Changes from adopted text to adopted text

RemovedArticle 8 – paragraph 1: 1. Without prejudice to Article 75, competent authorities and members of the SCB shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions taken in cases where a SoHO entity has failed to comply with an obligation under this Regulation and where such failure causes or may cause a serious risk to human health, including decisions to revoke, suspend or reinstate an authorisation for SoHO activities. Competent authorities shall also be transparent about the criteria used for the assessment and authorisation of SoHO preparations and SoHO entities.

RemovedArticle 9 – paragraph 1: 1. Competent authorities shall be responsible for the SoHO supervisory activities referred to in Chapter III in order to verify the effective compliance of SoHO entities and SoHO preparations authorised in their territory with the requirements set out in this Regulation.

RemovedArticle 9 – paragraph 2 – point a: (a) human and financial resources, operational capacity, and expertise, including technical expertise, to carry out the supervisory functions provided for in this Regulation;

RemovedArticle 9 – paragraph 2 – point b: (b) procedures to ensure the independence, impartiality, transparency, effectiveness, quality, suitability for purpose and consistency of their SoHO supervisory activities;

RemovedArticle 9 – paragraph 2 – point c: (c) appropriate and properly maintained facilities and equipment to ensure that personnel can perform their SoHO supervisory activities efficiently, safely and effectively;

RemovedArticle 14 – paragraph 1: 1. In all cases where questions arise as to the regulatory status of a substance, product or activity, competent authorities shall consult with the national authorities established in other relevant Union legislation referred to in Article 2(3), as relevant In such cases, competent authorities shall also consult the compendium referred to Article 3, point (33).

RemovedArticle 14 – paragraph 2 – subparagraph 2: If the SCB deems it necessary, it shall consult, in accordance with Article 68(1), point (b), with the equivalent advisory bodies established in other relevant Union legislation referred to in Article 2(3).

RemovedArticle 14 – paragraph 3 – subparagraph 1 a (new): To the extent possible, the competent authorities shall comply with the opinion of the SCB. In the event of non-compliance, they shall inform the SCB as soon as possible of the decision taken and justify their decision.

RemovedArticle 16 – paragraph 1 – point a a (new): (aa) make the declarations of interest referred to in Article 7(2) publicly available on their website;

RemovedArticle 20 – paragraph 3: 3. SoHO preparation authorisations shall be valid throughout the Union for the period defined in the terms of the authorisation, when such a time period has been defined, or until a competent authority has suspended or withdrawn the authorisation. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific SoHO preparation, that Member State may decline to recognise the validity of the SoHO preparation authorisation of another Member State pending verification that the more stringent measure has been met. This information shall be notified, without undue delay, on the EU SoHO Platform.

RemovedArticle 21 – paragraph 2 – subparagraph 1 a (new): Where the conditional authorisation referred to in point (c) has been granted, appropriate information for practitioners and patients on the conditional nature of the authorisation shall be provided by the SoHO entity.

RemovedArticle 21 – paragraph 4: 4. Competent authorities shall conclude the SoHO preparation authorisation steps, referred to in paragraph 2 of this Article, within 3 months from receipt of the application, excluding the time needed for clinical outcome monitoring or studies. They may suspend this time limit for the duration of the consultation processes referred to in Article 14(1) and (2) or if further information is required from the SoHO entity that made the request.

RemovedArticle 21 – paragraph 6 – subparagraph 1 – point a: (a) such preparation, or any of the activities performed for that preparation, do not comply with the conditions of its authorisation or the requirements of this Regulation; or

RemovedArticle 21 – paragraph 8: 8. Competent authorities may, in accordance with national legislation, withdraw the authorisation of a SoHO preparation if the competent authorities have confirmed that the SoHO preparation in question does not comply with subsequently updated criteria for authorisation or the SoHO entity has failed to comply with the conditions of its authorisation.

RemovedArticle 27 – paragraph 1: 1. Competent authorities shall provide guidelines and templates to allow that applications from SoHO entities for their authorisation as SoHO establishments are submitted in accordance with Article 49. When developing those guidelines and templates, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).

RemovedArticle 27 – paragraph 3 – subparagraph 1 – point a: (a) does not comply with the conditions of its authorisation or the provisions of this Regulation; or

RemovedArticle 27 – paragraph 3 – subparagraph 1 – point a a (new): (aa) does not take corrective or preventive action following an inspection by national authorities pursuant to Article 29(14); and

RemovedArticle 27 – paragraph 5: 5. Competent authorities may, in accordance with national legislation, withdraw the authorisation of a SoHO establishment if the competent authorities have confirmed that the SoHO establishment no longer complies with updated criteria for authorisation or the SoHO establishment has failed to comply with the conditions of its authorisation.

RemovedArticle 28 – paragraph 5 – point a: (a) that the SoHO entity in question does not comply with the conditions of the authorisation or the provisions of this Regulation; or

RemovedArticle 28 – paragraph 5 – point b: (b) that this non-compliance, or suspected non-compliance, implies a risk to the safety of SoHO recipients or offspring from medically assisted reproduction.

RemovedArticle 28 – paragraph 7: 7. Competent authorities may, in accordance with national legislation, withdraw the authorisation of an importing SoHO entity if the competent authorities have confirmed that the importing SoHO entity no longer complies with updated criteria for authorisation or the importing SoHO entity has failed to comply with the conditions of its authorisation.

RemovedArticle 28 – paragraph 9: 9. By way of derogation from paragraph 1, in the exceptional situations referred to in Article 61a or in case of emergency, competent authorities may authorise imports of SoHOs for immediate application to a specific recipient when duly justified by the clinical circumstances on a case-by-case basis.

RemovedArticle 29 – paragraph 11: 11. The interval between inspections shall be decided on based on the frequency necessary to mitigate any identified risks and shall not exceed 4 years.

RemovedArticle 32 – paragraph 1 – subparagraph 2 a (new): Inspectors shall be designated in accordance with procedures which ensure that they act in a transparent, independent and impartial manner. The designation criteria shall be clear and transparent.

RemovedArticle 32 – paragraph 1 a (new): 1a. All inspectors shall act in an impartial manner and be independent of any direct or indirect conflicts of interest. Inspectors shall declare such impartiality in writing and such declarations shall be made available on the competent authorities’ website.

RemovedArticle 32 – paragraph 3 – point a: (a) the inspection techniques and procedures to be followed, including practical exercises and conflict of interest rules;

RemovedArticle 34 a (new): Article 34a / Exchange of information on SoHO availability and continuity of supply / 1. As part of the national plans to ensure the continuity of SoHO supply referred to in Article 62, the competent authorities shall establish a digital communication channel through which they can exchange information on the availability of SoHOs in the national territory in a fast and efficient manner. Through that digital communication channel, the competent authorities may, in specific situations of need, oblige national SoHO entities to provide information on the availability of a certain SoHO. They shall also take into account alerts sent by national SoHO entities concerning the availability of SoHOs and potential shortages. The competent authorities shall ensure that the digital communication channel is available no later than ... [two years after the date of entry into force of this Regulation]. / 2. The competent authorities shall monitor the availability of SoHOs at national level through the digital communication channel referred to in paragraph 1. They shall provide guidance to SoHO entities to facilitate the exchange of information on the availability of SoHOs. / 3. The competent authorities shall store and analyse information on the availability of SoHOs and the fluctuations in such availability over time, as well as trends in demand and potential shortages of SoHOs, and shall draw up reports containing that information which may be made available to other Member States through …

RemovedArticle 36 a (new): Article 36a / Authorisation and registry of SoHO clinical studies / 1. Competent authorities shall authorise SoHO clinical studies after granting the approval for the clinical study proposal referred to in Article 41a(5) and verifying that the clinical study has been the subject of a positive recommendation by a relevant ethics committee where necessary. / 2. Competent authorities shall inform, instruct and assist SoHO entities in their Member State with regard to the authorisation and registration processes for SoHO clinical studies. Competent authorities shall provide SoHO entities with guidelines and assistance regarding technical and ethical aspects of SoHO clinical studies. / 3. Competent authorities shall register each authorised SoHO clinical study on the EU SoHO Platform, providing the following information: / (a) the name or business name and address of the SoHO entity or entities carrying out the clinical study, and the name and contact details of the researchers and a contact person; / (b) where necessary, a positive recommendation by a relevant ethics committee; / (c) a summary of the study design; / (d) date of commencement and completion of the various stages of the clinical study; / (e) not more than one year after the end of the clinical study, a summary of the results and conclusions; / (f) a summary intended for the general public of the clinical study and the results obtained. / 4. In cases where more than one SoHO entity participates in a SoHO clinical stu…

RemovedArticle 38 – paragraph 2: 2. The responsible person for release of SoHOs shall be in possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned and shall have at least 2 years of experience in the relevant field. The SoHO entity shall ensure that the responsible person for release of SoHOs receives adequate and up-to-date training, appropriate to their job and responsibilities, including specific training on those SoHOs that necessitate such training.

RemovedArticle 40 – paragraph 1: 1. SoHO entities shall not release or, in an autologous context, prepare and apply immediately to a recipient, SoHO preparations without prior SoHO preparation authorisation. In cases where a SoHO entity substantially modifies an activity carried out for an authorised SoHO preparation, it shall obtain an authorisation for that modified SoHO preparation. For the purposes of this Article, ‘substantial modification’ means a modification that has an impact on the purpose, quality, safety, efficacy or functionality of a SoHO preparation.

RemovedArticle 40 – paragraph 3: 3. SoHO entities may request to their competent authorities a derogation from the requirement for a SoHO preparation authorisation in the exceptional circumstances referred to in Articles 61 and 61a.

RemovedArticle 41 – paragraph 2 – point b: (b) the results of a risk assessment conducted in accordance with Article 41a(4); / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

RemovedArticle 41 – paragraph 2 – point c: (c) in cases where the indicated risk is other than negligible, a proposal for clinical outcome monitoring to demonstrate safety, quality and efficacy of the SoHO preparation, in line with the results of the risk assessment, and as set out in Article 41a(5);

RemovedArticle 41 – paragraph 3: deleted / (deleted) / (deleted) / (deleted)

RemovedArticle 41 – paragraph 4: 4. SoHO entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to Article 21(2), point (c), and submit the results and the analysis of those results to their competent authorities at the frequency determined in the authorisation. In conducting the clinical investigation study as referred to in Article 41a(5), points (a)(ii) and (a)(iii), for the SoHO preparation concerned, the applicant may use an existing clinical registry to record its results provided that their competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of data. The applicant shall register that study and the results obtained on the EU SoHO Platform in accordance with Article 36a.

RemovedArticle 41 – paragraph 5: 5. SoHO entities shall not make any substantial change to the chain of activities performed for an authorised SoHO preparation, without the prior written approval of their competent authorities. For the purposes of this Article, ‘substantial change’ means a change that has an impact on the purpose, quality, safety, efficacy or functionality of a SoHO preparation. SoHO entities shall also inform their competent authorities of changes in the SoHO preparation authorisation holder’s details.

RemovedArticle 41 a (new): Article 41a / SoHO clinical studies / 1. When conducting SoHO clinical studies, in the context of the monitoring plans referred to in Article 41(2), point (c), or with the aim of comparing or improving previously authorised treatments, SoHO entities shall comply with the requirements set out in this Regulation. / 2. SoHO clinical studies shall always have the safety and well-being of the participants in the clinical study as a priority and they shall comply with Articles 53, 54, 55, 56, 58 and 59, concerning the protection of donors, recipients and offspring from medically assisted reproduction. SoHO entities intending to start a SoHO clinical study shall seek to obtain robust and reliable data, through collaboration with other SoHO entities, if necessary. / 3. SoHO entities shall submit a request for approval of the SoHO clinical study to competent authorities before starting the clinical study, in accordance with the procedure set out in paragraphs 4 and 5. SoHO entities may request assistance regarding administrative, technical and ethical aspects of the clinical study from the competent authorities, in accordance with Article 36a. / 4. Prior to starting a SoHO clinical study, the applicant shall conduct a risk assesment, on the combination of SoHO activities performed for the SoHO preparation, together with the intended clinical indication, taking into account: / (a) whether the SoHO preparations are described in, and aligned with, an EDQM SoHO monograph included in the t…

RemovedArticle 43 – paragraph 4: 4. The importing SoHO entity authorisation holder shall be based in the Union, and be responsible for the physical reception and visual examination and verification of imported SoHOs prior to their release. The importing SoHO entity shall verify coherence between the SoHO received and the associated documentation and conduct an examination of the integrity of packaging and the compliance of labelling and transport conditions with the relevant standards and technical guidelines as referred to in Articles 57, 58 and 59. The importing SoHO entity shall ensure that the imported SoHOs meet safety and quality standards equivalent to those set out in this Regulation.

RemovedArticle 47 – paragraph 1: 1. SoHO entities shall maintain a system for detecting, investigating and recording information concerning adverse occurrences, including adverse occurrences detected during clinical outcome monitoring as part of a SoHO preparation authorisation application as referred to in Article 41 or as part of a SoHO clinical study as referred to in Article 41a.

RemovedArticle 47 – paragraph 3 a (new): 3a. Where a SAO notification concerns public health matters, competent authorities shall, without delay, communicate essential information to the general public and to the SCB.

RemovedArticle 48 – paragraph 1: 1. SoHO establishments shall not carry out any SoHO activities without prior SoHO establishment authorisation. This shall apply whether all activities are carried out by the establishment itself or one or more are contracted to another SoHO entity.

RemovedArticle 51 – title: Physicians

RemovedArticle 51 – paragraph 2 – point b: (b) investigation of suspected adverse occurrences in SoHO donors, SoHO recipients and, where relevant, offspring from medically assisted reproduction;

RemovedArticle 51 – paragraph 3: 3. By derogation from paragraph 2, in the case of SoHO entities that are authorised as SoHO establishments in accordance with Article 25(3), the physician shall be responsible for those tasks that are relevant to the SoHO activities performed by the SoHO entities and that have a direct influence on the health of SoHO donors, SoHO recipients and, where relevant, offspring from medically assisted reproduction.

RemovedArticle 52 – paragraph 2: 2. SoHO entities shall protect the physical and, where relevant, mental health of living SoHO donors before, during and after the donation.

RemovedArticle 52 – paragraph 2 a (new): 2a. SoHO entities shall ensure that the state of health of SoHO donors before the donation does not pose a disproportionate risk to the donation or to the health of such donors during or after the donation.

RemovedArticle 53 – paragraph 1 – point a: (a) meet all applicable informed consent or authorisation requirements in force in the Member State concerned;

RemovedArticle 53 – paragraph 1 – point b: (b) provide donors or their relatives or any persons granting authorisation on their behalf, in accordance with national legislation, with the information referred to in Article 55 and in a way that enables them to give informed consent and request further information if needed;

RemovedArticle 53 – paragraph 1 – point j: (j) verify, by means of national registries, that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in Article 56 and demonstrate that their health is not compromised;

RemovedArticle 53 – paragraph 1 – point j a (new): (ja) verify, by means of national registries, that donors meet donor eligibility criteria, if required in the case of specific types of donation, on the basis of the latest available scientific evidence and medical expertise;

RemovedArticle 53 – paragraph 1 – point l a (new): (la) inform the SoHO recipients of donor anonymity requirements and the possibility of ID release and the implications thereof for medically assisted reproduction with third party donation of reproductive cells, pursuant to national legislation.

RemovedArticle 53 – paragraph 1 a (new): 1a. SoHO entities shall not discriminate against SoHO donors on any of the grounds listed in Article 21 of the Charter of Fundamental Rights of the European Union, unless it is necessary to protect the health of the SoHO recipient, of the offspring from medically assisted reproduction or of the SoHO donor. Such discriminatory action shall be based on scientific evidence.

RemovedArticle 53 – paragraph 2: 2. In the course of the donor health evaluations referred to in paragraph 1, point (f), SoHO entities shall conduct interviews with the donors and gather information concerning the donors’ present and recent state of physical, and, where appropriate, mental health and their health histories to assure the safety of the donation process for those donors. SoHO entities may perform laboratory tests as part of the donor health evaluations. They shall perform such tests in cases where evaluations indicate that laboratory tests are necessary to establish the eligibility of those donors from the perspective of their own protection. The physician, as referred to in Article 51, shall approve the procedure and criteria for donor health evaluations.

RemovedArticle 53 – paragraph 3: 3. SoHO entities that collect SoHOs from donors that are subjected to a surgical procedure in order to donate, that are treated with hormones to facilitate donation, or that donate SoHOs that can be donated on a frequent and repeated basis, shall register such donors and the results of their donor health evaluations in a cross-entity registry that allows interconnection with other such registries at Union level, including cross-border registries, as referred to in paragraph 1, point (j). SoHO entities that manage such registries shall ensure interconnectivity between them. The concept of frequent and repeated donations shall be understood in accordance with the EDQM guidelines referred to in Article 71 for each type of donation.

RemovedArticle 53 – paragraph 6: 6. The Commission is empowered to adopt delegated acts in accordance with Article 77 in order to be able to supplement this Regulation in cases where additional standards are needed in order to ensure the protection of donors, in particular as regards the permitted frequency of donations in the event of non-application of the guidelines referred to in Article 56.

RemovedArticle 54 – paragraph 2: 2. Member States may allow for the compensation or reimbursement from the SoHO entities to living SoHO donors for losses or expenses related to their participation in donations, in accordance with the principle of voluntary and unpaid donation, and for example taking the form of compensatory leave, tax reductions or flat rate allowances set at national level. Based on transparent criteria, Member States shall establish the conditions for such forms of compensation or reimbursement in national legislation, ensuring that they are financially neutral and consistent with the standards laid down in this Article. / They may make compensation or reimbursement subject to the filing of applications by donors and delegate the setting of conditions for such forms of compensation or reimbursement to independent bodies that are established in accordance with national legislation. In that regard, the Commission shall support the exchange of best practices between Member States. The donors may also choose not to be compensated for losses or expenses associated with their donation.

RemovedArticle 54 – paragraph 3: 3. SoHO entities may compensate or reimburse living SoHO donors as provided for by their competent authorities pursuant to paragraph 2. SoHO entities shall report in a transparent manner to the competent authorities on any compensation and reimbursement measures they have in place, and on any changes they make in that respect.

RemovedArticle 54 – paragraph 3 a (new): 3a. Compensation or reimbursement shall not serve as an incentive for donations or engender financial competition, including cross-border competition, between institutions and entities that are seeking donors. It shall not lead to exploitation of vulnerable persons in society.

RemovedArticle 54 – paragraph 3 b (new): 3b. Member States shall regulate the advertising of the collection of SoHOs. Any advertising of SoHO donations linked to a financial reward shall be prohibited. Recruitment campaigns and advertisements shall not refer to any compensation.

RemovedArticle 54 – paragraph 3 c (new): 3c. By ... [two years after the date of entry into force of this Regulation] and every three years thereafter, the Commission shall assess the national conditions for the level of compliance with the principle of voluntary and unpaid donation as set out in this Regulation. That assessment shall determine, inter alia, whether compensation and reimbursement, under any circumstances, harm donor or recipient safety, constitute an incentive or a claim to recruit donors or expose vulnerable people in society to exploitation. Member States shall provide the Commission with the information requested to perform that assessment. / On the basis of the assessments referred to in the first subparagraph, the Commission shall adopt guidelines for Member States based on best practices in the implementation of compensation schemes and, where appropriate, make recommendations to Member States on how such practices can be improved. Those guidelines and recommendations shall be made available to the public.