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.
