L.S. 528.09 Regolamenti dwar Netwerks ta' Referenza Ewropej

(1)The title of these regulations is European Reference Networks Regulations. Citation and scope.

(2)The scope of these regulations is the implementation of Article 12 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare.

1. requires - In these regulations, unless the context otherwise "Advisory Committee; Committee" means the National Definitions. Advisory "Healthcare provider" means any licensed healthcare facility legally providing healthcare; "Network" means the European Reference Networks established by Article 12 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare; "Licensing Authority" means the Superintendent of Public Health as defined by the Public Health Act and the Health Act. Cap.
2. Cap.
4. The Licensing Authority is authorised to designate a healthcare provider to apply to be part of the Network. Functions of the Licensing Authority.
5. There shall be an Advisory Committee to be known as the National Advisory Committee, to assess and advise the Licensing Authority on requests presented by health care providers operating in Malta to enrol in European Reference Networks either as centres of expertise or as affiliated partners. National Advisory Committee. 5.

(1)The Licensing Authority shall appoint the Advisory Committee which shall be composed of three

(3)members, and one

(1)of these members shall serve as Chairperson. Appointment of Advisory Committee.

(2)A secretary to the Committee shall be appointed by the Licensing Authority. The secretary shall be a member of the public service.

(3)The Advisory Committee shall provide for any matter or procedure it may deem necessary for the better implementation of the functions of the Advisory Committee. 2 [ S.L. 528.09 Application. EUROPEAN REFERENCE NETWORKS 6.

(1)Health care providers may submit an application in writing to the Licensing Authority in order to apply to be enrolled as centres of expertise or as affiliated partners.

(2)The applications shall be submitted in writing to the Licensing Authority, through an application on the form prescribed by the Licensing Authority.

(3)The Licensing Authority shall refer the application to the Advisory Committee for its assessment. The Advisory Committee shall subsequently present its formal recommendations to the Licensing Authority. Function of Advisory Committee. 7.

(1)The Advisory Committee shall assess applications received by the Licensing Authority for enrolment as centres of expertise or as affiliated partners.

(2)The applications submitted shall be assessed according to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare and any implementing and delegated decision there under, and shall fulfil rules established by the Licensing Authority from time to time. The National Advisory Committee may adapt the assessment tools as it deems appropriate, following approval by the Licensing Authority.

(3)After receiving recommendations drawn up by the Advisory Committee, the Licensing Authority may issue the designation to the health care provider to the specified level for enrolment in the Network.

(4)The enrolment in the Network shall be subject to the conditions as set out by the Licensing Authority.

(5)The Licensing Authority and the Advisory Committee may request the applicant to present any further documentation or information in addition to those presented together with the application, at any stage during the evaluation of the application and after enrolment in the Network.

(6)The enrolment of a health-care provider as a centre of expertise or as an affiliated partner in the Network, shall be subject to a review every five

(5)years by the Licensing Authority.

(7)The healthcare provider that joins the Network must fulfil and abide with the obligations and responsibilities arising from participation within the Network. Consequence of breach.

1. The enrolment of a health-care provider as a centre of expertise or as affiliated partner in the Network may be withdrawn by the Licensing Authority when there is a breach of any condition for enrolment. EUROPEAN REFERENCE NETWORKS [ S.L. 528.09
2. The Licensing Authority may at any time make additional protocols for implementation of these regulations. Additional protocols. 3