What is Decree No. 457 / 2023 Coll.?

Decree No. 457 / 2023 Coll., establishing a list of medicinal products for human use not subject to the obligation of the marketing authorisation holder to ensure their delivery after the notified date of interruption or termination of supply — Ordinance establishing a list of medicinal products for human use not subject to the obligation of the marketing authorisation holder to ensure delivery after the notified date of interruption or termination of supply.

When it became Decree No. 457 / 2023 Coll. effectiveness?

Decree No. 457 / 2023 Coll. became effective 01.06.2024.

Is Decree No. 457 / 2023 Coll. still valid?

Yes, Decree No. 457 / 2023 Coll. is still valid and effective.

How many times was it Decree No. 457 / 2023 Coll. amended?

Decree No. 457 / 2023 Coll. has 3 time versions of the text.

Decree No. 457 / 2023 Coll.

Ordinance establishing a list of medicinal products for human use not subject to the obligation of the marketing authorisation holder to ensure delivery after the notified date of interruption or termination of supply

Valid Order Effective from 01.06.2024

Text versions: 01.06.2024 29.12.2023

§ 1 § 2

457

DECLARATION

of 19 December 2023

establishing a list of medicinal products for human use not subject to the obligation of the marketing authorisation holder to ensure that they are delivered after the notified date of interruption or termination of supplies

According to Section 114 (1) of the Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (the Law on Medicines), as amended by Act No. 456 / 2023 Coll., for the implementation of Section 33a (4) of the Act on Medicines:

§ 1

Subject matter

The list of medicinal products for human use which are not subject to the obligation of the marketing authorisation holder to ensure delivery after the notified date of interruption or termination of supplies pursuant to Section 33a (1) of the Medicines Act is set out in the Annex to this Decree.

§ 2

Efficacy

This decree shall take effect on the first day of the sixth calendar month following its publication.

Minister:

Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.

Annex to Decree No 457 / 2023 Coll.

List of medicinal products for human use not subject to the obligation of the marketing authorisation holder to ensure delivery after the notified date of interruption or termination of supply

ATC skupina	Léková forma	Síla	Cesta podání
Tixagevimab a cilgavimab (J06BD03)	všechny	všechny	všechny
Sotrovimab (J06BD05)	všechny	všechny	všechny
Regdanvimab (J06BD06)	všechny	všechny	všechny
Kasirivimab a imdevimab (J06BD07)	všechny	všechny	všechny
Vakcíny proti chřipce (J07BB)	všechny	všechny	všechny
Vakcíny proti covid-19 (J07BN)	všechny	všechny	všechny
Diagnostická radiofarmaka (V09), s výjimkou kitů	všechny	všechny	všechny
Terapeutická radiofarmaka (V10), s výjimkou kitů	všechny	všechny	všechny

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Regulation Information

Citation	Decree No. 457 / 2023 Coll., establishing a list of medicinal products for human use not subject to the obligation of the marketing authorisation holder to ensure their delivery after the notified date of interruption or termination of supply
Regulation Type	Order
Author	-
Collection	Code of Laws

Date of Promulgation	29.12.2023
Effective from	01.06.2024
Effective until	-
Status	Valid

Legal Areas: Administrative law Health

The regulation text is for informational purposes only.

Decree No. 457 / 2023 Coll.

Ordinance establishing a list of medicinal products for human use not subject to the obligation of the marketing authorisation holder to ensure delivery after the notified date of interruption or termination of supply

Contents

§ 1

§ 2

Contents

Comments 0

Regulation Information

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