Decree No. 100 / 2012 Coll.
Ordinance on the prescribing and handling of medical devices
Valid
Effective from 01.04.2012
100
DECLARATION
of 22 March 2012
on the prescription and handling of medical devices
According to Article 17 (1) of Act No. 123 / 2000 Coll., on Medical Devices and on the Amendment of Certain Related Acts, as amended by Act No. 130 / 2003 Coll. and Act No. 375 / 2011 Coll.:
Method of prescribing medical devices
(1) For the prescription of a medical device, a doctor (hereinafter referred to as "prescribing physician ') uses medical prescriptions which are vouchers and orders.
(2) The voucher should be used when prescribing a medical device to a specific patient when providing outpatient care,
(a) if the medical device is wholly or partly covered by public health insurance; or
(b) in the case of a medical device which is directly or indirectly liable to endanger human health (1).
(3) The order is to be used when prescribing medical devices to an indefinite patient group for the purpose of providing health services in the case of medical devices which may directly or indirectly endanger human health.
(4) Only characters or elements which do not restrict the legibility of the completed data and which do not contain data on other health service providers may be placed on the prescription.
(5) The medical prescription may be provided with protective features against its misuse.
(6) Only completed medical prescription forms can be obtained by printing the stamp of the health service provider (2).
Forms of the voucher for a covered medical device
(1) In the case of the prescription of a medical device wholly or partly covered by public health insurance, the following information shall appear on the voucher:
(a) the designation of the health insurance undertaking by a code number;
(b) the name and, where appropriate, the name and surname of the patient, the address of the patient's whereabouts, the patient's telephone number, if the patient agrees; the number of the insured person, if assigned; if the insured person's number has not been allocated, the date of birth; in the case of the Prison Service of the Czech Republic, the name and address of the prisoner, the address and address of the patient convicted for the offence and the name of the prison and the patient in charge of security detention, the address and name of the institution for the performance of security detention; a voucher issued at the request of a patient who intends to use it in another Member State shall always indicate the date of birth in addition to such information,
(c) the prescribed medical device, the name under which the medical device is placed on the market, the code under which the medical device is registered by the relevant health insurance undertaking, and the number of packages in the case of a mass-produced medical device;
(d) an individual design of the characteristics of the medical device and the code under which the medical device is registered by the relevant health insurance undertaking, where it is a custom medical device;
(e) the diagnosis of the patient for whom the medical device is prescribed; the diagnosis is given using the International Disease Classification Code,
(f) the stamp of the health service provider containing:
1. if it is a natural person, name and surname of the health service provider, the address of the place of provision of the health services, the identification number of the place of work of the healthcare establishment, if assigned by the health insurance undertaking, and the telephone number; or
2. if it is a legal person, name or business name, registered office, place of health services, identification number of the place of work of the healthcare establishment, if assigned by the health insurance company, and telephone number,
(g) the name and, where appropriate, the names of the prescriber, written in block letters or names; the voucher issued at the request of a patient who intends to use it in another Member State shall also show the professional qualifications and contact details, which are e-mails, telephone or fax, indicating the international choice and the indication "Czech Republic '; and
(h) the signature of the prescriber and the date of issue of the voucher.
(2) If the reimbursement of the medical device is linked to the approval of the medical examiner of the relevant health insurance company, then the medical examiner
(a) shall indicate on the front of the voucher the endorsement "Approved by the revision doctor," the date of approval, the signature and the stamp of the authorising inspector; or
(b) issue written consent to the repeated prescription of medical devices; the written consent shall be entered in the patient's medical file within 14 days at the latest. On the front of the voucher issued under the written consent of the medical examiner, the prescriber shall state the endorsement "Approved by the medical examiner."
(3) If it is a medical device, the payment of which is subject to approval by the medical examiner of the relevant health insurance company and the prescribing doctor is the doctor of the Czech Prison Service, the medical certificate is sent to the medical examiner of the relevant health insurance company for confirmation by that doctor. Otherwise, paragraph 2 (b) shall be followed.
Forms of the voucher on a medical device which may directly or indirectly endanger human health
(1) In the case of prescribing a medical device which may directly or indirectly endanger the health of a person who is also covered in full or in part by public health insurance, the information provided for in Section 2 shall be provided on the voucher.
(2) In the case of the prescription of a medical device which may directly or indirectly endanger the health of a person not covered by public health insurance, the following information shall appear on the voucher:
(a) the name and, where applicable, the patient's name and surname, the address of the patient's whereabouts, the patient's telephone number, if the patient agrees; the year of birth of the patient; in the case of the Prison Service of the Czech Republic, the name and address of the prisoner, the address and address of the patient convicted for the offence and the name of the prison and the patient in charge of security detention, the address and name of the institution for the performance of security detention; a voucher issued at the request of a patient who intends to use it in another Member State shall always indicate the date of birth in addition to such information,
(b) the prescribed medical device, the name under which the medical device is placed on the market, the detailed identification and the number of pieces;
(c) the words "Castle Patient,"
(d) the diagnosis of the patient for whom the medical device is prescribed; the diagnosis is given using the International Disease Classification Code,
(e) the stamp of the health service provider containing:
1. if it is a natural person, name and surname of the health service provider, the address of the place of provision of the health services, the identification number of the place of work of the healthcare establishment, if assigned by the health insurance undertaking, and the telephone number; or
2. if it is a legal person, name or business name, registered office, place of health services, identification number of the place of work of the healthcare establishment, if assigned by the health insurance company, and telephone number,
(f) the name and, where applicable, the names of the prescribing doctor, written in block letters or names; the voucher issued at the request of a patient who intends to use it in another Member State shall also show the professional qualifications and contact details, which are e-mails, telephone or fax, indicating the international choice and the indication "Czech Republic '; and
(g) the signature of the prescriber and the date of issue of the voucher.
Order details
(1) The order for a medical device contains the following information:
(a) the prescribed medical device, the name under which the medical device is placed on the market, the detailed identification and the number of pieces;
(b) the stamp of the health service provider containing:
1. if it is a natural person, name and surname of the health service provider, the address of the place of provision of the health services, the identification number of the place of work of the healthcare establishment, if assigned by the health insurance undertaking, and the telephone number; or
2. if it is a legal person, name or business name, registered office, place of health services, identification number of the place of work of the healthcare establishment, if assigned by the health insurance company, and telephone number,
(c) the name and, where applicable, the names of the prescribing doctor, written in block letters, or a name, unless the prescribing doctor is the provider of health services as referred to in point (b) (1); and
(d) the signature of the prescriber and the date of issue of the order.
(2) The order can be issued in electronic form. If the order is sent by the health service provider to a pharmacy connected to its local computer network, it shall be provided only with the health service provider's health service provider's certification code. If the order is sent by the health service provider to a pharmacy which is not connected to its local computer network, it shall be accompanied by a guaranteed electronic signature of the health service provider. The order shall contain the particulars referred to in paragraph 1, except for the stamp of the health service provider and the signature of the prescriber.
Duration of medical prescription
(1) A voucher containing the prescribed medical device may be used within 90 days of the date of its issue, unless the prescribing physician determines otherwise with regard to the patient's medical condition or the nature of the medical device.
(2) An order for a prescribed medical device may be made within 1 year of the date of issue.
Informing the patient
The person issuing the medical device shall provide the patient with the information necessary for the correct and safe use and basic maintenance of the medical device.
Medical voucher
(1) The medical device prescribed on the voucher is issued by a pharmacy (3) or by a person authorised to do so on the basis of a contractual relationship with the health insurance (4).
(2) If the quantity or type of medical devices prescribed is not available for the person authorised to issue the medical device, that person shall issue an extract of the voucher bearing the name "Extract 'on the missing medical device. The voucher extract shall contain the original voucher particulars; the original voucher shall be marked with the word" extract taken'. Paragraph 5 (1) shall apply mutatis mutandis to determine the period of validity of the extract.
(3) In the absence of a prescribed medical device for the person authorised to dispense the medical device and its immediate issue is necessary in view of the patient's medical condition, the issuing pharmacist or pharmaceutical assistant for medical devices (5) may replace the prescribed medical device with another medical device provided that the patient agrees and the replacement medical device is interchangeable. The issuer shall indicate the change made on the voucher. According to the first and second sentences, it is not possible to use the "Do not confuse 'note if the prescriber is to provide the voucher.
Order No
When issuing a medical device prescribed for an order, the doctor who issued the order shall confirm in writing the receipt or, to the extent that he is fit to pursue the medical profession without professional supervision, by an authorised healthcare professional (5).
Transitional provision
If a medical prescription has been issued before the date of entry into force of this Decree, a medical device shall be issued in accordance with existing legislation.
Efficacy
This Decree shall take effect on 1 April 2012.
Minister:
Doc. MUDr. Heger, CSc., v. r.
1) Decree of the Government No. 342 / 2000 Coll., establishing medical devices which may endanger human health.
2) § 2 of Act No. 372 / 2011 Coll., on Health Services and the Conditions for Their Provision (Health Services Act).
3) Act No. 372 / 2011 Coll., on Health Services and the Conditions for Their Provision (Health Services Act).
4) Article 17 (7) of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended by Act No. 369 / 2011 Coll.
5) Act No 95 / 2004 Coll., on the conditions for obtaining professional competence and specialised competence for the exercise of the medical profession of doctor, dental practitioner and pharmacist, as amended. Act No. 96 / 2004 Coll., on the conditions for acquiring and recognising the competence to pursue non-medical health professions and to carry out activities related to the provision of health care and amending certain related laws (Law on non-medical health professions), as amended.
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Regulation Information
| Citation | Decree No. 100 / 2012 Coll., on prescribing and handling of medical devices |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.03.2012 |
|---|---|
| Effective from | 01.04.2012 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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