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Decision extending submission of the export of the medicinal products Zypadhera 405 mg prolonged release suspension for IM injection (pulv. + solv.) vial 405 mg + 3 ml, Zypadhera 300 mg prolonged release suspension for IM injection (pulv. + solv.) vial [...]

Notification Number:

2025/0542/BE (Belgium)

Date received:

26/09/2025

End of Standstill:

29/12/2025

Draft Text:

FR BG HR CS DA EN ET FI GA DE EL HU IT LV LT MT PL PT RO SK SL ES SV NL

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Message

Message 001

Communication from the Commission - TRIS/(2025) 2642

Directive (EU) 2015/1535

Notification: 2025/0542/BE

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: 20252642.EN

1. MSG 001 IND 2025 0542 BE EN 26-09-2025 BE NOTIF

2. Belgium

3A. SPF Economie, PME, Classes moyennes et Energie
Direction générale Qualité et Sécurité - Service Bureau de Liaison - BELNotif
NG III – 2ème étage
Boulevard du Roi Albert II, 16
B - 1000 Bruxelles
be.belnotif@economie.fgov.be

3B. Agence fédérale des médicaments et produits de santé
Avenue Galilée 5/03
1210 Bruxelles
Division législation et contentieux
ius@fagg-afmps.be
+32 2 528 40 00

4. 2025/0542/BE - C10P - Pharmaceuticals

5. Decision extending submission of the export of the medicinal products Zypadhera 405 mg prolonged release suspension for IM injection (pulv. + solv.) vial 405 mg + 3 ml, Zypadhera 300 mg prolonged release suspension for IM injection (pulv. + solv.) vial [...]

6. The medicinal products Zypadhera 405 mg prolonged release suspension for injection (pulv. + solv.) vial 405 mg + 3 ml, Zypadhera 300 mg prolonged release suspension for IM injection (pulv. + solv.) vial 300 mg + 3 ml and Zypadhera 210 mg prolonged release suspension for IM injection (pulv. + solv.) vial 210 mg + 3 ml

7.

8. The draft extends an authorisation requirement for the export of a specific medicinal product intended for the Belgian market in the event of unavailability, under the conditions laid down in the Royal Decree of 19 January 2023 implementing Article 12f, subparagraph 2, of the Law of 25 March 1964 on medicinal products, Article 4(1), (2), first subparagraph, and (3), first subparagraph. Prior authorisation for a specific period (i.e. the duration of the notified planned unavailability period), namely until 31/03/2026.

9. Controlling the unavailability of medicinal products in Belgium, in the swiftest and most efficient way possible, with a view to ensuring public health protection.
This draft will enter into force through its publication in the Moniteur belge (national gazette) on 01/01/2026 in order to ensure continuity with the decision notified under 2025/0137/B, which expires on 31/12/2025.

10. References to basic texts: 2025/0317/BE

The basic texts were forwarded with an earlier notification:
2025/0317/BE

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
113187	2025	2643	COMEuropean Commission	003	Receipt of the draft text	26-09-2025
113188	2025	2644	COMEuropean Commission	037	Competitiveness analysis	26-09-2025
113238	2025	2694	COMEuropean Commission	301	Request for supplementary information	03-10-2025
113336	2025	2792	BEBelgium	201	Answer of the notifying Member State	09-10-2025	2025-2694

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