1. SoHO establishments shall not carry out any of the SoHO activities that would qualify them as a SoHO establishment as defined in Article 3, point (35), without prior SoHO establishment authorisation. This shall apply regardless of whether all SoHO activities are carried out by the SoHO establishment itself or whether one or more are contracted to another SoHO entity.
In the case of a decision on the need for a SoHO establishment authorisation under Article 24(4), the SoHO entity shall not carry out the SoHO activity requiring SoHO establishment authorisation as communicated by the SoHO competent authority, without prior SoHO establishment authorisation.
2. In cases where SoHO establishments contract other SoHO entities to perform a part or all of certain SoHO activities, the SoHO establishments shall ensure that those contracted SoHO entities carry out those contracted SoHO activities in compliance with this Regulation. Such contracted SoHO entities may be audited by the contracting SoHO establishment or inspected by the SoHO competent authority, in particular in cases where the contracted SoHO entity has not been accredited, certified or authorised, as part of a national programme, for the specific contracted SoHO activities.
3. The requirement to obtain a SoHO establishment authorisation shall be without prejudice to more stringent measures adopted by a Member State in accordance with Article 4 and directly affecting the SoHO activities carried out in the SoHO establishment or contracted SoHO entities concerned pursuant to paragraph 2 of this Article.
1. SoHO entities shall submit the application for authorisation as SoHO establishment to the SoHO competent authorities of their territories.
2. The applicant SoHO establishment shall provide the name and contact details of the responsible person as referred to in Article 36.
The SoHO establishment shall not make any significant changes with regard to the SoHO or the SoHO activities subject to the authorisation without the prior written authorisation of the SoHO competent authority.
3. Significant changes for the purposes of paragraph 2 means changes relating to the types of SoHO concerned, to the types of SoHO activities carried out, to the use of new premises or to the modification of premises having an impact on the conditions under which SoHO activities are carried out.
4. SoHO establishments shall also, without undue delay, inform their SoHO competent authorities of any changes of an administrative nature, related to the SoHO establishment authorisation, including a permanent or temporary replacement of the responsible person.
5. The legal entity that holds the SoHO establishment authorisation shall be based in the Member State where the SoHO establishment is authorised.
1. SoHO establishments shall not import SoHO without a prior importing SoHO establishment authorisation.
2. In the case of import of human plasma that is intended to be used for the manufacture of medicinal products regulated by other Union legislation and which is included in a plasma master file (PMF) as referred to in Directive 2001/83/EC, paragraph 1 of this Article shall not apply as the importers are to be authorised by other Union legislation. In those cases, the importers shall be registered as SoHO entities.
3. SoHO entities responsible for human application to a specific SoHO recipient may submit a request to their SoHO competent authorities for a derogation from the requirement for an importing SoHO establishment authorisation in the circumstances referred to in Article 26(6).
4. The Commission shall adopt delegated acts in accordance with Article 77 to supplement this Regulation by laying down obligations and procedures for importing SoHO establishments regarding the import of SoHO in order to verify equivalent standards of quality, safety and effectiveness of such imports.
Application for importing SoHO establishment authorisation
1. Article 46 shall apply mutatis mutandis to the applications for importing SoHO establishment authorisations.
2. Prior to applying for an importing SoHO establishment authorisation, SoHO establishments shall put in place written agreements with one or more third-country suppliers. Such agreements shall include the elements set out in paragraph 3, point (b).
3. The applicant SoHO establishment shall provide:
(a)
documentation of the accreditation, designation, authorisation or licence granted by a competent authority or authorities to the third-country supplier for carrying out the activities related to the SoHO to be imported;
(b)
a written agreement as referred to in paragraph 2 that shall include, at least:
(i)
details of the third-country supplier contracted;
(ii)
the requirements to be met to ensure the equivalence of the quality, safety and effectiveness of the SoHO to be imported;
(iii)
the right of the SoHO competent authorities to inspect the activities, including the facilities, of any third-country supplier or entity sub-contracted by that supplier, contracted by the importing SoHO establishment;
(c)
documentation describing the imported SoHO and demonstrating that the procedures the third-country suppliers have in place will ensure that the imported SoHO will be equivalent, in terms of quality, safety and effectiveness, to SoHO authorised in accordance with this Regulation.
4. The importing SoHO establishment shall be responsible for the physical reception and visual examination and verification of imported SoHO prior to their release. The importing SoHO establishment shall verify coherence between the SoHO received and the associated documentation and conduct an examination of the integrity of packaging, labelling and transport conditions, taking into account the relevant standards and technical guidelines as referred to in Articles 57, 58 and 59.
5. The releasing officer of an importing SoHO establishment shall release imported SoHO for distribution only after that officer has verified compliance with the quality, safety and effectiveness requirements specified in the agreement referred to in paragraph 3, point (b), and when the physical and documentation controls referred to in paragraph 4 are satisfactory.
6. An authorised importing SoHO establishment may delegate the physical reception, visual examination and verification referred to in paragraph 4 to the SoHO entity that will apply the SoHO to a SoHO recipient in cases where the import of SoHO is organised for a specific SoHO recipient.
In the case of national or international donor registries that are authorised as importing SoHO establishments, the physical and documentation controls referred to in paragraph 5 may be delegated to the SoHO entity that receives the imported SoHO for human application and the release step may be completed remotely.
7. The Commission shall adopt implementing acts specifying the information to be provided in an application for an importing SoHO establishment authorisation to ensure compatibility and comparability of such data.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
1. In cases where a SoHO establishment releases SoHO, it shall appoint one or more releasing officers.
2. The releasing officer shall be in possession of a diploma, certificate or other evidence of formal qualifications in the field of medical, pharmaceutical or life 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.
3. The releasing officer may delegate the task of releasing SoHO as referred to in paragraph 1 to other persons who shall be qualified by training and experience to perform such a task. In such cases, those persons shall perform that task under the responsibility of the releasing officer who will always be responsible for the release.
The responsibility for releasing SoHO may be delegated to an alternate in the event of short-term absence of the releasing officer, provided that the alternate meets the requirements set out in paragraph 2.
1. Each SoHO establishment shall appoint a physician who carries out their tasks in the same Member State and who shall at least fulfil the following conditions and have the following qualifications:
(a)
possession of formal qualification as a physician; and
(b)
at least 2 years’ practical experience in the relevant field.
2. The physician referred to in paragraph 1 shall be responsible for at least the following tasks:
(a)
development, review and approval of procedures for establishing and applying SoHO donor eligibility criteria, procedures for SoHO collection and criteria for the allocation of SoHO;
(b)
supervision of the implementation of procedures referred to in point (a) when they are carried out by SoHO entities contracted by the SoHO establishment;
(c)
the clinical aspects of investigation of suspected adverse reactions in SoHO donors, SoHO recipients and offspring from medically assisted reproduction from the perspective of the SoHO establishment;
(d)
design and supervision, in collaboration with treating physicians, of clinical-outcome monitoring plans to generate evidence required to support applications for SoHO preparation authorisations pursuant to Article 39;
(e)
other tasks of relevance to the health of SoHO donors, SoHO recipients and offspring from medically assisted reproduction in relation to SoHO collected or supplied by the SoHO establishment.
3. The physician may delegate the tasks referred to in paragraph 2 to other persons who shall be qualified by training and experience to perform such tasks. In such cases, those persons shall perform those tasks under the responsibility of the physician.
4. By way of derogation from paragraph 2 of this Article, where SoHO entities are authorised as SoHO establishments in accordance with Article 24(4), 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.
1. SoHO establishments shall ensure that SoHO released for export comply with the requirements of this Regulation.
2. By way of derogation from paragraph 1 of this Article, SoHO that do not comply with all the relevant standards and guidelines referred to in Articles 58 and 59 may be released for export in the case of exceptional release pursuant to Article 61(3). Nevertheless, SoHO establishments shall even in those circumstances comply with the standards referred to in Chapter VI, as well as the obligations related to vigilance and traceability.
