Decree of the Ministry of Health No 343 / 1997 Coll.
Decree of the Ministry of Health laying down the procedure for prescribing medicinal products, the formalities for medical regulations and the rules for their use
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343
DECLARATION
Ministry of Health
of 12 December 1997
laying down the procedure for the prescription of medicinal products, the formalities for the prescription and the rules for their use
In agreement with the Ministry of Agriculture, the Ministry of Defence, the Ministry of Interior and the Ministry of Justice pursuant to § 75 (3) of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain related laws, hereinafter referred to as "the Act":
GENERAL PROVISIONS
Preliminary provisions
(1) This Decree of the Ministry of Health sets out, in accordance with the law of the European Communities, the procedure for prescribing medicinal products, the formalities for prescription and the rules for their use.
(2) Medical prescription1a) completed and signed
(a) prescription forms
1. medicinal products containing group I2) and psychotropic substances of group II; (3) the model of this form is set out in Annex 1 to this Decree,
2. medicinal products for human use, with the exception of medicinal products containing narcotic substances in Group I2) and psychotropic substances in Group II, 3) for the purpose of providing health care, the model of the prescription form is set out in Annex 3 to this Decree,
3. veterinary medicinal products and medicinal products for human use, with the exception of products containing I2) and Group II psychotropic substances, 3) for the purpose of providing veterinary care,
(hereinafter referred to as "the recipes'),
(b) orders of medicinal products, including transfusions of natural and legal persons authorised to provide healthcare (hereinafter referred to as "provider") and natural or legal persons authorised to carry out veterinary activities (4), for medicinal products, with the exception of medicinal products containing I2) and psychotropic substances of Group II, 3 (hereinafter referred to as "vouchers");
(c) the forms of applications for medicinal products containing I2) and psychotropic substances of Group II; (3) the model of this form is set out in Annex 2 to this Decree.
(3) In the event of the consent of a sick natural person to such a procedure, a medical prescription shall also be deemed to be:
(a) a medical prescription sent by the prescribing physician to the pharmacy in electronic form, accompanied by a guaranteed electronic signature based on a qualified certificate in accordance with a special legislation (4a), provided that it otherwise satisfies the requirements laid down in this Decree;
(b) a medical prescription sent within the local computer network of one medical establishment prescribing to a pharmacy by a pharmacy in electronic form, bearing a verification code assigned by the health establishment operator to ensure the recipe against its abuse, provided that it otherwise complies with the requirements laid down in this Decree.
Treatment of medical prescription forms
(1) Providers, veterinary surgeons, natural persons and legal persons authorised to carry out veterinary activity (4) shall ensure the prescription forms referred to in Article 1 (a) (2) and (3) for persons entitled to produce and distribute them. providers and health insurance companies with which they have entered into a health care contract (hereinafter referred to as "the relevant insurance undertaking ').
(2) The recipes and requests must be stored in such a way as to prevent their loss or theft and the possibility of their misuse. The loss or theft of the uncompleted form of the prescription must be notified without undue delay to the municipal authority of the municipality with extended scope and the nearest department of the Police of the Czech Republic; providers shall notify the loss or theft of those forms to health insurance companies and the regional authority responsible for the place of operation of the medical establishment.
(3) Uncompleted medical prescription forms may not bear the stamp of the provider, natural or legal person authorised to carry out veterinary activity (4) or the name of the doctor.
Handling of recipes and requests marked with blue stripe
(1) The recipes and applications forms marked with a blue stripe (§ 3 (4)) are subject to registration.
(2) The production and distribution of recipes and applications, marked with a blue stripe, are provided by the local competent municipal authorities with extended scope on the basis of orders from persons operating health or constitutional welfare facilities (4b), or by natural or legal persons authorised to carry out professional veterinary activities (4c) (hereinafter referred to as authorised persons), with the place of performance of these activities in the administrative districts of municipal authorities with extended scope, for which forms are ordered. The municipal authorities with extended scope on the basis of these orders will ensure the production of recipes and requests marked with a blue stripe by the contracted manufacturer.
(3) In order to ensure the smooth distribution of recipes and requests marked with a blue stripe, the municipal authorities of the municipalities with extended coverage of the contingency supply of these forms shall, within a maximum of one fifth of their total distribution for the previous calendar year.
(4) The recipes and applications forms marked with a blue stripe contain the particulars in accordance with the models set out in Annexes 1 and 2 and are taken from the manufacturer by an authorised staff member of the municipal office of the municipality with extended scope. The authorised staff member shall prove to the manufacturer on receipt of the forms in force by delegation and shall acknowledge receipt by signature and stamp of the municipal office of the municipality with extended scope.
(5) The municipal authority of the municipality, with the extended scope of the recipes and requests forms marked with a blue stripe, shall register and invite the authorised person to pick them up. Forms of recipes and requests marked with a blue stripe may be issued only to authorised persons through their authorised representatives by municipal authorities with extended scope. 4d)
(6) On the issue of the forms, the municipal office of the municipality shall keep a copy of the forms, which shall contain details of the number of forms issued, including the serial numbers of the forms and details of the person entitled. The receipt of the form shall be confirmed by the authorised representative on the original order and by the signature in the form book.
(7) Where authorised persons issue prescription forms and applications marked with a blue stripe to persons having an employment relationship or similar relationship, the holder shall keep a record of such expenditure in accordance with paragraph 6.
(8) Impaired prescription forms and requests marked with a blue stripe, including their subscriptions, shall be required to refer those forms to the authorised person for further action.
(9) The authorised person shall keep a record of the surrendered impaired recipes and requests marked with a blue stripe, including their signatures. Submitted impaired forms, including their subscriptions, on a date agreed with the local competent municipal authority of the municipality with extended scope, shall be submitted to that municipal authority of the municipality with extended scope for liquidation. The handover and disposal of degraded recipes and requests marked with a blue stripe, including their signatures, shall be obtained by the municipal authority of the municipality with extended application of the protocol record and certified by the authorised person to take over.
(10) Forms of recipes and requests marked with a blue stripe, including their signatures, returned to the municipal authorities of the municipalities with extended scope for the reasons set out in the specific legislation4e) shall be kept by the municipal authorities of the municipalities with extended scope of registration.
(11) Article 2 (2) and (3) shall apply mutatis mutandis to the handling of recipes and requests marked with a blue stripe.
PRESENTATION OF HUMAN MEDICINAL PRODUCTS
Method of prescription
(1) One prescription form may be used
(a) one type of medicinal product containing I2) or psychotropic substances of II, 3); or
(b) not more than two types of other medicinal products, if they do not contain I2) or Class II.3 psychotropic substances)
(2) A maximum of five types of medicinal products containing I2) or group II.3 psychotropic substances may be prescribed per application)
(3) When prescribing original packages of medicinal products for human use or doses of an individually prepared medicinal product, the number of packages or doses must be indicated on the recipe or on request in Roman numerals and in Latin words.
(4) Human medicinal products containing I2) and Class II3 psychotropic substances are prescribed for recipes and vouchers marked with a blue stripe.
(5) When prescribing the medicinal products referred to in paragraph 4 to recipes:
(a) complete the first sheet and two copies; the first sheet and the first copy are intended for the delivery of the prescribed medicinal product to the pharmacy,
(b) leaves a second subscription in the block of recipes used;
(c) indicate:
1. the particulars referred to in paragraphs 3 and 4 (1) to (4);
2. the concentration (strength) of the medicinal product, the package size and the complete instructions for its use.
(6) The prescription of the medicinal products referred to in paragraph 4 on the application form shall be treated mutatis mutandis in accordance with paragraph 5, with the completion of the first sheet of the application form and three signatures; the first sheet of the application form and the two signatures are intended for the delivery of the prescribed medicinal product at the pharmacy, the third copy is left in the block of the requested goods.
Recipe requirements
(1) Unless otherwise specified, the recipe must have the following particulars:
(a) the designation of the health insurance undertaking by a code number (hereinafter referred to as the insurance undertaking code) where the medicinal product is covered by public health insurance, 5)
(b) the name, surname, address of the sick natural person; if the insured person is ill, his identification number if the medicinal product is covered by public health insurance (5); where the medicinal product is not covered by public health insurance, the date of birth shall be indicated instead of the identification number;
(c) Regulation
1. the mass-produced medicinal product, by its protected name, under which it was authorised, (6) pharmaceutical forms, concentrations (strengths) and pack sizes,
2. an individually prepared medicinal product using the pharmaceutical names or their synonyms or abbreviations listed in the pharmacopoeia;
(d) the symbol shown on the front of the recipe
1. "(!)" if the maximum dose of the medicinal product intended for pharmaceutical use is intentionally exceeded, (7) the maximum dose exceeded must be written in Latin,
2. "R," if the physician persists in issuing the prescribed medicinal product,
3. "I" - if the medicinal product is fully covered by health insurance,
"C '- if the medicinal product is partly covered by health insurance,
"P" - if the medicinal product is fully covered by the patient,
4. "Emergency," if it is a prescription issued by first aid medical services including dental care or constitutional emergency services,
(e) instructions for use of the medicinal product,
(f) the stamp of the supplier containing:
1. the name, surname, address including the telephone number of the place of health care and the number allocated by the competent insurance undertaking in the case of a natural person;
2. the name (trade name), the registered office including the telephone number of the place where the health care is provided on a permanent basis and the number allocated by the competent insurance undertaking in the case of a legal person;
in the case of a recipe sent electronically pursuant to Article 1 (3) (a) or (b), the particulars shown on the stamp shall be printed on the recipe at the place designated for the stamp;
(g) the name and surname of the prescribing doctor, in block letters or by name, if the health care has been provided to the provider who is a legal person; and
(h) the signature of the prescriber and the date of issue; in the case of a prescription sent electronically pursuant to § 1 (3) (a), the signature of the prescribing doctor shall be replaced by its guaranteed electronic signature; in the case of a prescription sent electronically pursuant to § 1 (3) (b), the signature of the prescribing doctor is replaced by a verification code assigned by the medical operator. The electronic signature of the treating physician or his certification code shall be indicated on the prescription at the place designated for the signature of the treating physician.
(2) The recipe for medicinal products for human use whose reimbursement is restricted from a professional point of view, 5) issued by a doctor of other expertise, must:
(a) contain on the front page the particulars referred to in paragraph 1; and
(b) include on the back the name, surname and expertise of the physician who recommended the prescription of the medicinal product.
(3) The provider shall indicate on the recipe the symbol "P" whenever he prescribes a medicinal product fully borne by the patient. If the medicinal product is fully covered by health insurance, the provider may mark the "I" symbol on the recipe and, if the medicinal product is partly covered by health insurance, the "C" symbol on the recipe may be indicated by the provider.
(4) Prescription medicinal products are prescribed on behalf of the Ministry of Health, marked "Ministry of Health of the Czech Republic," if such payment results from an international contract for the Ministry of Health.
(5) If the dispensing of a medicinal product for human use is to be repeated, the recipe shall include, in addition to the particulars referred to in paragraph 3, information on the number of repeated outcomes. Each dispensation of this medicinal product must bear a pharmacy stamp on the recipe. Repeating the dispensation must not be indicated on the prescription for medicinal products containing narcotic substances, psychotropic substances, ephedrine or pseudoephedrine in excess of 30 mg per unit of pharmaceutical form.
(6) If the payment of a medicinal product for human use is linked to the approval of a revised medicine5) the relevant insurance undertaking must:
(a) the endorsement "I approve" on the back of the recipe, together with the signature of the physician and the stamp of the insurance undertaking concerned; or
(b) in the case of the receipt of its prior consent or approval of re-prescribing on the back of the recipe, the endorsement "Approved by the revised physician" shall be given, indicating its name, surname, name of the relevant insurance undertaking and date of granting of prior consent or consent to re-prescribing, together with the signature of the prescriber and the stamp of the provider in which the prescribing doctor provides medical care; the written consent of the medical examiner of the insurance undertaking concerned must be based on the medical records of the patient no later than 14 days.
(7) The recipe for medicinal products for human use prescribed by a doctor providing medical care to himself, his spouse, his parents, grandparents, children, grandchildren and siblings, where his expertise is guaranteed by the Czech Chamber of Medicine or the Czech Chamber of Dentistry, (7a) contains the particulars referred to in paragraphs 1 (a) to (e) and (g) to (h) and must be accompanied by a note "for the needs of the family."
Recipes issued in exceptional cases
(1) In cases of danger of delay in providing the necessary assistance to a natural person who is at risk of death or shows signs of a serious health disorder, the medicinal product may be prescribed, exceptionally, on another appropriate medium, information which shall include the following particulars:
(a) the entry "Delay hazards,"
(b) the name, surname, date of birth of the sick natural person, his identification number and the code number of the relevant health insurance undertaking in the case of a sick insured person, where that information is available;
(c) the prescription of the medicinal product for human use;
(d) instructions for use of the medicinal product,
(e) the date of issue;
(f) the name, surname and address of the permanent residence, in block letters, the signature of the prescriber and his identification number allocated by the competent insurance undertaking (if any).
(2) When providing the assistance referred to in paragraph 1, only medicinal products for human use which are necessary for the provision of such assistance and in the amount required for subsequent treatment by the provider may be prescribed.
Requires
(1) An application for medicinal products for human use must contain the following particulars:
(a) the name of the provider;
(b) Regulation
1. the mass-produced medicinal product, by its protected name, under which it was authorised, pharmaceutical forms, concentrations (strengths), pack sizes,
2. an individually prepared medicinal product using the pharmaceutical names or their synonyms or abbreviations listed in the pharmacopoeia;
(c) the number of packages or doses of a medicinal product for human use, written in Roman numerals and in Latin;
(d) the stamp of the supplier containing:
1. the name, surname, address, including the telephone number of the place where the health care is provided on a permanent basis, and the number allocated by the insurance undertaking concerned in the case of a natural person;
2. name (trade name), registered office including telephone number and number allocated by the competent insurance undertaking in the case of a legal person;
(e) the date of issue;
(f) the signature of the prescribing physician; and
(g) the signature of the head doctor of the provider's department if the provider is a legal person.
(2) An application for medicinal products for human use by electronic means must contain:
(a) the particulars referred to in paragraph 1 with the exception of points (d), (f) and (g);
(b) the name and surname of the prescriber; and
(c) the name and surname of the head doctor of the provider's department and his signature protected from abuse if he is a legal person.
(3) The requirements for medicinal products containing I2) and Class II3 psychotropic substances should not be applied by calculation techniques.
(4) The application for transfusions must contain the following particulars:
(a) name of provider, IČO, department, IČP,
(b) the name, surname, date of birth and, where appropriate, the natural number of the intended consignee of the transfusion preparation. Where the necessary data are not known, an indication clearly identifying the intended beneficiary shall be provided,
(c) reason for administration of the transfusion product or diagnosis,
(d) blood type [ABO and Rh (D)],
(e) transfusion history: previous transfusion, parturition, pregnancy, etc.,
(f) the type of transfusion preparation (namely listed), the number in pieces or TU, the day and hour of administration,
(g) any subsequent modification of the transfusion preparation (e.g. deleucotization, exposure, etc.),
(h) the stamp of the supplier;
(i) the date of issue of the application;
(j) the name, surname and signature of the physician requesting the transfusion.
(5) In case an immunohaematologic examination is required at the same time and a sample is provided, the following shall be indicated on the request for transfusion products in addition to the data referred to in paragraph 4:
(a) the type of test required (e.g. blood type examination, irregular antibodies, compatibility test);
(b) the date of sampling;
(c) the name of the person who took the sample;
(d) the code number of the health insurance undertaking of the recipient of the transfusion product.
The sample for laboratory examination must be unmistakable and the accuracy of the data must be verified by signing the person who took the sample.
(6) An application for transfusions applied by the computer shall include the particulars referred to in points (a) to (j) of paragraph 4, or points (a) to (d) of paragraph 5, where applicable, and the authorisation referred to in points (h) and (j) of paragraph 4 shall be established in another unambiguous manner.
Duration of medical prescription
(1) Recipe on
(a) antibiotics and antimicrobial chemotherapeutic agents shall be valid for three calendar days from the date of its exposure, except for medicinal products for local use;
(b) other medicinal products seven calendar days, unless otherwise specified by the prescribing physician, starting on the day of issue.
(2) The recipe for repeated delivery is valid for a maximum of 6 months from the date of issue.
(3) The recipe issued by the first-aid medical service is valid for a maximum of one calendar day following the day of its issue. The same period of validity also has a prescription issued under Section 5.
(4) A medicinal product application containing I2) and Class II3 psychotropic substances is valid for a maximum of seven calendar days from the date of its exposure.
Recipe extract
(1) If a pharmacy does not have the prescribed number of packages or if two types of medicinal products are prescribed on the recipe and if one of them is not available or cannot be obtained promptly, the pharmacist shall issue an extract of the prescription "Extract" on the missing medicinal product. Similarly, in the case of repeated expenditure pursuant to Article 4 (5), where the recipe is a necessary document for inspection purposes, the procedure shall be followed.
(2) The extract must contain the particulars of the original recipe. The original recipe shall bear the note "Extract received '.
(3) The provisions on the period of validity of the recipe shall apply to the extract of the recipe, except for repeated expenditure. the period of validity of the extract shall be calculated from the date of issue, except for repeated expenditure.
The recipes referred to in § 1 (2) (a) (1) and the vouchers referred to in § 1 (2) (c) shall be kept in accordance with the special legislation (8a).
PRESENTATION OF MEDICINAL PRODUCTS IN THE CZECH REPUBLIC 'ARMY AND THE CZECH REPUBLIC' PENSION SERVICES
Prescription of medicinal products for human use in the Czech Army
(1) Prescription of medicinal products for human use in the Army of the Czech Republic shall be carried out in accordance with this Order, unless otherwise specified.
(2) The stamp of the supplier on the recipe and the claim issued in the Army of the Czech Republic must contain the particulars referred to in § 4 (1) (f) (2) and § 6 (1) (d) (2); and
(a) the number and place of the body in which the recipe was issued; or
(b) the name "Crew Sick Bay" or "Crew Medical Station" and the place of the crew medical establishment; or
(c) the entry "First-aid Crew Medical Service" if the recipe has been issued by the first-aid military medical service.
Prescription of medicinal products for human use in the Czech Prison Service
When prescribing medicinal products for human use in the Prison Service of the Czech Republic, this decree is followed by the fact that in § 4 (1) (b) and § 5 (1) (b), instead of the address of a sick person,
(a) the accused of the offence shall state the name and place of the detention prison; and
(b) the convicted for the offence shall state the name and place of the prison.
PRESENTATION OF MEDICINAL PRODUCTS FOR THE PURPOSE OF PROVISION OF VETERINARY HEALTH
Method of prescription
Prescription of medicinal products for the provision of veterinary care shall be carried out in accordance with this Decree, except for the provisions of Sections 4 and 6.
Recipe requirements
(1) The completed form shall contain the following particulars:
(a) the name, surname and address of the breeder of the animal, if any; in the case of a legal person, the name (trade name) and registered office;
(b) the type of animal;
(c) Regulation
1. the mass-produced medicinal product, by its protected name, under which it was authorised, (6) pharmaceutical forms, concentrations (strengths) and pack sizes,
2. an individually prepared medicinal product using pharmaceutical names and abbreviations,
(d) instructions for use;
(e) the date of issue;
(f) an imprint of the stamp containing the name and, where applicable, the name, surname (s) and place of business of the prescribing veterinarian; where the veterinarian carries out a professional veterinary activity (9) as an employee of a natural or legal person authorised to carry out a professional veterinary activity, the name, surname and permanent residence of that person, if any, or the name and address of the legal person; and
(g) the signature of the veterinarian.
(2) The period of validity of the recipes referred to in paragraph 1 is governed by Article 7.
(3) Handling in pharmacies of the recipes for veterinary medicinal products containing the substances of Group I2) and psychotropic substances of Group II3) is governed by Sections 3 (5) and 3 (6) of this Decree.
Requirements for medicated feed and handling
(1) The prescription for medicated feeding10) contains at least the following elements:
(a) the name, surname and place of business of the prescribing veterinarian;
(b) the name of the medicated premixture to be used for the manufacture of medicated feed, including the indication of strength;
(c) concentration of active substance in medicated feed;
(d) the name, surname and place of business of the breeder of the animal to which the medicated feed is to be used, if it is for a natural person, or the name and address of the legal person;
(e) the name, surname and place of business of the person receiving the medicated feed, if any, or the name and address of the natural person (§ 41k (13) of the Act);
(f) identification of the holding, (4) where the medicated feed is to be used;
(g) the species, category and number of animals for which medicated feed is to be produced,
(h) therapeutic (preventive) indications;
(i) the quantity of medicated feed;
(j) the method and time of feeding of medicated feed, including the frequency of administration and the quantity in which medicated feed is included in the daily ration, unless medicated feed is fed as a single feed;
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Regulation Information
| Citation | Decree of the Ministry of Health No 343 / 1997 Coll., laying down the procedure for prescribing medicinal products, the formalities for medical regulations and the rules for their use |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.12.1997 |
|---|---|
| Effective from | 01.01.1998 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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