Act No. 569 / 2020 Coll.
Act on the distribution of medicinal products containing a vaccine for vaccination against disease COVID-19, on compensation for damage caused to vaccinated persons by these medicinal products and amending Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended
Valid
Law
Effective from 23.12.2020
Text versions:
23.12.2020
569
THE LAW
of 16 December 2020
on the distribution of medicinal products containing vaccine for vaccination against disease COVID-19, on the replacement of harm caused to vaccinees by these medicinal products and amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended
Parliament has decided on this law of the Czech Republic:
DISTRIBUTION OF MEDICINAL PRODUCTS CONTAINING THE INCIDENT AGENTS AGAINST CONVIDE-19 AND REFERENCE OF INJURY ACCIDENT TO THE EXPECTED PERSONS OF SUCH MEDICINAL PRODUCTS
Distribution of medicinal products containing vaccine for vaccination against disease COVID-19
(1) In order to ensure the vaccination of patients on the territory of the Czech Republic against the disease of COVID-19 caused by SARS CoV-2 ("COVID-19 disease"), the Ministry of Health is authorised to ensure the distribution on behalf of Member States of medicinal products containing the vaccine against COVID-19 obtained from State budget resources under Commission Decision C (2020) 4192 of 18 June 2020 approving an agreement with the Member States on the acquisition of vaccines against COVID-19 on behalf of Member States and related procedures.
(2) The Ministry of Health may arrange the distribution of the medicinal product referred to in paragraph 1 by means of a distributor under the Law on medication1) selected jointly by health insurance companies carrying out public health insurance.
(3) The requirements in the field of the authorisation of the distribution of medicinal products provided for by the Law on Medication1) do not apply to the activities of the Ministry of Health referred to in paragraphs 1 and 2 where it only carries out the provision of the medicinal product referred to in paragraph 1 and its commercial transfer.
Compensation for damage caused to a person vaccinated with a medicinal product containing a vaccine for vaccination against COVID-19 disease
The State shall replace the person who has been vaccinated with a medicinal product as referred to in Article 1 (1) with the damage caused by vaccination with a medicinal product as referred to in Article 1 (1) if, as a result of such vaccination, there has been particularly serious harm to the health of the vaccinated, suffering pain, loss of earnings or difficulties in social application. In order to assess this injury and the extent of the refund, Act No 116 / 2020 Coll., on Compensation for Injury caused by compulsory vaccination shall apply mutatis mutandis.
Amendment to the Public Health Insurance Act
Act No. 1 / 2006, Act No. 1 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 6 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5, Act No. 5, Act No. 5, Act No. 2006, Act No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No Act No. 47 / 2016 Coll., Act No. 66 / 2017 Coll., Act No. 150 / 2017 Coll., Act No. 183 / 2017 Coll., Act No. 200 / 2017 Coll., Act No. 111 / 2019 Coll., Act No. 262 / 2019 Coll., Act No. 290 / 2017 Coll., Act No. 165 / 2020 Coll., Act No. 205 / 2020 Coll. and Act No. 538 / 2020 Coll., is amended as follows:
1. in Article 17 (7) (d), including footnote 35:
"(d) contracts to persons authorised to distribute medicinal products under the Drug Act;
1. medicinal products containing vaccines for regular vaccination according to the antigenic composition of vaccines established by the Ministry of Health under the Public Health Protection Act;
2. the distribution of all medicinal products containing the vaccine against the disease of COVID-19 caused by SARS CoV-2, which have been transmitted by the Ministry of Health for distribution under the law governing the distribution of vaccine for vaccination against the disease of COVID-1935), if the vaccination referred to in § 30 (2) (g),
35) Act No 569 / 2020 Coll., on the distribution of medicinal products containing a vaccine for vaccination against COVID-19, on compensation for harm caused to vaccinated persons by these medicinal products and amending Act No 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related acts, as amended. '
2. In Article 17, at the end of paragraph 7, the dot is replaced by a comma and the following point (g) is added:
"(g) the contracts of the Ministry of Health of medicinal products containing the vaccine against the disease COVID-19 caused by SARS CoV-2, if it is the vaccination referred to in Article 30 (2) (g); this contract shall be concluded by the relevant health insurance undertaking within 30 days of the date on which the Ministry of Health so requested. ';
3. In Paragraph 30, at the end of paragraph 2, the dot is replaced by a comma and the following point (g) is added:
"(g) vaccination and reimbursement of medicinal products containing a vaccine against a disease of COVID-19 caused by SARS CoV-2, where the vaccination is carried out by a medicinal product containing a vaccine obtained by Commission Decision C (2020) 4192 of 18 June 2020 approving an agreement with the Member States on the acquisition of vaccines against COVID-19 on behalf of the Member States and related procedures; the health insurance undertaking shall ensure that such vaccination is carried out within the time limits set for each group of insured persons; the groups of insured persons and the time limits for vaccination of each group of insured persons shall be laid down by a regulation. ';
EFFECTIVE
This Act shall take effect on the day of its publication.
z. Filip v. r.
Zeman v. r.
Babiš v. r.
1) Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended.
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Regulation Information
| Citation | Act No. 569 / 2020 Coll., on the distribution of medicinal products containing vaccine for vaccination against disease COVID-19, on the replacement of harm caused to vaccinated persons by these medicinal products and amending Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 23.12.2020 |
|---|---|
| Effective from | 23.12.2020 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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