Notification Detail | TRIS - European Commission

Granting hospital pharmacies the right to import medicinal products and active substances for the manufacture of medicinal products

Notification Number:

2025/0061/EE (Estonia)

Date received:

30/01/2025

End of Standstill:

02/05/2025

Issue of comments by:

European Commission

Draft Text:

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

Impact assessment:

ET EN FR DE

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Message

Message 001

Communication from the Commission - TRIS/(2025) 0284

Directive (EU) 2015/1535

Notification: 2025/0061/EE

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: 20250284.EN

1. MSG 001 IND 2025 0061 EE EN 30-01-2025 EE NOTIF

2. Estonia

3A. Majandus- ja Kommunikatsiooniministeerium, aadress Suur-Ameerika 1, 10122 Tallinn
Ettevõtluse ja tööstuse osakond,
karl.stern@mkm.ee

3B. Sotsiaalministeerium, aadress Suur-Ameerika 1, 10122 Tallinn
Tervishoiuteenuste osakond

4. 2025/0061/EE - C00P - PHARMACEUTICAL AND COSMETICS

5. Granting hospital pharmacies the right to import medicinal products and active substances for the manufacture of medicinal products

6. Medicinal products and active substances for the manufacture of medicinal products

7.

8. The amendment to the Medicinal Products Act grants hospital pharmacies the right to import medicinal products and
active substances for the manufacture of medicinal products to supply the hospital of which it is a structural unit.

9. The purpose of the draft is to make the possibilities of hospital pharmacies to improve the availability of medicinal products more flexible, and thereby improve the flexibility of planning of expenditure on medicinal products. As a result of the adoption of the draft, competition between wholesalers of medicinal products may increase. In this context, the prices of medicinal products for hospitals may decrease, and medicinal products may become more flexibly and readily available.

10. References to related legislation:

11. No

12.

13. No

14. No

15. Yes

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
110795	2025	0285	COMEuropean Commission	003	Receipt of the draft text	30-01-2025
110796	2025	0286	COMEuropean Commission	037	Competitiveness analysis	30-01-2025
111010	2025	0500	COMEuropean Commission	301	Request for supplementary information	20-02-2025
111121	2025	0608	EEEstonia	201	Answer of the notifying Member State	04-03-2025	2025-500
111705	2025	1184	COMEuropean Commission	303	Comments	02-05-2025
111996	2025	1469	EEEstonia	201	Answer of the notifying Member State	09-06-2025	2025-1184
112560	2025	2029	COMEuropean Commission	077	Continuation of dialogue between notifying Member State, other Member States and the Commission	29-07-2025	2025-1469

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