Notification Detail | TRIS - European Commission

Amendment of the Decree on public health and the Regulation on public health due to the introduction of a licensing obligation and a reporting obligation in relation to performing acting with poliovirus

Notification Number:

2024/0548/NL (Netherlands)

Date received:

27/09/2024

End of Standstill:

30/12/2024

Draft Text:

NL EN FR DE

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Message

Message 001

Communication from the Commission - TRIS/(2024) 2627

Directive (EU) 2015/1535

Notification: 2024/0548/NL

Notification of a draft text from a Member State

Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt

Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna

MSG: 20242627.EN

1. MSG 001 IND 2024 0548 NL EN 27-09-2024 NL NOTIF

2. Netherlands

3A. Ministerie van Financiën, Dienst Douane Noord, CDIU

3B. Ministerie van Volksgezondheid, Welzijn en Sport.
Directie Wetgeving en Juridische Zaken.

4. 2024/0548/NL - X00M - GOODS AND MISCELLANEOUS PRODUCTS

5. Amendment of the Decree on public health and the Regulation on public health due to the introduction of an authorisation requirement and a reporting obligation in relation to performing actions with poliovirus

6. Poliovirus (material)

7.
Directive 2006/123/EC on services in the internal market

Other
The authorisation requirement does not have a discriminatory effect, because the system does not distinguish between Dutch facilities or facilities from other Member States of the European Union.
The purpose of the authorisation requirement is to ensure that only facilities meeting the relevant requirements may carry out work with the designated types of poliovirus. The authorisation requirement is therefore necessary for protecting public health.
The requirement to obtain authorisation is the only appropriate means of achieving the objective pursued. Only in this way can provision be made for a system that creates a sufficiently high threshold for new facilities, meaning only facilities of an essential nature shall be allowed to carry out actions with poliovirus. It also provides for a system whereby a facility's compliance with the applicable requirements is assessed in advance, and if this is no longer the case following authorisation, the facility may be forced to cease operations as an ultimate remedy.

8. Articles 17(a) to 17(c) of the Decree on public health may contain technical regulations. In Chapter Va, this Decree lays down authorisation requirement for carrying out actions with certain types of poliovirus. The purpose of the authorisation requirement is to implement World Health Organisation Resolution WHA71.16 on polio eradication effectively. This Resolution is part of the WHO Global Polio Eradication Initiative, a global response approach to achieving a polio-free world, including ensuring that any facility working with eradicated polioviruses must handle and store poliovirus in accordance with the WHO Global Action Plan for Poliovirus Containment (GAP requirements).
The authorisation requirement shall apply in particular to facilities carrying out actions involving poliovirus for developing and producing vaccines, or for monitoring purposes. The types of poliovirus to which the authorisation requirement applies and the requirements to be met in order to obtain an authorisation shall be determined in accordance with the WHO GAP requirements. This shall take the principle of mutual recognition into account.

Annex 2 to the Regulation on public health may contain technical requirements. This Annex to the regulation further develops the authorisation requirement, inter alia by laying down the requirements that must be met in order to obtain a licence.

9. The authorisation requirement does not have a discriminatory effect, because the system does not distinguish between Dutch facilities or facilities from other Member States of the European Union. The purpose of the authorisation requirement is to ensure that only facilities meeting the relevant requirements may carry out work with the designated types of poliovirus. The authorisation requirement is therefore necessary for protecting public health. The requirement to obtain authorisation is the only appropriate means of achieving the objective pursued. Only in this way can provision be made for a system that creates a sufficiently high threshold for new facilities, meaning only facilities of an essential nature shall be allowed to carry out actions with poliovirus. It also provides for a system whereby a facility's compliance with the applicable requirements is assessed in advance, and if this is no longer the case following authorisation, the facility may be forced to cease operations as an ultimate remedy.

Furthermore, the limited period of authorisation is in accordance with Article 11(1)(c) of the Services Directive. Due to an overriding reason in the public interest, it is necessary periodically to reassess whether a facility is still eligible for a permit.

10. Numbers or titles of basic texts:

11. No

12.

13. No

14. No

15. No

16.
TBT aspects: No

SPS aspects: No

**********
European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu

Disclosed messages

message-id	Year	Number	Country	Type	Title	Date received	Is answer to
109582	2024	2628	COMEuropean Commission	003	Receipt of the draft text	27-09-2024
109583	2024	2629	COMEuropean Commission	037	Competitiveness analysis	27-09-2024

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