Text consolidated by Valsts valodas centrs (State
Language Centre) with amending regulations of:
29 March 2022 [shall come
into force on 1 April 2022];
13 February 2024 [shall come into force on 15 February
2024].
If a whole or part of a paragraph has been amended,
the date of the amending regulation appears in square
brackets at the end of the paragraph. If a whole
paragraph or sub-paragraph has been deleted, the date of
the deletion appears in square brackets beside the
deleted paragraph or sub-paragraph.
|
|
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 the fee 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 fee and procedures for its payment:
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 fee 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 fee 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 fee for the implemented
activities of State supervision and control (except for the
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 fee for the paid services provided by the Service shall
be collected in the amount specified in Annex 2 to this
Regulation.
6. The fee 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 (except for pet
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;
6.3. Annex 3 to this Regulation - for increased official
control or additional control in the event of suspicion of
non-conformity with the requirements of legal acts in the areas
specified in Article 1(2) of Regulation No. 2017/625 and also the
measures implemented in the event of non-conformity.
[13 February 2024]
7. The fee for the border control of consignments shall be
calculated according to the net weight and number of consignments
(cargoes).
8. The fee for the 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 fee 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 into 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 fee for
the postal services according to the rates of the postal operator
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 the performance of the activities of State
supervision and control and provision of services, and also
before the 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
Fee 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 authorisations, 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-conformity 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 source 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. |
Fee 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. |
Fee for the time of control if
the fee 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. |
Fee 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 an official travel, travel expenditures,
accommodation, and other expenditures according to the
corroborative documents and set rates |
| VII.
Supervision of food quality schemes |
| 25. |
Certification of products under
food quality scheme, annual inspection and repeat inspection
if non-conformity is found in Latvia (according to the actual
working time) |
hour |
17.60 |
| 26. |
Certification of
products under food quality scheme, annual inspection and
repeat inspection if non-conformity is found in another
European Union Member State (according to the actual working
time) |
hour |
17.60 |
|
daily allowance of an official travel, travel expenditures,
accommodation, 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
the event of non-conformity (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 the event of non-conformity |
hour |
17.60 |
| 33. |
Laboratory testing when
performing unscheduled control and implementing measures in
the event of non-conformity |
according to the actual costs of laboratory testing |
Notes.
1 Value added tax shall not be applied in
accordance with Section 3, Paragraph eight of the Value Added Tax
Law.
2 The fee shall include taking of official
samples.
3 The fee 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 granting such support.
5 When calculating the costs, a fee shall be
calculated in addition to the specified fee for any work carried
out outside the stated working hours, on public 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
[13 February 2024]
Fee 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 charge for the control of which is
specified in Regulation No. 2017/625): |
| 1.1. |
consignment transported in one
road vehicle (automobile) or container which weighs up to
5000 kg (except for the food referred to in Sub-paragraph 1.5
of this Annex) |
consignment |
24.31 |
| 1.2. |
consignment
transported in one road vehicle (automobile) or container
which weighs 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 |
24.31 |
| 1.2.2. |
for every additional 1000 kg
(over 5001 kg) |
1000 kg |
7.33 |
| 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 |
24.31 |
| 1.3.2. |
for every additional 1000 kg
(over 5001 kg) |
1000 kg |
4.48 |
| 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 |
24.31 |
| 1.4.2. |
for every additional 10 000 kg
(over 10 001 kg) |
10 000 kg |
7.33 |
| 1.4.3. |
maximum fee for the consignment
referred to in Sub-paragraphs 1.4.1 and
1.4.22 |
consignment |
148.92 |
| 1.5. |
salt consignment regardless of
the type of vehicle |
consignment |
24.31 |
| 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 |
24.31 |
| 2.2. |
weighing 5001 kg or
more: |
| 2.2.1. |
for 5000 kg |
consignment |
24.31 |
| 2.2.2. |
for every additional 1000 kg
(over 5001 kg) |
1000 kg |
2.43 |
| 2.2.3. |
maximum fee for the consignment
referred to in Sub-paragraphs 2.2.1 and
2.2.22 |
consignment |
157.96 |
| 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 |
24.31 |
| 3.2. |
for cargo weighing
5001 kg or more: |
| 3.2.1. |
for 5000 kg |
consignment |
24.31 |
| 3.2.2. |
for every additional 1000 kg
(over 5001 kg) |
1000 kg |
2.43 |
| 3.2.3. |
maximum fee for the consignment
referred to in Sub-paragraphs 3.2.1 and 3.2.2 |
consignment |
157.96 |
| 4. |
Control of animal
feedingstuffs (except for feedingstuffs of animal origin the
charge for the control of which is specified in Regulation No
2017/625) for a consignment: |
| 4.1. |
weighing up to 10 000 kg |
consignment |
24.31 |
| 4.2. |
for cargo weighing
10 001 kg or more: |
| 4.2.1. |
for 10 000 kg |
consignment |
24.31 |
| 4.2.2. |
for every additional 10 000 kg
(over 10 001 kg) |
10 000 kg |
7.33 |
| 4.3. |
maximum fee for the consignment
referred to in Sub-paragraphs 4.2.1 and
4.2.22 |
consignment |
148.92 |
| 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 charge for the control of which
is specified in Regulation No 2017/625) |
consignment |
24.31 |
| 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 |
24.31 |
| 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 |
24.31 |
| 8. |
Increased official
control or additional control in the event of suspicion of
non-conformity: |
| 8.1. |
fee for increased official
control in the cases specified in the legal acts of the
European Union3 |
consignment |
63.61 |
| 8.2. |
fee for increased official
control or additional control in the event of suspicion of
non-conformity3 (except in the case referred to in
Sub-paragraph 8.1 of this Annex) |
consignment |
138.56 |
| 8.3. |
laboratory testing |
according to the actual costs of laboratory testing |
| 9. |
Laboratory testing when
implementing measures in the event of non-conformity |
according to the actual costs of laboratory testing |
| 10. |
Control of pet animals |
animal |
55.00 |
| 11. |
Storage of a consignment which
is non-compliant or detained until the receipt of all control
results at the premises of a border control post |
hour |
8.70 |
Notes.
1 Value added tax shall not be applied in
accordance with Section 3, Paragraph eight of the Value Added Tax
Law.
2 This Sub-paragraph shall not be applied if the
consignment is subject to increased official control or
additional control in the event of suspicion of
non-conformity.
3 Applied in addition to the fee specified in
Paragraphs 1, 2, and 4 of this Annex and the fee which is applied
in accordance with Sub-paragraph 6.1 of this Regulation.
Annex 4
Cabinet
Regulation No. 681
17 December 2019
Paid Services of the Food and
Veterinary Service in the Circulation of Veterinary Medicinal
Products
[29 March 2022]
| No. |
Item of expenditures |
Unit of measurement |
Price (in
EUR)1 |
| I.
Evaluation and registration of veterinary medicinal products
for granting the marketing authorisation, re-registration,
and registration supervision |
| 1.
National procedure |
| 1.1. |
Expert examination
of the application and attached documentation for the
registration of veterinary medicinal products under the
national procedure: |
| 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. |
homeopathic medicinal products
(for granting marketing authorisation) |
application |
96.00 |
| 2.
Mutual recognition procedure |
| 2.1. |
Expert examination
of the application and attached documentation under the
mutual recognition procedure of veterinary medicinal products
or for subsequent recognition under the mutual recognition
procedure: |
| 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 procedure |
| 3.1. |
Expert examination
of the application and attached documentation under the
decentralised procedure of veterinary medicinal products or
for subsequent recognition under 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 the marketing
authorisation of veterinary medicinal products |
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 fee4 or: |
|
235.00 |
| 5.1.1. |
annual fee 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 fee 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 variations in the
registration documents of veterinary medicinal products
(for each product) |
| 6.1. |
Variations not to be
assessed |
one
variation |
132.50 |
| 6.2. |
Variations to be assessed (R
type variations) |
one
variation |
199.50 |
| 6.3. |
Variations to be assessed (E
type variations) |
one
variation |
391.50 |
| 6.4. |
Variations to be assessed (S
type variations) |
one
variation |
229.00 |
| 6.5. |
Variations related to the change
of the holder of the marketing authorisation (the new holder
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.
Distribution of veterinary medicinal products in parallel
trade |
| 7.1. |
Expert examination of the
application and attached documentation for the distribution
of veterinary medicinal products in parallel trade in
Latvia |
expert
examination |
225.00 |
| 7.2. |
Making variations in the
instructions on the use of veterinary medicinal products |
expert
examination |
65.50 |
| 7.3. |
Making variations in the
labelling of veterinary medicinal products |
expert
examination |
65.50 |
| 7.4. |
Making variations in the dossier
of veterinary medicinal products |
expert
examination |
26.50 |
| 7.5. |
Issuing of the permit for the
distribution of veterinary medicinal products in parallel
trade in Latvia |
permit |
6.65 |
| 8.
Distribution of veterinary medicinal products not registered
in the country |
| 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 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 conformity |
| 9.1. |
Evaluation of a product to
determine its conformity to 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 an authorisation of a clinical trial and
attached documents - review (assessment): |
| 10.2.1. |
productive animals |
application |
160.00 |
| 10.2.2. |
other animals |
application |
130.00 |
| 10.3. |
Issuance of the authorisation
for a clinical trial |
authorisation |
6.65 |
| 11.
Issuing of other permits |
| 11.1. |
For the importation
of a sample of a veterinary medicinal product: |
| 11.1.1. |
expert examination of the
application and documents for the importation of a sample of
a veterinary medicinal product |
expert
examination |
135.50 |
| 11.1.2. |
issuing of a permit for the
importation of a sample of a veterinary medicinal
product |
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. Conformity assessment, registration and licensing of
operation |
| 12.
Conformity assessment |
| 12.1. |
Conformity assessment of
documents |
expert
examination of documents |
40.00 |
| 12.2. |
Conformity assessment in a
veterinary pharmacy (including the assessment of documents
and the preparation of a protocol) |
1
pharmacy |
52.95 |
| 12.3. |
Conformity assessment 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 a
person for activities with the veterinary medicinal products
for ensuring its operation without the right to further
distribute them or with the medicinal products containing the
substances included in Schedule II or III of the narcotic
substances, psychotropic substances, and precursors to be
controlled in Latvia (according to the actual time of the
inspection, per working hour for one inspector) |
1 hour |
17.60 |
| 13.
Good manufacturing practice |
| 13.1. |
Conformity
assessment inspection in an importing/manufacturing
undertaking of veterinary medicinal products, assessment of
the provision of good manufacturing practice (in a country of
the European Economic Area) at the manufacturing undertaking
of veterinary medicinal products or at a laboratory that
conducts quality control for the manufacturing undertaking
according to a contract, if the inspection at the facility
(without the official travel costs and the costs of hired
experts3) takes: |
| 13.1.1. |
one day (one inspector) |
1
importing/manufacturing undertaking |
350.00 |
| 13.1.2. |
two days (one inspector) |
1
importing/manufacturing undertaking |
444.00 |
| 13.1.3. |
three days (one inspector) |
1
importing/manufacturing undertaking |
538.00 |
| 13.1.4. |
four days (one inspector) |
1
importing/manufacturing undertaking |
632.00 |
| 13.1.5. |
five days (one inspector) |
1
importing/manufacturing undertaking |
726.00 |
| 13.2. |
Conformity
assessment in an importing/manufacturing undertaking of
veterinary medicinal products, assessment of the provision of
good manufacturing practice (in a country outside of the
European Economic Area) at the manufacturing undertaking of
veterinary medicinal products or at a laboratory that
conducts quality control for the manufacturing undertaking
according to a contract if the inspection at the facility
(without the official travel costs and the costs of hired
experts3) takes: |
| 13.2.1. |
one day (one inspector) |
1
importing/manufacturing undertaking |
525.00 |
| 13.2.2. |
two days (one inspector) |
1
importing/manufacturing undertaking |
666.00 |
| 13.2.3. |
three days (one inspector) |
1
importing/manufacturing undertaking |
807.00 |
| 13.2.4. |
four days (one inspector) |
1
importing/manufacturing undertaking |
948.00 |
| 13.2.5. |
five days (one inspector) |
1
importing/manufacturing undertaking |
1088.50 |
| 13.3. |
Issuing of a certificate of good
manufacturing practice of veterinary medicinal products |
certificate |
40.00 |
| 13.4. |
Evaluation 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 on 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 applied 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 an official travel,
and costs of hired experts - according to the source documents
and tariffs specified in the laws and regulations regarding the
procedures for reimbursing the expenditures related to official
travels.
4 The owner (holder) of the marketing authorisation
or registration certificate of veterinary medicinal products
shall be exempted from the annual fee or a relief is granted to
the annual fee in accordance with the laws and regulations
regarding the registration of veterinary medicinal products.
5 Initial expert examination or, if new
scientifically supported data pertaining to the safety or
efficacy of the veterinary medicinal products have been
submitted.
6 Schedules of the narcotic substances,
psychotropic substances, and precursors to be controlled in
Latvia are determined in Annex 2 to the law On the Procedures for
the Coming into Force and Application of the Criminal Law.
Translation © 2024 Valsts valodas centrs (State
Language Centre)
