344/2008 Sb.
The DECREE
from day 4. September 2008
on the application, the prescription and dispensing of medicinal products in the provision
veterinary care
Change: 139/2011 Sb.
The Ministry of agriculture provides under section 114, paragraph. 4 of law No 378/2007
Coll., on pharmaceuticals and on amendments to some related laws (hereinafter referred to as
the "law"):
§ 1
Introductory provisions
This Decree incorporates the relevant provisions of European Community ^ 1)
and governs the rules for the use of medicinal products in the provision
veterinary care, including related prescription and dispensing of medicinal
preparations and requirements for keeping records of these activities,
Essentials reporting on the management of substances or preparations, including
conditions for the keeping and preservation of records of these activities, and
rules for exemptions from registration for veterinary medicinal products
registered in another Member State.
§ 2
Use of medicinal products in providing veterinary care for animals,
that produce animal products intended for human consumption
(1) the attending veterinarian before using, prescribing or
the issuing of a medicinal product shall ensure that the conditions are met for
the safe and effective use of the medicinal product, with particular regard to the
the dangers arising from the use of the medicinal product for the treated animal or
animals, humans and the environment, the danger arising from the transfer of
drug residues in food and the risk of the emergence and development of resistance to
the active substance or substances contained in the medicinal product.
(2) the Breeder, who as an entrepreneur ^ 2) behaving animals, which
produce animal products intended for human consumption, shall inform the
the attending veterinarian of the facts which may
adversely affect the safe and effective use of the medicinal product. If
keeper served a medicinal product to animals under section 9 (2). 12 of the Act,
to ensure the fulfillment of conditions for the safe and effective use of the medicinal
the product referred to in paragraph 1 apply mutatis mutandis. Medicinal products, whose issue is
bound to a medical prescription, keeper uses in accordance with the instructions
the attending veterinarian.
(3) medicinal product which contains antibiotics or chemotherapy,
in the decision on the registration of which has been established for its use
indicator limit, can only be used in the event that for the purpose of use
is not available another medicinal product for which such a restriction
is not specified, and when sensitivity to medicinal substance contained in the medicine
the product was established.
(4) If, in connection with the use of the medicinal product occurs
suspected adverse effect on the animal, which was such a product
filed, in the case of a man who served in the product, or if the transfer occurs
medicinal product residues in foodstuffs of animal origin raw materials or
or damage to the environment as a result of the use of the medicinal
the product, announce these facts breeders attending immediately
veterinary doctors.
§ 3
If not for the purposes of the provision of health care available to the veterinary
a medicinal product registered under section 25 of the Act for the indication and
for the species and category of animals, including medicated premix
administered in the form of medicated feed (hereinafter referred to as the ' competent
registered veterinary medicinal product "), for the treatment of the animals,
that produce animal products intended for human consumption,
to issue or use, in particular, to prevent the suffering of the treated
animals, in economy, in which there is a specific case,
exceptionally
a) a veterinary medicinal product authorised for other species, or
the animal category or for another indication in the same species,
(b)) a registered medicinal product, or a veterinary medicinal
the product is registered in another Member State, in accordance with section 9 (2). 1 (a).
(e)) and section 48 of the Act, for the same or a different kind of animals that produce
animal products intended for human consumption, if it is not available
the veterinary medicinal product in accordance with point (a)),
(c)) in bulk or individually in the pharmacy prepared medicinal product,
If it is not available or a medicinal product referred to in subparagraph (b)), or
(d) the autogenous vaccine) the animal, according to § 2 (2). 2 (a). (f)) of the Act,
or a medicinal product for which the exemption has been established under section 9 (2).
2 (a). and section 46 of the Act) and, if it is not available or the medicinal product
referred to in subparagraph (c)).
§ 4
Use of medicinal products in providing veterinary care for animals,
that do not produce animal products intended for human consumption
If not for the purposes of the provision of health care available to the competent
registered veterinary medicinal product can be used for the treatment of the animals,
that do not produce animal products intended for human consumption, including
animal belonging to the equidae family, which is in accordance with the
the relevant provisions of European Community ^ 3) declared that they are not
intended to slaughter for the nutritional purposes of man, prescribe, issue or
use, in particular, to prevent the suffering of the animals treated,
exceptionally
a) a veterinary medicinal product authorised for other species, or
the animal category or for another indication in the same species,
(b)) is not available if the veterinary medicinal product in accordance with point (a)),
authorised medicinal product, or a veterinary medicinal
the product is registered in another Member State in accordance with section 9 (2). 1 (a).
(e)) and section 48 of the Act,
(c)) is not available or if the medicinal product referred to in subparagraph (b)), bulk
or individually in the pharmacy prepared medicinal product, or
(d)) is not available or if the medicinal product referred to in subparagraph (c)),
Veterinary autogenous vaccine according to § 2 (2). 2 (a). (f)) of the Act, or
medicinal product for which the exemption has been established under section 9 (2). 2
(a). and section 46 of the Act).
§ 5
The use of medicinal products, veterinary doctors, who are resident
or are established in another Member State than in the Czech Republic and who
are authorized to provide health care on the territory of the Czech Republic
The veterinarian, who resides or is established in another Member
State than in the Czech Republic and who is entitled to provide health
care on the territory of the Czech Republic (hereinafter referred to as "visiting the veterinarian")
can be used in the provision of health care other than the competent
registered veterinary medicinal product satisfies this medicinal
the preparation of the following conditions:
and has a valid marketing authorisation granted) by the competent authority of the Member State,
in which the visiting veterinarian domiciled or in which it is
is established,
(b)) this is not an immunological medicinal product,
(c)) is to pass a visiting veterinarian in the original internal and
If there is one, and the outer packaging,
(d)) has the same qualitative and quantitative composition in respect of medicinal products
substance as a medicinal product authorised in the Czech Republic and
(e)), it established the withdrawal period, which is at least as long,
as for similar medicinal product authorised in the Czech Republic.
§ 6
(1) the keeper, which were distributed medicinal products under section 77
paragraph. 1 (a). (c) section 8 of the Act), may use these medicinal products,
If it has adequate space and facilities for their
storage. These facilities and equipment
a) are protected against access by unauthorized persons,
(b)) have sufficient capacity and are designed, arranged and fitted
so, that allow you to store medicinal products in accordance with the decision of the
their registration, or in accordance with the instructions of a veterinarian or
pharmacies, and exclude the risk of damage, contamination or substitution,
(c)) at the time when they are stored in these medicinal products,
continuously monitored and the conditions under which the medicinal products
stored, are regularly, but at least once a day
recorded,
(d)) are protected against the intrusion of pests and are subject to regular
maintenance, including measures against pests.
(2) the Unusable medicinal products eliminates the breeder without delay in
accordance with the requirements set out in section 88 of the Act.
(3) in cases where the medicinal product is for, who the breeder is stored,
ordered its withdrawal, shall ensure that the breeder that is a medicinal product withdrawn
from circulation, and is treated in accordance with the requirements that breeders
shall notify the holder of the marketing authorisation, or by the operator,
that medicinal product provided by the producer.
section 7 of the
The records kept on the use of medicinal products in the breeder
(1) the records kept by the breeder, who as an entrepreneur ^ 2) acts
farm animals that produce animal products intended for human consumption
the man, about the use of the medicinal product, which is bound to issue medical
prescription, contain
and the name of the medicinal product), where appropriate, the batch is on
the medicinal product,
(b) the date the use of the medicinal product),
(c)) species and category of animals for which the medicinal product used,
(d) the number and the identification of the animals), for which the medicinal product used,
(e)) reason for using the medicinal product or medical diagnosis,
(f)), if applicable, the amount of the dose of the medicinal product,
(g) the withdrawal period) laid down under section 3 (3). 2 of the Act,
(h) the identification of the holding) ^ 4), where the medicinal product has been used.
(2) in the case of a medicinal product shall apply in accordance with section 9 (2). 12
the law shall ensure the implementation of, the breeder of record of the use of the medicinal product
in accordance with paragraph 1 of the breeder. In the event that the medicinal product used
veterinarian, shall ensure the implementation record of the use of the medicinal
the product referred to in paragraph 1, a veterinary doctor.
(3) for the keeping of records on the use of medicinal products containing
hormonal substances and of beta-agonists, the provisions of the Decree on the
the ban on reporting of certain substances to animals, whose products are intended
to feed ^ 8).
(4) in experiments on animals allowed on the basis of other legal
^ 5) rules, if they are carried out on animals, which produce
animal products intended for human consumption, shall keep records in accordance with paragraph
1 head try to ^ 6).
(5) the records kept by the breeder referred to in paragraph 1 must be clear,
clear and legible. The records must be kept in accordance with section 9 (2). 11
law so as to be protected against deterioration, damage or
the loss.
§ 8
The records kept on the use of medicinal products, veterinarian
(1) the records kept by the veterinarian on each question used by
the product, which is bound to issue a prescription, contain
and the name of the medicinal product), where appropriate, the batch is on
the medicinal product,
(b) the date the use of the medicinal product),
(c)), where appropriate, the amount of the dose of the medicinal product,
(d)) reason for using the medicinal product or medical diagnosis, if the
the use of the medicinal product, in which the marketing authorisation was for
the use of the medicinal product provided for indicating restrictions limiting
the use of the medicinal product, in cases where, for a given intended use is not
available to other suitable medicinal product and when sensitivity to medicinal substance
contained in the medicinal product was determined in an appropriate manner, or
medicinal product which contains as active ingredient
1. a substance which is listed in annex IV of the regulation directly applicable
EC ^ 7), or
2. a substance for which there is a set of restrictions for the use or putting into
under other legislation ^ 8),
e) animal species for which the medicinal product used,
(f)) the number of animals for which the medicinal product used,
(g) the name or names), surname and place of residence of the breeder
the animals, in the case of a natural person, or the business name or name and
registered office, in the case of a legal person.
(2) a veterinarian who uses for farm animals, which
produce animal products intended for human consumption, other than
the authorised veterinary medicinal product in addition to the records
the records referred to in paragraph 1, the following information:
and the date of examination of the animals),
(b)) the duration of the treatment,
(c) the reason for the use of the medicinal product) or medical diagnosis,
(d) the prescribed withdrawal period) under section 3, paragraph 3. 2 of the Act.
(3) the records referred to in paragraphs 1 and 2 of the lead veterinarian so that the
clear, unambiguous and legible. The records must be retained in accordance with § 9
paragraph. 11 of the Act so as to be protected against deterioration, damage
or loss.
(4) If a veterinarian performs professional work as
employee of a natural or legal person authorized to perform the professional
veterinary activities, shall keep records in accordance with paragraphs 1 and 2 of this person.
§ 9
The records kept by the prescribing and dispensing of medicinal products in the
the provision of veterinary care
(1) the records kept by the veterinarian in the provision of animal health
care of any issue, or the prescription of a medicinal product whose supply is
bound to a medical prescription, contain
and issued or prescribed) name of the medicinal product,
(b) the date of issue or prescription) medicinal product,
(c) the quantity of the issued or prescribed) of the medicinal product,
(d)) the species and number of animals for which the medicinal product is intended, and if the
farm animals that produce animal products intended for human consumption
man, the type, number, category and destination of the animals, for which a medicinal
medicinal product is intended,
(e) the name or names), surname and place of residence of the breeder
the animals, in the case of a natural person, or the business name or name and
registered office, in the case of a legal person,
(f) medical diagnosis or reason) the issue or the prescription of a medicinal
the product, in the case of animals that produce animal products
to the nutrition of man.
(2) the records kept by the farmer, who as an entrepreneur ^ 2) acts
farm animals that produce animal products intended for human consumption
a man of any medicinal product which has been issued or
distributed under section 77, paragraph. 1 (a). (c) section 8 of the Act) and the issue is
bound to a medical prescription, contain
and the name of the medicinal product)
(b)), the date when the medicinal product issued or distributed,
(c) the quantity, or number) of the benefits of the issued or distributed
of the medicinal product and the reason for the supply or distribution of the medicinal product,
(d) the designation of the person) of the medicinal product to the producer or
distributed,
e) species, category, number and destination of the animals, for that was the medicinal
the product is issued or distributed.
(3) the records referred to in paragraphs 1 and 2 of the leading veterinarian and breeder,
to be clear, unambiguous and legible. The records must be kept
pursuant to section 9 (2). 11 of the Act so as to be protected against deterioration,
damage or loss.
(4) If a veterinarian performs professional work as
employee of a natural or legal person authorized to perform the professional
veterinary activities, shall keep records in accordance with paragraph 1 of this person.
§ 10
Essentials reporting on the management of substances that have anabolic,
can, anti-parasitic, anti-inflammatory, hormonal action,
or addictive substances or precursors, and the records of those
the activities of the
(1) the notice on the implementation of the activities under section 78, paragraph. 2 of the law contains
and, where appropriate, the names of the) name, surname and place of residence of the physical
the person, or the business name or the name and address of the legal person,
(b) designation and address) all places of business where treatment with
substances under section 78, paragraph. 1 of the Act,
(c) a dial-up connection) or the address for electronic mail,
(d) the designation of the substance or substances), that handle, with an indication of the current
the name referred to in section 4, paragraph 4. 1 of the Act,
(e)) the purpose for which the substance or substances.
(2) any changes in the data referred to in paragraph 1 shall be notified to the
immediately Institute for State control of veterinary Biologicals and
pharmaceuticals.
(3) the records kept and shall be natural or legal persons on the
all commercial activities under section 78, paragraph. 4 of the Act, contain the
and the treatment of substance) or substances,
(b) the date when appropriate) transactions took place,
(c) the quantities and labelling of the substance) or substances which have been subject to the relevant
the transaction,
(d) the name or names), surname, place of residence and
the identification number of the natural person who is the supplier or
the customer; for the customer or vendor that is a legal person,
its trading name, or the name and address and the registration number,
(e)) how to modify the substance or substances.
(4) the records referred to in paragraph 3, including electronic, photographic
or other systems, provides so that they are clear, unambiguous and
legible. The records must be kept in accordance with section 9 (2). 11 of the Act, so that the
be protected against deterioration, damage or loss.
§ 11
The information referred to in the application for the import of the veterinary medicinal product
registered in another Member State
(1) an application for the importation of the veterinary medicinal product authorised in the
another Member State presented to the attending veterinarian
contains
and, where appropriate, the name) the names, forenames and, where appropriate, place of business, the place of
performance practice veterinarian; If the veterinarian performs
professional work as an employee of a natural or legal
a person authorized to perform the professional veterinary activities, says
name, or name, last name and place of business of the person, if the
a natural person, or the name and address, in the case of a legal person,
(b)) a veterinary medicinal product
1. the name under which the veterinary medicinal product authorised in the
the Member State from which the imported goods,
2. composition with the listing of all medicinal substances contained in veterinary
the medicinal product and, where applicable, indicating auxiliary substances, which may
a special way to affect the therapeutic effect of veterinary medicinal
of the product,
3. strength,
4. pharmaceutical form,
5. the nature and size of the container,
6. the size of the packaging,
7. the indications for which the veterinary medicinal product authorised in the
another Member State, and
8. the Member State in which the veterinary medicinal product is authorised,
(c) details of the method of marketing of) the veterinary medicinal product into circulation
1. the Member State from which the veterinary medicinal product is to be
imported,
2. the person shall ensure that imports of veterinary medicinal product,
3. the declared date of introduction and
4. the estimated timetable for the use of the veterinary medicinal
of the product,
(d)), the amount of the veterinary medicinal product to be of
another Member State imported; in the event that the importation is to be ensured in
the longer schedule, information on the quantities imported within the set
time intervals,
(e) an indication of the method of use), the veterinary medicinal product
1. the species of animal for which the veterinary medicinal product is to be used,
2. reason for use, specifying the therapeutic or preventive indications
medical diagnosis or disease, the diagnosis should be using
the veterinary medicinal product, provided
3. in the event that it is for the indication, for which it is an exception from registration
for the veterinary medicinal product is presented to the application in the Czech Republic
available to other appropriate registered veterinary medicinal product,
the reasons why in a particular case cannot be such veterinary medicinal
the product used,
4. If the veterinary medicinal product is to be used in the longer
the time interval, the justification for the necessity of the proposed use of the
the veterinary medicinal product and the
5. in the case of veterinary medicinal products, to be used for
animals that produce animal products intended for human consumption,
enter on the address and registration number of the holding, in which the
veterinary medicinal product used, and an indication of the withdrawal period, which
It will be after the submission of the veterinary medicinal product,
(f)) for more information which may be relevant for the examination of the application, as
data on adverse reactions to the veterinary medicinal product, links
on the use of the proposed therapeutic procedure published in the professional
literature,
g) a declaration that the veterinarian will be the Institute for State control
Veterinary Biologicals and pharmaceuticals to report in accordance with the law all
suspicion of the occurrence of serious adverse effects, unexpected
side effects and adverse effects, which are in connection with the
the use of the veterinary medicinal product have occurred in humans, and
h) date and signature of veterinarian.
(2) the annex to the application form a copy of the package insert information, as
authorised in the Member State where the veterinary medicinal product
registered, and a copy of the certificate of compliance with the conditions for the performance of the health
therapeutic and preventive activities issued by the Chamber of veterinary surgeons
According to another legal regulation ^ 9).
(3) an application may be made for more than one of the veterinary medicinal product.
In this case, the information referred to in paragraph 1 (b). b), c), (d)), (e)) and
(f)) shall be shown separately for each veterinary medicinal product which the
exemption from registration the competent veterinary doctor asks.
§ 12
The model order for importation of a veterinary medicinal product
registered in another Member State
(1) the model order for importation of a veterinary medicinal product in accordance with section
paragraph 48. 2 of the Act is set out in the annex to this Decree.
(2) If this is the case under section 48, paragraph. 4 of the Act shall be in the
the order of the words "exemption from authorization for a veterinary medicinal product
-the case of a direct threat to the health or life of the animal. "
section 13
Data on imports of veterinary medicinal product authorised in another
the Member State of
(1) the attending veterinarian shall keep pursuant to section 48, paragraph. 6 of the Act
the following documents about imports of veterinary medicinal products
registered in another Member State:
and a copy of the application referred to in section) 11,
(b) a copy of the order), pursuant to section 12, if the distribution of the veterinary
the medicinal product has asked the person entitled to the distribution of veterinary
medicinal products, and
(c) the details of the purchase) the veterinary medicinal product in a Member
State if the requested distribution of the veterinary medicinal product
the person entitled to the distribution of veterinary medicinal products; These
the data contain
1. name of the veterinary medicinal product,
2. the date of purchase of the veterinary medicinal product,
3. the purchased quantities of veterinary medicinal product and the
4. the identification of the person from which the veterinary medicinal product
bought in, including information about the dial-up connection, or an address for
by electronic mail.
(2) If a veterinarian performs professional work as
employee of a natural or legal person authorized to perform the professional
veterinary activities, shall keep records in accordance with paragraph 1 of this person.
(3) the Distributor shall keep on the distribution of the veterinary medicinal product
distributed under section 48 the law of another Member State records
under section 77, paragraph. 1 (a). (e) a copy of the Act and further) the order under section 12.
§ 14
Cancellation provisions
Decree No 325/2003 Coll., laying down rules for the application of
medicinal products in the provision of health care, including
related prescription and dispensing of medicinal products and the requirements for
keeping records of these activities, and requirements for notification of the loading
substances or preparations, including the conditions for keeping and storing
records of these activities, is hereby repealed.
§ 15
The effectiveness of the
This Decree shall take effect on the date of 15. September 2008.
Minister:
Mgr. Gandalovič in r.
Annex
The model order for importation of a veterinary medicinal product
registered in another Member State in accordance with section 48, paragraph. 2 of the Act
1) European Parliament and Council Directive 2001/82/EC of 6 May 2003. November
2001 on the Community code relating to veterinary medicinal products
preparations.
European Parliament and Council Directive 2004/28/EC of 31 March 2004. March
2004 amending Directive 2001/82/EC on the Community code
relating to veterinary medicinal products.
2) Act No 513/1991 Coll., the commercial code, as amended
regulations.
3) Commission decision 93/623/EEC of 20 December. October 1993 laying
provides for the identification document (passport) accompanying registered
equidae.
Commission decision 2000/68/EC of 22 December 2004. December 1999, amending
Commission decision 93/623/EEC and establishing the identification of equidae for breeding and
equidae.
4) § 3 (3). 1 (a). (b)) Law No 166/1999 Coll. on veterinary care and
changes to some related laws (health law), as amended by
Law No. 131/2003 Coll.
Act No. 154/2000 Coll., on the breeding, breeding and registration of economic
animals and amending certain related laws (law plemenářský).
5) Act No 246/1992 Coll., on the protection of animals against cruelty, as amended by
amended.
6) § 18a Act No 246/1992 Coll., as amended by law No. 243/1997 Coll.,
the finding of the Constitutional Court declared under no. 30/1998 Coll., Act No.
77/2004 Coll., Act No. 413/2005 Coll. and Act No. 77/2006 Sb.
7) Council Regulation (EEC) No 2377/90 of 26 June 1990. June 1990, establishing the
lays down a Community procedure for the establishment of maximum residue limits of
of veterinary medicinal products in foodstuffs of animal origin.
8) Decree No 291/2003 Coll., concerning the prohibition on the submission of certain substances
the animals, whose products are intended for human consumption, and for monitoring the
(monitoring of the) presence of illicit substances, residues and substances
contaminants to which animal products could be harmful to the
the health of people, animals and their products, as amended
regulations.
9) Law No 381/1991 Coll., on the Czech Chamber of veterinary surgeons
Republic, as amended by law No 318/2004 Sb.
