expert examination of the
application and attached documentation for the distribution
of parallel-imported veterinary medicinal products in
Latvia |
expert
examination |
225.00 |
7.2. |
Making of variations in the
instructions for the use of parallel-imported veterinary
medicinal products |
expert
examination |
65.50 |
7.3. |
Making of variations in the
labelling of parallel-imported veterinary medicinal
products |
expert
examination |
65.50 |
7.4. |
Making of variations in the
documentation of parallel-imported veterinary medicinal
products (change of the legal address of the merchant) |
expert
examination |
26.50 |
7.5. |
Issuing of a permit for the
distribution of parallel-imported medicinal products in
Latvia |
permit |
6.65 |
8.
Distribution of veterinary medicinal products not registered
in the state |
8.1. |
In-depth scientific
assessment of the application and documents submitted for the
issuing of a permit for the importation and distribution for
ensuring veterinary medical practice (for each product) |
expert
examination of one product |
70.00 |
8.2. |
Expert examination of the
application and documents submitted for the issuing of a
permit for the importation and distribution for ensuring
veterinary medical practice, without in-depth scientific
assessment (for each product) |
expert
examination of one product |
35.00 |
8.3. |
Making of variations in a
permit for the importation and distribution for ensuring
veterinary medical practice (for each product) |
expert
examination of one product |
15.00 |
8.4. |
Permit for the importation
and use in exceptional cases (also for immunological
veterinary medicinal products), if requested by a wholesaler
or importer (for each product) |
permit for one
product |
28.15 |
8.5. |
Permit for the importation
and use in exceptional cases (also for immunological
veterinary medicinal products), if requested by a veterinary
medical care institution or a practising veterinarian (for
each product) |
permit for one
product |
5.85 |
8.6. |
Permit for the importation
and use of an immunological veterinary medicinal products in
exceptional cases, if the immunological veterinary medicinal
products are necessary for systematic vaccination |
permit |
28.15 |
8.7. |
Making of variations in a
permit for the importation and use in exceptional cases, also
for immunological veterinary medicinal products (for each
product) |
permit for one
product |
15.00 |
8.8. |
Issuing of a permit for the
distribution of non-registered veterinary medicinal products
(in addition to the activities referred to in Sub-paragraphs
8.1, 8.2, and 8.3 of this Annex) |
permit |
6.65 |
9.
Assessment of product compliance |
9.1. |
Evaluation of a product to
determine its compliance with the definition of a veterinary
medicinal product (without laboratory tests) |
expert
examination |
275.00 |
10.
Clinical trial |
10.1. |
Application for a
clinical trial and attached documents - review
(assessment): |
10.1.1. |
productive animals |
application |
376.25 |
10.1.2. |
other animals |
application |
270.00 |
10.2. |
Application for
amendments to a clinical trial permit and attached documents
- review (assessment): |
10.2.1. |
productive animals |
application |
160.00 |
10.2.2. |
other animals |
application |
130.00 |
10.3. |
Issuing of a clinical trial
permit |
permit |
6.65 |
11.
Issuing of other permits |
11.1. |
For the
importation of a sample of veterinary medicinal
products: |
11.1.1. |
expert examination of the
application and documents for the importation of a sample of
veterinary medicinal products |
expert
examination |
135.50 |
11.1.2. |
issuing of a permit for the
importation of a sample of veterinary medicinal products |
permit |
6.65 |
11.2. |
For the
distribution of remaining reserves: |
11.2.1. |
expert examination of the
application and attached documentation for the distribution
of the remaining reserves of veterinary medicinal
products |
expert
examination |
26.50 |
11.2.2. |
issuing of a permit for the
distribution of the remaining reserves of veterinary
medicinal products |
permit |
6.65 |
III.
Assessment of conformity, registration and licensing of the
operation |
12.
Assessment of conformity |
12.1. |
Assessment of conformity of
documents |
expert
examination of documents |
40.00 |
12.2. |
Assessment of conformity in a
veterinary pharmacy (including the assessment of documents
and the preparation of a protocol) |
1
pharmacy |
52.95 |
12.3. |
Assessment of conformity in a
wholesaler of veterinary medicinal products (including the
assessment of documents and the preparation of a
protocol) |
1
wholesaler |
210.60 |
12.4. |
Assessment of conformity of
such person who is not engaged in veterinary practice, but is
entitled to purchase veterinary medicinal products from a
wholesaler for ensuring its operation without the right to
further distribute the veterinary medicinal products
(according to the actual time of the inspection, per working
hour for one inspector) |
1 hour |
17.60 |
13.
Good manufacturing practice |
13.1. |
Inspection to
assess compliance in an importation/production undertaking of
veterinary medicinal products, assessment of the provision of
good manufacturing practice (in a state of the European
Economic Area) at the production undertaking of veterinary
medicinal products or at a laboratory that conducts quality
control for the production undertaking, according to a
contract, if the inspection at the facility (without
including the travel costs and the costs of hired
experts3) takes: |
13.1.1. |
one day (one inspector) |
1
importation/production undertaking |
350.00 |
13.1.2. |
two days (one inspector) |
1
importation/production undertaking |
444.00 |
13.1.3. |
three days (one
inspector) |
1
importation/production undertaking |
538.00 |
13.1.4. |
four days (one
inspector) |
1
importation/production undertaking |
632.00 |
13.1.5. |
five days (one
inspector) |
1
importation/production undertaking |
726.00 |
13.2. |
Assessment of
compliance in an importation/production undertaking of
veterinary medicinal products, assessment of the provision of
good manufacturing practice (in a state that is not a member
of the European Economic Area) at the production undertaking
of veterinary medicinal products or at a laboratory that
conducts quality control for the production undertaking,
according to a contract, if the inspection at the facility
(without including the travel costs and the costs of hired
experts3) takes: |
13.2.1. |
one day (one inspector) |
1
importation/production undertaking |
525.00 |
13.2.2. |
two days (one inspector) |
1
importation/production undertaking |
666.00 |
13.2.3. |
three days (one
inspector) |
1
importation/production undertaking |
807.00 |
13.2.4. |
four days (one
inspector) |
1
importation/production undertaking |
948.00 |
13.2.5. |
five days (one
inspector) |
1
importation/production undertaking |
1088.50 |
13.3. |
Issuing of a certificate of
good manufacturing practice of veterinary medicinal
products |
certificate |
40.00 |
13.4. |
Assessment of the documents
of good manufacturing practice of veterinary medicinal
products |
expert
examination of documents |
142.30 |
IV.
Control of samples of veterinary medicinal products |
14.
Samples of veterinary medicinal products |
14.1. |
Taking of a sample |
sample |
17.60 |
V.
Processing of statistical data of veterinary medicinal
products |
15.
Statistics, information |
15.1. |
Information upon request
(subject to agreement), for every working hour |
1 hour |
15.00 |
Notes.
1 Value added tax shall not be imposed in
accordance with Section 3, Paragraph eight of the Value Added Tax
Law.
2 Shall be applicable if the application is
submitted concurrently with the first pharmaceutical form and
strength of the veterinary medicinal product of the same
name.
3 The travel costs, costs of a business trip, and
costs of hired experts - according to the corroborative documents
and tariffs specified in the laws and regulations regarding the
procedures for reimbursing the expenditures related to business
trips.
4 The owner (holder) of the marketing authorisation
of veterinary medicinal products shall be exempted from the
annual charge or a relief is granted to the annual charge in
accordance with the laws and regulations regarding the
registration of veterinary medicinal products.
5 Initial expert examination or in case if new
scientifically supported data pertaining to the safety or
effectiveness of the veterinary medicinal product have been
submitted.
Minister for Agriculture K. Gerhards
Translation © 2021 Valsts valodas centrs (State
Language Centre)