Union training and exchange of SoHO competent authorities’ personnel
1. The Commission shall, in cooperation with SoHO national authorities, organise Union training on the implementation of this Regulation.
2. The Commission may provide Union training to personnel of SoHO competent authorities of EEA Member States, of countries that are applicants or candidates for Union membership and to personnel of bodies to whom specific responsibilities for SoHO supervisory activities have been delegated. It may organise aspects of the training in collaboration with international organisations and regulators working in the field of SoHO.
3. SoHO competent authorities shall ensure that the knowledge and materials acquired through the Union training activities referred to in paragraph 1 of this Article are disseminated as necessary and appropriately used in the personnel training activities referred to in Article 8.
4. The Commission may support, in cooperation with the SoHO national authorities, the organisation of programmes for the exchange of SoHO competent authorities’ personnel between two or more Member States and for the temporary secondment of personnel from one Member State to the other as part of personnel training.
5. The Commission shall maintain a list of the SoHO competent authority personnel that have successfully completed the Union training referred to in paragraph 1 of this Article, with a view to facilitating joint activities, in particular those referred to in Articles 22, 29, and 71. The Commission shall make this list available to the SoHO national authorities.
Commission controls
1. The Commission shall perform controls to confirm whether Member States effectively apply the requirements relating to:
(a)
SoHO competent authorities and delegated bodies provided for in Chapter II;
(b)
the SoHO supervisory activities carried out by SoHO competent authorities and delegated bodies;
(c)
the notification and reporting requirements of this Regulation.
2. The Commission shall organise the controls referred to in paragraph 1 in cooperation with the SoHO national authorities, and shall carry them out in a manner that avoids unnecessary administrative burden.
3. When performing the controls referred to in paragraph 1 of this Article, the Commission shall consult the relevant best practices documented and published by the SCB, as referred to in Article 69(1), point (d), on SoHO supervisory activities.
4. The Commission, in carrying out the controls referred to in paragraph 1 of this Article, may be supported by experts from the SoHO competent authorities selected, whenever possible, from the list referred to in Article 70(5). Experts from the SoHO competent authorities shall be given the same rights of access as the Commission.
5. Following each control, the Commission shall:
(a)
prepare a draft report on the findings and, where appropriate, include recommendations addressing the shortcomings identified;
(b)
send a copy of the draft report referred to in point (a) to the SoHO national authority concerned for its comments;
(c)
take the comments referred to in point (b) into account in preparing the final report; and
(d)
make publicly available a summary of the final report on the EU SoHO Platform.
Assistance by the Union
1. To facilitate the fulfilment of the requirements provided for in this Regulation, the Commission shall support implementation by:
(a)
providing secretariat and technical, scientific and logistic support to the SCB and its working groups;
(b)
funding Commission controls in Member States, including the costs of Member State experts assisting the Commission;
(c)
providing funding from the relevant Union programmes in support of public health to:
(i)
support collaborative work between SoHO competent authorities and organisations representing groups of SoHO entities and SoHO professionals with the aim of facilitating efficient and effective implementation of this Regulation, and in particular of collaborating on initiatives to achieve sufficiency of supply, including actions to promote donation and optimal use of critical SoHO, and on training activities referred to in Article 70(1) and programmes for the exchange of SoHO competent authorities’ personnel referred to in Article 70(4);
(ii)
where applicable, support financially in accordance with the relevant Union programmes, the development and updating of technical guidelines with a view to contributing to the implementation of this Regulation, including through cooperation, as provided for in Union law, with the EDQM on the guidelines published by them;
(d)
facilitating the cooperation between the SCB and advisory bodies established by other Union legislation referred to in Article 2(6), in particular through the organisation of joint meetings on the experience acquired with the application of Article 69(1), point (c), and aiming for a common approach to the assessment of the regulatory status of substances, products and activities, taking into account the specificities and the scope of each legal framework;
(e)
establishing, managing and maintaining the EU SoHO Platform.
2. With regard to the support referred to in paragraph 1, point (a), the Commission shall, in particular, organise the meetings of the SCB and its working groups, the travel, reimbursement and special allowances for participants in those meetings.
3. Upon request from Member States, technical support may be provided, through the Technical Support Instrument established by Regulation (EU) 2021/240 of the European Parliament and of the Council ( 22 ) , for the reform of national or regional SoHO supply supervision, provided those reforms aim to achieve compliance with this Regulation.
4. In order to perform the activities referred to in paragraph 1 to the mutual benefit of the Commission and of the beneficiaries, relating to preparation, management, monitoring and controls, as well as to support expenditure, the Commission shall have recourse to the technical and administrative assistance it might need.
