About How The Prescription Of Medicinal Products And Of The Doctor. Regulations

Original Language Title: o způsobu předepisování léčivých přípravků a o lékař. předpisech

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=66711&nr=54~2F2008~20Sb.&ft=txt

54/2008



DECREE



of 6 May 1999. February 2008



about how the prescription of medicinal products, the information to be entered on the

medical prescription and the rules of use of prescriptions



405/2008: Sb.



177/2010: Sb.



190/2013: Sb.



The Ministry of health in consultation with the Ministry of agriculture,

The Ministry of Defense, Ministry of Interior, Ministry of Justice

and the Ministry of Finance shall determine pursuant to section 114 para. 3 and to implement section 80

Act No. 378/2007 Coll., on pharmaceuticals and on amendments to some related

laws (law on medicinal products):



PART THE FIRST



GENERAL PROVISIONS



§ 1



Introductory provisions



(1) this Ordinance shall determine the method of prescribing medicinal products,

particulars to appear on medical prescription and medical usage rules

regulations.



(2) for prescribing medicinal products doctors use medical

^ 1 rules)



and recipes intended for prescribing)



1. medicinal products containing narcotic substances included in the list

I ^ 2) (hereinafter referred to as "drugs") or psychotropic substances listed in

list II ^ 3) (hereinafter referred to as "psychotropic substances"), which are marked with the

blue stripe; the pattern of this recipe is given in Appendix 1 of this

the Decree,



2. medicinal products with the exception of the medicinal products referred to

in point 1, in order to provide health care services, even for their

a recurring issue in accordance with § 6 para. 4,



3. veterinary medicinal products and medicinal products, with the

the exception of the medicinal products referred to in point 1, in order to provide

veterinary care, and even for their repeated dispensing pursuant to § 6 paragraph 1. 4,



(b) providers of health care services) of the order (hereinafter referred to as

"provider") and natural or legal persons empowered to carry out

^ 5 veterinary activities), the medicines, including blood

products, except for the medicinal products referred to in point (a)), point 1

(hereinafter referred to as "requisition"),



c) requisition of the medicinal products referred to in point (a)) point 1 that are

marked with a blue stripe; the format of this requisition is given in annex 2 to this

the Decree.



(3) for prescribing medicinal products can also be used



and) recipe in electronic form (hereinafter referred to as "electronic prescription")

sent to a central store of electronic prescribing doctor

recipes ^ 6) signed by a recognized electronic signature prescribing

doctor under another law ^ 7) (hereinafter referred to as "electronic

the signature "), or



b) requisition in electronic form (hereinafter referred to as "electronic requisition")

sent by the prescriber and provided with a verification code assigned

provider, if it is sent within the local computer networks this

health care facility, pharmacy, which is a part of it; or

signed by electronic signature, if it is sent to a pharmacy outside of this

a local computer network, provided that they fulfil the requirements pursuant to §

6 or 13.



(4) On medical prescription and on the statement from the recipe may not be placed

characters or elements that restrict the readability of data returned

the provider or that should advertising character.



(5) medical prescription with the exception of a prescription marked blue

Strip can be fitted with protective features against abuse.



§ 2



Treatment with medical regulations



Prescriptions shall be stored so as to prevent their loss or

alienation and the possibility of their misuse. Unfilled prescriptions cannot be

stamp of the provider, the natural or legal person authorized to

to carry out professional activities ^ 5).



Treatment of prescriptions marked by a blue stripe



§ 3



(1) production and distribution of prescriptions marked with blue stripe

provide the competent local municipal authorities of municipalities with extended powers

for contracted manufacturer of these forms, secured on the basis of

orders of the providers or by natural persons or legal entities

authorized to perform the professional veterinary activities ^ 5) (hereinafter referred to as

"authorized person") with the place of the performance of these activities in the administrative

the circuits of the municipal authorities of municipalities with extended powers ^ 8).



(2) to secure a smooth distribution of prescriptions marked

blue stripe create the municipal authorities of municipalities with extended powers

their emergency supply of not more than one-fifth of their

the total distribution for the previous calendar year.



(3) the prescriptions marked with a blue stripe containing the particulars referred to in

models set out in annexes 1 and 2 of this order and is

designated staff member takes over the local authority of the municipality with extended

scope. The authorized employee shall demonstrate the manufacturers when taking the

ordered prescriptions valid authentication credentials and confirm acceptance

signature and stamp of the Municipal Office of the municipality with extended competence.



(4) Municipal Office municipality with extended powers prescriptions marked

blue stripe after the takeover of registers and authorised person to invite

pickup. Prescriptions marked with a blue stripe can be municipal

authorities of municipalities with extended powers issued only to authorized persons or

their accredited representatives ^ 8).



(5) on the issue of prescriptions marked with a blue stripe leads the municipal

Office of the municipality with extended competence paper forms, which contains data

the number of prescriptions issued, including their serial numbers and

identification of the person entitled. The takeover of prescriptions

marked with a blue stripe confirm authorized person or an authorized

representative ^ 8) on the original order and the signature in the book of forms.



(6) the loss or theft of an unfilled prescription marked

blue stripe shall, without undue delay, notify the municipality of the village with

extended powers that these forms issued to the beneficiary, and

at the same time this loss or theft shall be notified and the police of the Czech Republic.



§ 4



(1) If an authorized person shall issue prescriptions marked blue

the bar, in addition to persons who are in an employment relationship to the beneficiary

or in a similar relationship, leads the beneficiary about this issue, register the

According to § 3 (2). 5.



(2) the Debased or unneeded prescriptions marked blue

stripe, including their průpisů, be transmitted to the person to whom these

prescriptions issued by an authorised person, this person.



(3) an authorized person shall cast the impaired or unnecessary

prescriptions marked with a blue stripe, including their průpisů,

the registration of. Such prescriptions shall transmit to the authorized person locally

the competent municipal office municipality with extended powers to liquidate.

The local authority shall draw up a report on the liquidation of the medical record

the rules marked with a blue stripe, including their průpisů, in which

confirm their acceptance by an authorized person.



(4) the prescriptions marked with a blue stripe, including their

průpisů, returned by the municipal authorities of municipalities with extended powers lead

these municipal authorities.



(5) on the treatment of prescriptions marked with blue stripe

apply, mutatis mutandis, the provisions of § 2



(6) the prescriptions marked with a blue stripe issued for authorized persons

in the scope of the Defence Ministry this Ministry together with the

code. For dealing with these prescriptions, the provisions of section 3 of the

paragraph. 3 to 6 and paragraphs 1 to 5 of this provision, saying that the activities of the

entrusted to locally competent municipal office municipality with extended competence

provides the Department of Defense. Loss or theft of prescriptions

marked with a blue stripe shall be reported to the competent military healthcare

authority and the military police.



PART TWO



THE PRESCRIPTION OF MEDICINAL PRODUCTS



§ 5



Way of prescribing



(1) the Recipe may not contain more than



and) one kind of medicinal product which contains the narcotic substances or

psychotropic substances, or



(b)) two kinds of other medicinal products; If it is in accordance with § 6 para. 4

picking on the recipe prescribed number of packs you can repeat prescribe two

types of medicinal products only if the number of repetitions in each species

medicinal products the same.



(2) if the medicine is prescribed on account of public health

insurance can be on one recipe to prescribe more than one package one

the kind of the medicine to ensure the treatment of a patient in his next

visits to the doctor, but no longer than for a period of three

months and usually up to three packs, unless otherwise stipulated.



(3) on a single requisition can prescribe a maximum of 5 types of medicinal products,

which contain a narcotic or psychotropic substances.



(4) when the prescription of medicinal products shall be indicated on the recipe number

packaging or charges and the Roman numeral words in Latin.



(5) Medicinal preparations containing narcotic drugs or psychotropic substances

prescribe the prescriptions marked with a blue stripe.



(6) when prescribing medicinal products referred to in paragraph 5,



and fills the first sheet and) two a copy of the recipe; the first copy of the first sheet, and


It is designed for the dispensing of the medicinal product prescribed in the pharmacy, the second

the copy is kept in the block used recipes



(b)) to the recipe indicate the situation referred to in paragraph 4 and pursuant to section 6.



(7) when prescribing medicinal products referred to in paragraph 5, the

the requisition shall follow the procedure referred to in paragraph 6, by analogy with the fact that fills in the first

the requisition worksheet and a copy of the three; the first sheet, and a copy of the requisition, the two are

designed for the dispensing of the medicinal product prescribed in the pharmacy, the third

the copy is kept in the block used requisitions.



§ 6



Particulars to appear on recipe



(1) unless otherwise stipulated, the recipe will contain the following information:



and the health insurance companies) code number, if it has to be

product is paid from public health insurance ^ 9); If the medicinal product

the product should not be paid for from public health insurance ^ 9) States

the recipe "pays the sick", which is also in the case that

the prescriber does not have a contract with a health insurance company

the patient-the insured person ^ 9), unless it is an emergency or acute care

referred to in subparagraph (d)), section 6,



(b) the name or names), surname, address of the place where the patient

present, the telephone number of the patient, but your doctor may only be given with the

the consent of the patient; social security number ^ 9), if assigned; If the number

the insured person was not assigned, or if you cannot determine the number of the insured person

his age, age of the patient, and that for children under 3 years of age, specifying the months of

other people over the years; in the case of persons in custody, the sentence

liberty or security of the detention shall state the address of the existing remand

prison or prison,



(c)) the prescribed medicine, and it



1. a protected name under which a medicinal product registered ^ 10),

pharmaceutical form, strength and package size,



2. the international non-proprietary name recommended by the World Health

Organization with an indication of the required dosage form, strength and quantity, or



3. the Pharmacopoeial name or synonym, or its abbreviation referred to in

The Czech Pharmacopoeia ^ 11) or the name of the active or excipients listed in

the list established by specific legislation, or the name of the substance, to

that authorisation was granted by the Ministry of health according to the

the law on pharmaceuticals, and even for its individual components with the current

indicating the desired quantity, in the case that this is a prepared

the medicinal product,



(d)) symbol or wording appearing on the front page of the recipe



1. "(!)", in the case of the deliberate breaching the dosage prescribed by the Czech

Pharmacopoeia ^ 11) or the dosage or indication referred to in the summary of

of ^ 12); exceeding the dosage must be printed words in Latin

languages, in the case of individually prepared medicine



2. in the case of a patient of preschool age, your doctor may also give its

weight in kg, in the case that this is not appropriate to his age,



3. "not to be confused", if the prescriber takes on the issue of

prescribed medicinal product,



4. "emergency room", in the case of a medical emergency recipe issued

service and emergency service in the field of dentistry,



5. "Increased payment", if it is a prescription medicine that has

under another law ^ 9) 2 level of remuneration and the prescriber

requires the use of a higher payment,



6. "urgent care" or "acute care", if the medicinal product

prescribed on account of the non-contracted doctor general health insurance system ^ 9)

in the context of paid emergency or acute care



7. "Unregistered medicine", in the case of prescription

an unauthorised medicinal product,



(e)) the main diagnosis linked to předepisovanému medicine

If the prescriber required increased payment or in

If it is předpisován Medicine awarded to medical

prescription pursuant to § 39 para. 4 of the law on medicinal products or

individually prepared a medicine containing cannabis for therapeutic

purposes, in the form of numeric diagnosis according to the international statistical

classification list of diseases and related health problems,



f) instructions for use of the medicinal product,



g) stamp of the provider that contains the



1. the name or names, the surname of the doctor, address including the telephone

numbers places the regular provision of health care and the identification

number assigned to the health insurance company, if a health insurance company

allocated; If the doctors providing health care referred to in paragraph

6, which otherwise does not provide health care, must be entered in place of the address

the place of the regular provision of health care, place of residence, in the case of

a natural person,



2. the name or business name, registered office, including the telephone number of the place

permanently provides health care, and the identification number assigned to the

health insurance, health insurance, if it is an

the Treaty, in the case of a legal person,



3. in the case of prescription issued by a provider in the army of the United

Republic, location of the unit, including the phone number of the provider,

for which it was issued, or the name of the recipe, "Garrison infirmary" or

"Garrison medical station and the site of a military medical

equipment including the phone number or the name "Garrison medical

first aid service "including telephone number, if the recipe

exposed to military medical first aid service; the information referred to in point

1, 2, or 3, in the case of use of an electronic recipe appear on

This recipe in place of the specified data interface,



h) the name, or name and surname prescriber opened

in block letters or a name tag, if health care was provided

in the provider, which is a legal person, and



I) signature of the prescriber, and the release date of the recipe; in the case of

electronic prescription prescriber signature is replaced by its

an electronic signature.



(2) a recipe for medicinal products the remuneration from public health

insurance is in terms of the expertise of the prescribing physician limited ^ 9) and

It is issued by a doctor, contains other expertise



and on the front of the information) in accordance with paragraph 1,



(b)) on the back of



1. the name, or name, last name, identification number assigned to the

the health insurance company and the expertise of the doctor, that a medicinal prescription

of recommended



2. the words "on the recommendation of a specialist doctor," along with its

identification number, signed by the prescriber and label and

with the stamp of the provider, in which the prescribing doctor provides

health care; the recommendation of a specialist doctor must be no later than the day

the prescription of a medicinal product based on medical documentation

the patient-the insured person, if the prescription of a medicinal product used

electronic recipe, proceed as indicated in paragraph 1 (b). (I)); details

According to letters and) and (b)) shall be entered in the location specified data interface.



(3) on behalf of the Ministry of health to prescribe medicinal products,

the recipe is marked on the front of the note, "MINISTRY", if such a

remuneration is apparent for the Ministry of health of the international treaty

or the endorsement "ZSZS", if it is a payment pursuant to section 83 of the Act therapy

about the specific health services.



(4) If a dispersing on the recipe required package

of repeat, enter on the front of the recipe, in addition to data

referred to in paragraphs 1 to 3, the instruction to issue,

as a rule, the word "Repetatur", and the words of the indication of the number and the total number of

issues. Each newly launched issue is considered to be the first issue of the

packaging prescribed medicinal product and as such is subject to the

the regulatory fee pursuant to the Act on public health insurance.

The amount prescribed for an individual issue is subject to the restrictions referred to in § 5

paragraph. 2. in the case of medicinal products containing addictive substances ^ 13) according to the

legislation governing the treatment of addictive substances or

precursors by directly applicable European Union legislation ^ 22)

a recurring issue cannot be used.



(5) if payment of a medicinal product is tied to the approval of the revision

doctor the competent health insurance company ^ 9), it shall be indicated on the back side of the

the amount of the remuneration or approved recipe has the medicinal product to be fully

paid the words "full payment" and



and note the "I approve") together with the signature of the doctor and the imprint of the

stamp the appropriate health insurance, or



(b)) Note "approved the review by a doctor", the date of the grant of consent

along with the signature of the prescribing physician and a stamp

the provider, in which the prescribing physician provides health care;

written consent of the competent medical health insurance is

not later than 14 days spawns in the medical record

the patient-the insured person.



(6) the recipe for medicines prescribed by the doctor providing the

health care for yourself, your spouse, parents, grandparents, children, grandchildren

and siblings, based on expertise provided for other legal

Regulation of ^ 14), contains the information referred to in paragraph 1 (b). a) to (f)), (b). (g))


point 1 (a). h) and (i)) and is on the front of the recipe annotated

"The disposal of the family" or "Ad usum proprium".



§ 6a



Particulars to appear on the recipe in cross-border care



(1) on the recipe at the request of the patient, things which it intends to use the

in another Member State ^ 23), at least the following information:



and, where appropriate,) the name, first name, surname, date of birth, telephone number,

the patient and the address of the place where he resides,



(b)) the international non-proprietary name recommended by the world of active substance

Health Organization with an indication of the required dosage form, strength, and

the amount,



c) instructions for use of the medicinal product, including the dosage,



(d) the name or names), surname, expertise of the prescribing physician,

address of the place of the regular delivery of health services including the

the State's name, email address, and phone number or fax, stating the

International preferences



e) stamp and signature of the prescriber; in the case of

electronic recipe with stamp and signature of the prescriber

replaced by his electronic signature, and the



f) release date recipe.



(2) by way of derogation from paragraph 1 (a). (b)) the prescriber shall apply

a protected name under which was a medicinal product is authorised, under

dosage form, strength and package size in the case that



and) is a biological medicinal product, or



(b)) is in accordance with the prescribing physician is necessary having regard to the patient's

the State of health; in this case, the recipe must be briefly listed

the reasons for such a procedure.



§ 7



Creation and sending of electronic prescriptions and their processing

central repository of electronic recipes



(1) the electronic recipe is created through the information system

prescriber in standard Extensible format

Markup Language-XML (hereinafter referred to as "markup language"), without

unique electronic identification marks of the recipe and medicinal

products which are to be issued according to this recipe.



(2) the electronic recipe contains the information set out in paragraph 6 apply mutatis mutandis.

If no health insurance identification number allocated, the

in the box "00000000". It may also be an electronic recipe

supplemented by other data, which are of particular note:



and for issuing pharmacist)



(b)) for the patient,



(c)) regarding the prescribed medicine.



(3) Issued an electronic recipe is through the information

system of the prescribing physician is sent to a central repository

electronic prescriptions.



(4) the central repository shall send by return e-recipes

prescriber information system acknowledgement of receipt,

processing and storage of the electronic prescription. Part of sent

confirmation is supplemented by an electronic recipe transfer about electronic

identification signs.



(5) information system to the prescriber is saves the passed

electronic identification marks to issued an electronic recipe

for enlarging the access to an electronic prescription in doctor

a central repository of electronic recipes.



(6) passed the electronic identification signs e-recipe

the prescribing doctor passes the patient to uniquely identify

prescribed medicinal product when dispensing at the pharmacy.



(7) if it is not based on an electronic recipe made picking,

such electronic recipe date of expiry of its period of validity.



§ 8



Change the data sent to a central electronic recipe storage

electronic prescriptions



(1) the prescriber can, if necessary, make a change to the data

electronic prescription sent to a central repository of electronic

the recipes, which was confirmed by the adoption of the hub

electronic prescriptions, if not an electronic recipe made available

to the issuing pharmacist.



(2) a change to the data referred to in paragraph 1 shall be sent by

prescriber information system to a central repository

electronic prescriptions in the markup language format, with

electronic identification electronic recipe to which

to change the subject, and of medicinal products which are to be in accordance with this

prescription issued.



(3) information on the changed data to the central repository for electronic prescriptions

stores and a turnover of prescriber will send information system

a confirmation of the changes.



(4) the change of the data is always indicated in the additional information under section 7

paragraph. 2 (a). a) and (b)).



§ 9



Cancellation of e-prescription sent to a central repository

electronic prescriptions



(1) the electronic prescription sent to a central repository of electronic

recipes may cancel the prescribing doctor



and in the event of new) facts unknown at the time

the prescription,



(b) in the case of exposure to bad) electronic recipe sent to

a central repository of electronic prescriptions, or



(c)) in another case, always provided that it was not based on the

implemented in dispensing pharmacy.



(2) Discontinuing the electronic prescription pursuant to paragraph 1 in the Central

store electronic prescriptions to be cancelled and cannot be on its

the basis of the issue to take place in the pharmacy.



(3) cancellation of an electronic recipe is sent through the

prescriber information system to a central repository

electronic prescriptions in the markup language format, with

electronic identification electronic recipe, which is

cancelled, and medicinal products should be in accordance with this recipe

issued, as well as stating the reason for which is an electronic recipe

cancelled.



(4) the cancellation of an electronic recipe in a central repository

electronic stores in the form of electronic marking recipes recipe for

cancelled and the central store of electronic prescriptions promptly send

prescriber information system certificate of completion

cancellation of e-recipe.



(5) the reasons for which the electronic recipe cancelled, are stored in the

additional information according to § 7 (2). 2 (a). a) and (b)).



§ 10



Access the prescriber to the exposed electronic prescriptions and to

those electronic prescriptions, were already on the basis of the medicinal products

released



(1) the doctor through its information system accesses the

electronic prescriptions that are stored in a central repository of electronic

recipes using electronic identification electronic

the recipe and the electronic identification of medicinal products

listed in the recipe.



(2) the doctor has access to electronic prescriptions that



and prescribed through the information system), and sent them to the

a central repository of electronic prescriptions, and has stored them

electronic identification signs, regardless of whether their

the basis of the medicinal products were or were not issued or



(b)) have been prescribed by other doctors, to which he gave the patient

electronic identification signs, regardless of whether their

the basis of the medicinal products were or were not released.



§ 11



Communication with the central repository of electronic prescriptions and

the technical documentation for electronic prescribing



(1) the information system of the doctor with a central repository of electronic

recipes communicates through software communication adapter.

Electronic communication between the doctor and the hub

electronic prescriptions takes place in a secure manner, with the



and all data sent) central repository of electronic recipes

are signed by electronic signature,



(b)) all data received from the central store of electronic recipes

are signed by electronic signature,



(c)) the data or the communication channel is encrypted.



(2) each time you access a doctor to a central repository of electronic

recipes is this storage to satisfy its access permissions.



(3) Issued an electronic recipe, request for amendment, cancellation

electronic recipe and all other data are established and the doctor

the central electronic repository of recipes sent in the format

markup language.



(4) the central store of electronic prescriptions after the adoption of the electronic

the recipe will ensure that



and electronic recipe has allocated) unique electronic

identification mark,



b) medicinal product appearing on an electronic recipe has assigned

a unique electronic identification character.



(5) a central store of electronic recipes always confirms

the sending side of the adoption, and store data.



(6) all communications and data transmitted between the doctor and the Central

electronic storage of recipes are recorded in the register of records

the inputs and the activities of the central store of electronic prescriptions (hereinafter referred to as

"the register"). In particular, shall be recorded in the register.



including the receipt of the request) sent data, identification of the consigning

doctor, date and time of receipt of the request, and any other needed

information related to the request,




b) send data from a central repository of electronic prescriptions,

identification of the physician, the data being sent, the date and time of receipt of the request and

any other necessary information related to sending data.



(7) the technical documentation to electronic prescribing recipes is in

electronically published in the information resource of the State Institute

for drug control, and it contains



and) format specification markup language interface all the necessary

documents for the prescription, including the definition of schemas for validation

documents in the format of a standard Extensible language-DTD and

documents for the validation of markup language format,



(b) electronic identification marks) specification, including format,



(c)) detailed description of the communication with a central repository of electronic

recipes and adapter for communication,



d) specification of access security and traffic information

the system doctor and electronic central repository of recipes and more

the necessary specifications.



§ 11a



The registry entry for medicinal products with restrictions



(1) the doctor to access the register of medicinal products restricted uses

the same login as for communication with a central repository

electronic prescriptions. For communication with the registry for medicinal products

limited to § 11 shall apply mutatis mutandis. Through the registry for

the restricted medicines the doctors immediately told whether they are fulfilled

conditions for the prescription of a medicinal product with the restriction.



(2) the conditions are fulfilled for the prescription of a medicinal product with a

restrictions, the doctor will issue the electronic prescription. Through

a central repository of electronic prescriptions is the registry of medicinal

products with restrictions inserted record of prescribed medicine with

limitations and the prescriber is immediately communicated to the identification mark,

which is sent by an electronic recipe coated.



§ 12



Particulars to appear on the recipe in the rare case



(1) in case of danger of delay in delivery of health care

the patient, who is in danger of death, or showing signs of serious disorders

health, medicine may be prescribed and on another

suitable medium with the information, which includes:



a), the words "risk of default",



(b)) the name or name, last name, social security number; If the number

the insured person was not assigned, or if you cannot determine the number of the insured person

his age, age of the patient, and this baby up to 3 years, specifying the months and

for other people over the years, the code number of the competent health insurance company, and

If that information is available,



(c) the name of the medicinal product)



d) instructions for use of the medicinal product,



e) release date,



f) the name or name, last name, address of the prescriber

the place of the regular provision of health care, or the address of residence,

written in capital letters,



(g) the signature of the prescribing physician) and his identification number assigned to the

the health insurance company, if it has been allocated.



(2) the provision of health services referred to in paragraph 1 may be

to prescribe medicinal products in quantity as needed to a subsequent

treatment provider.



section 13 of the



Particulars to appear on the request form



(1) Requisition of medicinal products, with the exception of blood products

include the following information:



and the name of the provider)



(b) the name of the prescribed medicinal product),



1. a protected name under which a medicinal product registered ^ 10),

where appropriate, the name of the active substance that is contained in it, pharmaceutical form,

strength and pack size,



2. the international non-proprietary name recommended by the World Health

Organization with an indication of the required dosage form, strength and quantity, or



3. the Pharmacopoeial name or synonym, or its abbreviation referred to in

The Czech Pharmacopoeia ^ 11) or the name of the active or excipients listed in

the list established by specific legislation, or the name of the substance, to

that authorisation was granted by the Ministry of health according to the

the law on pharmaceuticals, and even for its individual components with the current

indicating the desired quantity, in the case that this is a prepared

the medicinal product,



(c)) the number of packages or benefits of a medicinal product; in the case of

preparations containing addictive substances, listed the Roman numeral and

words in Latin,



d) stamp of the provider that contains the information referred to in section 6 (1). 1 (b).

(g)),



e) release date,



(f) the name, if applicable) name, surname and signature of the prescribing physician.



(2) the Requisition on transfusion products contain the following information:



and the name of the provider, its) identification number, if one has been assigned,

Department name and identification number of health insurance companies,



(b)) the name or name, last name and social security number, which is

the scheduled recipient of transfusion medicine, where it has been granted; in

the absence of the necessary information, shall clearly

identifying the planned recipient,



(c) the reason for the submission of a blood product) or diagnosis of the patient,



(d)) blood group (Abo and RhD) if it has been subjected,



(e)) had a history of previous transfusion of blood containing, transfusional

reaction, births, pregnancy and so on,



(f)) kind of transfusion medicine, specifically referred to the number of pieces or

blood units, the day and hour of filing,



g) any requirements for the next adjustment of the blood product, for example,

deleukotizací or,



h) stamp of the provider,



I) release date,



j) the name, or name, surname and signature of the physician who requested the

transfusion medicine.



(3) in the event that the required examination and imunohematologické at the same time

a sample is attached to the requisition on transfusion medicine, in addition to data

referred to in paragraph 2, further States:



and the type of applied examination) which is, for example, examination of the blood

the Group of irregular antibodies, the test of the compatibility,



(b) the date of sampling),



(c)) the name, or first and last name of the person who removed the pattern,



(d)) code number of the recipient's health insurance of a blood product.

Sample for laboratory examination shall be marked so as not to maybe its

confusion, and accuracy of the data is verified signature of the person that the sample

has removed.



(4) electronic requisition on transfusion products containing the information listed

in paragraph 2 (a). a) to (g)) and i), and the stamp of the provider

the information referred to in section 6 (1). 1 (b). (g)).



§ 14



The validity of medical prescriptions



(1) the Recipe with the prescribed



and antibiotics and antimicrobial chemotherapy) is valid for a maximum of 5

calendar days from the date of its issuance, unless it is about the healing

products for local use,



(b)) other medicinal products applies 14 calendar days from the date of

his exposure, unless the doctor otherwise, but no longer than 1 year.



(2) the Recipe with the prescribed medicinal products only to

to repeat, the 6 months, unless the prescribing doctor otherwise,

from the date of issue, but no longer than 1 year.



(3) a prescription issued by a medical emergency service or emergency

service in the field of dentistry, or if the recipe stated

"Acute care" or "urgent care" according to § 6 paragraph 1. 1 (b). (d)), section 6,

valid until the end of the first calendar day following the date

his exposure.



(4) the Inquiry on medicines containing narcotic substances or

psychotropic substances is valid for a maximum of 14 calendar days from the date of

its issue.



§ 15



Listing of recipe



(1) if it is not available at the pharmacy the prescribed number of the packaging, or if

on the recipe are prescribed 2 types of medicinal products, of which one

is not available and cannot be quickly obstarán, the pharmacist shall issue

the missing medicine extract from the recipe marked with "extract". When

repeated dispensing pursuant to § 6 paragraph 1. 4, unless it is the last issue,

the pharmacist shall issue the certificates issued from the recipe listing package that serves as the

document for the purposes of checks or bill your health insurance company.



(2) an extract from the recipe contains the details of the original recipe; the original recipe

shall bear the note "Recorded listing". In the case that the pharmacist to the listing of the

the recipe lists all of one kind of medicinal product and

the regulatory fee imposed by other legislation ^ 9), enter

comment "no selected Fee". If the statement of the recipe this note

provided, that the regulatory fee issuing pharmacist.



(3) The determination of the period of validity of the statement from the recipe § 14 para.

1 apply mutatis mutandis.



(4) in the case of the statement from the electronic prescription shall apply mutatis mutandis.



section 16 of the



Storage of prescriptions marked with blue stripe



Prescriptions marked with a blue stripe shall be kept under another

^ Law 8).



PART THREE



THE PRESCRIPTION OF MEDICINAL PRODUCTS IN ORDER TO PROVIDE VETERINARY CARE



§ 17



Way of prescribing



(1) On one recipe can be used to prescribe



and) one kind of medicinal product which contains the narcotic substances or

psychotropic substances, or



(b) not more than two kinds of other) medicines.




(2) when prescribing medicinal products shall be indicated the number of packages or

benefits and the Roman numeral words in Latin.



(3) medicinal products containing narcotic drugs or psychotropic substances

prescribe the recipes marked with a blue stripe.



(4) when prescribing medicinal products referred to in paragraph 3,



and fills the first sheet and) 2 a copy; the first copy of the first sheet, and is intended

for the dispensing of the medicinal product prescribed in the Pharmacy; the second copy is

leaves in the block used recipes



(b)) indicate data referred to in paragraph 2, and in section 18 para. 1.



(5) If a medicinal product to repeat, proceed

According to § 6 paragraph 1. 4 apply mutatis mutandis, in cases where the risk of delay in

the provision of veterinary care are proceeding according to § 12 apply mutatis mutandis, and

in the case of the issuance of the statement from the recipe, proceed under section 15

adequately.



section 18



Particulars to appear on recipe



(1) on the recipe will contain the following information:



and, where appropriate, names) the name, surname, address of residence,

where appropriate, the place of residence in the territory of the Czech Republic, in the case of foreigners, and

phone number of the breeder of the animal, if it is a natural person; for legal

the person's name or business name, address and telephone number; phone

the numbers are given only in the event that their users agree



(b)) animal species for which the medicinal product is prescribed,



(c)) the prescribed medicine, and it



1. a protected name under which a medicinal product registered ^ 10),

pharmaceutical form, strength and package size, or



2. the Pharmacopoeial name or synonym, or its abbreviation referred to in

The Czech Pharmacopoeia ^ 11), and also for its individual components in the case that

It is a medicinal product which is prepared,



d) instructions for use,



e) release date,



f) stamp that contains the name or name, surname and place of

business, or place of practice prescribing veterinarian.

doctor; If the veterinarian performs professional veterinary

^ 5) activities as an employee of a natural or legal person authorized to

to carry out professional activities ^ 5), it is reported along with the name,

the names, forenames and, where appropriate, instead of the regular provision of veterinary

care for this person, in the case of a natural person, or the name and address, in the case of

legal person, phone number and



g) signature of the veterinarian.



(2) the validity of prescription shall be governed by section 14 apply mutatis mutandis.



§ 19



Particulars to appear on prescription for a medicated feedingstuff



(1) a prescription for a medicated feedingstuff ^ 15) contains



and, where appropriate,) the name, first name, surname and place of business, or a place

the performance practice of the prescribing veterinarian



(b) the name of the Medicated pre-mix) ^ 4), to be used for the production of

medicated feedingstuffs, including the placing of power,



(c)) the concentration of the active substances in medikovaném feed



(d)) the name, or name, surname and place of business of the keeper of the animal,

that has to be medicated feed used, in the case of a natural person,

name and registered office, in the case of a legal person,



(e)) the name, or name, surname and place of business of the person who is

recipient of the medicated feed, in the case of a natural person, the name and address,

in the case of a legal person ^ 17),



(f)), address and registration number of the holding ^ 5), where it should be medicated

the feed used,



(g)) the type, category and the number of animals for which it is to be medicated feed

made,



(h) the therapeutic or preventive indication),



I) quantity of medicated feed,



j) how and when the feeding of medicated feed, including frequency

the Administration and the amount that is assigned to the medicated feed daily

ration, if zkrmováno is not medicated feed as a single feed,



the name or names), surname and place of business of the manufacturer

Medicated feed, in the case of a natural person, or the name and address,

in the case of a legal person,



l) guidelines for breeders, including special warnings,



m) release date regulation for medicated feed,



n) the indication "production or putting into circulation of medicated feed cannot be

This prescription for medicated feed repeat "



o) stamp that contains the name or name, surname and place of

business, or place of practice prescribing veterinarian.

doctor; If the veterinarian performs professional veterinary

^ 5) activities as an employee of a natural or legal person authorized to

to carry out professional activities ^ 5), it is reported along with the name,

the names, forenames and, where appropriate, instead of the regular provision of veterinary

care for this person, in the case of a natural person, or the name and address, in the case of

legal person, and



p) signature of veterinarian prescription for a medicated feedingstuff

posted by.



(2) a prescription for a medicated feedingstuff shall be drawn up according to the model prescription

for medicated feed, which shall be published by the Institute for State control

Veterinary Biologicals and medicaments in its information resource.



(3) Regulation for the manufacture of medicated feedingstuffs shall draw up a veterinarian

in five copies. A copy of the veterinarian, who shall keep the

prescription for a medicated feedingstuff issued, the other 4 copies of the prescription

for medicated feed passes veterinarian manufacturers of medicated

feed.



(4) the manufacturer shall keep a copy of the medicated feed regulation for

Medicated feed, one copy of any use, for

means of data transmission, regional Veterinary Administration, that is locally

the appropriate holding of medicated feed should be used, and two

copies to the distributor of medicated feed. In the case that

the manufacturer ensures the distribution itself it made medicated feed,

It also holds the copy intended for the Distributor.



(5) a Distributor of medicated feed, or a manufacturer that provides

distribution of medicated feed, a copy of the regulation for

Medicated feed stores and the other, passes to the person referred to in

paragraph 1 (b). e). If the beneficiary is medicated feed animal

the doctor who issued the prescription for a medicated feedingstuff, passes it when

the use of medicated feed.



(6) the veterinarian may ask the manufacturer to provide copies of the

copy of the prescription for a medicated feedingstuff with a view to their transmission to the

in accordance with paragraphs 3 to 5; This fact shows the veterinarian at the

prescription for a medicated feedingstuff. In this case, it draws up a veterinary

the doctor only 2 copies of the prescription for a medicated feedingstuff. The manufacturer's

make copies of the submitted for medicated feed shall ensure

the copies were legible and intact.



(7) in the event that the manufacturer of the medicated feed is a person established in another

Member State than in the Czech Republic and if it produced distribution

Medicated feed ensures the distributor, the liability of the manufacturer for

treatment with medicated feedingstuffs referred to in paragraph 6 to ensure

distributor of medicated feed.



section 20



Retention regulations for medicated feed



(1) a veterinarian prescription for a medicated feedingstuff,

breeder, that the medicated feedingstuff used shall keep relevant

copy of the prescription for a medicated feedingstuff for at least 5 years from the date of

his exposure.



(2) medicated feed Manufacturers and distributor of medicated feed

keep the appropriate copy of the prescription for a medicated feedingstuff in accordance with

requirements laid down in ordinances ^ 18).



section 21



Particulars to appear on prescription for veterinary autogenous vaccines



(1) Prescription for veterinary autogenous vaccine contains:



and, where appropriate,) the name, first name, surname and place of business, or a place

the performance practice of the prescribing veterinarian



b) indication or reason to use,



(c) the designation of the antigens or pathogens), from which it is to be autogenous vaccine

made,



d) address and registration number of the holding from which they have to be removed

antigens or pathogens for the production of veterinary vaccines oxyacetylene; in

If the antigens or pathogens have been removed pursuant to § 71 para. 5

the law on pharmaceuticals, the holding and the site from which the

antigens or pathogens have been removed, and the date of such a collection,



e) species and category of animals for which a veterinary autogenous vaccine

designed,



(f)) number of doses of the vaccine or the veterinary autogenous quantity

to be made,



g) a special warning to be given on the packaging or in the package insert

autogenous vaccines, veterinary information



h) stamp that contains the name or name, surname and place of

business, or place of practice prescribing veterinarian.

doctor; If the veterinarian performs professional veterinary

^ 5) activities as an employee of a natural or legal person authorized to

to carry out professional activities ^ 5), it is reported along with the name,

the names, forenames and, where appropriate, instead of the regular provision of veterinary

care for this person, in the case of a natural person, his or her name and address,

in the case of a legal person, and



I) signature of veterinarian prescription for veterinary oxyacetylene

the vaccine issue.



(2) Prescription for veterinary autogenous vaccine exposes the


the attending veterinarian, in three copies, one of which you

leaves and 2 copy must provide veterinary autogenous vaccines.

The manufacturer shall keep a copy of's and a copy of the passes,

the possible use of funds to transfer data, the regional veterinary

the Administration, in which the circumference of the scope of the veterinary autogenous vaccine

used.



(3) the veterinarian may ask the manufacturer of the veterinary oxyacetylene

the vaccine to provide a copy of the copy of the prescription for health

autogenous vaccine in order to pass them in accordance with paragraph 2; This

indicated on the prescription of a veterinarian for veterinary

autogenous vaccine. In this case, it draws up a veterinarian only

2 copy of the prescription for veterinary autogenous vaccine. The manufacturer's

make copies of the passed prescription for veterinary autogenous vaccine

shall ensure that the information on the copies were legible and intact.



section 22



Retention regulations for veterinary autogenous vaccines



(1) a veterinarian prescription for veterinary autogenous vaccine

issued, this Regulation shall keep, for at least 5 years from the date of its

exposure.



(2) the manufacturer of a veterinary prescription for autogenous vaccine stores

Veterinary autogenous vaccine according to the requirements laid down in other legal

^ Regulation 19).



Article 23 of the



The prescription of medicinal products with a view to their distribution to farmers



(1) the Recipe, on the basis of the medicinal products to be distributed

breeders in accordance with § 77 para. 1 (b). (c) section 8 of the Act) on pharmaceuticals (

"the recipe for distribution to the producer"), cannot be used for recurring

issue.



(2) the Recipe for the distribution of breeders attending veterinary exposes

doctor.



(3) The recipe for the distribution of breeders can only be prescribed by a veterinary

a medicine that



and) is not a product containing antibiotics or chemotherapy, which

It is in accordance with the decision on registration of the intended for injection route of administration,



(b)) is not limited to its use by a veterinarian under section 40

paragraph. 5 of the law on pharmaceuticals,



(c)) is not limited in circulation or in its use by another

^ law 20),



(d)) is not the immunological veterinary medicinal product which contains the

live the originator of diseases or diseases transmissible from animals to humans ^ 5) or

preparation for the preventive vaccination of animals against diseases and illnesses

transmissible from animals to humans, that are included on the list of diseases and

diseases transmissible from animals to humans, the animals shall not be

preventively vaccinated ^ 5),



(e)) does not contain addictive substance or precursor in accordance with other legal

prescription ^ 21),



(f)) has the marketing authorisation given species of animal for which it is

prescribed.



(4) The recipe for the distribution of breeders can prescribe a veterinary medicinal

product, the issue is subject to medical prescription, not exceeding in

quantity corresponding to the need for treatments prescribed by the treating

veterinarian, for a period not exceeding 28 days. The disposal of the

emergency treatment can be prescribed the veterinary medicinal product in

the amount not exceeding the average weekly use in the

economy.



(5) in addition to requirements referred to in § 17 paragraph 2. 2, and in section 18 para. 1

includes a recipe for the distribution of breeders on



and) address and registration number of the holding ^ 5), for which the veterinary

medicinal product is intended,



(b)) medical diagnosis or reason for prescription of veterinary medicinal

of the product,



(c)) the number and category of animal for which the veterinary medicinal product

specified.



(6) when prescribing medicinal products on prescription for distribution

keeper of the attending veterinarian will fill the first sheet, and a copy of the two.

The first copy of the first sheet, and passes the prescribing veterinarian

breeders. The second copy retained by the veterinarian. Breeder's

the first sheet keeps the original and the copy passes upon delivery of the Distributor

veterinary medicinal products. Breeder, veterinarian and

the distributor shall keep the recipe or its copy in accordance with the requirements of

laid down in § 9 para. 11 of the law on medicinal products.



(7) The determination of the period of validity of the recipe for the distribution of breeders with

§ 14 para. 1 apply mutatis mutandis.



PART FOUR



TRANSITIONAL AND FINAL PROVISIONS, THE CANCELLATION



section 24



Transitional provisions



Existing prescriptions may be used if they are prescribing

doctor accompanied by the relevant information in accordance with this Ordinance, to

depleting the existing stocks.



§ 25



Regulation (EEC)



Shall be repealed:



1. the Decree of the Ministry of health no. 343/1997 Coll., which

Specifies how the prescription of medicinal products, the particulars of medical

the rules and the rules for their application,



2. the Decree of the Ministry of health no. 157/2001 Coll., amending the

Decree of the Ministry of health no. 343/1997 Coll. laying down

how the prescription of medicinal products, the particulars of medical

the rules and the rules for their application,



3. Decree No. 30/2003 Coll., amending Decree of the Ministry of

health care no 343/1997 Coll. laying down the method of prescribing

medicinal products, the particulars of prescriptions and their rules

of use, as amended by Decree No. 157/2001 Coll.



4. Decree No. 34/2004 Coll., amending Decree of the Ministry of

health care no 343/1997 Coll. laying down the method of prescribing

medicinal products, the particulars of prescriptions and their rules

of use, as amended,



5. Decree 643/2004 Coll., amending Decree of the Ministry of

health care no 343/1997 Coll. laying down the method of prescribing

medicinal products, the particulars of prescriptions and their rules

of use, as amended,



6. Decree 301/2006 Coll., amending Decree of the Ministry of

health care no 343/1997 Coll. laying down the method of prescribing

medicinal products, the particulars of prescriptions and their rules

of use, as amended.



section 26



Final provision



This Decree shall take effect on the date of its publication.



Minister:



Mudr. Julínek, MBA in r.



Annex 1



PATTERN RECIPE on medicines containing narcotic substances included in

list I ^ 2) and psychotropic substances included in list II ^ 3) and its

first and the second by a self-copying process



Annex 2



The pattern of the requisition on medicines containing narcotic substances of list I and

psychotropic substances list II and its first to third a self-copying process



Selected provisions of the novel



Article. (II) Decree 405/2008 Coll.



Transitional provision



For a period of two years from the entry into force of this decree can be used on the recipe site

the age of the patient to indicate the date of his birth.



1) Article. 1 (1). 19 of the European Parliament and Council Directive 2001/83/EC of

January 6. November 2001 on the Community Code concerning

medicinal products, as amended by Directive 2002/98/EC, 2003/63/EC, the

2004/24/EC and 2004/27/EC and European Parliament and Council Regulation (EC) No.

1901/2006. Article. 1 point 21 directive of the European Parliament and of the Council

2001/82/EC of 6 May 1999. November 2001 on the Community code relating to

veterinary medicinal products, as amended by Directive 2004/28/EC.



2) Annex No. 1 of the law No. 167/1998 Coll. on addictive substances and amending

certain other acts, as amended.



3) Appendix 5 Act No. 167/1998 Coll., as amended.



5) Act 166/1999 Coll., on health care and on amendments to certain

related laws (health law), as amended.



6) § 81 of Act No. 378/2007 Coll., on pharmaceuticals and on changes of some

related laws (law on medicinal products).



7) Act 227/2000 Coll., on electronic signature and amending certain

other laws (the law on electronic signature), as amended

regulations.



8) section 13 of Act No. 167/1998 Coll., as amended.



9) Act 48/1997 Coll., on public health insurance and amending and

certain related laws, as amended.



10) § 32 Act No. 378/2007 Coll.



11) section 11 (b). (d) Act No. 378/2007) Sb.



12) § 3 (1). 1 of law No 378/2007 Sb.



13) § 2 (b). and) Act No. 167/1998 Coll., as amended.



14) Act 95/2004 Coll., on conditions for the acquisition and recognition of professional

competence and specialized competence to perform the medical

the professions of doctor, dentist and pharmacist, as amended by Act No.

125/2005 Sb.



15) § 2 (2). 6 of Act No. 378/2007 Coll.



16) § 2 (2). 5 of law No 378/2007 Sb.



section 74 paragraph 17). 7 of law 378/2007 Coll.



18) for example, § 73 and 74 of the Act No. 378/2007 Coll.



19) for example, § 71 and 72 of Act No. 378/2007 Coll.



20) Decree No. 291/2003 Coll., on the ban on the feeding of certain substances

animals, whose products are intended for human consumption, and tracking

(monitoring of the) presence of illicit substances, residues and substances

contaminants to which animal products could be harmful to the

the health of humans, animals and their products, as amended

regulations.




21) Act 167/1998 Coll., as amended.



22) European Parliament and Council Regulation (EC) No 273/2004 on

drug precursors.



23) implementing the directive Commission 2012/52/EU of 20. December 2012,

laying down measures to facilitate the recognition of prescriptions

issued in another Member State.