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1. SoHO entities shall maintain a system for detecting, investigating and recording information concerning adverse reactions and adverse events, including those detected during clinical-outcome monitoring as part of a SoHO preparation authorisation application as referred to in Article 39.

2. SoHO entities shall make all reasonable efforts to encourage prospective parents of children born from third-party donation to communicate information concerning serious genetic conditions as soon as they emerge in the children, to the SoHO entity where they were treated. The SoHO entity shall communicate, without undue delay, that information to the SoHO establishment that released the reproductive SoHO for human application with a view to investigating the suspected serious adverse reaction and preventing further distribution of SoHO from the implicated SoHO donor, in accordance with national legislation on the storage and use of reproductive SoHO.

3. In cases where SoHO entities detect or suspect that an adverse reaction or adverse event falls within the definition of a serious adverse reaction as set out in Article 3, point (45), or the definition of a serious adverse event as set out in Article 3, point (46), they shall submit a notification to their SoHO competent authorities without undue delay and shall include the following information:

(a) a description of the suspected serious adverse reaction or serious adverse event;

(b) a preliminary assessment of the level of imputability, where applicable;

(c) details of any immediate steps taken to limit harm, where applicable;

(d) a preliminary assessment of the seriousness of the consequences of the suspected serious adverse reaction or serious adverse event.

4. SoHO entities other than SoHO establishments shall communicate adverse reactions or adverse events to the SoHO establishment for which they carry out SoHO activities on the basis of an agreement or to the SoHO establishment that distributed the SoHO to them, as appropriate. In such cases, the SoHO establishments which receive the communication shall be responsible for the investigation and shall report to their SoHO competent authorities when the adverse reaction or adverse event concerned is deemed to be a serious adverse reaction or serious adverse event. SoHO entities other than those referred to in the first subparagraph shall investigate and report serious adverse reactions or serious adverse events directly to their SoHO competent authorities.

5. Upon receipt of information regarding a serious incident and field safety corrective action within the meaning of Regulation (EU) 2017/745 or (EU) 2017/746, concerning a medical device or in vitro diagnostic medical device that is used by a SoHO entity, the SoHO entity receiving such information shall communicate it to its SoHO competent authority.

6. SoHO entities shall have in place a procedure to accurately, efficiently and verifiably withdraw from distribution or use those SoHO affected, or suspected to be affected, by serious adverse reactions or serious adverse events, as referred to in paragraph 3, as appropriate. In the case of reproductive SoHO, such procedure shall be in accordance with national legislation.

7. SoHO entities shall conduct an investigation of each serious adverse reaction or serious adverse event detected by, or communicated to, them in accordance with paragraph 4. On completion of that investigation, SoHO entities shall provide an investigation report to their SoHO competent authorities. The SoHO entities shall include in the report:

(a) a full description of the investigation of the serious adverse reaction or serious adverse event and the final assessment of the imputability of the serious adverse reaction to the collection process or to the human application of the SoHO, where applicable;

(b) the final assessment of the seriousness of the harm to a SoHO donor, a SoHO recipient or the offspring from medically assisted reproduction or for public health in general, including a risk assessment of the likelihood of recurrence, where relevant;

(c) a description of the corrective or preventive actions that have been taken to limit any harm or to prevent recurrence.

8. SoHO entities shall communicate information concerning a serious adverse reaction or serious adverse event to other SoHO entities engaged in the collection, processing, testing, storage and distribution of SoHO collected from the same SoHO donor, or otherwise possibly affected. They shall only communicate information necessary and appropriate in order to facilitate traceability and ensure quality and safety of SoHO in such cases, and shall, in particular, limit the information to details necessary to take risk mitigating actions. A risk assessment of the seriousness and likelihood of recurrence shall be included in the communication. SoHO entities shall, where relevant, also communicate such information to organ procurement organisations in cases where the SoHO donor who is implicated in the serious adverse reaction or serious adverse event has also donated organs or to manufacturers in cases where SoHO collected from that SoHO donor have been distributed to manufacture products regulated by other Union legislation, as referred to in Article 2(6).