Decree No. 522 / 2021 Coll.
Decree amending Decree No. 329 / 2019 Coll., on the Prescription of Medicinal Products for the Provision of Health Services, as amended by Decree No. 53 / 2020 Coll.
Valid
Order
Effective from 01.01.2022
Text versions:
01.01.2022
23.12.2021
522
DECLARATION
of 16 December 2021
amending Decree No 329 / 2019 Coll., on the prescription of medicinal products for the provision of health services, as amended by Decree No 53 / 2020 Coll.
The Ministry of Health sets out, pursuant to Article 114 (1) of Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Act No. 262 / 2019 Coll. and Act No. 366 / 2021 Coll., and § 81e Sb., and § 13 (d) of Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll., Act No. 44 / 2019 Coll., Act No. 262 / 2019 Coll. and Act No. 81e Sb., and § 44c. 5 of Act No. 167 / 1998 Coll., Act No. 5 Sb. (a) and (f) to (h), § 81 (4), and § 81a (b), § 81e Sb.
Regulation No 329 / 2019 Coll., on the prescription of medicinal products for the provision of health services, as amended by Decree No 53 / 2020 Coll., is amended as follows:
1. in Article 1 (l) and (m):
"(l) the extent of the data needed to create, modify and delete the vaccination record;
(m) the way in which the requirements for the establishment, modification and cancellation of the vaccination record are sent. ';
2. At the end of § 1, the dot is replaced by a comma and the following points (n) to (r) are added:
"(n) the extent of the information given in the extract of the vaccination carried out and its form;
(o) the model of the blue stripe recipe, which is displayed in paper form, and the model of the blue stripe demand, which is displayed in paper form,
(p) the particulars given on the blue-striped recipe, which shall appear in paper form, its period of validity and the rules governing its use;
(q) data provided on requests with a blue stripe, which is displayed in paper form, its period of validity and the rules governing its use;
(r) the rules and method of distribution, record keeping, return and disposal of recipes and blue stripe requests. ';
3. In Paragraph 3, the sentence "This procedure shall not apply when a doctor or pharmacist accedes to eRecept through the National Identification and Authentication Point is added at the end of paragraph 4. '.
4. In Article 5 (1), the following point 5 is added at the end of point (c):
"5." highly addictive substance, "if it is a recipe for a substance-containing medicinal product listed in Annex 1 or Annex 5 to the Government Regulation on substance-containing lists which are not listed in Annex 8 to the Government Regulation on substance-containing substances,"
5. In Paragraph 5 (4), the comma at the end of point (c) is replaced by a dot and point (d) is deleted.
6. In Article 5, at the end of paragraph 6, the sentence "The requirement to create an electronic recipe for a substance-containing medicinal product listed in Annex 1 or 5 to the Government Ordinance on substance-containing lists which are not listed in Annex 8 to the Government Ordinance on substance-containing substances shall not contain more than one type of medicinal product."
7. In Paragraph 7 (1), the word "sent 'is replaced by" stored in' and the word "received 'is replaced by" created'.
8. In Paragraph 9, the following paragraph 2 is inserted after paragraph 1:
"(2) The electronic recipe, which contains the flag" highly addictive substance, "shall be valid for 14 calendar days starting on the day following its issue, unless otherwise specified by the prescribing physician, but not more than 30 calendar days."
Paragraphs 2 to 4 shall become paragraphs 3 to 5.
9. In Section 9 (3), the words "Recurrent recipe 'are replaced by the words" Electronic recipe containing the flag "Recurrent recipe', '.
10.
Verified eRecept output
(1) When requesting the issuance of a certified eRecept output, the patient should select in the case of a certified output containing data relating to each
(a) to a patient prescribed an electronic recipe or an electronic voucher which has been created in a patient of the chosen period, the period for which he requests to create a verified output, indicating the date, month and year of the beginning and end of that period, and whether the validated output should contain only data on electronic recipes, only on electronic vouchers, or both; the validated eRecept system output also contains data from recipes exposed to the patient in paper form, which have been transferred to electronic storage in the patient's chosen period (11); or
(b) a record of the vaccination of a patient who was created in the patient's chosen period, the period for which he requires the verified output to be created, indicating the date, month and year of the beginning and end of that period.
(2) The verified eRecept output referred to in paragraph 1 (a) contains:
(a) the name and, where appropriate, the name, surname and date of birth of the patient;
(b) the selected period during which the verified output was created;
(c) details of the electronic recipe and the electronic record to the extent
1. the date of creation, the identifier, the flag referred to in Article 5 (1) (c) and the number of repetitions in case it is a repetitive recipe;
2. the name and, where applicable, the name of the prescriber, the name of the health service provider;
3. the name, type, pharmaceutical form, strength, package size, amount and instructions for use of the prescribed medicinal product,
4. an indication of whether the electronic recipe has already been delivered or if the electronic recipe has been cancelled,
5. the date of issue of the prescribed medicinal product, the name and address of the pharmacy where the medicinal product was delivered, the quantity of the medicinal product delivered and its name, if different from that prescribed,
(d) electronic voucher details to the extent
1. date of creation and identifier,
2. the name and, where applicable, the name of the prescriber, the name of the health service provider;
3. the code, name, group, type and quantity and, where applicable, other information relating to the group of prescribed medical devices;
4. an indication of whether the electronic voucher has already been issued or if the electronic voucher has been cancelled,
5. the date of issue of the prescribed medical device, the name and address of the dispenser at which the dispenser was issued, the quantity of medical device issued and its name, if different from the prescribed medical device.
(3) The verified eRecept output referred to in paragraph 1 (b) contains:
(a) the name and, where appropriate, the name, surname and date of birth of the patient, the insured person's number, if allocated, and the number and type of electronically readable patient identification documents;
(b) the selected period during which the verified output was created;
(c) a unique alphanumeric indication of the vaccination record and the date of its creation;
(d) the name and, where applicable, the names of the doctor and the identification of the health service provider;
(e) the name of the applied human immunological medicinal product, including the indication of the disease against which the product is intended, the lot and the order of the dose applied,
(f) the date of application of the immunological medicinal product for human use and, where appropriate, the scheduled date of administration of the following dose, if applicable, if it is a multi-dose immunological medicinal product for human use. "
11. The following Sections 12a to 12e are inserted after Section 12:
Scope of data needed to create a vaccination record
(1) In the request for a vaccination record, in relation to a patient to whom a medicinal product has been administered by a doctor for immunological use, the following information should be provided:
(a) the indication of the patient's health insurance by a code number, if the vaccination is to be covered by public health insurance (5), or a sign that the reimbursement of the medicinal product results from an international agreement or other legislation6),
(b) the name and, where appropriate, the name, surname, birth number and address of the patient's permanent residence, and, if he is not resident, the address of the patient's residence;
(c) the number of insured persons (5), if allocated; if the insured person's number has not been assigned to the patient or if the insured person's number cannot be determined by his age, the date of birth of the patient,
(d) the e-mail address and patient telephone number provided by the patient to the physician for the purpose of sending information from the central repository of vaccination records.
(2) The requirement to establish a vaccination record shall include, in relation to the vaccination carried out:
(a) the date of vaccination carried out and, where appropriate, the planned date of the subsequent dose;
(b) method of payment, by stating the words:
1. "paid by the patient," if vaccination is not to be covered by public health insurance,
2. "insurance undertaking" means a medicinal product to be covered by public health insurance,
3. "to be reimbursed by the State," if the medicinal product is to be covered by the State budget,
(c) the name of the applied human immunological product, including the indication of the lot;
(d) the journey, place and side of the application,
(e) an indication of whether the vaccination carried out was carried out on a regular, special, exceptional or voluntary basis.
(3) The requirement to create an alert on vaccination should include, in relation to the doctor and the health service provider:
(a) identification of the health service provider to the extent
1. the name and, where applicable, the surname of the doctor, the address including the telephone number, the place of provision of the health services, the name of the workplace and the identification number allocated by the health insurance company, if the health insurance company is a natural person; or
2. name or business name, registered office including telephone number, place of provision of health services, place of work name and identification number assigned by the health insurance undertaking, if the health insurance undertaking is to conclude a contract, if it is a legal person,
(b) the name and, where applicable, the name of the doctor, and the surname of the doctor if the health care has been provided to the health service provider who is a legal person or who is a natural person.
(4) The requirement to create a vaccination record may contain only one application of the immunological medicinal product for human use.
Method of sending requirements for a vaccination alert
(1) The requirement to create a vaccination record is sent by the doctor to the eRecept system, giving the information referred to in § 12a, in accordance with § 3.
(2) After receiving the set of data necessary to create a vaccination record, eRecept will create a vaccination record.
(3) The eRecept system will send a confirmation, through its information system, of the creation of the vaccination record, processing and storage to the doctor via a web or mobile application. A unique alphanumeric tag of the eRecept log is part of the sent confirmation and information on whether the patient has been successfully identified against the population registry.
Change of vaccination record
(1) In order to correct the data on the vaccination record, the doctor may amend the vaccination record stored in the eRecept system for which the eRecept system has confirmed its creation.
(2) The requirement to modify the vaccination record is sent by the doctor of the eRecept system, indicating its alphanumeric marking and the data that is changed. Once the vaccination record has been established, the identification of the doctor, the health service provider and the date of its issue may not be changed in the vaccination record.
(3) Information on the modification of the data of the vaccination record shall be stored and returned by the eRecept system to the physician through its information system, web or mobile application, a confirmation that the required change to the vaccination record has been made.
Repeal of the vaccination record
(1) The vaccination record established in the eRecept system may be cancelled by the doctor if new facts are found unknown at the time the alert is created or if structured data are missent in order to create an eRecept record.
(2) The requirement to cancel the vaccination record is sent by the doctor of the eRecept system, indicating its alphanumeric marking.
(3) The record of the vaccination for which the cancellation request has been sent shall be marked by the eRecept system as cancelled.
(4) The eRecept system will, by turn, send a confirmation to the doctor via its information system, web or mobile application of the cancellation of the vaccination record.
List of vaccinations carried out
(1) The list of the vaccinations carried out is displayed by the eRecept system in PDF format.
(2) The extract of the vaccination carried out may be presented in the form of:
(a) a specific record of vaccination; or
(b) the list of vaccinations carried out after the patient's chosen period.
(3) The statement referred to in paragraph 2 (a) shall include:
(a) a two-dimensional barcode for unambiguous identification of the vaccination record;
(b) a unique alphanumeric indication of the vaccination record and the date of its creation;
(c) the name and, where applicable, the name, surname and date of birth of the patient and the number and type of electronically readable patient identification documents;
(d) the name and, where applicable, the names of the doctor and the identification of the health service provider;
(e) the name of the applied human immunological medicinal product, including the indication of the disease against which the product is intended, the lot, the order of the dose applied and the route, the site, the page and the quadrant of administration,
(f) identification of the health service provider that issued the extract to the patient and the date of issue of the extract.
(4) The statement referred to in paragraph 2 (b) shall include, in relation to each vaccination record created in the patient's chosen period:
(a) the name and, where appropriate, the name, surname and date of birth of the applicant and the number and type of electronically legible identification documents of the applicant;
(b) the selected time period for which the verified output was created,
(c) a unique alphanumeric indication of the vaccination record and the date of its creation;
(d) the name and, where applicable, the names of the doctor and the identification of the health service provider;
(e) the name of the applied human immunological medicinal product, including the indication of the disease against which the product is intended, the lot and the order of the dose applied,
(f) identification of the health service provider that issued the extract to the patient and the date of issue of the extract. ';
12. in Article 13 (2), the text "§ 9 (1) and (3)" is replaced by "§ 9 (1) and (4)."
13. in Article 19 (1) (b) (2), the words "and, in the case of an individually prepared medicinal product containing cannabis for therapeutic use, the name and, where applicable, the name, surname and number of the insured person for whom the medicinal product is intended, shall be added after the word" language. "
14. The heading of Section 21 reads: "Preservation of medical prescription forms with blue stripe."
15. in Article 21, the words "medical regulations" are replaced by the words "medical forms."
16. In Paragraph 22 (2), the sentences of the second to fourth are deleted.
17. The group title for Sections 22 and 23 reads: "Treatment of medical prescription forms with blue stripe."
Efficacy
This Decree shall take effect on 1 January 2022.
Minister:
Mgr. et Mgr. Vojtěch, MHA, v. r.
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Regulation Information
| Citation | Decree No. 522 / 2021 Coll., amending Decree No. 329 / 2019 Coll., on the Prescription of Medicinal Products for the Provision of Health Services, as amended by Decree No. 53 / 2020 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 23.12.2021 |
|---|---|
| Effective from | 01.01.2022 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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