# C_2020209EN.01001402.xml

| 22.6.2020 | EN | Official Journal of the European Union | C 209/14 |
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22.6.2020

EN

Official Journal of the European Union

C 209/14

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Request for a preliminary ruling from the Consiglio di Giustizia Amministrativa per la Regione Siciliana (Italy) lodged on 26 March 2020 — Analisi G. Caracciolo s.r.l. v Regione Siciliana — Assessorato regionale della salute — Dipartimento regionale per la pianificazione and Others

(Case C-142/20)

(2020/C 209/21)

Language of the case: Italian

Referring court

Consiglio di Giustizia Amministrativa per la Regione Siciliana

Parties to the main proceedings

Applicant: Analisi G. Caracciolo s.r.l.

Defendants: Regione Siciliana — Assessorato regionale della salute — Dipartimento regionale per la pianificazione, Regione Sicilia — Assessorato della salute — Dipartimento per le attività sanitarie e osservatorio, Accredia — Ente Italiano di accreditamento, Azienda sanitaria provinciale di Palermo

Questions referred

| 1. | Does Regulation (EC) No 765/2008 (1) preclude a provision of national law (such as Article 40 of Law No 88/2009) being interpreted as allowing accreditation to be carried out by bodies not established in a Member State of the European Union — and therefore without the party concerned being required to apply to the single accreditation body — where such bodies in any event ensure that standards UNI CEI EN ISO/IEC 17025 and UNI CEI EN ISO/IEC 17011 are complied with and demonstrate (by means of mutual recognition agreements, for example) possession of a qualification which is essentially the same as that of the single bodies referred to in Regulation (EC) No 765/2008? |
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1.

Does Regulation (EC) No 765/2008 (1) preclude a provision of national law (such as Article 40 of Law No 88/2009) being interpreted as allowing accreditation to be carried out by bodies not established in a Member State of the European Union — and therefore without the party concerned being required to apply to the single accreditation body — where such bodies in any event ensure that standards UNI CEI EN ISO/IEC 17025 and UNI CEI EN ISO/IEC 17011 are complied with and demonstrate (by means of mutual recognition agreements, for example) possession of a qualification which is essentially the same as that of the single bodies referred to in Regulation (EC) No 765/2008?

| 2. | In the light of Article 56 TFEU, Articles 20 and 21 of the Charter of Fundamental Rights of the European Union and Article 102 TFEU –in so far as it establishes essentially a national monopoly in respect of accreditation by the ‘single body’ system, does Regulation (EC) No 765/2008 infringe the principles of primary EU law and, in particular, the principles of freedom to provide services and non-discrimination, the prohibition of unequal treatment and competition rules that prohibit monopoly situations? |
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2.

In the light of Article 56 TFEU, Articles 20 and 21 of the Charter of Fundamental Rights of the European Union and Article 102 TFEU –in so far as it establishes essentially a national monopoly in respect of accreditation by the ‘single body’ system, does Regulation (EC) No 765/2008 infringe the principles of primary EU law and, in particular, the principles of freedom to provide services and non-discrimination, the prohibition of unequal treatment and competition rules that prohibit monopoly situations?

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(1)  Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ 2008 L 218, p. 30).

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