Veterinary Requirements For Trade In Semen And Eggs. Cell

Original Language Title: veterinární požadavky na obchodování se spermatem a vaječ. buňkami

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=55995&nr=380~2F2003~20Sb.&ft=txt

380/2003 Coll.
DECREE


Dated 3 November 2003

On veterinary requirements for trade in semen, egg cells and embryos
on veterinary conditions for their import from third countries


Change: 155/2006 Coll.

Change: 447/2009 Coll.

Change: 125/2013 Coll.

Change: 64/2015 Coll.

Ministry of Agriculture, pursuant to § 78 of Act no. 166/1999 Coll., On
veterinary care and amending certain related laws (Veterinary
Act), as amended by Act no. 131/2003 Coll., (Hereinafter "the Act") to implement
§ 28 para. 5, § 31 par. 3 point. a) and § 34 para. 5 of the Act:
Introductory provisions


§ 1
Subject Matter


(1) This Decree implements the relevant regulations of the European Union ^ 1) and adjusts


A) veterinary requirements for trade in semen, egg cells and embryos
(hereinafter referred to as "germinal products"), cattle, pigs, sheep, goats and equine
with the Member States of the European Union (hereinafter referred to as' Member State ')

B) animal health conditions for importation of seed products from countries that are not
Member States (hereinafter referred to as "third countries")

C) conditions for issuing the health certificate that accompanies embryonic
products.

(2) This Decree does not apply to

A) organization of artificial insemination as a whole, especially on the distribution
semen

B) embryos obtained by nuclear transfer,

C) bovine semen collected and processed in a Member State before 1 January
1990s.

§ 2
Basic concepts


For the purposes of this Decree

A) cattle - animals of the cattle (Bos), including species of bison (Bison bison) and
buffalo (Bubalus bubalis) reared or kept as livestock

B) pigs - animals of the genus Sus reared or kept as farm animals
,

C) Equidae - animals of a horse and a donkey, and their hybrids and animal species
zebra,

D) bovine semen - ejaculate cattle, modified or diluted,

E) porcine semen - pig ejaculate, unprocessed, modified or diluted
,

F) of bovine embryos - the initial stage of development of cattle which can be transmitted to cows
(recipient)

G) the AIC - approved and monitored
venture, or other facilities on the territory of a Member State or third country in which it is produced
bovine semen for artificial insemination

H) center for the collection of semen - approved and monitored
venture or other facilities on the territory of a Member State or third country in which semen is produced
other farm animal species,

I) sperm bank - approved and monitored undertaking or other device
on the territory of a Member State or third country in which it is stored
bovine semen for artificial insemination,

J) sampling - quantity of semen taken from one animal once,

K) embryo collection team - approved group of technicians under the supervision of a veterinarian
, which is based on the requirements laid down by this Decree
competent to perform the collection, processing and storage
embryos

L) embryo production team - collection team approved
based on the requirements set out in this Decree also for in vitro fertilization
under veterinary supervision

M) consignment - consignment of semen, which is exposed to one
veterinary certificate; in the case of embryos refers to the shipment quantity
embryos originating from one sample from one donor
covered by a single health certificate

N) countries taking - Member State or third country in which semen is collected and
where it is sent to a Member State; in the case of the embryo, it is understood countries taking
Member State or third country in which embryos are produced,
collected, processed, or stored and from where they are sent to
Member State

O) approved laboratory - a laboratory located in the territory of a Member State or third country
approved by the competent veterinary authority to conduct
examinations provided by this decree,

P) Semen storage center - approved and monitored
venture or other facilities on the territory of a Member State or third country in which it is stored
sperm sheep, goats or equine.

Veterinary requirements for trade in bovine semen

§ 3

(1) Bovine semen may be the subject of trading, where


A) have been collected and processed, stored or even for the purposes of artificial insemination
in semen collection or sperm bank approved by the Veterinary
terms of trading with the Member States (hereinafter
"trading") | ||
B) was collected from an animal of the bovine species whose health status complies
requirements specified in Annex no. 2 hereto,

C) was collected, processed, stored and transported in accordance with
requirements specified in Annexes Nos. 1 and 3 of this Decree,

D) during transport to the Member State of destination is accompanied by the original
correctly and fully completed veterinary certificate issued by an official veterinarian
Member State of collection in accordance with the model set
European Union regulations.

(2) semen of bulls who have been vaccinated against foot-and-mouth disease, can not be
trading within the refuse.

(3) If the semen referred to in paragraph 2 comes from a bull
vaccinated against foot-and-mouth disease during the 12 months prior to collection,
shall be 5% of the semen (with a minimum of 5 straws) of each collection intended to || | another Member State subject to an approved laboratory in the Member State of destination
or in an approved laboratory designated by it
test for virus isolation for the detection of foot-and-mouth disease with negative results.

§ 4

(1) Conditions for the approval of semen collection or bank
semen from a veterinary point of view are given in Annex no. 1 hereto.

(2) If compliance with the conditions for approval of semen collection
or sperm banks may be in accordance with § 49 para. 1 point. h)
1 point, or § 49 para. 1 point. d) of the Act is suspended or revoked
approval; The Central Veterinary Authority in accordance with § 48 para. 1
point. a) point 2 of the Act shall inform of such action the European Commission
(hereinafter "Commission") and the Member States.

(3) the Central Veterinary Authority in accordance with § 48 para. 1 point. j)
law results, published on the website of the State Veterinary Administration and
updates the list of approved semen collection centers and sperm banks
assigned to them veterinary approval number.

§ 5

If there is a suspicion that bovine semen is infected or contaminated by pathogenic microorganisms
, adopts the regional veterinary administration in accordance with law
necessary measures, including storage of semen in quarantine
to confirm or exclude this suspicion .

Veterinary requirements for trade in porcine semen

§ 6

Porcine semen may be the subject of trading, where

A) have been collected and processed for the purposes of artificial insemination in a center
semen collection centers approved for animal health purposes for trading

B) they were collected from animals of the porcine species whose health status complies
requirements specified in Annex no. 5 hereto,

C) was collected, processed, stored and transported in accordance with
requirements specified in Annexes Nos. 4 and 6 hereto,

D) during transport to the Member State of destination is accompanied by the original
correctly and fully completed veterinary certificate issued by an official veterinarian
Member State of collection in accordance with the model set
European Union regulations.

§ 7

(1) Conditions for the approval of semen collection centers from a veterinary point of view
are listed in Annex no. 4 hereto.

(2) If compliance with the conditions for approval of the collection center
semen, may be in accordance with § 49 para. 1 point. h), point 1, or
§ 49 paragraph. 1 point. d) of the Act is suspended or revoked its approval;
Central Veterinary Authority in accordance with § 48 para. 1 point. a) point 2 of the Act
informed of such measures to the Commission and the Member States.

(3) the Central Veterinary Authority in accordance with § 48 para. 1 point. j)
law results, published on the website of the State Veterinary Administration and
updated list of approved centers for semen collection with them
assigned veterinary approval number.

§ 8

(1) If there is a suspicion that porcine semen is
infected or contaminated by pathogenic microorganisms, adopts regional veterinary
Administration in accordance with the law necessary measures, including storage in quarantine
sperm to confirm or Excluding this suspicion.

(2) Storage of pig semen in quarantine is possible only
provided that this does not affect its viability.


Veterinary requirements for trade in bovine embryos

§ 9

Bovine embryos may be subject to trading if

A) were conceived by artificial insemination or in vitro fertilization with semen from a bull
AIC or semen imported from a third country under the conditions laid down
this decree, or - in the case of embryos of certain specific species and
If so decided Commission - if it were conceived naturally
bulls whose health status complies with
listed in Annex no. 2 hereto,

B) have been collected from animals of the bovine species whose health statusv
corresponding to the requirements specified in Annex no. 8 hereto,

C) have been collected, processed and stored by an approved collection team
embryos in accordance with the requirements specified in Annex no. 7 to this Decree,

D) during transport to the Member State of destination shall be accompanied by the original
correctly and fully completed veterinary certificate issued by an official veterinarian
Member State of collection in accordance with the model set
European Union regulations.

§ 10

(1) Conditions for the approval of embryo collection team and production team
embryos from a veterinary point of view are listed in Annex no. 7 to this Decree
; Approval must be renewed each time the veterinary doctor
embryo collection team, and after any major changes in his
organization, or in the laboratory or in a facility that has this team to
available.

(2) If compliance with the conditions for the approval of embryo collection team,
may be in accordance with § 49 para. 1 point. h), point 1 or § 49 paragraph
. Point 1. d) of the Act is suspended or revoked its approval;
Central Veterinary Authority in accordance with § 48 para. 1 point. a) point 2 of the Act
informed of such measures to the Commission and the Member States.

(3) the Central Veterinary Authority in accordance with § 48 para. 1 point. j)
law results, published on the website of the State Veterinary Administration and
updated list of approved embryo collection teams with their assigned
veterinary approval number.
Heading left


§ 11


Canceled
Veterinary requirements for trade in semen of sheep, goats and equine


§ 12

Semen sheep, goats and horses may be subject to trading if

A) was collected, processed and stored to the needs
artificial insemination in a center or a semen collection center for semen storage
approved for animal health purposes for trading
or - in the case of sheep and goats - in an economy that suits
requirements laid down in special legislation, ^ 2)

B) they were collected from animals meeting the requirements set out in Part B of Annex
. 9 hereto,

C) was collected, processed, preserved, stored and transported in
accordance with the requirements set out in Part C of Annex no. 9 hereto,

D) during transport to the Member State of destination is accompanied by the original
correctly and fully completed veterinary certificate issued by an official veterinarian
Member State of collection in accordance with the model set
European Union regulations.

§ 13

(1) Conditions for the approval of semen collection centers and centers for
storage of semen from a veterinary point of view are listed in Part A of Annex
. 9 hereto.

(2) If compliance with the conditions for approval
collection center or semen storage centers can be in accordance with §
49 paragraph. 1 point. h), point 1, or § 49 para. 1 point. d) of the Act
suspended or withdrawn its approval; The Central Veterinary Administration
accordance with § 48 para. 1 point. a) point 2 of the Act informs
such measures to the Commission and the Member States.

(3) the Central Veterinary Authority in accordance with § 48 para. 1 point. j)
law results, published on the website of the State Veterinary Administration and
updated list of approved centers for semen collection centers and semen storage
with their assigned
veterinary approval numbers.

Veterinary requirements on trading in egg cells and embryos sheep
goats, swine and equine

§ 14

(1) ova and embryos of sheep, goats, swine and equine animals may be subject
trading if

A) they were taken by an approved embryo collection team or produced

Approved embryo production; Conditions for approval team
embryo collection and embryo production teams listed in Part A of Annex
no. 9 hereto,

B) were collected from animals meeting the requirements set out in Part D
Annex no. 9 hereto,

C) have been collected, processed, stored in an appropriate laboratory, stored and transported
in accordance with Part C of Annex no. 9 hereto,

D) during transport to the Member State of destination are accompanied by the original
correctly and fully completed veterinary certificate issued by an official veterinarian
Member State of collection in accordance with the model set
European Union regulations.

(2) Semen used for the insemination of donor females must comply with the requirements specified in §
6, in the case of pigs, or in § 12, in the case of sheep, goats and equines
.

Veterinary conditions for imports of bovine semen from third countries

§ 15

(1) imported from a third country may bovine semen that

A) comes from a third country, or part thereof, listed
third countries drawn up and published by the Commission, all of which can be imported
bovine semen to the territory of the Member States (hereinafter referred to as "the European Union"),

B) comes from a semen collection or sperm bank in a third country
that the competent authorities in third countries approved for export of semen
to the European Union and on the list of semen collection and semen banks
assembled and published by the Commission, all of which can be sent
bovine semen to the European Union.

(2) Bovine semen must

A) come from animals that immediately before his collection was
kept for at least six months on the territory of a third country listed
pursuant to paragraph 1. a)

B) meet the requirements laid down by the Commission for the imports of bovine semen
relevant third countries particularly with respect to requirements in terms
tuberculosis and bovine brucellosis, included in a special legal
regulation, 3) or - decided if so, the Commission in a particular case -
animal health guarantees offered by the third country that are
these requirements at least equivalent

C) be accompanied during transportation by the original correctly and fully completed
veterinary certificate issued by an official veterinarian of the third
country in which semen was collected, in accordance with the model set
European Union regulations.

(3) For imports of bovine semen from third countries shall apply mutatis mutandis § 3 para. 2 and 3


Veterinary conditions for imports of porcine semen from third countries

§ 16

(1) imported from a third country may porcine semen, which

A) comes from a third country, or part thereof, listed
third countries drawn up and published by the Commission, all of which can be imported
porcine semen to the European Union,

B) comes from a semen collection center in a third country, which has been
competent authority of the third country authorized to export semen
on the territory of the European Union and on the list of semen collection centers
compiled and published by the Commission of which may be porcine semen
sent to the territory of the European Union.

(2) Porcine semen must

A) come from animals that immediately before his collection was
kept for at least three months on the territory of a third country listed
pursuant to paragraph 1. a)

B) meet the requirements laid down by the Commission for the importation of porcine semen from
relevant third countries particularly with regard to the requirements specified in § 6 and
seq. and Annexes no. 4-6 hereto, or - decide if
and the Commission in a particular case -
animal health guarantees offered by the third country to which those requirements
least equivalent

C) be accompanied during transportation by the original correctly and fully completed
veterinary certificate issued by an official veterinarian of the third
country in which semen was collected, in accordance with the model set
European Union regulations.

(3) For the importation of porcine semen from third countries and storing sperm
pigs in quarantine § 8 applies mutatis mutandis.

Veterinary conditions for imports of bovine embryos from third countries

§ 17

(1) imported from a third country may bovine embryos that

A) come from a third country, or part thereof, listed
third countries drawn up and published by the Commission, all of which can be imported

Bovine embryos to the European Union,

B) was collected from an embryo collection team in a third country authorized
collect, process or store embryos in the Member States and
on the list of those teams compiled and published by the Commission.

(2) bovine embryos must

A) be collected from animals that

First immediately prior to collection have been kept for at least 6 months
territory of a third country listed under paragraph 1.
A), a maximum of two different herds meeting the requirements concerning
tuberculosis, brucellosis and enzootic bovine
and are listed in the annexes to a particular piece of legislation. ^ 3) decided to do so
in the specific case of the Commission, just when bovine embryos correspond
animal health guarantees offered by the third country, if such guarantees
similar and at least equivalent to those requirements

Second come from a holding where during the 30 days prior
embryos was no animal vaccinated against FMD and that
subject to any extraordinary veterinary measures prohibiting or
quarantine measures

B) meet the requirements laid down by the Commission for the importation of embryos from the relevant
third country

C) be accompanied during transportation by the original correctly and fully completed
veterinary certificate issued by an official veterinarian of the third
country in which the embryos were collected in accordance with the model set
European Union regulations.

§ 18

(1) from third countries where vaccination against foot-and-mouth disease
may be imported only frozen embryos.

(2) Before sending must be frozen embryos referred to in paragraph 1
stored under approved conditions specified in Annex no. 7 to this Decree
at least 30 days.

Health conditions for imports of products embryonic pigs, sheep, goats and equine
from third countries

§ 19

(1) imported from a third country products may embryonic pigs, sheep, goats and equine
that

A) come from a third country, or part thereof, listed
third countries drawn up and published by the Commission, all of which can be imported
germinal products in the European Union,

B) meet the requirements laid down for dealing in
or are at least equivalent to those requirements,

C) during transport, are accompanied by the original correctly and fully completed
veterinary certificate issued by an official veterinarian of the third
country in which the germinal products withdrawn in accordance with the model set
European Union regulations.

(2) The health certificate referred to in paragraph 1. c)
must attest that germinal products meet the requirements specified in paragraph 1
point. b) and come from approved centers
semen collection and storage centers, embryo collection teams or teams
embryo production, providing the requisite guarantees.

The conditions for issuing the health certificate that accompanies embryonic
Products

§ 20

(1) Animal health certificate which accompanies embryonic
products intended for trading must be

A) in at least one of the official languages ​​of the Member State of collection
and one of the official languages ​​of the Member State of destination

B) on a single sheet of paper; if this is not possible and a health certificate is drawn
multiple sheets, these sheets must be properly connected and
labeled so as to form an indivisible whole,

C) intended for one recipient

D) stamped and signed by an official veterinarian in a color different from the color
rest of the text, as well as the serial number.

(2) A health certificate, which accompanies the germinal products intended for trading
must accompany the consignment to its destination.

(3) Unless otherwise specified, the period of validity
veterinary certificate which accompanies germ products intended for trading
10 days from the date of its issuance.

§ 21

(1) Animal health certificate which accompanies embryonic
products imported from third countries must

A) be drawn up in at least one of the official languages ​​of the Member State
destination and one of the official languages ​​of the Member State in which it is carried
veterinary inspection pursuant to a special legal regulation, 4)

B) meet the requirements of § 20 para. 1 point. b) to d).


(2) A health certificate, which accompanies embryonic
products imported from third countries, must accompany the consignment to its destination.
Common provisions


§ 22

Conditions for approval of semen collection or bank
semen from a veterinary point of view, for the approval of semen collection centers from
veterinary point of view, for the approval of embryo collection team and the team
production of embryos from a veterinary point of view also applies in the case of embryonic
products put into circulation in the Czech Republic.

§ 23

(1) In the case of suspected non-compliance with the provisions of this Order, as well
even in case of doubt regarding animal health or the quality of semen,
egg cells or embryos, makes regional veterinary authority
any inspections for which it is legally entitled.

(2) If it is found violations of the provisions of this ordinance or regulations
European Union, in particular, unless they meet the germ products provided
requirements, if it was non-compliance of the health certificate or other document
with their actual state, or does not correspond to their designation
this decree, if not come germinal products from third countries listed
on a list compiled and published by the Commission or the Centre for their procurement
approved for export of these products to the European
Union, apply the penalties under the Act.

(3) Acceptance of a consignment of seed products may be in accordance with § 34 paragraph
. 1 Law refused if checking documents accompanying the shipment
proves that non-compliance on trading
or conditions for their import.

(4) If the regional veterinary administration for rejecting a consignment
germ products, and if they disagree country of collection within 30 days, in case
fresh seed products immediately, returning the consignment, Regional Veterinary Administration


A) order in accordance with § 49 para. 1 point. d) and § 54 para. 1 of the Act
disposal germ products

B) inform about the measures and the reasons for the consignor or his representative
.

§ 24

(1) If there is spreading or if a third country an infection that can be transmitted
germ products and could endanger the health
animals in the Czech Republic, or if required by any other
reason connected with animal health, the competent authority shall do so in accordance with the law
appropriate measures, especially ban the import of products from germ
relevant third country, or part thereof. The Central Veterinary Administration
informed in accordance with § 48 para. 1 point. a) point 2 of the Act
Commission and Member States on such measures and the reasons that led to their adoption
.

(2) The procedure under paragraph 1, it is irrelevant whether the germ
products imported from a third country to the Czech Republic, directly or indirectly
through another Member State.

§ 25

Entry germ products listed in § 14 that have passed through the territory of a third country
in the Czech Republic, may be subject to the presentation
veterinary certificate confirming their compliance with the requirements of this ordinance
. The application of this procedure requires about him
Central Veterinary Administration in advance to inform the Commission and the Member States.

§ 26


Canceled
§ 27

(1) The organization and manner of veterinary checks germ
products intended for trading purposes or imports from third countries and measures
arising from the results of these checks are regulated by special laws, regulations
. ^ 5)

(2) Where the Commission implements its experts veterinary spot checks
Czech Republic or in a third country in order to ensure uniform application of
European Union rules on animal health requirements
trading germ products and veterinary
terms of their imports from third countries, provides it with the State veterinary Administration
required cooperation, mainly consisting of the necessary assistance and participation
veterinary experts from the Czech Republic on these checks.

§ 28

Dealing with embryonic products intended for zoos and
imports from third countries are also subject to the specific requirements laid down
Commission acts.

§ 29
Efficiency


This Decree shall take effect on the date of the accession
Czech Republic to the European Union enters into force, with the exception of § 4, 7, 10, 13 and 22,

Which come into force on the day of its publication.
Minister
:

Ing. Palas vr


Příl.1
CONDITIONS FOR APPROVAL OF BANK semen collection centers and semen from
VETERINARY ASPECTS AND SUPERVISION IN THEM

A

Conditions for approval of semen collection centers and sperm banks

Semen collection centers must:

A) be under the constant supervision of a center veterinarian approved
regional veterinary administration;

B) have at least:

I) allowing the stables and quarantine of animals;

Ii) semen collection facilities including a separate room intended for
cleaning, disinfection or sterilization of equipment;

Iii) the rooms for treatment of sperm that are not necessarily located at the same site
;

Iv) a semen storage room which need not necessarily be in the same place
;

C) be constructed or isolated so that it can not come into contact with animals outside
;

D) be so constructed that the animal housing and facilities for the collection, treatment and storage
sperm are easily cleaned and disinfected;

E) to have the quarantine stables, which can not directly communicate with the ordinary
operation;

F) be so designed that the animal accommodation physically separated from the preparation room
sperm and that these two spaces are separated from
semen storage room.

Bank semen must be:

A) under the constant supervision of a veterinarian approved sperm banks
regional veterinary administration;

B) constructed or isolated so that it can not come into contact with animals outside
;

C) designed so that facilities for the storage of semen is
easy to clean and disinfect;
B


Conditions for the supervision of semen collection centers and sperm banks

The collection centers must:

A) supervised so as to ensure that only animals live here
of the species whose semen is to be collected. Permits may also be other
animals that are indispensable for the operation of AIC, if
pose no risk of infection for animals of the species from which semen is collected
, and if they meet the conditions laid down by the veterinarian || | AIC;

B) supervised so as to ensure that it is kept
list of all the animals at the center, which provides information regarding
breed, date of birth and identification of each animal the way, and it must
be a record of all performed
veterinary examinations and all vaccinations;

C) official veterinarian at least twice a year
performed a routine inspection which includes a check on the conditions of approval and supervision
control;

D) supervised in order to determine whether conditions are created
to prevent the entry of unauthorized persons. If the visit allowed
may be taken only under conditions set by a veterinarian
AIC;

E) employ only technically qualified personnel adequately trained in matters
disinfection procedures and hygiene techniques that allow
prevent the spread of disease;

F) supervised so as to ensure compliance with the following conditions
:

(I) authorized AIC can be edited and stored
only semen in authorized artificial insemination centers collected without
come into contact with any other consignment of semen. Semen uncollected
authorized AIC may, however, be treated in the approved
semen collection centers under the conditions that:

- Such semen was obtained from bovine animals corresponding to the conditions set out in Part A
point 1. d) Annex no. 2 hereto,

- The semen must be carried out by different equipment or other
time from semen intended for trade within the European Union
. In this case, the equipment must be cleaned after use and sterilized
,

- Such semen may not be the subject of trade within the European Union and
must never come into contact with or be stored with semen intended
trading within the European Union

- Such semen must be marked in any other way than the indication referred to in paragraph
vii).

In addition, the approved semen collection centers can also
store frozen embryos, provided that:


- Such storage is subject to the approval of the regional veterinary administration

- The embryos meet the requirements of this Order

- The embryos are spaces for storing approved semen
stored in separate storage containers;

(Ii) collection, processing and storage of semen is carried out only in
areas designated and under the conditions of the strictest hygiene;

(Iii) any items that come into contact with the semen or the donor-
animal during collection and treatment of semen must be before each use
properly disinfected or sterilized instruments except
disposable ;

(Iv) products of animal origin used in the editing of semen
including additives and solvents, must come from sources that do not pose any health risk
, or be modified before use so that such risk
was excluded;

(V) of the container (containers) used for the storage and transport of semen
must before each filling properly disinfected or sterilized
except for disposable containers;

(Vi) freezing medium used must not have been previously used for other
products of animal origin;

(Vii) each individual dose of semen must be clearly marked so
to quickly and easily could find the date of collection of the semen, the breed, the animal is
^ 6) - donor and veterinary approval number insemination
station. Each Member State shall inform the Commission and other Member States with data on
manner and type of marking used in its territory;

(Viii) the storage unit must comply with specific conditions
relating to the supervision of banks semen.

The sperm banks must:

A) be supervised so that the record is kept of all movements
sperm (from the bank to the bank) and the Statute of the bulls-donor whose sperm is stored in the bank
who must meet the requirements of this Order ;

B) the official veterinarian at least twice a year to perform regular
control. As part of this inspection is to check the conditions of approval and supervision
control;

C) be supervised so as to prevent entry of unauthorized persons
. In addition, when a visit is allowed, it can only be taken under the conditions laid down
veterinarian responsible for sperm bank;

D) be employed only our skilled workers to the extent needed
familiar with disinfection procedures and hygiene techniques that allow
prevent the spread of disease;

E) they are supervised so as to ensure that:

(I) only semen collected at collection centers approved in
accordance with this decree is stored in approved banks without
come into contact with any other semen.

It may also be approved to bank sperm delivered only sperm
comes from an approved semen collection or sperm banks and
which is transported under conditions that provide every possible
health guarantees, while not in contact with other semen.

The approved banks may also be stored frozen embryos for
provided that:

- This storage given consent regional veterinary administration,

- The embryos meet the requirements of this Order

- The embryos are spaces for storing approved semen
stored in separate storage containers,

(Ii) the semen is stored only in reserved areas and
strictest hygiene conditions;

(Iii) all instruments which come into contact with semen, with the exception
disposable instruments are carefully before use
disinfected or sterilized;

(Iv) storage and transport containers are thoroughly disinfected or sterilized
before each filling, except
disposable containers;

(V) using the freezing means may be used before freezing
other products of animal origin;

(Vi) each individual dose of semen is marked to be easily and quickly
could determine the date of collection of the semen, the breed and identification of the animal
^ 6) -dárce and veterinary approval number of the semen collection;
Each Member State to inform the Commission and other Member States with data on
manner and type of label used on its territory.


Příl.2
HEALTH REQUIREMENTS FOR bovine animals admitted to the AIC AND ITS INVESTIGATIONS


A


Requirements for bovine animals admitted to a semen collection

First All bovine animals admitted to a semen collection center must meet the following requirements
:

A) must pass at least 28 days in isolation facilities for this purpose
specially approved by the regional veterinary administration, which may be housed only
toed ungulates that have at least the same health status
;

B) before being placed in isolation referred to in subparagraph a) to live in a herd
officially tuberculosis free and officially brucellosis free in accordance with
Decree no. 299/2003 Coll., On measures for prevention and control | || infections and diseases transmissible from animals to humans (Directive 64/432 / EEC).
Animals previously not live in one or more herds of a lower health status
,

C) must come from a herd officially free of enzootic bovine
under the definitions contained in Decree no. 299/2003 Coll. (
Directive 64/432 / EEC) or are born to mothers who were after weaning from the mother
investigated imunodifúzním test in accordance with Part C of Annex no. 23
to Decree no. 299/2003 Coll. (Chapter II of Annex D
Directive 64/432 / EEC), with negative results. In the case of animals obtained
embryo transfer is the "mother" means the recipient of the embryo.

If this requirement can not be met, semen may not be suitable for
trade if the donor has reached the age of two years and has been investigated
with negative results in accordance with Part B, point 1. C);

D) during the 28 days preceding the isolation referred to in subparagraph a)
must be tested with negative results at each examination except
detection of antibodies against BVD / MD, and examinations for tuberculosis
cattle, bovine brucellosis and enzootic bovine made by
methodical instructions of the State veterinary administration (in accordance with Annexes B, C and D
Directive 64/432 / EEC) and

I) for infectious bovine rhinotracheitis (IBR / IPV)
serological examination of blood samples (whole virus), where the animals come from herds free
IBR / IPV, as defined in Article 2.3.5.3 || | International animal health Code;

Ii) for BVD / MD isolating a virus or an assay for a viral antigen and
serological tests to detect the presence or absence
antibodies.

The Regional Veterinary Administration can give consent to testing
referred to in subparagraph d) was performed from samples taken in isolation.
In such case, the isolation period referred to in subparagraph a)
start before the date of sampling. However, in the case of a positive result in any
tests indicated in the list under a) the animal is immediately
removed from the isolation unit. In the case of an isolated group can not
isolation period remaining animals referred to in subparagraph a) begin until
is removed the animal, which has been tested with positive results;

E) the isolation period referred to in subparagraph a) and at least 21 days after receipt
into isolation (for at least seven days after being admitted to isolation due
investigation for Campylobacter fetus ssp. Venerealis and Trichomonas
fetus) was tested with negative results at each examination, with the exception
serological test for antibodies against BVD / MD (see
(iii) below):

(I) for bovine brucellosis serological tests carried out by
quideline State Veterinary Administration (in accordance with Annex C to
Directive 64/432 / EEC);

(Ii) for IBR / IPV serology blood sample (whole virus).

If any animal tests positive, these animals
immediately removed from the isolation and other animals of the same group
remain in isolation and must be at least 21 days after the removal of positive animals
re-examined, with negative results ;

(Iii) for BVD / MD

- Isolating the virus or examination for viral antigen, and

- Serology to determine the presence or absence
antibodies.

Any animal (or séronegativnímu séropozitivnímu)
may be allowed entry into the semen collection centers where the animals that were
before entering the isolation tested negative in the serological examination
, seroconversion will not occur.

If seroconversion occurs, all animals that remain seronegative
remain in isolation for an extended period until the next seroconversion
not occur in a period of 3 weeks. serologically positive

Animals may be allowed entry into the semen collection;

(Iv) for Campylobacter fetus ssp. Venerealis:

- In the case of animals less than six months or kept since that age before
isolation in a group of animals of one sex, single sample examination
výplašku artificial vagina or předkožkového bag;

- In the case of animals aged six months or older that could have before
insulation to be in contact with females, examination of a sample výplašku
artificial vagina or předkožkového bag three times at weekly intervals;

(V) for Trichomonas fetus:

- In the case of animals less than six months or kept since that age in
group of animals of one gender over insulation, single-sample testing
výplašku předkožkového bag;

- In the case of animals aged six months or older that could have before
insulation to be in contact with females, examination of a sample výplašku
předkožkového bag three times at weekly intervals.

If any of the above examinations is positive, the animals must
be removed from isolation. In the case of group isolation, the regional veterinary administration
take all necessary measures to re
reached the eligibility of the remaining animals for entry into the collection
station in accordance with this Annex;

F) prior to the initial dispatch of semen from bulls serologically positive
for BVD / MD, a semen sample from each animal is designed to isolate the virus
or viral antigen for ELISA testing for BVD / MD.
In the case of a positive result, the bull is removed from the AIC and its
sperm disposed of.

Second All examinations must be performed in an accredited laboratory.

Third Animals may be taken to the collection center on the basis
express permission of the center veterinarian.
All transfers to and from AIC AIC
must be recorded.

Fourth No animals accepted into the collection center not on the day when
clinical symptoms appear. All animals must, without prejudice to paragraph 5
come out of isolation, mentioned in point 1. a) that on the day of departure
officially satisfies the following conditions:

A) is situated in the middle area of ​​10 kilometers radius in which
been no case of foot-and-mouth disease at least 30 days;

B) is at least three months from foot-and-mouth disease and brucellosis;

C) is at least 30 days free from those bovine diseases which are compulsorily notifiable
in accordance with Annex no. 1 to Decree no. 382/2003 Coll., On veterinary
requirements for trade in animals and animal health conditions
imported from third countries (Annex E to Directive 64/432 / EEC).

Fifth Assuming that the conditions set out in Section 4
during the preceding 12 months was made necessary examinations referred to in Part B and
transfer is direct, animals may be moved from one approved
semen collection center to another approved AIC
same health status, without being isolated or investigated.
Animals concerned must not come into direct or indirect contact with cloven
lower health status and the means of transport used must be disinfected before use
. If done movement from one semen collection center to another
AIC between Member States must be
conducted in accordance with Decree no. 382/2003 Coll. (
Directive 64/432 / EEC).
B


Mandatory testing of cattle at a collection center

First All bovine animals kept at an approved semen collection center must be
least once a year examined by the methodical instructions
The State Veterinary Administration (in accordance with the procedures set out in Annexes B, C and D
Directive 64/432 / EEC) with a negative result for:

A) bovine tuberculosis intradermal tuberculin test;

B) bovine brucellosis serology;

C) enzootic bovine serology;

D) of infectious bovine rhinotracheitis (IBR / IPV) serology (s
whole virus);

E) BVD / MD assay for antibodies, which is only used for
seronegative animals. If the animal become serologically positive
must each ejaculate collected since the last negative examination
either removed or examined for the presence of virus with negative results;

F) Campylobacter fetus ssp. Venerealis examination sample výplašku

Předkožkového bag. They must be examined only bulls intended to produce
semen or bulls, who have been in contact with bulls used for semen production
. Bulls returning to collection after more than six-month break
are investigated at least 30 days before resuming the production of semen;

G) Trichomonas fetus on a sample examination výplašku předkožkového bag.
Investigation should be only fighting bulls for semen production and bulls
who were in contact with bulls used for semen production.
Bulls returning to collection after more than six-month break are investigated
later than 30 days before resuming the production of sperm.

Second All examinations must be performed in an accredited laboratory.

Third If any of the above tests is positive, the animal must
be quarantined and the semen collected from him at the time of
last negative test may not be traded within the European Union
except for BVD / MD if semen from every ejaculate
examined for virus BVD / MD negative.

Semen, collected from all other animals at the center since the
examination was performed with a positive result must be stored separately and not
with him until the health status of the center
station deal within the European Union.


Příl.3
VETERINARY REQUIREMENTS for bovine semen intended for trading
INSIDE THE EUROPEAN UNION OR IMPORTED INTO THE EUROPEAN UNION

First Bovine semen must come from animals that:

A) the day the semen does not appear clinical signs of disease;

B)

I) have not been vaccinated against foot-and-mouth disease during the 12 months preceding the collection
or

Ii) have been vaccinated against foot-and-mouth disease during the 12 months preceding the collection
and in this case, 5% of the semen (with a minimum of 5
straws) of each collection investigated isolation of FMD virus with negative
results;

C) have not been vaccinated against foot-and-mouth disease in the 30 days immediately preceding the collection
;

D) lived in an approved semen collection center for at least 30 days continuously
preceding the collection of semen if they are taking
fresh semen;

E) are not allowed to serve naturally;

F) are located in semen collection centers that are free of foot-and-mouth disease
, for at least three months prior to semen collection and
30 days following collection, or when they are fresh semen, until
ship date. These stations are located in the middle region with a radius
10 kilometers, in which no case of FMD
at least 30 days;

G) were kept in semen collection centers which are for the period between
thirtieth day prior to and the thirtieth day after collection or, if this is the
fresh semen, until the date of dispatch, from those bovine diseases subject || | mandatory reporting in accordance with Annex no. 1 to Decree no. 382/2003 Coll.
(Annex E to Directive 64/432 / EEC).

Second Into semen must be added to the following antibiotics, so that after
final diluted semen was achieved following concentrations:

Least 500 micrograms per 1 ml streptomycin,
500 IU penicillin per 1 ml
150 micrograms per 1 ml lincomycin,
300 micrograms per 1 ml spectinomycin.


It can also be used different combinations of antibiotics with an equivalent effect
against campylobacter, leptospires and mycoplasmas.

Immediately after the addition of the antibiotics the diluted semen must be kept at a temperature of at least 5
st. C for at least 45 minutes.

Third Semen intended for trade within the European Union must:

A) be stored for at least 30 days prior to dispatch in an approved
conditions. This requirement does not apply to fresh semen;

B) be transported to the Member State of destination in containers which were before
cleaned and disinfected or sterilized, and that before
dispatch from the approved storage place, sealed and numbered.
Appendix 4


CONDITIONS FOR THE APPROVAL OF CENTRES FOR COLLECTING pig semen
OF VETERINARY ASPECTS AND SUPERVISION IN THEM

A

Conditions for the approval of semen collection centers

Centre semen collection centers must:

First be under constant veterinary supervision centers;

Second have at least:

A) animal housing including facilities for the quarantine of animals

Successfully undergone the tests described in Part B of Annex no. 5 hereto
or showing clinical signs of disease;

B) semen collection facilities including a separate room for
cleaning and disinfection or sterilization of equipment;

C) semen processing room which need not necessarily be on the same
place;

D) the semen storage room which need not necessarily be on the same
place;

Third be constructed or insulated so that they can not come into contact with animals outside
;

Fourth be so constructed that the animal housing and facilities for the collection, processing and storage
flasks are easy to clean and disinfect
;

Fifth be solved so that the animal accommodation physically separated from
semen processing room and that the two areas were separated
from the semen storage room.
B


Conditions for the supervision of semen collection centers

In the centers for collection must be:

First supervised to ensure that the Centre only animals
of the species whose semen is collected;

Second supervised to ensure record, file or computer record
of all porcine animals at the center, indicating
breed, date of birth and identification of each animal, and records
file or computer record of all successful health | || checks and vaccinations, also providing information on documentation
health status of each animal;

Third the official veterinarian at least twice a year
performed a routine inspection which includes a check on the conditions of approval and supervision
control;

Fourth supervised in order to determine whether conditions are created
to prevent the entry of unauthorized persons. In addition to input from persons authorized
they should be required to meet the conditions laid down
center veterinarian;

Fifth employed professionally competent staff suitably trained
procedures for disinfection and hygiene procedures relating to the control
spread of disease;

6th supervised to ensure that

A) in approved centers is processed and stored only
semen collected at an approved center without coming into contact with
any other consignment of semen

B) the collection, processing and storage of semen
made only in areas designated for this purpose and under the strictest hygiene
conditions

C) all tools and utilities that come during collection and processing
into contact with the semen or the donor animal, prior
using properly disinfected or sterilized

D) products of animal origin used in the processing of semen - including additives or diluents
- are obtained from sources which present no
risk to animal health, or to be treated prior to use so that such
avoid danger,

E) containers for storage and transport prior to the start of each performance
properly disinfected or sterilized

F) the cryogenic agent used has not been previously used for other products of animal origin
,

G) each collected semen, whether it is separated into individual doses,
or not, it was clearly marked so that the date of collection
semen and the breed and identification of the donor, as well as the name and the veterinary || | approval number of the center, preceded by the name of the country of origin
(or you can use the code); characteristics and method of marking
will be determined by the Commission.
Annex 5


HEALTH REQUIREMENTS FOR PIGS TO BE TAKEN INTO COLLECTION CENTRES
SPREMATU PIGS AND THEIR INVESTIGATION

A

Requirements for pigs accepted into the semen collection centers

(1) All animals received at the Centre for the collection of semen must:

A) be subjected to isolation at least 30 days in a facility that has been approved
especially for this purpose, the regional veterinary administration and
which are only animals of at least the same health status
;

B) before entering into isolation referred to in subparagraph a)
chosen from herds or holdings

First which are free of brucellosis in accordance with the Chapter on porcine brucellosis
Terrestrial Animal Health Code of the World Organisation for Animal Health
(OIE)

Second in which, during the previous 12 months, there has been no animal

Vaccinated against foot-and-mouth disease

Third which was not in the previous 12 months
been no clinical, serological, virological or pathological evidence of Aujeszky
disease

Fourth which are not in the restricted area defined by Decree No.
. 299/2003 Coll., Decree no. 389/2004 Coll. or Decree no. 202/2004 Coll.
Due to the occurrence of the disease in pigs.

Animals must not have been kept in any herd of a lower health status
than the status described in paragraphs 1-4;

C) within 30 days prior to entry into isolation below the set point. a)
undergo with negative results the following tests carried out in
accordance with the standards set out or referred to in the relevant legal regulations of the European Union
:

First as regards brucellosis, brucellosis, a buffered Brucella antigen
(Rose Bengal test), or cELISA or
felis,

Second as regards the Aujeszky's disease

02.01 in case of non-vaccinated animals ELISA tests to detect antibodies to whole
Aujeszky's disease virus or its glycoprotein B
(ADV-gB) or glycoprotein D (ADV-gD) or a serum neutralization
examination

02.02 in the case of animals vaccinated with a gE deleted vaccine
ELISA tests to detect antibodies to glycoprotein E (ADV-gE) virus
Aujeszky's disease;

Third as regards classical swine fever ELISA tests for antibodies or
serum neutralization tests.

, Responding If any animal in the tests for brucellosis referred to in Section 1
positively not be animals which responded negatively, the same
economy taken in isolation until acknowledged status of the herd or farm of origin
animals with positive results as plain
brucellosis.

The Regional Veterinary Administration may allow the isolation
conducted examinations to which this section refers, when the results are known before the beginning
insulation specified in point. and).

As for Aujeszky's disease serological tests carried out in
accordance with this decree must meet the standards laid down in Annex no. 3
Decree no. 382/2003 Coll .;

D) be subjected to the following tests carried out on samples taken during the past
fifteen days of isolation specified in point. a):

First as regards brucellosis, brucellosis, a buffered Brucella antigen
(Rose Bengal test), or cELISA or
felis;

Second as regards the Aujeszky's disease

02.01 in case of non-vaccinated animals ELISA tests to detect antibodies to whole
Aujeszky's disease virus or its glycoprotein B
(ADV-gB) or glycoprotein D (ADV-gD) or a serum neutralization
examination

02.02 in the case of animals vaccinated with a gE deleted vaccine
ELISA tests to detect antibodies to glycoprotein E (ADV-gE)
Aujeszky's disease virus.

Responds If any animal on brucellosis referred to in paragraph 1
positive, and if not suspicion of brucellosis is ruled in accordance with
point. e) it must be immediately removed from the animal isolation.

Reacts when an animal during an examination for Aujeszky's disease referred to in Section 2
positive, it must be immediately removed from the animal isolation.

In the case of isolation of a group of animals has regional veterinary administration
take all necessary measures to ensure that the remaining
animals in tests mentioned in paragraphs 1 and 2 responded negatively
have before they are admitted to semen collection centers
in accordance with this Annex decree satisfactory health status;

E) actions taken in case of suspicion of brucellosis:

As regards animals that responded when brucellosis
mentioned in point. d) 1, positively, the following shall apply:

First positive sera are subjected to at least one of the alternative tests
referred to in point. d) 1, which was not carried out on samples
referred to in point. d);

Second the holdings of origin of the reacting animals, carry out
epidemiological investigation;

Third the animals which in tests referred to in point. d) Section 1 and Section 1
responded positively to perform at least one of the following
tests on samples taken at least seven days after sampling
mentioned in point. d)

03.01 of brucellosis, a buffered Brucella antigen (test
RBT)

03.02 sérumaglutinační test


03.03 complement fixation test,

04.03 cELISA,

05.03 felis.

Suspicion of brucellosis is eliminated if:

I) either were repeated examinations referred to in paragraph 1
carried out with negative result, the epidemiological inquiry on the holding of origin did not reveal
presence of porcine brucellosis and the test referred to in Section 3
was conducted with negative results; or

Ii) an epidemiological investigation on the farm of origin did not reveal the presence
porcine brucellosis and all the animals, which during the examination referred to in paragraphs 1 or 3
responded positively, have been subjected to post mortem examination and
to identify the source of brucellosis pigs in both cases
negative.

After suspicion of brucellosis is ruled out, may be all animals
isolation referred to in point. d) the second paragraph taken to the center for the collection of semen
.

(2) All tests must be carried out in an approved laboratory.

(3) Animals can be in centers for the collection of semen taken only with the express permission
veterinarian centers.
All animal movements to and from the resort center, must be recorded.

(4) No animal accepted into the semen collection centers not on the day of receipt
show no clinical signs of disease;
without prejudice to the provisions of paragraph 5, all animals must come directly from the isolation
pursuant to paragraph 1. a) that the date of sending
meet the following conditions:

A) not located in a restricted area defined under Decree no.
299/2003 Coll., Decree no. 389/2004 Coll. or Decree no. 202/2004 Coll.
Because of outbreaks of disease in pigs;

B) has not been there in the past 30 days been any clinical,
serological, virological or pathological evidence of Aujeszky's disease.

(5) Assuming that the conditions set out in paragraph 4 and
that during the previous 12 months were performed routine tests referred to in Part B
, animals may be moved from one approved
centers semen collection to another with equivalent health status
without isolation or testing if this is the direct transfer.
Relevant animal must not come into direct or indirect contact with cloven with
lower health status and the means of transport used to be before
cleaned and disinfected.

(6) For the purposes of paragraph 5 and in the case of trade between Member States must
animals will be accompanied by a veterinary certificate for breeding pigs
in accordance with the model laid down by European Union rules.
B


Compulsory routine tests on pigs in centers for the collection of semen

(1) Compulsory routine tests must be carried out as follows:

A) all animals kept at an approved center for the collection of semen must undergo
with negative results the following tests:

First as regards brucellosis, brucellosis, a buffered Brucella antigen
(RBT) or cELISA or felis;

Second as regards the Aujeszky's disease

02.01 in case of non-vaccinated animals ELISA tests to detect antibodies to whole
Aujeszky's disease virus or its glycoprotein B
(ADV-gB) or glycoprotein D (ADV-gD) or a serum neutralization
examination

02.02 in the case of animals vaccinated with a gE deleted vaccine
ELISA tests to detect antibodies to glycoprotein E (ADV-gE) virus
Aujeszky's disease;

Third as regards classical swine fever ELISA tests for antibodies or
serum neutralization tests;

B) tests set out in point. a) must be carried out on samples taken
:

First from all animals immediately prior to leaving the collection center
sperm or immediately after arrival at the slaughterhouse, and in no case later
than 12 months after the date of admission to semen collection centers, or

Second every three months by at least 25% of the animals at the Centre for taking
semen and veterinarian semen collection centers must ensure that
animals from which samples are taken, representing all
population centers, particularly as regards age groups and housing;

C) if done in accordance with the examination point. b) paragraph 2 shall
veterinarian semen collection centers ensure that
all animals tested in accordance with point. a) at least once during their stay in
Centre semen collection and at least once

Twelve months from the date of receipt, if it exceeds their stay
twelve months.

(2) All tests must be carried out in an approved laboratory.

(3) If any of the above tests is positive, the animal must be put into quarantine
and the semen collected from it since the last time
negative test may not be the subject of trafficking in the European Union.

Semen each animal at the center, which was collected in the period from
last negative test is stored separately and can not be
until the health status of the Centre Regional Veterinary Administration
subject of trafficking in the European Union.
Appendix 6


ANIMAL HEALTH REQUIREMENTS FOR THE COLLECTED porcine semen collection center
semen HELD FOR TRADING IN THE EUROPEAN UNION

(1) Semen must be obtained from animals that:

A) the day the semen showed no clinical signs of disease;

B) are not vaccinated against foot and mouth disease;

C) satisfy the requirements set out in Part A of the Annex no. 5 to this Decree;

D) are not allowed to serve naturally;

E) are kept in semen collection centers which must not be
located in an area restricted by Decree no. 299/2003 Coll., Decree No.
. 389/2004 Coll. or Decree no. 202/2004 Coll. because of outbreaks of disease among pigs
;

F) are kept in semen collection centers, which was not
period of 30 days immediately prior to collection recorded no clinical,
serological, virological or pathological symptom of Aujeszky's disease.

(2) The diluent or in the final diluted semen must be added
effective combination of antibiotics, in particular against leptospires.
In the case of frozen semen, antibiotics must be added before freezing.

A) the effectiveness of this combination of antibiotics must be at least equivalent
following concentration in the final diluted semen:

Least 500 mcg of streptomycin per 1 ml of the final dilution

500 IU penicillin per 1 ml of the final dilution

Lincomycin 150 micrograms per 1 ml of the final dilution

300 ppm spectinomycin per 1 ml of the final dilution;

B) immediately after addition of the antibiotics must be diluted semen preservation at
temperature at least 15 ° C for at least 45 minutes.

(3) Semen for intra-EU trade should be:

) To dispatch stored under conditions provided for in paragraph 2
point. d) and Part B, paragraph 6 point. a), b), e) and f) of Annex no. 4 to this decree
;

B) transported to the Member State of destination in containers which were before
cleaned and disinfected or sterilized, and that before
dispatch from the approved storage place, sealed.

(4) The State Veterinary Administration may refuse to accept the Czech Republic
sperm from semen collection centers in which they are accepted
boars vaccinated against Aujeszky's disease.


Příl.7
Conditions for the approval of embryo collection teams and embryo production teams
AND HEALTH REQUIREMENTS FOR embryo collection and production

A

Conditions for the approval of embryo collection teams and embryo production teams

Each embryo collection team, to be approved, it must meet the following requirements
:

A) collection, processing and storage of embryos must be carried out either veterinary
team physician or under his responsibility by one or more technicians
competent and trained by the team veterinarian in hygienic
methods and techniques of hygiene;

B) must be under state veterinary supervision;

C) must have at its disposal permanent or mobile laboratory facilities
investigation, processing and packaging of embryos, which consists
least a work surface, a microscope and cryogenic equipment;

D) in respect of a permanent laboratory, it must have at its disposal:

- A room where embryos can be manipulated which is adjacent to
space where to handle the donor animals during collection, but
physically separate from the area,

- A room or area equipped for cleansing and sterilizing
tools and equipment used for the collection and manipulation of embryos,

- If done micromanipulation of the embryo which occurs
penetration through the zona pellucida, performs this act in an appropriate
laminar flow, which is between parts of
properly cleaned and disinfected;

E) as regards mobile laboratory, it must have a specially

Equipped part of the vehicle consists of two separate parts, of which
:

- One that is part of the net is designed for the examination and manipulation of embryos
,

- The second is intended for storage of equipment and materials used in
contact with the donor animals.

Mobile laboratory shall always have contact with a permanently sited laboratory to ensure the sterilization
equipment and the provision of fluids and other material
necessary for the collection and manipulation of embryos.

In addition, in order to be approved as a team for the production of embryos obtained
fertilization in vitro and / or in vitro culture, the team
embryo production to meet the following additional requirements:

F) the personnel must be trained about the proper
disease control and laboratory techniques, especially those working in sterile conditions;

G) it must have a permanent laboratory for processing must:

- Have adequate equipment and facilities, including separate rooms for
obtaining oocytes from ovaries, and separate rooms or areas for processing
egg cells and embryos, and storing embryos
,

- Must have laminar flow, which must be processed
all egg cells, sperm and embryos. Spin
sperm, however, can be performed outside of the laminar flow
if they are respected all public
security measures;

H) where oocytes and other tissues harvested at the slaughterhouse, must have
available suitable equipment for the hygienic and safe collection and transport
ovaries and other tissues to the processing laboratory.
B


Requirements for collection or production, processing, storage and transport of embryos


First Procurement or production and processing of embryos

A) Embryos shall be collected and processed by an approved collection team,
without coming into contact with any other consignment of embryos
satisfying the requirements of this ordinance.

B) Embryos shall be collected in a place which is isolated from other parts of the building or
economy; this place must be in good condition and
be easy to clean and disinfect.

C) Embryos shall be processed (examined, washed, treated and placed in identified
sterile containers) in a fixed or mobile
lab that is not located in areas subject
veterinary prohibition or quarantine measures.

D) All of the tools coming into contact with the embryos or the donor
animal during collection and processing shall be disposable or shall be
before using properly disinfected or sterilized.

E) products of animal origin used during collection of the embryos and in the transport medium
must come from sources that do not pose risks
for Animal Health, or must be treated prior to use
such a way that eliminates the risk .

All media and solutions are sterilized by approved methods
in accordance with the recommendations of the manual of the International Society for transfer
embryos (International Embryo Transfer Society - IETS).
Antibiotics may be added to the media in accordance with this manual.

F) Containers for storage and transport must be before each filling
properly disinfected or sterilized.

G) the composition is used for freezing can not be previously used for other
animal products.

H) Each container of embryos, as well as the vessel in which embryos are
stored and transported shall be clearly marked with the code number
set by the Commission, which makes it easy to find the date of collection of the embryos, and breed
identity of the donor and the donor animal and veterinary approval number
team.

I) Each embryo shall be washed at least ten times in a special fluid for embryos
that for each wash and replace
contain trypsin, in accordance with internationally recognized procedures, if not by the letter
m) decided otherwise. Each wash shall be a hundred times
dilution of the previous wash and a transfer embryos must be
sterile micropipette.

J) After the last wash each embryo is subjected over its entire surface
microscopic examination at a magnification of at least 50x, in order to determine whether
zona pellucida is intact and free from any adherent particles.

Any micromanipulation which involves penetration through the zona

Pellucida must be carried out in establishments approved for that purpose
after the last wash and examination. Such micromanipulation may
performed only on embryos with intact zona pellucida.

K) Each consignment of embryos that has successfully undergone the examination provided
letter j) shall be placed in a sterile container marked in accordance with the letter h
) and sealed immediately.

L) If necessary, each embryo as soon as possible
frozen and stored in a place which is under the control of the team veterinarian and
under regular inspection by an official veterinarian.

M) In accordance with the procedure laid down by the Commission will be prepared a protocol regarding
approved liquids for rinsing and washing
washing techniques and, where necessary, enzymatic treatments together with
approved transport medium.

Until the adoption of a protocol on enzymatic treatments continue to apply,
in accordance with the general provisions of the Treaty, national legal
regulations for the use of trypsin.

N) Each collection team must submit routine samples of fluids
rinsing and washing, disintegrated embryos, unfertilized egg cells
etc., From its activities for official examination
for bacterial and viral contamination.
The procedure for taking samples, conducting such examinations, together with the standards, which has
be achieved shall be decided in accordance with the procedure laid down by the Commission.
If the set standards are not achieved, the regional veterinary
Administration, which approved the team, this approval will be canceled.

O) Each collection team must keep records of their activities
respect of embryo collection during the 12 months before and 12 months
after storage, including data on:

- The breed, age and identification of the donor animals concerned,

- The place of collection, processing and storage of embryos collected by the team,

- Identification of the embryos together with details of their destination if known
.

- Details of micromanipulation techniques which involve penetration
through the zona pellucida or other techniques such as in vitro fertilization
and / or in vitro culture, which were used for embryos.
For embryos obtained in vitro fertilization, the identification may be done on the basis
game, but must contain details of the date and place of sampling
ovaries and / or oocytes. It must also be possible to identify the herd of origin
donor animals.

The conditions laid down under a) to o) shall apply as appropriate to
collection, processing, storage and transport of ovaries, oocytes and other tissues
used during fertilization in vitro and / or in the cultivation
in vitro. In addition, the following additional conditions:

P) If the ovaries and other tissues are collected at abattoirs, slaughterhouses
approved and subject to inspection by an official veterinarian, who is responsible for implementing
inspection of donor animals ante mortem and post mortem
.

Q) materials and equipment coming into direct contact with ovaries and other tissues
are sterilized before use and after sterilization
are used solely for these purposes. For handling the egg cells and embryos
from different batches of donor animals are used separate
equipment.

R) ovaries and other tissues can not be forwarded to the laboratory for processing
before completion of post-mortem examinations of the game. If the game
donor animals or any animal slaughtered in such slaughterhouses
that day finds serious infection, all tissues from that
lot must be found and eliminated.

S) Wash and investigations specified in letters i) and j) are carried
after completion of cultivation.

T) Any micromanipulation which involves penetration through the zona pellucida
be conducted in accordance with the provisions of paragraph j)
after the completion of the procedures laid down under letter s).

U) in the same ampoule (straw) can be stored only embryos from the same batch
donor animals.

Second Storing embryos

Each collection team or embryo production ensure that the embryos
stored at suitable temperatures in premises approved for this purpose
regional veterinary administration. In order to be approved, it must
room:

I) at least one lockable room intended exclusively for embryo storage
;


Ii) be easily cleaned and disinfected;

Iii) have permanent records of all incoming and outgoing movements of embryos.
These records must be especially noted the final destination of the embryos;

Iv) be subject to inspection by an official veterinarian.

The Regional Veterinary Administration can give consent to the storage of semen
meeting the requirements of this ordinance in the approved
storing embryos.

Third Transportation embryos

Embryos for trade must be transported from the approved
storage facilities to its destination in satisfactory hygienic
conditions in sealed containers.

Containers must be marked in such a way that the number coincides with the number
on the animal health certificate.


Příl.8
HEALTH REQUIREMENTS FOR DONOR ANIMALS

First For the purposes of embryo collection donor animals must meet the following requirements
:

) Must reside at least 6 months prior to the European Union
or in a third country where collection is carried out;

B) they must be located in the herd of origin for at least 30 days before
collection;

C) they must come from herds which are:

- Officially tuberculosis free,

- Officially brucellosis free or brucellosis free,

- Enzootic bovine leucosis.

Exception of the requirements in the third indent may come from a herd
(or herds) which (s) is / are not simple (s) leucosis, but (s)
gained (- a) confirmation that it (them) over the past 3 years
been any clinical case of enzootic bovine animals;

D) shall not be located during the previous year in the herd (or herds
) in which (which) was detected
any clinical sign of infectious bovine rhinotracheitis / infectious pustular vaginitis.

Second On the day of embryo donor:

A) they must be kept in a holding which is not subject to veterinary prohibition or quarantine measures
;

B) showed no clinical signs of disease.

Third The above conditions apply in addition to live animals intended
as a donor egg cell by flushing capture egg cells
or ovariectomy.

Fourth In the case of donation ovaries and other tissues to be collected after
slaughtered in the slaughterhouse, the animals may not be intended for slaughter under a national program
sanitation, or come from a holding
subject to restrictions on grounds of disease.

Fifth Slaughterhouse, where they are removed ovaries and other tissues shall not be located
in an area subject to veterinary prohibition or quarantine measures
.


Příl.9
CONDITIONS FOR THE APPROVAL OF CENTRES semen collection of sheep, goats
equine semen storage centers sheep, goats
equine embryo collection teams, sheep, goat, pigs or horses and production teams
embryos of the ovine, caprine, porcine or equine
CONDITIONS FOR SUPERVISION IN THEM AND HEALTH REQUIREMENTS FOR collecting semen SHEEP, gOATS AND HORSES
AND COLLECTION egg cells and embryos of ovine, caprine, porcine and HORSES
|| |
A

Conditions for approval of semen collection centers for sheep, goats or
equine semen storage centers sheep, goats or
equine embryo collection team of sheep, goats, pigs or horses and production team
embryos of sheep, goats, swine and equine, and supervision of them


I. Conditions for approval of semen collection centers and centers for storage of semen


Centre for semen collection

(1) Centre for the collection of semen must be supervised by a veterinary doctor
centers.

(2) Centre for the collection of semen must have at least:

A) lockable animal accommodation and if necessary, run for
equines, physically separated from the semen collection facilities and the room
for the treatment and storage;

B) equipment for the quarantine of animals without a direct connection to conventional
stable space;

C) semen collection facility which allows protection
adverse weather conditions, non-slip floor that protects
against serious injury in the event of a fall in the place of semen collection and neighborhood;

D) a room for cleaning and disinfection or sterilization of equipment;

E) a room for treatment of sperm from separate facilities for sampling and
room for cleaning equipment referred to in point. d) which does not

Necessarily at the same site;

F) a semen storage room which need not necessarily be on the same site
.

(3) Centre for the collection of semen must be constructed or isolated
so as to prevent contact with animals outside.

(4) Centre for the collection of semen must be designed so that
entire center except the office and, in the case of equine except paddock
easily cleaned and disinfected.

Storage centers

(1) semen storage centers must have special registration
number for each animal species whose semen is stored at the center
if storage is not limited to a single sperm
species collected at an approved center for
semen collection or if you are in a storage center
embryos stored in accordance with this decree.

(2) storage centers must be under the supervision of a veterinarian
centers.

(3) storage center must have a storage room
semen, equipped with the necessary facilities for the storage of semen, embryos and possibly
which is designed so that these products and
devices are protected against adverse environmental effects and
weather.

(4) storage center must be constructed so that
not come into contact with farm or other animals outside.

(5) storage center must be constructed so that it
entire center except the office rooms and, in the case of equine except
paddock easily cleaned and disinfected.

(6) storage center must be designed so as to effectively
prevent access by unauthorized persons.

II. Conditions for the supervision center for semen collection and storage center for semen


Centre for semen collection

(1) The Centre for semen collection should be controlled so that

A) to ensure that resort stay only animals of the kind
whose semen is collected.

Other animals may be accepted if they present no risk of infection
animal species from which semen is collected and
if they meet the conditions laid down by the center veterinarian.

If, in the case of equine center for subscription shares space with
center for artificial insemination or mating, are mares, stallions and stallion
assayers destination for natural breeding admitted if
meet the requirements of Part B of Section I paragraphs 1 to 4;

B) prevent the entry of unauthorized persons. If the visit allowed
may be taken only under the conditions set veterinarian
centers;

C) was employed only personnel who have basic knowledge in caring for animals and
is adequately trained on issues
disinfection and hygiene practices capable of preventing the spread of diseases.

(2) The semen collection center must be ensured by monitoring

A) keeping records for ascertaining:

First species, breed, date of birth and identification of each animal present in the center
,

Second any movements of animals entering the center and
leaving the resort

Third health history and all diagnostic tests and the results
treatments and vaccinations carried out on animals held,

Fourth date of collection and treatment of semen

Fifth the destination of semen,

6th storage of semen;

B) that no animal held in the resort was not for at least 30 days before
first semen collection and during the sampling period used for
natural service;

C) to collection, processing and storage of semen
conducted only in areas designated for that purpose;

D) that all tools that come into contact with the semen or
donor animal during collection or processing of semen were either
before using properly disinfected or sterilized instruments except
new, disposable and after use deleted if, in the case
equine collection center shares a site with the place where he performs artificial insemination or mating
must semen and instruments and equipment for
artificial insemination or natural service clearly separated from
instruments and equipment coming into contact with donor animals or

Other animals kept in the collection center;

E) products of animal origin used in the treatment of semen
such as diluents, additives or fillers
posed no risk to animal health, or have been treated prior to use so that
was such danger excluded ;

F) to freezing mixture used for the preservation or storage of semen
been previously used for other products of animal origin;

G) the storage and transport container prior to filling each
properly disinfected or sterilized, except for new bottles, and disposable
deleted after use;

H) to ensure clear identification of each individual dose of semen or
each ejaculate of fresh semen intended for further processing
allowing to determine the date of collection, the species, breed and
identification of the donor animal and veterinary approval number | || approved center which has collected semen.

(3) The center for the collection of semen must be carried out inspections
official veterinarian during the period připouštěcího
least once a year in the case of animals with seasonal reproduction, and twice a year in the case
non-seasonal reproduction in order to assess and verification
all matters relating to the conditions of approval and supervision, as required under
records, standard operating procedures and internal audits.

Storage centers

(1) The storage center must be supervised so as to


A) to ensure that the health status of the donor animals whose
semen is stored at the center complies with the requirements of this Decree;

B) prevent the entry of unauthorized persons. If the visit allowed
may be taken only under the conditions set veterinarian
centers;

C) was employed only personnel who have basic knowledge in caring for animals and
is adequately trained on issues
disinfection and hygiene practices capable of preventing the spread of disease;

D) ensure that records are kept of all movement of semen
received and leaving the storage center.

(2) The storage center must be ensured by monitoring, in order


A) to an approved storage centers was accepted only semen
which was collected and coming from an approved collection center or an approved
semen storage centers,
been transported under conditions that guarantee all veterinary guarantees
and coming into contact with the semen of substandard conditions of this Order;

B) the semen was under strict hygienic conditions
stored only in areas designated for that purpose;

C) all instruments which come into contact with semen, prior
using properly disinfected or sterilized instruments except
disposable;

D) storage and transport containers before any filling
properly disinfected or sterilized, except for disposable containers;

E) cryogenic agents used for preservation or storage of semen
not been previously used for other products of animal origin;

F) each dose of semen is clearly marked so that it can be easily
specify the date of collection, the species, the breed and identification of the donor
animal and veterinary approval number of the approved center.

(3) storage center may, notwithstanding paragraph. 2 point. a)
stored embryos if the embryos meet the requirements of this ordinance and
are stored in separate containers.

(4) The storage center must be ensured that
storage center supervised by an official veterinarian
doctor at least twice in each calendar year to analyze and verify
all aspects relating to the conditions approval, supervision and monitoring
as necessary based on records, standard operating
procedures and internal audits.

III. Conditions for the approval and supervision of embryo collection teams and teams for embryo production


Embryo collection team

(1) collection, processing and storage of embryos carried out either by a veterinarian
team, or under the responsibility of one or more eligible technicians
veterinarian trained in hygiene methods and techniques and
in the techniques and principles disease control.


(2) Team veterinarian responsible for all team activities, ie.
Inter alia:

A) verification of the identity and health status of the donor animals;

B) sanitary safety of treating donor animals and surgical procedures
;

C) disinfection and hygiene procedures;

D) keeping records which records:

First species, breed, date of birth and identification of each donor
animal

Second medical records, all diagnostic tests and the results thereof, treatments and vaccinations
donor animals

Third place and date of collection, processing and storage of egg cells and embryos
,

Fourth identification data of embryos and details of their destination
if known.

(3) The team shall be subject to the general supervision by an official veterinary
doctor who control at least once in every calendar year
ensure compliance with the sanitary conditions for the collection, processing and storage of embryos
and verifies all aspects
conditions of approval and supervision as necessary based on records, standard operating procedures
and internal audits.

(4) The team must have on the investigation, treatment and storage of embryos available
permanent or mobile laboratory, which has at least workspace
optical or electron microscope and, if necessary refrigeration equipment.

(5) Permanent laboratory shall have:

A) a room for processing embryos is physically separate from the area for
donations from donor animals;

B) a room for cleaning and sterilizing instruments, if they are not used
instruments disposable;

C) a room for storing embryos.

(6) mobile laboratory shall:

A) have a specially equipped part of the vehicle, split into two separate sectors
:

First sterile - the investigation and processing of embryos and

Second storage - equipment and materials used in contact with donor animals
;

B) use only single-use equipment unless it can be combined with
permanent laboratory to ensure the sterilization of equipment and fluid intake and
other products necessary for the collection and processing of embryos.

(7) Construction and layout of buildings and laboratories and implementation
team's activities shall be such as to protect against contamination of mutual
embryos.

(8) The team must have available storage space permitting:

A) set aside at least one lockable room for the storage
egg cells and embryos;

B) easy cleaning and disinfection;

C) keep permanent records of all incoming and issued
egg cells and embryos;

D) storage containers to egg cells and embryos to place a controlled
team veterinarian and regularly
controllable by an official veterinarian.

(9) storage of semen in storage premises referred to in paragraph 8
may be authorized by the competent authority under the conditions that:

A) the semen meets the requirements of this ordinance for sheep, goats or equines or
requirements of this ordinance for trade in porcine semen and
imports;

B) semen is stored for the needs of the team in separate storage containers
in premises approved for the storage of embryos.

Embryo production team must be in addition to the requirements for collection team
meet the following additional conditions:

(1) Team members are adequately trained in disease control and
laboratory techniques, particularly as regards the procedures for working in sterile conditions
.

(2) The team has a permanent laboratory which:

A) have adequate equipment and facilities, including separate rooms for
:

First isolating oocytes from the ovaries,

Second processing of egg cells and embryos

Third storing embryos;

B) has a laminar-flow or other suitable device to
technical operations under specific sterile conditions (processing
oocytes, embryos and semen).

Spin sperm can not under hygienic conditions
carried out outside the laminar-flow or other device.

(3) In the event that the egg cells and other tissues harvested at the slaughterhouse,
slaughterhouses must have at its disposal suitable equipment for the hygienic and safe
collection and transport of ovaries and other tissues to the lab for treatment.
B


Requirements for animals taken into semen collection centers for sheep

Goats or equine

Requirements male - donor

I. stallions

Collection of semen can be used only stallion that meets the following requirements
certified veterinarian centers:

(1) Not for the adoption and the day the semen
show no signs of disease.

(2) They must come from the territory or, in the case of regional breakdowns, in part
territory of a Member State or third country and holdings under veterinary supervision
that meet the requirements of Decree no. 382/2003 Coll.
veterinary requirements for trade in animals and animal
conditions for their import from third countries, as amended.

(3) Must be 30 days prior to semen collection in holdings where
during this period shows no equines
any clinical signs of equine viral arteritis or contagious equine metritis
.

(4) May not be for a period of 30 days prior to first semen collection and during the withdrawal period
used for natural breeding.

(5) must be subjected to the following tests in accordance with the schedule set out in paragraph
. 6 and carried out in an approved laboratory:

A) agar-gel immunodiffusion test (Cogginsův test) or an ELISA
for equine infectious anemia with negative result;

B) virus isolation test for equine viral arteritis or finding
its genome by polymerase chain reaction or
polymerase chain reaction in real time, carried out with negative results
carried out on an aliquot of the entire semen of the donor stallion | || unless a negative result is obtained serologically
neutralization test with equine arteritis virus in a serum dilution of 1: 4;

C) test to determine the originator of contagious equine metritis carried out with
negative result on samples taken 3 donor stallion
twice at an interval of at least seven days and not earlier than seven days for systemic therapy or
21 days for local treatment after possible antimicrobial treatment
donor stallion least foreskin urethral fossa
glandis.

First Before sending it to the laboratory, samples must be placed in
transport medium with charcoal, for example Amies.

Second Samples must be subjected to at least one of the following tests:

2.1 culturing under microaerophilic conditions for at least 7 days to isolate
Taylorella equigenitalis based within 24 hours after removing
sample from the donor animal, or within 48 hours when the samples during transport
refrigerated or

2.2 Polymerase Chain Reaction or PCR
real time to detect genome Taylorella equigenitalis carried out in
48 hours of taking samples from the donor animal.

(6) must be subjected to one of these programs, examination:

A) if the donor stallion is continuously resided at the Centre for the collection of semen
least 30 days before the first semen collection and during
collection, and if no equidae center for the collection of semen did not come into direct contact
with equidae of lower health status than the donor stallion
carry out the tests referred to in paragraph. 5
on samples taken from donor stallions, at least once a year at the beginning of a herd
season or before the first semen collection intended for trade, and at least
14 days after the initial date of the stay lasting at least 30 days prior to the first semen collection
;

B) if the donor stallion is continuously placed in the center for the collection of semen
least 30 days before the first semen collection and after
sampling period, but can occasionally leave the station with the written approval of a veterinarian
centers on
continuous period shorter than 14 days or other equines center for semen collection
come into direct contact with equidae of lower health status
carry out the tests referred to in paragraph 5 as follows:

First at least once a year on samples collected at the donor stallion
beginning of the breeding season or prior to the first semen collection intended for trade and
least 14 days after the initial date of placement
lasting at least 30 days prior to the first semen collection,

Second for the collection of semen intended for trade follows:

2.1 test pursuant to paragraph 5. a) on samples taken
than 90 days prior to semen collection intended for trade,


2.2 test pursuant to paragraph 5. b) samples taken up to 30 days prior to collection
semen to store, except when test
virus isolation, polymerase chain reaction or the polymerase chain reaction
realtime performed on samples aliquots || | all semen collected more than 6 months prior to semen collection
intended for trade, confirms that donor stallion is not propagator, and when
donor stallion responded positively to neutralization test for equine viral arteritis
serum diluted at a ratio of at least 1 4,

2.3 test pursuant to paragraph 5. c) for samples taken up to 60 days prior to collection
semen to trade, which may be the case
PCR or polymerase chain reaction in real time
performed on 3 specimens (swabs) taken only once;

C) if the donor stallion does not meet the conditions referred to in subparagraphs a) and b
), and if the semen collection done for the purposes of trade in frozen semen
carry out the tests referred to in paragraph. 5 samples taken
donor stallion as follows:

First at least once a year at the beginning of the breeding season

Second during the storage period referred to in Part C, Section I, paragraph. 3 point. b)
before removing semen from the Centre or use on samples collected
14 to 90 days after the date of collection of the semen.

Derogation from point 2 is not the procedure for taking samples and testing for infectious equine arteritis
described in paragraph. 5 point. b) required in the event that the test
virus isolation, polymerase chain reaction or the polymerase chain reaction
realtime performed on an aliquot of the entire
semen collected twice a year at least four months interval
confirms that seropositive stallion is not a promoter of the donor stallion
responded positively to neutralization test for equine viral arteritis
serum, diluted at least 1: 4

(7) comes out if any of the tests referred to in paragraph. 5 positive, must be
donor stallion isolated and the semen collected from it since the last negative test
not traded in the market; except in the case of infectious arteritis
equine semen from each ejaculate that was
subjected to virus isolation test for equine viral arteritis with negative
result.

Semen collected from all other stallions at the Centre for taking
sperm from the date of the last sample with a negative result
one of the tests referred to in paragraph. 5 is stored separately and can not be traded
until the health status of centers semen collection
will be restored and the stored sperm will not be subjected to appropriate official
examination, which will rule out the presence of pathogens causing diseases listed in
paragraph. 5th

(8) Semen collected from stallions at the Centre for the collection of semen, who
subject to prohibition pursuant to § 19 para. 2 of Decree no. 382/2003 Coll.
Is stored separately and may not be traded until the veterinary
status of centers for the collection of semen will not be renewed by the official veterinarian
stored sperm will be subjected to appropriate official examination,
which will rule out the presence of pathogens causing infections horses
notifiable in accordance with Annex no. 1 to Decree no. 382/2003 Coll
.

II. And goats

(1) All rams, and goats admitted to the semen collection center
following conditions apply:

A) for at least 28 days they were placed in isolation in which they find themselves
only animals of at least the same health status;

B) before being placed in isolation were holding keeping sheep and goats
officially brucellosis-free according to Annex no. 24 to Decree no. 299/2003 Coll
. and they were previously kept in a holding of a lower health status
regarding brucellosis;

C) come from a holding where during the 60 days before being placed in isolation
undergone a serological test for epididymitis of rams (
Brucella ovis) carried out in accordance with Annex D to Directive 91/68 / EEC or any other || | test with equivalent sensitivity and specificity;

D) underwent the following tests on blood samples taken during
28 days before the start of the insulation by point. a) in all cases
negative results, except for the test for Border disease virus of sheep
according to section 3 sub 3.2 .:

First The brucellosis (Brucella melitensis) - serological test carried out in
accordance with Annex C of Directive 91/68 / EEC;


Second to epididymitis of rams (B. ovis) -
serological test according to Annex D of Directive 91/68 / EEC or any other test with an equivalent sensitivity and specificity
;

Third on Border disease of sheep:

03.01 virus isolation test or a test to demonstrate viral antigen

03.02 a serological test to determine the presence or absence
antibody (test antibody).

The Regional Veterinary Administration may allow the tests listed in
this point on samples taken in isolation. If this is the
permits issued, not isolation period referred to in point. a) commence before the date of collection of samples
. However, if the result of one of the tests referred to in this point
positive, the animal concerned shall be immediately removed from isolation.
In the case of group isolation is not isolation period referred to in point. a)
start for other animals before the animals test positive
removed;

E) at least 21 days after acceptance into isolation, with negative results were
subjected to the following tests on samples taken during the isolation of
point. a):

First The brucellosis (Brucella melitensis) - serological test carried out in
accordance with Annex C of Directive 91/68 / EEC;

Second to epididymitis of rams (B. ovis) -
serological test according to Annex D of Directive 91/68 / EEC or any other test with an equivalent sensitivity and specificity
;

F) underwent tests for Border disease of sheep by point. d) Point 3
subsections 1.3 and 3.2, carried out on blood samples taken in the course of isolation by
point. a) at least 21 days after being admitted to isolation.

Any animal (whether seronegative or seropositive) may be
allowed in the centers for the collection of semen only if it does not
seroconversion in any animal which was before entering the isolation
seronegative.

If seroconversion must all animals that remain seronegative
, remain isolated until this group already
no further seroconversion for three weeks.

Serologically positive animals can be added to the semen collection center
accepted subject to a negative test result by point. d) sub-section 3
01.03

(2) animals into semen collection centers accept only with the express consent
veterinarian centers. Any moves to
centers for the collection of semen from him shall be recorded.

(3) No animal admitted to the semen collection center not on the day of receipt
appear no clinical signs of disease. Notwithstanding paragraph. 4
has received all the animals come out of isolation, which on the day of departure
animals into semen collection centers meet the following conditions:

A) is located in, in which for the past 30 days there has been no case of foot-and-mouth disease
within a radius of 10 kilometers;

B) at least three months in isolation to prevent brucellosis, foot-and-mouth disease
;

C) at least 30 days in isolation occurred infection of sheep or goats
compulsorily notifiable in accordance with Annex no. 1 to Decree no. 382/2003 Coll
.

(4) If the conditions set out in paragraph. 3 and 12 months before
movement of animals were carried out routine tests in accordance with paragraph. 5
animals can be transferred from one approved semen collection centers to || | second with the same health status, without isolation or tests
if the shipment straight. The animal in question must not come into direct or indirect contact with
cloven-hoofed animals of a lower health status and used
means of transport must be disinfected before use.
Transporting animals from one semen collection centers for the second in another Member State
must be conducted in accordance with Decree no. 382/2003 Coll.

(5) All sheep and goats located in an approved center for
semen collection must be at least once every calendar year
subjected to the following tests with negative results:

A) for brucellosis (Brucella melitensis) - serological test carried out in
accordance with Annex C of Directive 91/68 / EEC;

B) to epididymitis of rams (B. ovis) -
serological test carried out in accordance with Annex D to Directive 91/68 / EEC, or any other test with an equivalent
sensitivity and specificity;

C) for Border disease of sheep - antibody test under paragraph. 1 point. d)
section 3 sub-3.2 is performed only in seronegative animals.

(6) All tests referred to in this section shall be performed by an approved laboratory
.


(7) If the result of one of the tests referred to in paragraph. 5 positive
must be the animal isolated and the semen collected from it since the last
negative test result may not be traded in the market.

This animal must be out of semen collection centers removed, with the exception of the case
Border disease of sheep, the animal must undergo a test
under paragraph. 1 point. d) section 3 sub-1.3 with negative results.

Semen collected from all other animals at the center for taking
sperm from the date of the last sample with a negative result
one of the tests referred to in paragraph. 5 is stored separately and can not be subject
trade until the health status semen collection centers will
restored and stored sperm is not subjected to appropriate official
examination, which will rule out the presence of pathogens causing diseases listed in
paragraph. 5th

(8) Semen may be chosen from animals that:

A) show no clinical signs of disease on the day the semen is collected;

B) during the 12 months prior to the date of semen collection:

First either they have not been vaccinated against foot-and-mouth disease, or

Second He has been vaccinated against foot-and-mouth disease at least 30 days before
collection; In this case 5% (minimum of five straws) of each collection of semen
undergone a virus isolation test for foot-and-mouth disease, with negative results
;

C) in the case of collection of fresh semen was continuously
at least 30 days prior to collection of in an approved center for the collection of semen;

D) meet the requirements specified in § 15, 15a and 15b Decree no. 382/2003 Coll .;


E) if they have been reared on holdings listed in § 12 letter. a)
underwent during the 30 days prior to semen collection, with negative results, these tests
:

First serological test for brucellosis (Brucella melitensis)
conducted in accordance with Annex C of Directive 91/68 / EEC

Second serological test for epididymitis of rams (B. ovis)
conducted in accordance with Annex D to Directive 91/68 / EEC, or any other test with an equivalent
sensitivity and specificity,

Third test for Border disease virus of sheep;

F) has not been used for natural breeding at least 30 days before
date of the first semen collection and between the date of the first sample by
paragraph. Point 1. e) and f) or point. e) by the end of the collection period.

(9) Semen collected from donor rams and goats at the Centre for
semen collection or holdings referred to in § 12 letter. a) on which
health reasons is subject to a prohibition pursuant to § 15
Decree no. 382/2003 Coll., are stored separately and can not be subject
trade until the health status of the semen collection center
sperm is not restored by the official veterinarian and stored sperm will undergo
corresponding official examination, which will rule out the presence
pathogens causing infections sheep or goats compulsorily
report in accordance with Annex no. 1 to Decree no. 382/2003 Coll.

C

Requirements for semen of sheep, goats and equine oocyte and embryo
sheep, goats, swine and equine

I. Requirements for the collection, processing, preservation, storage and transport of semen


(1) Where in accordance with the Law on Pharmaceuticals
added antibiotics or mixtures thereof with germicidal effect for each milliliter of semen
least equivalent bactericidal effect of a mixture of gentamicin (250
mcg), tylosin (50 mcg ), lincomycin-spectinomycin (150/300 ppm)
penicillin (500 IU), streptomycin (500 mcg), lincomycin-spectinomycin (150/300 ppm)
amikacin (75 micrograms) or divekacin (25 mcg ), the name
antibiotics along with concentrations indicated in the veterinary certificate.

(2) All instruments used for the collection, processing, preservation or freezing of semen
must be treated before use properly disinfected or sterilized
, with the exception of disposable instruments.

(3) Frozen semen must be:

A) filing and storage in storage containers:

First which had been previously cleaned and disinfected or sterilized
except for disposable containers,

Second with a freezing mixture, which was not previously used for other products
animal origin;

B) before transporting or using stored under approved conditions for
least 30 days from the date of collection.

(4) Semen to be subject of trade must be:

A) transported to the Member State of destination in transport containers which

Before use were cleaned and disinfected or sterilized, with the exception
disposable containers, and which have been sealed and numbered
prior to dispatch from the approved semen collection centers or storage centers
;

B) marked so that the number on pejetách or other containers
coincides with the number on the health certificate and container in
which are stored and transported.

II. Conditions for egg cells and embryos

(1) Collection and processing of in vivo derived embryos

In vivo derived embryos shall be considered as the result of artificial insemination
semen meeting the requirements of this Decree and for their collection, handling and conservation
following requirements apply:

A) collection and treatment performed by an approved embryo collection team, while
embryos must not come into contact with any other dose embryos
which do not meet the requirements of this Decree;

B) embryo is conducted at a location that is separate from other parts of the resort or
economy is in good shape and construction solutions
allows for efficient and easy cleaning and disinfection;

C) processing the embryos (the investigation, cleaning, care and storage to
identified and sterile straws, ampoules or other containers)
is performed in a fixed or mobile laboratory for the susceptible species situated in the area
, in which for the past 30 days there has been no case of foot-and-mouth
within a radius of 10 kilometers;

D) all equipment used for the collection, handling, washing, freezing and storing embryos
must either be sterilized before use, or
properly cleaned and disinfected according to the manual of the International Society for
Embryo Transfer Society (IETS) or be disposable;

E) any biological product of animal origin used in the media and
solutions for the collection, processing, washing or storage of embryos must be
free from pathogenic microorganisms. Media and solutions used for collection,
freezing and storage of embryos must be approved by
sterilized in accordance with the Manual of the International Society for transfer
embryos (IETS) and handling must take place so that their || | sterility maintained. In accordance with the Manual of the International Society for
Embryo Transfer Society (IETS) may, as appropriate to the media for the collection, processing, washing and storage
add antibiotics;

F) cryogenic agents used for preservation or storage of embryos must be
previously used for other products of animal origin;

G) any straws, ampoules or other reservoirs embryos must be clearly labeled by
standardized system
Guide International Embryo Transfer Society (IETS);

H) washing the embryos must be carried out according to the manual
International Embryo Transfer Society (IETS) and in front of him, after him, even during his
not be disturbed zona pellucida. If it is necessary to inactivate or remove
certain viruses may be standard washing procedure be amended to include other
wash with the enzyme trypsin, according to the manual
International Embryo Transfer Society (IETS);

I) embryos from different donor animals shall not be washed together;

J) the zona pellucida of each embryo must be examined over its entire surface
at least fifty times magnification and must be confirmed by the
intact and without adhering foreign particles;

K) benefits from an embryo proven by point. j) are stored in sterile
straws, vials or other containers of the point. g) and immediately sealed;

L) Each embryo intended for freezing must be immediately frozen and stored
place, which is under the control of the team veterinarian;

M) each embryo collection team shall submit for official examination
bacterial and viral contamination routine samples of non-viable
embryos or egg cells, flushing fluids or washing
on the basis of its activities under the International Society for manual transmission
embryos (IETS);

N) Each collection team must keep records of their activities,
regards embryo collection and keep them two years after the transaction or
import embryos. The records contain the following information:

First breed, age and identification of the donor animals;

Second the place of collection, processing and storage of embryos collected by the team;

Third identification of embryos and details of their recipients.


(2) Collection and processing of egg cells of the ovaries and other tissues to
production of embryos obtained in vitro

Conditions set out in paragraph. 1 point. a) to n) apply likewise for the collection and processing
egg cells, ovarian, and other tissues for fertilization in vitro
and culture in vitro. In addition, the following conditions apply:

A) the competent authority must know the economy from which the donor animals
come and take him to the appropriate authority;

B) if the ovaries and other tissues harvested at the slaughterhouse, and it
either from individual animals or groups of animals (hereinafter referred to as "group
removal") must be officially approved slaughterhouses under Regulation
European Parliament and Council Regulation (EC) no. 854/2004 of 29 April 2004 laying
down specific rules for the organization of official controls on products
animal origin intended for human consumption, as amended, and
must be under the supervision of a veterinarian whose responsibility is to ensure that
conducted inspections of potential donor animals before
mortem and post-mortem, and confirm that the animals are free of symptoms
relevant diseases transmissible to animals. Slaughterhouses must lie in an area in which
terms of susceptible species in the last 30 days there is no
case of foot-and-mouth disease within a radius of 10 kilometers;

C) the benefits of the ovaries may not get into the processing laboratory until
not inspected donor animals after slaughter;

D) equipment for the removal of the ovaries and other tissues, and their transfer
must be cleaned before use and disinfected or sterilized and
may be used solely for this purpose.

(3) Development of embryos obtained in vitro

Conditions set out in paragraph. 1 point. a) through n) apply mutatis mutandis to the treatment
embryos obtained in vitro. In addition, the following conditions apply:

A) embryos obtained in vitro are considered the result of in vitro fertilization
semen meeting the requirements of this Decree;

B) after in vitro culture must embryo before freezing, storage and transport
washed and treated in accordance with paragraph. 1 point. h), j) and
k);

C) embryos from different donor animals, in the case of individual
collection or collections from various group should not be washed together;

D) embryos from different donor animals, in the case of individual
collection or a different group donations must not be stored in the same
straws, ampoules or other container.

(4) Development of embryo micromanipulation subjected before micromanipulation,
which violated the zona pellucida must be all embryos or egg cells
collected and processed according to the sanitary conditions set out in paragraph
. 1, 2 and 3. In addition, the following conditions apply:

A) micromanipulation of the embryo which involves penetration of the zona pellucida
must be carried out in a suitable laboratory facilities under supervision of an approved
team veterinarian;

B) Each collection team must keep records of their activities by
paragraph. Point 1. n), including details of micromanipulation techniques which
includes penetration of the zona pellucida and which have been performed on
embryos. Identification of embryos obtained in vitro fertilization can be carried out by
benefits, but it must contain the date and place of sampling
ovaries or egg cells and allow for the identification
holding of donor animals originated.

(5) Storage of embryos

A) Each embryo collection and production teams must provide storage
embryos at suitable temperatures in storage premises referred to in Part A of Chapter III
.
8th
B) Frozen embryos must be completed before
stored under approved conditions for at least 30 days from the date of collection or production.

(6) Transportation embryos

A) Embryos to be subject of trade must be transported
to the Member State of destination in transport containers that were before
cleaned and disinfected or sterilized, or
containers are disposable, and which have been sealed and numbered prior to dispatch from the approved
storage centers.

B) straws, ampoules or other containers should be labeled so that the number
on pejetách, vials or other containers coincided with the number
health certificate as the container in which they are stored and
transported.
D


Requirements female - donor


(1) to use for the collection of embryos or egg cells have a donor
economy from which they originate, meet the requirements for
trade in animals of each species Decree no. 382/2003 Coll.
verified by an official veterinarian.

(2) In addition to the requirements laid down in § 4-11 of the Decree no. 382/2003 Coll.
donor pigs must, except in vivo derived embryos treated with trypsin
fulfill the conditions relating to Aujeszky's disease,
specified in § 12 and 13 of Decree no. 382/2003 Coll.

(3) For the donor sheep and goats, the requirements specified in § 15-18
Decree no. 382/2003 Coll.

(4) For the donor mare apply in addition to the requirements set § 19-25
Decree no. 382/2003 Coll. the following conditions:

) May not be used for natural breeding at least 30 days before the date of collection
egg cells and embryos, and in the period from the date of first
sampling by point. b) and c) until the date of collection of egg cells and embryos
;

B) must have a negative Coggins test result immuno
agarose gel or an ELISA test for equine infectious anemia
performed on a blood sample taken at least 14 days after the start date
placement lasting at least 30 days under point a) and
than 90 days prior to collection of ova and embryos intended for trade

C) shall be subjected to tests to identify the source of contagious equine metritis
carried out with negative results in the laboratory under Part B of Part I.
paragraph 5 at least two samples taken from a donor mare
first 7 days in the system treatment or 21 days for local treatment after possible
antimicrobial therapy donor mare least mucosal surfaces
clitoralis fossa and sinus clitoralis.

First Samples must be collected within the period specified in subparagraph a)
twice at an interval of at least 7 days for tests according to section 3.1 and one for tests
according to section 3.2.

Second Before sending it to the laboratory, samples must be placed in
transport medium with charcoal, for example Amies.

Third Samples must be subjected to at least one of the following tests:

3.1 culturing under microaerophilic conditions for at least 7 days to isolate
Taylorella equigenitalis based within 24 hours after removing
sample from the donor animal, or within 48 hours when the samples during transport
refrigeration; or

3.2 Polymerase chain reaction or PCR
real time to detect genome Taylorella equigenitalis carried out in
48 hours of sampling from the donor animal.


Příl.10

Canceled
1) Council Directive 88/407 / EEC of 14 June 1988 concerning veterinary
requirements for trade in bovine semen within the Community and its
imports.

Council Directive 90/120 / EEC of 5 March 1990 amending Directive
88/407 / EEC on animal health requirements for trade in deep-frozen bovine semen
within the Community and imports.

Council Directive 90/425 / EEC of 26 June 1990 concerning veterinary and zootechnical checks
trade in certain live animals and
products within the Community with a view to completing the internal market.

Council Directive 93/60 / EEC of 30 June 1993 amending Directive
88/407 / EEC on animal health requirements for trade in deep-frozen bovine semen
within the Community and imports and by
its scope expanded to cover fresh bovine semen.

Council Directive 90/429 / EEC of 26 June 1990 laying down
animal health requirements for trade in semen of domestic pigs inside
Community and imports.

Council Directive 89/556 / EEC of 25 September 1989 on animal health
trade in bovine embryos in the Community and imports from these embryos
third countries.

Council Directive 90/425 / EEC of 26 June 1990 concerning veterinary and zootechnical checks
trade in certain live animals and
products within the Community with a view to completing the internal market.

Council Directive 93/52 / EEC of 24 June 1993 amending Directive
89/556 / EEC on health problems affecting trade in bovine embryos
Community and imports of such embryos from third countries.

Council Directive 92/65 / EEC of 13 July 1992 on the health
rules for trade in animals, semen, embryos and egg cells
within and imports into the Community, unless they are

Not subject to Community veterinary legislation listed in Annex
A Section I to Directive 90/425 / EEC.

2) Decree no. 382/2003 Coll., On veterinary requirements for trading
animals and on veterinary conditions for their import from third countries.

3) Decree no. 299/2003 Coll., On measures for prevention and eradication
infections and diseases transmissible from animals to humans.

4) Decree no. 376/2003 Coll., On veterinary checks on imports and transit
products from third countries.

5) Decree no. 376/2003 Coll., On veterinary checks on imports and transit
products from third countries, as amended by Decree no. 259/2005 Coll.

Decree no. 377/2003 Coll., On veterinary checks on imports and transit
animals from third countries, as amended by Decree no. 259/2005 Coll.

6) § 22 paragraph. 1 of Act no. 154/2000 Coll., On breeding and
registration of livestock and amending certain related laws
(Breeding Act), as amended.