Notification Detail | TRIS - European Commission

Draft Regulation of the Minister of Health regarding the Threat Monitoring System

Notification Number:

2013/0119/PL (Poland)

Date received:

25/02/2013

End of Standstill:

27/05/2013 (closed)

Draft Text:

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

Impact assessment:

PL DE FR EN

Final Text:

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Message

Message 002

Communication from the Commission - SG(2013) D/5597
Directive 98/34/EC
Translation of the message 001
Notification: 2013/0119/PL

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 - Nao 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: 201300597.EN)
1. MSG 002 IND 2013 0119 PL EN 25-02-2013 PL NOTIF

2. PL

3A. Departament Innowacji i Przemysłu, Ministerstwo Gospodarki,
Plac Trzech Krzyży 3/5, 00-507 Warszawa,
tel. +48-22/693-5407, fax: +48-22/693-4084, e-mail: notyfikacja@mg.gov.pl

3B. Ministerstwo Zdrowia - Dyrektor Departamentu Organizacji Ochrony Zdrowia - Piotr Warczyński, tel. +48 22 63 49 277, p.warczynski@mz.gov.pl; dep-oz@mz.gov.pl

4. 2013/0119/PL - SERV

5. Draft Regulation of the Minister of Health regarding the Threat Monitoring System

6. The minimum functionality and organisational and technical conditions for collecting and sharing data in the Threat Monitoring System.

7. -

8. The draft Regulation implements the statutory authorisation stipulated in Article 26(9) of the Health Protection Information System Act of 28 April 2011, and specifies the minimum functionality and organisational and technical conditions for collecting and sharing data in the Threat Monitoring System.
The Threat Monitoring System is an information and communication system within the meaning of Article 2(3) of the Act of 18 July 2002 on Providing Services by Electronic Means. It constitutes one of the elements of the information system in health protection. The objective of the draft Regulation is to enable collection and processing of data in one location within the duties of entities that maintain registers of incidents of infectious diseases and positive results of laboratory tests; entities that maintain registers of adverse post-vaccination reactions; the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, who performs the tasks of collecting reports and information about the adverse effects of medicinal products, investigational medicinal products, veterinary medicinal products, and investigational veterinary medicinal products; as well as medical practicioners specified in Article 26(1) of the Infectious Diseases Prevention and Control Act of 5 December 2008 and Article 45a of Act of 5 December 1996 on the Professions of Medical Doctors and Dental Practicioners.

9. Data collected in the Threat Monitoring System will constitute an important instrument in taking actions to prevent the effects of adverse medical events that have an impact on human life and health. Merging the Threat Monitoring System with the data collected in the Medical Information System will cause the ministerial early warning system, which enables authorised entities and bodies to enter and access information on threats and adverse medical events that constitute a threat to human life or health, to work quickly and efficiently.

10. References to basic texts: Health Protection Information System Act of 28 April 2011(Journal of Laws No 113(657) and No 174(1039)).

11. No

12. -

13. No

14. No

15. Yes

16. TBT aspects

NO - the draft has no significant impact on international trade

SPS aspects

NO - the draft has no significant impact on international trade

Catherine Day,
Sekretarz Generalny
Komisji Europejskiej

Punkt kontaktowy Dyrektywa 98/34
faks: (32-2) 296 76 60
e-mail: dir83-189-central@ec.europa.eu

Disclosed messages

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