Annexes to COM(2020)727 - Serious cross-border threats to health - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2020)727 - Serious cross-border threats to health. |
|---|---|
| document | COM(2020)727  |
| date | November 23, 2022 |
(22) Regulation (EU) 2015/479 of the European Parliament and of the Council of 11 March 2015 on common rules for exports (OJ L 83, 27.3.2015, p. 34).
(23) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
(24) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).
(25) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(26) OJ L 123, 12.5.2016, p. 1.
(27) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11. 2001, p. 67).
(28) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(29) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5. 2017, p. 176).
(30) Commission Implementing Decision (EU) 2019/570 of 8 April 2019 laying down rules for the implementation of Decision No 1313/2013/EU of the European Parliament and of the Council as regards rescEU capacities and amending Commission Implementing Decision 2014/762/EU (OJ L 99, 10.4.2019, p. 41).
(31) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41).
(32) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53).
(33) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1).
(34) Regulation (EU) 2021/697 of the European Parliament and of the Council of 29 April 2021 establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 (OJ L 170, 12.5.2021, p. 149).
(35) Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1).
(36) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(37) Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
(38) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(39) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
(40) Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European Environment Agency and the European Environment Information and Observation Network (OJ L 126, 21.5.2009, p. 13).
(41) Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (OJ L 376, 27.12.2006, p. 1).
(42) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53).
(43) Council Decision 2014/415/EU of 24 June 2014 on the arrangements for the implementation by the Union of the solidarity clause (OJ L 192, 1.7.2014, p. 53).
(44) Commission Decision of 30 May 2016 establishing horizontal rules on the creation and operation of Commission experts groups (not published in the Official Journal).
ANNEX I
Section 1
Criteria for selection of communicable diseases and related special health issues to be covered by epidemiological surveillance within the network for epidemiological surveillance
Union surveillance shall provide information for public health action at Union level. More specifically, one of the following criteria shall be met:
| 1. | significant morbidity, significant mortality or emerging disease (increasing five-year trend) in a sizeable percentage of Member States; |
| 2. | potential to cause cross-border outbreaks; |
| 3. | high-threat pathogen (transmissibility and severity); |
| 4. | specifically targeted national or Union public health programmes in place that require monitoring and evaluation; |
| 5. | Union surveillance adds public health value to national surveillance systems other than what is implied in criteria 1 to 4. |
Section 2
Criteria for use in the definition and classification of cases:
| 1. | clinical criteria; |
| 2. | laboratory criteria; |
| 3. | epidemiological criteria. |
Classification of cases:
| 1. | possible case; |
| 2. | probable case; |
| 3. | confirmed case. |
Section 3
Procedures for the operation of the network for epidemiological surveillance
The terms of procedures of the network for epidemiological surveillance shall cover at least the following points:
| 1. | membership and appointment; |
| 2. | terms of reference (detailing responsibilities of the national representatives and the ECDC secretariat of the network, including roles and tasks); |
| 3. | administrative, for example relating to the convening of meetings and decision-making, and technical work procedures, for example relating to data reporting mechanisms, tools and platforms, data analysis and dissemination; and |
| 4. | mechanism for periodic evaluation/review of administrative and technical work procedures. |
ANNEX II
Correlation table
| Decision No 1082/2013/EU | This Regulation |
| Article 1 | Article 1 |
| Article 2 | Article 2 |
| Article 3 | Article 3 |
| Article 4(1) | Article 6 |
| Article 4(2) | Article 7 |
| Article 5 | Article 12 |
| Article 6 | Article 13 |
| Article 7 | Article 17 |
| Article 8 | Article 18 |
| Article 9 | Article 19 |
| Article 10 | Article 20 |
| Article 11 | Article 21 |
| Article 12 | Article 23(1), (3), (4) |
| Article 13 | Article 25 |
| Article 14 | Article 23(2) |
| Article 15 | – |
| Article 16(1) | Article 27 |
| Article 16(2) to (8) | Article 28 |
| Article 17 | Article 4 |
| Article 18 | Article 29 |
| Article 19 | Article 33 |
| Article 20 | Article 34 |
| Article 21 | Article 35 |
| Article 22 | – |
| Annex | Annex I |