Decree No. 461 / 2023 Coll.
Decree amending Decree No. 229 / 2008 Coll., on the production and distribution of medicines, as amended
Valid
Order
Effective from 01.01.2024
Text versions:
01.01.2024
29.12.2023
461
DECLARATION
of 20 December 2023
amending Decree No. 229 / 2008 Coll., on the production and distribution of medicines, as amended
The Ministry of Health and the Ministry of Agriculture, pursuant to § 114 (2) of Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Act on Medicines), as amended by Act No. 456 / 2023 Coll., provides for the implementation of § 77 (1) (f) of the Act on Medicines:
Decree No. 229 / 2008 Coll., on the production and distribution of medicinal products, as amended by Decree No. 252 / 2018 Coll. and Decree No. 180 / 2019 Coll., is amended as follows:
1. In Article 35b (1), the words "the volume of medicinal products for human use which he has distributed to pharmacies and other health service providers, other distributors, dealers of reserved medicines and veterinary care operators' and the word" the tenth 'are replaced by the words "the fifth'.
2. Paragraph 35b (3) reads as follows:
"(3) Where the distributor finds that he has entered incomplete or incorrect information in the report, he shall immediately send a correction to the Institute. ';
3. in Article 35b (4) (e):
"(e) the identification of the person to whom the medicinal product has been supplied, by indicating the type of customer referred to in Article 77 (1) (c) of the Law on Medicines and, in the case of a distribution warehouse, a transfer service facility, a pharmacy or a separate pharmacy department for the supply of medicinal products and medical devices, also the identification number of the person and the workplace identification code allocated by the Institute, and the details of whether it is a customer in the Czech Republic or outside the Czech Republic."
4. The following Section 35e is inserted after Section 35d:
(1) The distributor provides the Institute with the data referred to in Section 77 (1) (f) of the Drug Act on the quantity of medicinal product for human use,
(a) which is indicated by the "restricted availability" flag under Section 33b of the Drug Act by means of an electronic notification within 1 working day of the date of designation of the medicinal product for human use by the "restricted availability" flag and at the end of each working day in which the designation of the medicinal product for human use took place,
(b) where the Institute has published a call in a way that allows remote access due to a suspected threat of availability, by electronic notification within 3 working days of the date of publication of the call.
(2) Paragraph 35b (2) shall apply mutatis mutandis for the purposes of providing the data referred to in paragraph 1.
(3) Where the distributor finds that he has entered incomplete or incorrect information in the report, he shall immediately send a new report to the Institute indicating the actual quantity of the medicinal product concerned.
(4) The reports referred to in paragraphs 1 and 3 shall contain:
(a) the identification code of the distribution warehouse allocated by the Institute in which the distributor has a medicinal product for human use;
(b) the unique message identifier assigned by the Constitution;
(c) the code of the medicinal product for human use allocated by the Institute; and
(d) the number of packages of the medicinal product for human use. ';
Efficacy
This decree shall take effect on the first day of the calendar month following its publication.
Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
Minister for Agriculture:
Mgr. Excellent v. r.
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Regulation Information
| Citation | Decree No. 461 / 2023 Coll., amending Decree No. 229 / 2008 Coll., on the Production and Distribution of Drugs, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.12.2023 |
|---|---|
| Effective from | 01.01.2024 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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