Annexes I, VI and VII of Regulation (EU) No 1178/2011 are amended as follows:
Annex I (Part-FCL) is amended as follows:
in point FCL.010, the following definitions are inserted:
‘“Evidence based training (EBT) operator” means an organisation that is holding an air operator certificate (AOC) in accordance with Annex III (Part-ORO) to Regulation (EU) No 965/2012 and that has implemented an EBT programme approved by the competent authority, in accordance with the provisions of that Regulation.’;
‘“EBT practical assessment” means a method for assessing performance that serves to verify the integrated performance of competencies. It takes place in either a simulated or an operational environment.’;
‘“EBT programme” means a pilot assessment and training programme in accordance with point ORO.FC.231 of Annex III (Part-ORO) to Regulation (EU) No 965/2012.’;
‘“Mixed EBT programme” means an operator’s recurrent training and checking programme provided for in point ORO.FC.230 of Annex III (Part-ORO) to Regulation (EU) No 965/2012, a portion of which is dedicated to the application of EBT but which does not replace proficiency checks provided for in Appendix 9 to this Annex.’;
in point FCL.015, the following point (g) is added:
Training completed in aircraft or in FSTDs in accordance with Annex III (Part-ORO) to Regulation (EU) No 965/2012 shall be taken into account for the experience and revalidation requirements established in this Annex (Part-FCL).
;
in point FCL.035(a), the following point (4) is added:
All hours flown in aeroplanes or TMGs that are subject to a decision of a Member State taken in accordance with points (a) or (c) of Article 2(8) of Regulation (EU) 2018/1139 or that fall within the scope of Annex I to that Regulation shall be credited in full towards fulfilling the flight time requirements of point FCL.140.A(a)(1) and point FCL.740.A(b)(1)(ii) of this Annex, provided that the following conditions are met:
the aeroplane or TMG concerned is of the same category and class as the Part-FCL aircraft in respect of which the hours flown are to be credited;
in case of training flights with an instructor, the aeroplane or TMG used is subject to an authorisation specified in point ORA.ATO.135 of Annex VII (Part-ORA) or point DTO.GEN.240 of Annex VIII (Part-DTO).
;
in point FCL.235, point (a) is replaced by the following:
Through the completion of a skill test, applicants for a PPL shall demonstrate the ability to perform as PIC on the appropriate aircraft category the relevant procedures and manoeuvres with the competency appropriate to the privileges granted.
;
point FCL.625 is amended as follows:
in point (b), the following point (4) is added:
Applicants for the revalidation of an IR shall receive full credits for the proficiency check as required in this Subpart when they complete EBT practical assessment in accordance with Appendix 10 related to the IR at an EBT operator.
;
point (c) is replaced by the following:
Renewal
If an IR has expired, in order to renew their privileges, applicants shall comply with all of the following:
in order to determine whether refresher training is necessary for the applicant to reach the level of proficiency needed to pass the instrument element of the skill test in accordance with Appendix 9, they shall undergo an assessment at either of the following organisations:
at an ATO;
at an EBT operator that is specifically approved for such refresher training;
if deemed necessary by the organisation providing the assessment in accordance with point (1), they shall complete refresher training at that organisation;
after complying with point (1) and, as applicable, point (2), they shall pass a proficiency check in accordance with Appendix 9 or complete EBT practical assessment in accordance with Appendix 10 in the relevant aircraft category. That EBT practical assessment may be combined with the refresher training specified in point (2);
they shall hold the relevant class or type rating unless specified otherwise in this Annex.
;
points (e) and (f) are replaced by the following:
Holders of a valid IR on a pilot licence issued by a third country in accordance with Annex 1 to the Chicago Convention shall be exempted from complying with the requirements in points (c)(1), (c)(2) and (d) when renewing the IR privileges contained in licences issued in accordance with this Annex.
The proficiency check specified in point (c)(3) may be combined with a proficiency check performed for the renewal of the relevant class or type rating.
;
point FCL.625.A(a) is amended as follows:
point (2) is replaced by the following:
pass a proficiency check in accordance with Appendix 9, or complete EBT practical assessment in accordance with Appendix 10, if the IR revalidation is combined with the revalidation of a class or type rating;
;
point (4) is replaced by the following:
An FNPT II or an FFS representing the relevant class or type of aeroplane may be used for the revalidation pursuant to point (3), provided that at least each alternate proficiency check for the revalidation of an IR(A) is performed in an aeroplane.
;
point FCL.740 is replaced by the following:
FCL.740
<Strong>Validity and renewal of class and type ratings</Strong>
Validity
The validity period of class and type ratings shall be 1 year, except for single-pilot single-engine class ratings for which the validity period shall be 2 years, unless otherwise determined in the OSD. If pilots choose to fulfil the revalidation requirements earlier than prescribed in points FCL.740.A, FCL.740.H, FCL.740.PL and FCL.740.As, the new validity period shall commence from the date of the proficiency check.
Applicants for the revalidation of a class or type rating shall receive full credits for the proficiency check as required in this Subpart when they complete EBT practical assessment in accordance with Appendix 10 at an operator that has implemented EBT for the relevant class or type rating.
Renewal
For the renewal of a class or type rating, applicants shall comply with all of the following:
in order to determine whether refresher training is necessary for the applicant to reach the level of proficiency to safely operate the aircraft, they shall undergo an assessment at one of the following:
at an ATO;
at a DTO or at an ATO, if the expired rating concerned a non-high-performance single-engine piston class rating, a TMG class rating or a single-engine type rating for helicopters referred to in point DTO.GEN.110(a)(2)(c) of Annex VIII;
at a DTO, at an ATO or with an instructor, if the rating expired no more than 3 years ago and the rating concerned a non-high-performance single-engine piston class rating or a TMG class rating;
at an EBT operator that is specifically approved for such refresher training;
if deemed necessary by the organisation or the instructor providing the assessment as per point (1), they shall complete refresher training at that organisation or with that instructor;
after complying with point (1) and, as applicable, point (2), they shall pass a proficiency check in accordance with Appendix 9 or complete EBT practical assessment in accordance with Appendix 10. That EBT practical assessment may be combined with the refresher training specified in point (2).
By way of derogation from points (b)(1), (b)(2) and (b)(3), pilots holding a flight test rating issued in accordance with point FCL.820 who were involved in the development, certification or production flight tests for an aircraft type and have completed either 50 hours of total flight time or 10 hours of flight time as PIC in test flights in that type during the year prior to the date of their application, shall be entitled to apply for the revalidation or renewal of the relevant type rating.
Applicants shall be exempted from the requirement in points (b)(1) and (b)(2) if they hold a valid rating for the same class or type of aircraft on a pilot licence issued by a third country in accordance with Annex 1 to the Chicago Convention and if they are entitled to exercise the privileges of that rating.
Pilots who leave an operator’s EBT programme after having failed to demonstrate an acceptable level of competence in accordance with that EBT programme shall not exercise the privileges of that type rating until they have complied with one of the following:
they have completed EBT practical assessment in accordance with Appendix 10;
they have passed a proficiency check in accordance with point FCL.625(c)(3) or point FCL.740(b)(3), as applicable. In such a case, point FCL.625(b)(4) and point FCL.740(a)(2) shall not apply.
;
point FCL.720.A is amended as follows:
point (a) is amended as follows:
the first paragraph is replaced by the following:
Applicants for the initial issue of privileges to operate a single-pilot aeroplane in multi-pilot operations, either when applying for the issue of a class or type rating or when extending the privileges of a class or type rating already held to multi-pilot operation, shall meet the requirements in point (b)(4) and, before starting the relevant training course, point (b)(5).
;
point (3) is replaced by the following:
Single-pilot high-performance complex aeroplanes
Applicants for the issue of a type rating for a complex single-pilot aeroplane classified as a high-performance aeroplane shall, in addition to meeting the requirements in point (2), comply with all of the following:
they shall hold or have held a single- or multi-engine IR(A), as appropriate and as established in Subpart G;
for the issue of the first type rating, they shall, before starting the type rating training course, meet the requirements in point (b)(5).
;
point (b) is amended as follows:
the introductory phrase is replaced by the following:
Applicants for the issue of the first type rating for a multi-pilot aeroplane shall be student pilots currently undergoing training on an MPL training course or shall, before starting the type rating training course, comply with the following requirements:
;
point (5) is replaced by the following:
have completed the training course specified in point FCL.745.A, unless they comply with any of the following:
they completed, within the preceding 3 years, the training and checking in accordance with points ORO.FC.220 and ORO.FC.230 of Annex III (Part-ORO) to Regulation (EU) No 965/2012;
they have completed the training specified in point FCL.915(e)(1)(ii).
;
in point FCL.740.A(a), point (1) is replaced by the following:
pass a proficiency check in accordance with Appendix 9 or complete EBT practical assessment in accordance with Appendix 10 in the relevant class or type of aeroplane or an FSTD representing that class or type, within the 3 months immediately preceding the expiry date of the rating; and
;
point FCL.905.TRI is replaced by the following:
FCL.905.TRI
TRI – Privileges and conditions
The privileges of a TRI are to instruct for:
the revalidation and renewal of an IR, provided the TRI holds a valid IR;
the issue of a TRI or SFI certificate, provided that the holder meets all of the following conditions:
has at least 50 hours of instructional experience as a TRI or SFI in accordance with this Regulation or Regulation (EU) No 965/2012;
has conducted the flight instruction syllabus of the relevant part of the TRI training course in accordance with point FCL.930.TRI(a)(3) to the satisfaction of the head of training of an ATO;
in the case of the TRI for single-pilot aeroplanes:
the issue, revalidation and renewal of type ratings for single-pilot high-performance complex aeroplanes provided that the applicant seeks privileges to operate in single-pilot operations.
The privileges of the TRI(SPA) may be extended to flight instruction for single-pilot high-performance complex aeroplane type ratings in multi-pilot operations, provided that the TRI meets any of the following conditions:
holds or has held a TRI certificate for multi-pilot aeroplanes;
has at least 500 hours on aeroplanes in multi-pilot operations and completed an MCCI training course in accordance with point FCL.930.MCCI;
the MPL course on the basic phase, provided that he or she has the privileges extended to multi-pilot operations and holds or has held an FI(A) or an IRI(A) certificate;
in the case of the TRI for multi-pilot aeroplanes:
the issue, revalidation and renewal of type ratings for:
multi-pilot aeroplanes;
single-pilot high-performance complex aeroplanes when the applicant seeks privileges to operate in multi-pilot operations;
MCC training;
the MPL course on the basic, intermediate and advanced phases, provided that, for the basic phase, he or she holds or has held an FI(A) or IRI(A) certificate;
in the case of the TRI for helicopters:
the issue, revalidation and renewal of helicopter type ratings;
MCC training, provided he or she holds a multi-pilot helicopter type rating;
the extension of the single-engine IR(H) to multi-engine IR(H);
in the case of the TRI for powered-lift aircraft:
the issue, revalidation and renewal of powered-lift type ratings;
MCC training.
The privileges of a TRI include privileges to conduct EBT practical assessment at an EBT operator, provided that the instructor complies with the requirements of Annex III (Part-ORO) to Regulation (EU) No 965/2012 for EBT instructor standardisation at that EBT operator.
;
in point FCL.905.SFI, the following point (e) is added:
The privileges of an SFI include privileges to conduct EBT practical assessment at an EBT operator, provided that the instructor complies with the requirements of Annex III (Part-ORO) to Regulation (EU) No 965/2012 for EBT instructor standardisation at that EBT operator.
;
in point FCL.930.SFI, point (a) is replaced by the following:
The training course for the SFI shall include:
the FSTD content of the applicable type rating course;
the relevant parts of the technical training and the FSTD content of the flight instruction syllabus of the applicable TRI training course;
25 hours of teaching and learning instruction.
;
in point FCL.1015, point (a) is replaced by the following:
An applicant for an examiner certificate shall undertake a standardisation course which is provided by the competent authority or which is provided by an ATO and approved by the competent authority.
;
in point FCL.1025(b), points (1) and (2) and the introductory phrase of point (3) are replaced by the following:
before the expiry date of the certificate, have conducted at least six skill tests, proficiency checks, assessments of competence, or EBT evaluation phases during an EBT module referred to in point ORO.FC.231 of Annex III (Part-ORO) to Regulation (EU) No 965/2012;
in the period of 12 months immediately preceding the expiry date of the certificate, have completed an examiner refresher course which is provided by the competent authority or which is provided by an ATO and approved by the competent authority;
one of the skill tests, proficiency checks, assessments of competence or EBT evaluation phases conducted in accordance with point (1) shall take place in the period of 12 months immediately preceding the expiry date of the examiner certificate and shall:
;
point FCL.1010.SFE(a) is amended as follows:
in point (1), point (ii) is replaced by the following:
hold an SFI(A) certificate for the applicable type of aeroplane; and
;
in point (2), point (ii) is replaced by the following:
hold an SFI(A) certificate for the applicable class or type of aeroplane; and
;
Appendix 1 is amended as follows:
point 1 is replaced by the following:
LAPL and PPL
;
points 1.1., 1.2., 1.3. and 1.4. are replaced by the following:
For the issue of an LAPL, the holder of an LAPL in another category of aircraft shall be fully credited towards requirements of theoretical knowledge on the common subjects established in point FCL.120(a).
For the issue of an LAPL or a PPL, holders of a PPL, CPL or ATPL in another category of aircraft shall be credited towards requirements of theoretical knowledge on the common subjects established in point FCL.215(a). This credit shall also apply to applicants for an LAPL or a PPL who hold a BPL issued in accordance with Annex III (Part-BFCL) to Regulation (EU) 2018/395 or an SPL issued in accordance with Annex III (Part-SFCL) to Implementing Regulation (EU) 2018/1976, except that the subject ‘navigation’ shall not be credited.’
For the issue of a PPL, the holder of an LAPL in the same category of aircraft shall be fully credited towards the requirements of theoretical knowledge instruction and examination.
By way of derogation from point 1.2, for the issue of an LAPL(A), the holder of an SPL issued in accordance with Annex III (Part-SFCL) to Implementing Regulation (EU) 2018/1976 with privileges to fly TMGs shall demonstrate an adequate level of theoretical knowledge for the single-engine piston aeroplane- land class in accordance with point FCL.135.A(a)(2).
;
point 4.1. is replaced by the following:
Applicants for an IR, or for a BIR, who have passed the relevant theoretical examinations for a CPL in the same aircraft category, shall be credited towards the theoretical knowledge requirements in the following subjects:
Human Performance,
Meteorology,
Communication.’;
in Section A of Appendix 3, point (b) in point 9 is replaced by the following:
70 hours as PIC, of which up to 55 hours may be SPIC. The instrument flight time as SPIC shall only be counted as PIC flight time up to a maximum of 20 hours;
;
in Section A of Appendix 6, point 2 is replaced by the following:
Applicants for a modular IR(A) course shall be the holder of a PPL(A) or a CPL(A). Applicants for the Procedural Instrument Flight Module, who do not hold a CPL(A), shall be a holder of a BIR or of a Course Completion Certificate for the Basic Instrument Flight Module.
The ATO shall ensure that the applicant for a multi-engine IR(A) course who has not held a multi-engine aeroplane class or type rating has received the multi-engine training specified in Subpart H prior to commencing the flight training for the IR(A) course.
;
Section B of Appendix 9 is amended as follows:
point (5) is amended as follows:
in point (k), the table is replaced by the following:
|
(1)
|
(2)
|
(3)
|
(4)
|
(5)
|
|---|
|
Type of operation
|
|---|
|
Type of aircraft
|
SP
|
MP
|
SP → MP (initial)
|
MP → SP (initial)
|
SP
+
MP
|
|---|
|
Training
|
Testing/checking
|
Training
|
Testing/checking
|
Training
|
Testing/checking
|
Training, testing and checking (SE aeroplanes)
|
Training, testing and checking (ME aeroplanes)
|
SE aeroplanes
|
ME aeroplanes
|
|---|
|
Initial issue
| | | | | | | | | | |
| All (except SP complex) | Sections 1-6 | Sections 1-6 |
MCC
CRM
Human factors
TEM
Sections 1-7
| Sections 1-6 |
MCC
CRM
Human factors
TEM
Section 7
| Sections 1-6 | 1.6, 4.5, 4.6, 5.2 and, if applicable, one approach from Section 3.B | 1.6, Section 6 and, if applicable, one approach from Section 3.B | | |
| SP complex | 1-7 | 1-6 |
|
Revalidation
| | | | | | | | | | |
| All | n/a | Sections 1-6 | n/a | Sections 1-6 | n/a | n/a | n/a | n/a |
MPO:
Sections 1-7 (training)
Section 1-6 (checking)
SPO:
1.6, 4.5, 4.6, 5.2 and, if applicable, one approach from Section 3.B
|
MPO:
Sections 1-7 (training)
Sections 1-6 (checking)
SPO:
1.6, Section 6 and, if applicable, one approach from Section 3.B
|
|
Renewal
| | | | | | | | | | |
| All | FCL.740 | Sections 1-6 | FCL.740 | Sections 1-6 | n/a | n/a | n/a | n/a |
Training: FCL.740
Check: as for the revalidation
|
Training: FCL.740
Check: as for the revalidation
|
;
in the table in point (l), the row for exercise 7.2.2 is replaced by the following:
| 7.2.2 |
The following upset exercises:
recovery from nose-high at various bank angles; and
recovery from nose-low at various bank angles.
| P |
X
An aeroplane shall not be used for this exercise
| | | |
;
the following Appendix 10 is added:
Appendix 10
<Strong>Revalidation and renewal of type ratings, and revalidation and renewal of IRs when combined with the revalidation or renewal of type ratings – EBT practical assessment</Strong>
A –
<Strong>General</Strong>
1.
The revalidation and renewal of type ratings as well as the revalidation and renewal of IRs when combined with the revalidation or renewal of type ratings in accordance with this Appendix shall be completed only at EBT operators which comply with all of the following:
they have established an EBT programme relevant for the applicable type rating or the IR in accordance with point ORO.FC.231 of Annex III (Part-ORO) to Regulation (EU) No 965/2012;
they have an experience of at least 3 years in conducting a mixed EBT programme;
for each type rating within the EBT programme, the organisation has appointed an EBT manager. EBT managers shall comply with all of the following:
they shall hold examiner privileges for the relevant type rating;
they shall have extensive experience in training as an instructor for the relevant type rating;
they shall either be the person nominated in accordance with point ORO.AOC.135(a)(2) of Annex III (Part-ORO) to Regulation (EU) No 965/2012 or a deputy of that person.
2.
The EBT manager responsible for the relevant type rating shall ensure that the applicant complies with all qualification, training and experience requirements of this Annex for the revalidation or the renewal of the relevant rating.
3.
Applicants who wish to revalidate or renew a rating in accordance with this Appendix shall comply with all of the following:
they shall be enrolled in the operator’s EBT programme;
in the case of revalidation of a rating, they shall complete the operator’s EBT programme within the period of validity of the relevant rating;
in the case of renewal of a rating, they shall comply with procedures developed by the EBT operator in accordance with point ORO.FC.231(a)(5) of Annex III (Part-ORO) to Regulation (EU) No 965/2012.
4.
The revalidation or renewal of a rating in accordance with this Appendix shall comprise all of the following:
continuous EBT practical assessment within an EBT programme;
demonstration of an acceptable level of performance in all competencies;
the administrative action of licence revalidation or renewal for which the EBT manager responsible for the relevant type rating shall do all of the following:
ensure that the requirements of point FCL.1030 are complied with;
when acting in accordance with point FCL.1030(b)(2), endorse the applicant’s licence with the new expiry date of the rating. That endorsement may be completed by another person on behalf of the EBT manager, if that person received a delegation from the EBT manager to do so in accordance with the procedures established in the EBT programme.
B –
<Strong>Conduct of the EBT practical assessment</Strong>
The EBT practical assessment shall be conducted in accordance with the operator’s EBT programme.
;
Annex VI (Part-ARA) is amended as follows:
point ARA.GEN.125 is replaced by the following:
ARA.GEN.125
<Strong>Information to the Agency</Strong>
The competent authority shall notify the Agency in case of any significant problems with the implementation of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof within 30 days from the time the authority became aware of the problems.
Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and the delegated and implementing acts adopted on the basis thereof, the competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports stored in the national database, as soon as possible.
;
point ARA.GEN.135 is amended as follows:
points (a) and (b) are replaced by the following:
Without prejudice to Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof, the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information.
The Agency shall implement a system to appropriately analyse any relevant safety information received and without undue delay provide to Member States and the Commission any information, including recommendations or corrective actions to be taken, necessary for them to react in a timely manner to a safety problem involving products, parts, non-installed equipment, persons or organisations subject to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.
;
point (d) is replaced by the following:
Measures taken under point (c) shall immediately be notified to all persons or organisations that need to comply with them under Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. The competent authority shall also notify those measures to the Agency and, when combined action is required, the other Member States concerned.
;
point ARA.GEN.200 is amended as follows:
in point (a), point (1) is replaced by the following:
documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. The procedures shall be kept up to date and serve as the basic working documents within that competent authority for all related tasks;
;
point (c) is replaced by the following:
The competent authority shall establish procedures for participation in a mutual exchange of all necessary information and assistance with other competent authorities concerned, whether from within the Member State or in other Member States, including the following information:
on all findings raised, corrective follow-up actions taken pursuant to such findings and enforcement measures taken as a result of oversight of persons and organisations exercising activities in the territory of a Member State but certified by or having made declarations to the competent authority of another Member State or the Agency;
stemming from mandatory and voluntary occurrence reporting as required by point ORA.GEN.160 of Annex VII.
;
point ARA.GEN.210 is replaced by the following:
ARA.GEN.210
<Strong>Changes in the management system</Strong>
The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. That system shall enable it to take action as appropriate to ensure that its management system remains adequate and effective.
The competent authority shall update its management system to reflect any change to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof in a timely manner, so as to ensure effective implementation.
The competent authority shall notify the Agency of changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.
;
point ARA.FCL.200 is amended as follows:
point (c) is replaced by the following:
Endorsement of licences by examiners. Before specifically authorising an examiner to revalidate or renew ratings or certificates, the competent authority shall develop appropriate procedures.
;
in point (e), point (1) is replaced by the following:
points BFCL.315(a)(4)(ii) and BFCL.360(a)(2) of Annex III (Part-BFCL) to Regulation (EU) 2018/395; and
;
in Appendix VIII, the words ‘EASA Form XXX Issue 2’ are replaced by the words ‘EASA Form 157 – Issue 2’;
Annex VII (Part-ORA) is amended as follows:
point ORA.GEN.160 is replaced by the following:
ORA.GEN.160
<Strong>Occurrence reporting</Strong>
As part of its management system, the organisation shall establish and maintain an occurrence-reporting system, including mandatory and voluntary reporting. For organisations having their principal place of business in a Member State, that system shall meet the requirements of Regulation (EU) No 376/2014 and Regulation (EU) 2018/1139 as well as the delegated and implementing acts adopted on the basis of those Regulations.
The organisation shall report to the competent authority and, in case of aircraft not registered in a Member State, the State of Registry any safety-related event or condition that endangers or, if not corrected or addressed, could endanger an aircraft, its occupants or any other person, and in particular any accident or serious incident.
Without prejudice to point (b), the organisation shall report to the competent authority and the design approval holder of the aircraft any incident, malfunction, technical defect, exceeding of technical limitations, occurrence that would highlight inaccurate, incomplete or ambiguous information, contained in data established in accordance with Regulation (EU) No 748/2012, or other irregular circumstance that has or may have endangered an aircraft, its occupants or any other person and has not resulted in an accident or serious incident.
Without prejudice to Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof, reports in accordance with point (c) shall:
be made as soon as practicable, but in any case no later than 72 hours after the organisation has identified the event or condition to which the report relates unless exceptional circumstances prevent this;
be made in a form and manner established by the competent authority, as defined in point ORA.GEN.105;
contain all pertinent information about the condition known to the organisation.
For organisations not having their principal place of business in a Member State:
initial mandatory reports shall:
appropriately safeguard the confidentiality of the identity of the reporter and of the persons mentioned in the report;
be made as soon as practicable, but in any case, no later than 72 hours after the organisation has become aware of the occurrence unless exceptional circumstances prevent this;
be made in a form and manner established by the Agency;
contain all pertinent information about the condition known to the organisation;
where relevant, a follow-up report providing details of actions the organisation intends to take to prevent similar occurrences in the future shall be made as soon as those actions have been identified; those follow-up reports shall:
be sent to relevant entities initially reported to in accordance with points (b) and (c);
be made in a form and manner established by the Agency.
;
in point ORA.GEN.200(a), point (7) is replaced by the following:
any additional relevant requirements prescribed in Regulation (EU) 2018/1139 and in Regulation (EU) No 376/2014 as well as in the delegated and implementing acts adopted on the basis thereof.
.