ANNEX I
MODULES AND FUNCTIONALITIES
The EU SoHO platform shall provide at least the following modules and functionalities:
(1)
a module on the registration of SoHO entities and authorisation of SoHO establishments that allows:
(a)
actors to register their SoHO entity, including critical SoHO entity, in the system;
(b)
a confirmation of receipt of the registration that can be automatically generated by the EU SoHO Platform;
(c)
the verification of the registration by the SoHO competent authorities, the request of additional information and the reply to this request;
(d)
the registration to be rejected, modified, or validated and published, with the result automatically communicated via the EU SoHO Platform to the actor who registered the SoHO entity; including critical SoHO entity;
(e)
actors and authorised actors to apply for authorisation as a SoHO establishment, including importing SoHO establishment;
(f)
a confirmation of receipt of the application for authorisation that can be automatically generated by the EU SoHO Platform
(g)
the SoHO establishment authorisation to be verified by the SoHO competent authority;
(h)
the authorisation to be rejected, modified, or validated and published, with the result automatically communicated via the EU SoHO Platform to the actor or authorised actor who applied for the SoHO establishment authorisation, including importing SoHO establishment authorisation;
(i)
to submit, retrieve, store, manage, handle, exchange, analyse, track and delete data on (critical) SoHO entities and on SoHO establishments, including importing SoHO establishments;
(j)
to bulk import data on verified SoHO entities; including critical SoHO entities, and on SoHO establishments, including importing SoHO establishments, by the SoHO competent authorities;
(2)
a module on the compendium of authorised SoHO preparations and the compendium of approved clinical studies on SoHO preparations that allows:
(a)
SoHO competent authorities to manage information related to the authorisation of SoHO preparations;
(b)
SoHO competent authorities to assign preparation authorisations to SoHO entities;
(c)
access to information regarding approved SoHO clinical studies that are submitted to the EU SoHO platform;
(d)
to submit, retrieve, store, manage, handle, exchange, analyse, track and delete data on SoHO preparation authorisations;
(3)
a module on the SoHO Coordination Board membership and a compendium of advice that:
(a)
provides a list of SoHO Coordination Board members and alternates, their institution of origin and declaration of interest;
(b)
provides a compendium of advice given on the regulatory status of substances, products or activities;
(c)
allows the exchange of data between the SoHO Coordination Board members;
(4)
a module on vigilance reporting and rapid alerts that allows:
(a)
the SoHO national authority or SoHO competent authority to communicate with other SoHO national authorities and SoHO competent authorities, as well as with the European Centre for Disease Prevention and Control (ECDC) in case of SoHO rapid alerts related to communicable diseases;
(b)
SoHO national authorities to submit an annual summary of confirmed serious adverse reactions (SAR) or serious adverse events (SAE) notifications and of the related investigation reports to the EU SoHO Platform;
(5)
an activity data module that allows:
(a)
providing information about supply flows, supply alert for critical SoHO and shortages;
(b)
the SoHO competent authority and/or its SoHO entities to communicate activity data to the EU SoHO Platform;
(c)
the SoHO competent authority to verify the data submitted by SoHO entities and demand corrections if necessary;
(d)
compile the activity data reported from the SoHO entities within the same Member State and prepare an annual aggregated SoHO activity report;
(e)
the SoHO competent authority to communicate activity data to the Commission including from registries via bulk import;
(f)
the SoHO national authority to communicate with other SoHO national authorities about supply flows, monitor shortages and submit supply alerts;
(6)
a module on guidelines for implementation of standards that allows:
(a)
the SoHO competent authorities to store technical guidelines for implementation of standards;
(b)
to publish or refer to general guidelines;
(c)
the SoHO national authorities to publish or refer to specific Member State measures;
(7)
a collaboration module that:
(a)
allows exchange of data between Member States, SoHO national authorities, SoHO competent authorities, the Commission, the SoHO Coordination Board and SoHO entities via secure communication channels for restricted exchange of information and data, in particular:
(1)
Member States’ SoHO national authorities;
(2)
two SoHO competent authorities within the same Member State or between a SoHO competent authority and its SoHO national authority;
(3)
SoHO national authorities and the Commission, in particular in relation to activity data concerning SoHO activities of SoHO entities, summaries of notifications and investigation reports of confirmed SAR or SAE, SoHO rapid alerts and SoHO supply alerts;
(4)
SoHO national authorities and the SoHO Coordination Board;
(5)
SoHO national authorities and the ECDC in relation to SoHO rapid alerts related to communicable diseases, where relevant;
(6)
SoHO entities and their respective SoHO competent authorities, when the SoHO competent authorities choose to use the EU SoHO Platform for such exchanges;
(8)
a publication module that consists of:
(a)
a data and document repository component that manages all data and documents entering the EU SoHO Platform, incorporating functionalities such as data recording with versioning, automatic input data validation before recording, and a data history feature for audit trails and traceability of changes by authorised actors;
(b)
a restricted website which, with the use of data publishing, data searching, viewing and exporting, as well as data analytics, presents information to authorised actors and makes the information available in accordance with their access rights;
(c)
a public website which allows the general public to view, search and download all publicly available data and documents referred to in Article 74(3) of Regulation (EU) 2024/1938.
