The Use Of Prescribing And Dispensing Of Veterinary Medicinal Products

Original Language Title: používání, předepisování a výdej veterinárních léčivých přípravků

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=67403&nr=344~2F2008~20Sb.&ft=txt

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.