1. Member States shall designate the SoHO competent authority or authorities to which they confer responsibility for SoHO supervisory activities. The SoHO competent authority or authorities designated shall be independent from any SoHO entity.
2. A Member State may confer responsibilities for SoHO supervisory activities to more than one SoHO competent authority, at national, regional or local level.
3. Member States shall ensure that SoHO competent authorities:
(a)
have the autonomy to act and make decisions independently and impartially while respecting the internal administrative organisational requirements determined under national legislation;
(b)
have the necessary powers:
(i)
to properly perform the SoHO supervisory activities they have been made responsible for, including having access to the premises of, and documents and samples kept by, SoHO entities and any third parties contracted by a SoHO entity;
(ii)
to order the immediate suspension or cessation of a SoHO activity that poses an immediate risk to SoHO donors, SoHO recipients, offspring from medically assisted reproduction or the general public;
(c)
have, or have access to, sufficient human and financial resources, operational capacity, and expertise, including technical expertise, to achieve the aims of, and fulfil their obligations under, this Regulation;
(d)
are subject to appropriate confidentiality obligations in order to comply with Article 75.
4. When a Member State designates only one SoHO competent authority in accordance with paragraph 1 of this Article, that SoHO competent authority shall also be considered as the SoHO national authority. When a Member State designates more than one SoHO competent authority in accordance with that paragraph, it shall designate a single SoHO national authority among them, in accordance with national law. The SoHO national authority shall be responsible for the tasks referred to in Article 8(2). The designation of a single SoHO national authority shall not prevent the Member State from assigning certain tasks to other SoHO competent authorities, in particular the management of SoHO rapid alerts, in order to ensure an efficient and agile communication when serious adverse reactions or serious adverse events involve more than one Member State.
5. Member States shall submit to the EU SoHO Platform, and keep updated, information on:
(a)
the name and contact details of the SoHO national authority referred to in paragraph 4;
(b)
the names and contact details of any SoHO competent authority designated in accordance with paragraph 1, when such SoHO competent authority is different from the SoHO national authority referred to in paragraph 4.
1. When performing their tasks and exercising their powers, SoHO competent authorities shall act independently and impartially, in the public interest and free from any external influence, such as political influence or industry interference.
2. SoHO competent authorities shall ensure that personnel performing SoHO supervisory activities, including inspectors and assessors, have no financial or other interest that might be considered prejudicial to their independence and, in particular, that they are not placed in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. Personnel performing SoHO supervisory activities shall provide a declaration of their interests and regularly update that declaration. On that basis, SoHO competent authorities shall take the relevant measures to mitigate the risk of conflict of interests.
1. SoHO competent authorities shall:
(a)
carry out the SoHO supervisory activities they have been made responsible for in a transparent manner, at least by complying with the publication requirements provided for in this Regulation; and
(b)
make any enforcement decision pursuant to Article 19(7), (8) and (9), Article 25(3), (4) and (5), or Article 27(8), point (h), and the reasons for it, accessible and clear to the public in cases where:
(i)
a SoHO entity does not comply with this Regulation; or
(ii)
there is a serious risk to the safety of SoHO donors, recipients or offspring from medically assisted reproduction or to public health.
2. Paragraph 1 of this Article shall be without prejudice to Article 75 and to national legislation on access to information.
3. SoHO competent authorities shall lay down in their internal rules practical arrangements for implementing the transparency rules referred to in paragraph 1.
General responsibilities and obligations of SoHO competent authorities
1. SoHO competent authorities shall be responsible, within their territory, for SoHO supervisory activities in order to verify the effective compliance by:
(a)
SoHO entities with the requirements set out in this Regulation; and
(b)
SoHO preparations with their corresponding authorisation.
2. The SoHO national authority designated in accordance with Article 5(4) shall be responsible for coordinating the information exchanges with the Commission and with other Member States’ SoHO national authorities, as well as for carrying out other tasks, provided for in Article 4(2), Article 12(4), Article 13(2), (3) and (4), Article 16(1), Article 31(4), Article 33(13) and (14), Article 34(2), Article 62, Article 64(3), Article 65(3) and (4), and Article 68(2) and (5). The SoHO national authority may also be responsible for the task provided for in Article 12(1).
3. SoHO competent authorities shall:
(a)
have, or have access to, a sufficient number of suitably qualified and experienced personnel, human and financial resources, operational capacity, and expertise, including technical expertise, to carry out the SoHO supervisory activities they have been made responsible for, efficiently and effectively;
(b)
have procedures in place to ensure compliance with the confidentiality obligations set out in Article 75;
(c)
ensure the independence, impartiality, transparency, effectiveness, quality, suitability for purpose and consistency of their SoHO supervisory activities;
(d)
have appropriate and properly maintained premises and equipment to ensure that the personnel can perform their SoHO supervisory activities safely, efficiently and effectively;
(e)
have a quality management system or standardised documented procedures in place for the SoHO supervisory activities they have been made responsible for that includes a plan for continuity of their activities in the case of crisis situations that impede the normal performance of their tasks;
(f)
develop and implement, or provide access to, training programmes to ensure that personnel performing SoHO supervisory activities receive, for their area of competence, appropriate training;
(g)
provide opportunities for their personnel to participate in the Union training referred to in Article 70 where such training is available and relevant.
Delegation of certain SoHO supervisory activities to other bodies
1. Member States may empower a SoHO competent authority responsible for any of the SoHO supervisory activities referred to in Articles 20, 22, 27, 28 and 29, Article 31(1), Article 32(1), Article 33(2) and (3), Article 33(4), point (a), and Article 33(5), (6) and (8) to (12), to delegate that SoHO supervisory activity to one or more other bodies (‘delegated bodies’).
2. Member States shall ensure that the delegated bodies have the powers needed to effectively perform the SoHO supervisory activities delegated to them and fulfil the obligations set out in Article 10. SoHO competent authorities that delegate SoHO supervisory activities in accordance with paragraph 1 of this Article to a delegated body shall have in place a written agreement with that delegated body.
3. The delegating SoHO competent authorities shall ensure that the written agreement referred to in paragraph 2 of this Article includes at least the following:
(a)
a precise description of the SoHO supervisory activities that the delegated body is expected to perform, and the conditions under which those activities are expected to be performed;
(b)
the condition that the delegated body participates in certification or other schemes at Union level, when available, to ensure the uniform application of principles of good practices required for their relevant sector;
(c)
a precise description of the arrangements ensuring an efficient and effective coordination between the delegating SoHO competent authority and the delegated body;
(d)
provisions on the fulfilment of the obligations set out in Articles 10 and 11;
(e)
provisions on its termination in the case of withdrawal of the delegation pursuant to Article 11.
4. SoHO competent authorities that have delegated SoHO supervisory activities pursuant to paragraph 1 shall submit the names and contact details of the delegated bodies, together with the details concerning the delegated SoHO supervisory activities, to the EU SoHO Platform.
1. Delegated bodies to which SoHO supervisory activities are delegated in accordance with Article 9 shall:
(a)
meet the obligations set out in Article 8(3);
(b)
inform the delegating SoHO competent authorities, on a regular basis and whenever those delegating SoHO competent authorities so request, of the outcome of the SoHO supervisory activities performed by them;
(c)
immediately inform the delegating SoHO competent authorities whenever the outcome of the delegated SoHO supervisory activities indicates non-compliance or points to the likelihood of non-compliance, unless specific written arrangements established between those delegating SoHO competent authorities and the delegated bodies provide otherwise; and
(d)
fully cooperate with the delegating SoHO competent authorities, including by providing access to their premises and documentation, including their information technology (IT) systems.
2. Articles 6 and 75 and, where relevant, Articles 23 and 30 shall apply to delegated bodies.
Obligations of the delegating SoHO competent authorities
SoHO competent authorities that have delegated certain SoHO supervisory activities to delegated bodies in accordance with Article 9 shall:
(a)
regularly conduct audits of the delegated bodies;
(b)
fully or partly withdraw the delegation without delay, where necessary, and in particular in cases where:
(i)
there is evidence that the delegated bodies are failing to properly perform the SoHO supervisory activities delegated to them;
(ii)
the delegated bodies have failed to take appropriate and timely action to remedy the shortcomings identified in the course of conducting SoHO supervisory activities; or
(iii)
there is evidence that the independence or impartiality of the delegated bodies has been compromised.
The interval between the audits referred to in the first paragraph, point (a), of this Article shall be determined by the delegating SoHO competent authority, taking into account the participation of the delegated bodies in certification or other schemes referred to in Article 9(3), point (b), as well as the scope and the impact of the delegated SoHO supervisory activities on the quality and safety of SoHO.
Communication and coordination between SoHO competent authorities
1. Where more than one SoHO competent authority is responsible for performing SoHO supervisory activities in a Member State pursuant to Article 5(2), the Member State or the SoHO national authority shall ensure efficient and effective coordination between all the SoHO competent authorities concerned in order to guarantee consistency and effectiveness of the SoHO supervisory activities performed on its territory.
2. Within a Member State, SoHO competent authorities shall cooperate with each other. They shall communicate information to each other and, in particular, to the SoHO national authority as necessary for the effective implementation of the SoHO supervisory activities provided for in this Regulation and of the tasks of the SoHO national authority, as referred to in Article 8(2).
3. In cases where a SoHO competent authority issues an opinion to a SoHO entity on the applicability of this Regulation to a particular substance, product or activity on its territory, that SoHO competent authority shall notify the SoHO national authority of the opinion issued, which, in turn, shall notify the SCB, for publication of that opinion in the SoHO compendium.
4. Following a duly substantiated request from the SoHO national authority of another Member State, the SoHO national authority shall without undue delay, and ensuring compliance with the confidentiality obligations set out in Article 75, inform the requesting SoHO national authority of the outcome of the SoHO supervisory activities concerning a SoHO entity on its territory, and, as necessary and proportionate, provide the requesting SoHO national authority with the relevant documentation related to the SoHO supervisory activities referred to in Articles 27 and 28.
Consultation and cooperation with authorities of other regulatory sectors
1. Member States shall ensure that their SoHO national authority has appropriate mechanisms in place to communicate with the competent authorities for organs designated under Directive 2010/53/EU and any competent authorities designated under other Union legislation referred to in Article 2(6) of this Regulation within the Member State concerned.
2. In all cases where questions arise as to the regulatory status of a substance, product or activity, the SoHO competent authorities shall, in addition to the obligation set out in Article 12(2), consult, via the SoHO national authority, with the competent authorities referred to in paragraph 1 of this Article, as appropriate, with a view to reaching a decision on the regulatory status of that substance, product or activity. In such cases, the SoHO competent authorities involved in the consultation shall also consult the SoHO compendium, and consider any relevant regulatory status decision and take into account any relevant opinion included therein.
3. In the course of the consultation referred to in paragraph 2, the SoHO competent authorities involved in such consultation may also, via their SoHO national authority, submit a request to the SCB for an opinion on the regulatory status of the substance, product or activity under this Regulation. The SoHO competent authorities shall do so in all cases where the consultation referred to in paragraph 2 has not lead to a decision on the regulatory status of such a substance, product or activity in the Member State concerned.
The SoHO competent authorities involved in the consultation referred to in paragraph 2 of this Article may also, via their SoHO national authority, indicate if they consider that there is a need for the SCB to consult, before issuing its opinion and in accordance with Article 69(1), point (c), with the relevant equivalent advisory bodies established under other relevant Union legislation referred to in Article 2(6).
The SoHO competent authorities involved in the consultation shall take into account the opinion issued by the SCB following such a request.
4. When a consultation referred to in paragraph 2 and, where relevant, paragraph 3 of this Article leads to a regulatory status decision, the SoHO competent authorities shall, via their SoHO national authority, inform the SCB of the decision taken in the Member State concerned with a view to the publication thereof by the SCB in the SoHO compendium, pursuant to Article 69(1), point (e). The SoHO competent authorities shall include a description of the reasons for the decision, and where the decision taken differs from the SCB opinion, provide a justification.
5. The Commission shall, upon a duly substantiated request from a Member State following the consultation referred to in paragraph 2 of this Article, or may on its own initiative, by means of implementing acts, determine the regulatory status of a substance, product or activity under this Regulation, where such a determination is needed to avoid risks to the safety of SoHO donors, recipients or offspring from medically assisted reproduction, or risks of a compromised access of recipients to safe and effective treatment. Such a request from a Member State shall be considered duly substantiated where questions arise in respect of the regulatory status of a substance, product or activity under this Regulation, in particular where such questions cannot be resolved at Member State level, or in consultations conducted in accordance with Article 69(1), point (c), between the SCB and the advisory bodies established under other relevant Union legislation referred to in Article 2(6).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
6. In the case of SoHO referred to in Article 2(6) or (8), the SoHO competent authorities shall cooperate with the competent authorities responsible for the supervisory activities under other relevant Union legislation referred to in Article 2(6), with a view to ensuring coherent oversight. During that process, the SoHO competent authorities may seek, via their SoHO national authority, the assistance and advice of the SCB concerning, inter alia, good cooperation practices that ensure coherent oversight when the regulatory status of SoHO changes.
7. The consultation and cooperation referred to in paragraphs 2, 3 and 6 may also be initiated on the basis of a request from a SoHO entity for an opinion.
8. Where a SoHO competent authority takes an enforcement decision concerning a SoHO entity that performs SoHO activities and activities regulated by other Union legislation and overseen by competent authorities as referred to in paragraph 1, the SoHO competent authority shall, without undue delay, via the SoHO national authority, inform the relevant competent authority designated under that other Union legislation of its decision.
SoHO competent authorities and delegated bodies shall cooperate with the Commission in respect of the performance of the Commission controls referred to in Article 71. In particular, they shall:
(a)
take appropriate follow-up measures to remedy the shortcomings identified through those Commission controls;
(b)
provide the necessary technical assistance and the available documentation, upon justified request, as well as any other support that the Commission requests to enable it to perform controls efficiently and effectively, including facilitating access to all premises or any part thereof, and to documentation, including IT systems, of the SoHO competent authority or delegated body that is relevant for the execution of their duties.
Transparency regarding fees for technical services required for making SoHO available
Member States may take appropriate measures which aim to ensure transparency in the fees in respect of technical services required for making SoHO available.
