Decree No. 421 / 2022 Coll.
Decree amending Decree No. 329 / 2019 Coll., on the Prescription of Medicinal Products for the Provision of Health Services, as amended
Valid
Order
Effective from 01.01.2023
Text versions:
01.01.2023
16.12.2022
421
DECLARATION
of 7 December 2022
amending Decree No 329 / 2019 Coll., on the prescription of medicinal products for the provision of health services, as amended
According to § 114 (1) of Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Act on Medicines), as amended by Act No. 366 / 2021 Coll. and Act No. 314 / 2022 Coll., to implement § 81fb (5) of the Act on Medicines:
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. and Decree No. 522 / 2021 Coll., is amended as follows:
1. in Paragraph 1, point (m) is deleted;
Points (n) to (r) shall be renumbered as points (m) to (q).
2. Paragraph 12a, including the title and footnotes No 17 and 18, reads as follows:
Scope of data needed to create a vaccination record
In the requirement to create a record of vaccination in the register of the current health status of natural persons who have become ill with infectious diseases and of natural persons suspected of being infected under the Public Health Protection Act (17), in the context of the application of a human immunological medicinal product:
(a) in relation to the patient, the departmental identifier of the patient; If there is a patient who is not registered in the basic population register under the Basic Registers Act 18), please indicate:
1. name, if any, and surname,
2. date of birth,
3. the number of the insured person, if assigned,
4. citizenship,
5.
6. type and identification document number,
(b) in relation to vaccination carried out:
1. the identification data of the health service provider to the extent of the identification number of the person, the code of the medical establishment and the workplace identification number, if assigned by the health insurance undertaking,
2. the name or code of the applied human immunological product allocated by the Institute; the batch number or expiration date, if known at the time of application of the immunological medicinal product,
3. Date of vaccination,
4. the health insurance code or the indication that it is a self-payee;
5. an indication of the type of vaccination, whether it is primary vaccination or re-vaccination; in the case of primary vaccination, indicate the order of the dose of vaccination applied; and
6. in the case of a patient, e-mail address and telephone number for the public mobile telephone network, if the patient has communicated them; or
7. Where vaccination has not been carried out in accordance with the Summary of Product Characteristics, at least the route of administration and the site of administration of the immunological medicinal product for human use.
17) Paragraph 79 (2) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended.
18) Sections 16 to 23 of Act No. 111 / 2009 Coll., on Basic Registers, as amended. '
3. Sections 12b to 12d are deleted, including the headings.
4. in Article 12e (3) (d) and Article 12e (4) (d), the words "the name and, where appropriate, the names and surnames of the doctor and the identification" shall be replaced by the words "identification."
5. in Article 12e (3) and (4) (e):
"(e) the name or code of the applied human immunological medicinal product allocated by the Institute, including the indication of the disease against which the product is intended, the batch number or expiry date, if known at the time of application of the human immunological medicinal product and in the case of primary vaccination, the order of the dose applied;"
Efficacy
This Decree shall take effect on 1 January 2023.
Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
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Regulation Information
| Citation | Decree No. 421 / 2022 Coll., amending Decree No. 329 / 2019 Coll., on the prescription of medicinal products for the provision of health services, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 16.12.2022 |
|---|---|
| Effective from | 01.01.2023 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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