Notification Detail | TRIS - European Commission

Ordinance of the Federal Minister for Labour, Social Affairs, Health and Consumer Protection on ensuring the supply of medicines

Notification Number:

2019/0516/A (Austria)

Date received:

18/10/2019

End of Standstill:

20/01/2020 (closed)

Issue of comments by:

European Commission

Draft Text:

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

Impact assessment:

DE EN FR

Final Text:

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

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Message

Message 002

Communication from the Commission - TRIS/(2019) 02915
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2019/0516/A

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201902915.EN)
1. MSG 002 IND 2019 0516 A EN 18-10-2019 A NOTIF

2. A

3A. Bundesministerium für Digitalisierung und Wirtschaftsstandort
Abteilung III/8
A-1010 Wien, Stubenring 1
Telefon +43-1/71100-805436
E-Mail: not9834@bmdw.gv.at

3B. Bundesministerium für Arbeit, Soziales, Gesundheit und Konsumentenschutz
Abteilung IX/A/4, Mag. Daniel D'Orlando, Dr. Robert Semp
A-1010 Wien, Stubenring 1
Telefon +43-1/711 00-644134
E-Mail daniel.dorlando@sozialministerium.at

4. 2019/0516/A - C10P

5. Ordinance of the Federal Minister for Labour, Social Affairs, Health and Consumer Protection on ensuring the supply of medicines

6. Prescription proprietary medicinal products

7. -

8. The proposal is primarily composed of the following measures:

Introduction of an obligation for the marketing authorisation holder to immediately notify any restriction of the domestic distribution of a prescription proprietary medicinal product.

Publication of all notified proprietary medicinal products on the website of the Federal Office for Safety in Health Care.

Obligation of notification of the Federal Office for Healthcare Safety [Bundesamt für Sicherheit im Gesundheitswesen] if the marketing authorisation holder does not or does not sufficiently observe his notification obligation or if for other reasons the supply is not adequate to cover the needs of patients.

Introduction of a ban on exports to another Member State of the European Economic Area.

9. Supply bottlenecks and shortages especially with prescription
proprietary medicinal products are a global problem that occurs with increasing frequency. It is therefore urgently necessary to improve transparency in these situations, enabling physicians and pharmacists to respond promptly to distribution restrictions.

10. Reference(s) to basic text(s): The Ordinance of the Federal Minister for Labour, Social Affairs, Health and Consumer protection on ensuring the supply of medicines is based on § 57a of the Medicines Act [Arzneimittelgesetz] (AMG, Federal Law Gazette I No 185/1983, in the version currently in force).

11. No

12. -

13. No

14. No

15. Yes

16. TBT aspect

No - the draft is neither a technical regulation nor a conformity assessment

SPS aspect

No - The draft is neither a sanitary nor a phytosanitary measure

**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

Disclosed messages

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