Certification&of&suitability&to&Monographs&of&the&European&PharmacopoeiaEDQM&PA/PH/CEP&(04)&2,&4
PA/PH/CEP (04) 2, 4R
Strasbourg, December 2009
Certification of suitability to Monographs of the European
Pharmacopoeia
Guideline on Requirements for Revision/Renewal of
Certificates
of Suitability to the European Pharmacopoeia monographs
EDQM PA/PH/CEP (04) 2, 4R
Certification of Substances Division
GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF
CERTIFICATES OF SUITABILITY
TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS
Date of implementation: 1 March 2010
Introduction:
The holder of a Certificate of suitability shall inform the EDQM of
any change to the information in the certification dossier by
sending an application form and all necessary documents
demonstrating that the conditions laid down in the present
guideline are met.
Classification of changes
The changes have been classified in three categories
(notification/minor/major) depending on the potential impact of the
change on the quality of the final substance. These three
categories are based on those (IA-IAIN/IB/II) of the Commission
Regulation (EC) No
concerning the examination of
variations to the terms of marketing authorisation for medicinal
products for human use and veterinary medicinal products.
Any change not classified as a notification or a major change
should be classified as a minor change except in the following
cases where a new application should be submitted:
- addition of a new route of synthesis and/or a new manufacturing
site where the specifications of the final substance are different
from the one already approved
- transfer to a new holder that is not the same legal entity as the
approved one, where the transfer does not occur because of a merger
or because the company is sold, and where the manufacturer does not
take out the Certificate of suitability in their own name.
The changes related to Ph. Eur. monograph revisions or any other
regulatory requirements are treated separately and generally
initiated by the EDQM.
Documentation to be provided
For any revision the documentation should consist of:
- a cover letter
- the application form, duly filled and listing all the changes
applied for
- a description of each change together with a justification
- data showing, when applicable, that the conditions have been
- update of the relevant section(s) of the dossier (presented in
EU-CTD format).
- the specific documents described below for each change and
supporting the change
- supportive information, including comparative data with the
previous version of the dossier (in tabular format), showing the
approved and the proposed section and highlighting the
Consequential changes should be identified and the relation between
the changes should be described.
Each time batch data are needed:
- they should be in accordance with the specifications of the
current Ph. Eur. monograph and when relevant with the additional
requirements included in the Certificate of suitability
- the manufacturing site, the manufacturing date and the size of
the batches should be specified.
- quantitative results should be presented numerically (i.e. not in
general terms such as “complies”) and with the appropriate number
of decimal places.
The changes are presented in five sections:
 Notifications (N and T)
 Typical minor revisions for Certificates of suitability for
chemical purity and microbiological quality or for TSE Certificates
of suitability
 Major revisions (MAJ)
 Renewal
 Transfer of holdership
Editorial changes should not be submitted as separate variations
but should be reported at the same time as changes concerning the
respective part of the dossier. In any case, a declaration should
be provided that the content of the concerned part of the dossier
has not been changed by the editorial changes (except for the
change itself).
NOTIFICATIONS (IN/AN)
Notifications are split into immediate notifications and
notifications with annual reporting.
1. Immediate notifications (IN):
IN1) Change in the name and/or address of the certificate holder of
the final substance (former N1)
Conditions:
- the certificate holder shall remain the same legal entity (except
where the company is sold or in case of a merger).
Specific Documentation:
- a formal document from a relevant official body (e.g. Chamber of
Commerce) in which the new name or the new address is
- all updated declarations (annexes to the application form).
IN2) Change in the name and/or address of the manufacturing site
for the final substance (former N2)
Conditions:
- the location of the manufacturing site shall remain the
Specific Documentation:
- a formal document from a relevant official body (e.g. Chamber of
Commerce) in which the new name or the new address is
- updated declarations of manufacture in accordance with the
dossier and according to GMP rules and of willingness to be
inspected.
IN3) Deletion of any manufacturing site for the final substance
(former N3)
Conditions:
- the deletion should not be due to critical deficiencies
concerning manufacturing.
Specific Documentation:
- the justification of the deletion.
IN4) Change or addition of a manufacturer of a starting material or
intermediate used in the manufacturing process of the final
substance when the proposed manufacturer is part of the same group
as the currently approved manufacturer
Conditions:
- the specifications and the route of synthesis (including
In-Process Controls, methods of analysis of all materials used) of
the concerned material are identical to those already
- the final substance is not a biological substance or a sterile
substance.
Specific Documentation:
- a declaration from the holder of the Certificate of suitability
that the specifications of the final substance are the same as
those already approved
- a declaration from the holder of the Certificate of suitability
that the synthetic route (or in case of herbal material, where
appropriate, the method of preparation, geographical source and
production), the specifications and the quality control procedures
of the starting material or intermediate are the same as those
already approved
- a list of approved and proposed sites
- batch analysis data (in a comparative tabular format) for at
least two batches (minimum pilot scale) of the final substance from
the approved and proposed sites.
IN5) Change or addition of a manufacturing site/workshop for the
final substance when the proposed manufacturer is part of the same
group as the currently approved manufacturer
Conditions:
- the specifications of the final substance (including in process
controls, methods of analysis of all materials), method of
preparation (including batch size) and detailed route of synthesis
are identical to those already approved
- the final substance is not a biological substance or a sterile
substance.
Specific Documentation:
- a declaration from the holder of the Certificate of suitability
that the synthetic route (or in case of herbal material, where
appropriate the method of preparation, geographical source and
production), quality control procedures and specifications of the
final substance are the same as those already approved
- a list of approved and proposed sites
- batch analysis data (in a comparative tabular format) for at
least two batches (minimum pilot scale) of the final substance from
the approved and proposed sites
- updated declarations of manufacture in accordance with the
dossier and according to GMP rules and of willingness to be
inspected for the new site.
IN6) Tightening of the specification limits for the final substance
(former N8)
Conditions:
- the change does not result from unexpected events arising during
manufacture
- any change should be within the range of currently approved
- the test procedure remains the same, or changes in the test
procedure are minor.
Specific Documentation:
- comparative table of approved and proposed specifications.
IN7) Minor changes to a test procedure for the final substance.
Editorial changes to a method description annexed to a certificate
of suitability (former N7)
Conditions:
- appropriate validation studies have been performed in accordance
with the relevant guidelines and show that the updated test
procedure is at least equivalent to the former test procedure
- there have been no changes of the t no new
unqualified impurities are detected
- the method of analysis should remain the same (e.g. a change in
column length or temperature, but not a different type of column or
- the test method is not a biological method, or a method using a
biological reagent for a biological substance (does not include
standard pharmacopoeial microbiological methods).
Specific Documentation:
- updated description of the method in a format to be appended to
the certificate of suitability
- amendment of the relevant section(s) of the dossier, including
description of the analytical method, summary of validation
- comparative validation results, or if justified comparative
analysis results showing that the approved test and the proposed
one are equivalent.
IN8) Addition of a specification parameter for the final
Conditions:
- the change does not result from unexpected events arising during
manufacture
- any new test method does not concern a novel non-standard
technique or a standard technique used in a novel way
- the test method is not a biological method or a method using a
biological reagent for a biological substance (does not include
standard pharmacopoeia microbiological methods)
- the change does not concern a genotoxic impurity
Specific Documentation:
- comparative table of approved and proposed specifications
- details of any new analytical method and validation data, where
- batch analysis data on two production batches of the relevant
substance for all specification parameters.
IN9) Removal/reduction of the re-test period from the Certificate
of suitability / change to more restrictive storage conditions
(former N11)
Conditions:
- the change should not be the result of unexpected events arising
during manufacture or because of stability concerns
Specific Documentation:
- the justification of the removal/reduction of the re-test
IN10) Deletion of an approved change management protocol for design
space submission
Conditions:
- the deletion of the approved change management protocol is not a
result of unexpected events or out of specification results during
the implementation of the change (s) described in the
Specific Documentation:
- amendment of the relevant section(s) of the dossier
2. Notification with annual reporting (AN):
AN1) Change in the name and/or address of a manufacturer of a
starting material or intermediate used in the manufacture of the
final substance
Conditions:
- the location of the manufacturing site shall remain the
Specific Documentation:
- updated list of manufacturers of starting
material/intermediate
AN2) Deletion of a manufacturer of a starting material/intermediate
used in the manufacture of the final substance (former N4)
Conditions:
- the deletion should not be due to critical deficiencies
concerning manufacturing
Specific Documentation:
- the justification of the deletion
- updated list of manufacturers of starting
material/intermediate
AN3) Change in the code product/reference number and/or in the
brand name of the final substance or any material used in its
manufacture (former N9)
Condition:
- the change does not regard the quality of the final substance or
the concerned material
Specific Documentation:
- approved and proposed code product / reference number / brand
AN4) Minor change in the manufacturing process of the final
substance (former R1)
Conditions:
- the specifications of the final substance or intermediates are
unchanged and there is no adverse change in qualitative and
quantitative impurity profile
- the synthetic route remains the same, i.e. intermediates remain
the same and there are no new reagents, catalysts or solvents used
in the process. In the case of herbal products, the geographical
source and production of the herbal material remain unchanged
- the final substance is not a biological substance.
Specific Documentation:
- batch analysis data (in comparative tabular format) of at least
two batches (minimum pilot scale) manufactured according to the
currently approved and proposed process.
AN5) Change in batch size of final substance or intermediate up
to 10-fold compared to the original batch size (former N5)
Conditions:
- any changes to the manufacturing methods are only those
necessitated by scale-up, e.g. use of different-sized
- test results of at least two batches of the final substance
complying with the approved specifications should be available for
the proposed batch size
- the substance is not a biological substance or a sterile
- the change does not affect the reproducibility of the
manufacturing process
- the specifications of the final substance/intermediates remain
- the currently approved batch size was not approved via a
notification
Specific Documentation:
- the batch numbers of the tested batches having the proposed batch
- approved and proposed batch size
- updated description of the full process specifying the proposed
batch size
- a declaration from the certificate holder that the changes to the
manufacturing methods are only those necessitated by scale-up, that
the change does not adversely affect the reproducibility of the
process, and that the specifications of the final
substance/intermediates remain the same.
AN6) Change in batch size of final substance or intermediate:
downscaling (former N6)
Conditions:
- any changes to the manufacturing methods are only those
necessitated by the downscaling, e.g. use of different-sized
- test results of at least two batches of the final substance
complying with the approved specifications should be available for
the proposed batch size
- the substance is not a biological substance or a sterile
- the change does not affect the reproducibility of the
manufacturing process
- the change should not be the result of unexpected events arising
during manufacture or because of stability concerns
- the currently approved batch size was not approved via a
notification.
Specific Documentation:
- the batch numbers of the tested batches having the proposed batch
- approved and proposed batch size
- updated description of the full process specifying the proposed
batch size
- a declaration from the certificate holder that the changes to the
manufacturing methods are only those necessitated by downscaling,
that the change does not adversely affect the reproducibility of
the process, that it is not the result of unexpected events arising
during manufacture or because of stability concerns and that the
specifications of the final substance/intermediates remain the
AN7) Addition of a new in-process test and limit applied during
the manufacture of the final substance
Conditions:
- the change does not result from unexpected events arising during
manufacture
- any new test method does not concern a novel non-standard
technique or a standard technique used in a novel way
- the new test method is not a biological method or a method using
a biological reagent for a biological substance (does not include
standard pharmacopoeial microbiological methods).
Specific Documentation:
- comparative table of approved and proposed in-process tests
- details of any new non-pharmacopoeial analytical method and
validation data, where relevant.
AN8) Deletion of a non significant in-process test applied during
the manufacture of the final substance
Conditions:
- the change does not result from unexpected events arising during
manufacture.
Specific Documentation:
- comparative table of approved and proposed in-process tests
- justification /risk-assessment from the certificate holder as
appropriate showing that the parameter is non-significant.
AN9) Tightening of the limits of in-process tests applied during
the manufacture of the final substance
Conditions:
- the change does not result from unexpected events arising during
manufacture
- the test procedure remains the same, or changes in the test
procedure are minor.
Specific Documentation:
- comparative table of approved and proposed in-process
AN10) Addition of a specification parameter for a starting
material/intermediate/reagent
Conditions:
- the change does not result from unexpected events arising during
manufacture
- any new test method does not concern a novel non-standard
technique or a standard technique used in a novel way
- the test method is not a biological method or a method using a
biological reagent for a biological substance (does not include
standard pharmacopoeia microbiological methods).
Specific Documentation:
- comparative table of approved and proposed specifications
- details of any new analytical method and validation data, where
AN11) Deletion of a non-significant specification parameter for the
final substance/starting material/intermediate or deletion of a
test procedure for a starting material/intermediate/reagent
Condition:
- the change does not result from unexpected events arising during
manufacture
- the parameter is non-significant or an alternative test procedure
is already approved.
Specific Documentation:
- comparative table of approved and proposed specifications
- justification/ risk-assessment from the holder of the certificate
as appropriate showing that the parameter is non-significant.
AN12) Minor changes to a test procedure for a starting
material/intermediate/reagent used in the manufacturing process of
the final substance (former N7)
Conditions:
- the method of analysis should remain the same (e.g. a change in
column length or temperature, but not a different type of column or
- appropriate (re-)validation studies have been performed in
accordance with relevant guidelines and show that the new updated
test procedure is at least equivalent to the former one
- the final substance is not a biological substance.
Specific Documentation:
- updated method description.
AN13) Tightening of the specification limits for a starting
material/ intermediate/reagent used in the manufacturing process of
the final substance (former N8)
Conditions:
- the change should not be the result of unexpected events arising
during manufacture
- any change should be within the range of currently approved
- the test procedure remains the same, or changes in the test
procedure are minor.
Documentation
- comparative table of approved and proposed specifications.
AN14) Change in the composition of the immediate packaging
Conditions:
- the proposed packaging material must be at least equivalent to
the approved material in respect of its relevant properties
- relevant stability studies have been started under ICH conditions
and relevant
stability parameters have been assessed in at least two pilot scale
or industrial scale batches and at least three months satisfactory
stability data are at the disposal at time of implementation.
NB: if the proposed packaging is more resistant than the existing
packaging, the three months stability data do not yet have to be
available.
These studies must be finalized and the data will be provided
immediately to EDQM if outside specifications or potentially
outside specifications at the end of the re-test period (with
proposed action).
- the final substance is not a sterile, liquid or biological
substance.
Specific Documentation:
- comparison of the approved and proposed immediate packaging
specifications, if applicable
- appropriate data on the new packaging including a confirmation
that the material complies with relevant pharmacopoeial
requirements or EU legislation on plastic materials and objects in
contact with foodstuffs
- a declaration from the holder of the certificate as appropriate
that the required stability studies have been started under ICH
conditions (with indication of the batch numbers concerned) and
that, as relevant, the required minimum satisfactory stability data
were at the disposal at time of implementation and that the
available data did not indicate a problem. Assurance should also be
given that the studies will be finalized and that data will be
provided immediately to the competent authorities if outside
specifications or potentially outside specifications at the end of
the approved re-test period (with proposed action).
AN15) Change in the specification parameters and/or limits of the
immediate packaging of the final substance
Conditions:
- the change does not result from unexpected events arising during
manufacture of the packaging material or during storage of the
final substance
- the test procedure remains the same, or changes in the test
procedure are minor
- any new test method does not concern a novel non-standard
technique or a standard technique used in a novel way.
Specific Documentation:
- comparative table of approved and proposed
specifications.
NOTIFICATIONS FOR TSE CERTIFICATES (TIN/TAN)
1. Immediate notifications (TIN):
TIN1) Deletion of a source country or change in source of a
material used in the preparation of the final substance from a TSE
risk material to a vegetable, synthetic, or non-TSE risk material
(former N12)
Conditions:
- no change in the manufacturing process.
Specific Documentation:
- if applicable a declaration from the certificate holder or
manufacturer of the material that it is purely of vegetable,
synthetic or non-TSE risk origin.
TIN2) Change or addition of a manufacturing site for the final
substance when the proposed manufacturer is part of the same group
as the approved manufacturer (former T1)
Conditions:
- no change in the manufacturing process, in the materials and in
the origin of the material used in the process
- no other TSE risk material is processed in the new manufacturing
Documentation:
- a declaration from the holder of the certificate/manufacturer
that the manufacturing process is identical to that already
- a declaration from the holder of the certificate/manufacturer
that no other TSE risk material is processed in the new
manufacturing site
- updated declarations of manufacture in accordance with the
dossier and according to GMP rules/quality system and of
willingness to be inspected
- information on the quality assurance system (including
traceability) applied in the new manufacturing site.
TIN3) Change in the quality assurance system applied in the
manufacturing site (Former T3)
Conditions:
- the new quality assurance system is at least equivalent to the
former one
- no change in the manufacturing process (including process
parameters) or in the specifications of the final
substance.
Documentation
- updated information on the quality assurance system (including
traceability)
- updated declarations of manufacture in accordance with the
dossier and according to GMP rules/quality system and of
willingness to be inspected.
2. Notifications with annual reporting (TAN):
TAN1) Minor change in the manufacturing process (including process
parameters) or in the specifications of the final substance (Former
Conditions:
- the change has no impact on the TSE risk
- the certificate of suitability covers only the TSE risk and does
not cover the chemical purity and microbiological quality.
Documentation:
- comparison of the approved and proposed process
- a declaration from the holder of the certificate/manufacturer
that the change has no impact on the TSE risk.
TYPICAL MINOR CHANGES FOR CERTIFICATES FOR CHEMICAL PURITY AND
MICROBIOLOGICAL QUALITY
THIS IS A NON EXHAUSTIVE LIST OF MINOR CHANGES INTENDED TO HELP THE
SUBMISSION AND THE PREPARATION OF THE DOCUMENTATION.
Change in batch size of the final substance or an intermediate more
than 10-fold compared to the original batch size (former R2)
Specific Documentation:
- updated description of the full process specifying the new batch
- batch analysis data (in comparative tabular format) on a minimum
of one production batch manufactured according to both the approved
and the proposed sizes.
Change or addition of a manufacturer of a starting material or
intermediate used in the manufacturing process of the final
Specific Documentation:
- a declaration from the holder of the Certificate of suitability
that the synthetic route (or in case of herbal material, where
appropriate the method of preparation, geographical source and
production), the specifications and the quality control procedures
of the starting material or intermediate are the same as those
already approved
- a list of approved and proposed sites
- for a manufacturer of intermediate, declarations of manufacture
in accordance with the dossier and according to GMP rules and of
willingness to be inspected for the proposed site
- batch analysis data (in comparative tabular format) on a minimum
of one production batch manufactured with the approved and the
proposed sources of material.
Change or addition of a manufacturing site/workshop for the final
Specific Documentation:
- a declaration from the holder of the Certificate of suitability
that the synthetic route (or in case of herbal material, where
appropriate the method of preparation, geographical source and
production), quality control procedures and specifications of the
final substance are the same as those already approved
- a list of approved and proposed sites
- updated declarations of manufacture in accordance with the
dossier and according to GMP rules and of willingness to be
inspected for the proposed site
- batch analysis data (in comparative tabular format) on a minimum
of one production batch manufactured in both the approved and the
proposed sites.
For a “double” Certificate of suitability (for chemical purity and
microbiological quality and for TSE risk), change in source of a
material used in the preparation of the final substance from a TSE
risk material to a vegetable, synthetic, or non-TSE risk material
(former R5)
Specific Documentation:
- updated specifications of the proposed source of the
- batch analysis data (in a comparative tabular format) for at
least two batches (minimum pilot scale) of the final substance from
the approved and proposed source of the material or
intermediate
- a declaration from the manufacturer of the material that it is
purely of vegetable, synthetic or non-TSE risk origin (specifying
the origin)
- a declaration from the holder of the certificate that there is no
change in the manufacturing process and that the specifications of
the final substance remain the same.
Extension/addition of the re-test period of the final substance
and/or change in the storage conditions for the final substance
(former R7)
Specific Documentation for addition of a re-test period:
- results of long-term and accelerated stability studies for at
least two pilot or production scale batches
- appropriate data on the packaging material including a
confirmation that the material complies with relevant
pharmacopoeial requirements or EU legislation on plastic materials
and objects in contact with foodstuffs.
Specific Documentation for an extension of the re-test period /
change in the storage conditions for the final substance:
- updated results of stability studies for at least two pilot or
production scale batches.
Change/addition of a manufacturer of starting material/intermediate
used in the manufacturing process of a biological substance
Specific Documentation:
- a declaration from the holder of the certificate that the
manufacturing process, quality control procedures and
specifications of the final substance and of the concerned material
are the same as those already approved
- a list of approved and proposed sites
- for a manufacturer of intermediate, declarations of manufacture
in accordance with the dossier and according to GMP rules and of
willingness to be inspected for the proposed manufacturer
- batch analysis data (in comparative tabular format) on 3 batches
(minimum pilot scale) manufactured according to both the approved
and the proposed manufacturers.
Change/addition of the manufacturer of a biological substance
Specific Documentation:
- a declaration from the holder of the certificate that the
manufacturing process, quality control procedures and
specifications of the final substance are the same as those already
- batch analysis data (in a comparative tabular format) for at
least 3 batches (minimum pilot scale) of the final substance from
the approved and the proposed sites
- updated declarations of manufacture in accordance with the
dossier and according to GMP rules and of willingness to be
inspected.
Minor changes in the manufacturing process of a biological
substance, including change in batch size
Specific Documentation:
- a direct comparison of the approved and the proposed
- a declaration from the holder of the certificate that the
specifications of the final substance are the same as those already
- batch analysis data (in comparative tabular format) of at least 3
batches (minimum pilot scale) of the final substance manufactured
according to the approved and proposed process or according to both
approved and proposed batch sizes, demonstrating that the change
has no negative impact on the quality of the final substance.
Changes to a test procedure (including replacement or addition) for
the biological substance/starting material/intermediate or changes
to a biological method
Specific Documentation:
- description of the analytical method, a summary of validation
- comparative analysis results showing that the approved and the
proposed test are equivalent. This requirement is not applicable in
case of an addition of a new test procedure.
MAJOR CHANGES (MAJ)
MAJ1 & Change/addition of the manufacturer of a starting material
or intermediate, when the proposed manufacturer uses a
substantially different route of synthesis or manufacturing
conditions, which are likely to change the qualitative and/or
quantitative impurity profile (eg. new reagents, solvents,
materials are introduced in the synthesis)
MAJ2 - Change in the manufacturing process of the final substance
that regards the sterilization step(s), including changes in batch
size of a sterile substance
MAJ3 - Substantial change to the manufacturing process/addition of
an alternative manufacturing process for a starting material,
intermediate or final substance likely to change the qualitative
and/or quantitative impurity profile (eg. new reagents, solvents,
materials are introduced in the synthesis)
MAJ4 - Changes in the manufacturing process of a herbal substance
related to geographical source or production
MAJ5 - Widening or deletion of approved in-process test limits,
which may have a significant effect on the overall quality of the
final substance
MAJ6 & Widening of the approved specifications limits for the final
MAJ7- Widening of the approved specifications limits for starting
materials/ intermediates, which may have a significant effect on
the overall quality of the final substance
MAJ8 - Deletion of a specification parameter which may have a
significant effect on the overall quality of the final
MAJ9 - Change in the composition of immediate packaging for a
sterile substance
MAJ10 - Introduction of a new design space or extension of an
approved design space or of a post approval change management
protocol related to the final substance
TSE changes
MAJ11 & Change/addition of a source country or tissues for TSE risk
MAJ12 - Change/addition of a manufacturer of a starting material or
intermediate
MAJ13 & Change/addition of a manufacturing site where other TSE
materials than the substance are processed
MAJ14 - Substantial changes in the manufacturing process that are
likely to affect the TSE risk
The Certificate of suitability is valid for five years from the
date when the original certificate was granted. Regardless of any
revisions treated in the meantime, the holder of a Certificate of
suitability shall ask for the renewal of the Certificate of
suitability six months prior to expiry date by providing an update
of the certification dossier.
If no change has been made since the last Certificate of
suitability was granted
Documentation:
- a statement that no changes that may affect the quality, safety
or efficacy of the final substance have been made
- certificates of analysis from at least two recent production
- updated declarations as appendixes to the application form.
If changes are included in the request for renewal
Documentation:
- an updated dossier in CTD format and/or updated sections affected
by the changes
- list of changes introduced in the format of a comparative
- relevant data supporting each change as described in this
- certificates of analysis from at least two recent production
- updated declarations as appendixes to the application form.
TRANSFER OF HOLDERSHIP OF A CERTIFICATE OF SUITABILITY
A transfer of the holdership of the Certificate of suitability
(i.e. change in the name of the certificate holder that is not the
same legal entity and where the change does not occur following a
sale or a merger) is feasible in exceptional cases with the below
conditions:
- the current Certificate of suitability is held by another company
than the manufacturer
- the manufacturer takes out the Certificate of suitability in
their own name.
Documentation:
- a letter signed by both parties, i.e. the former holder and the
manufacturer, agreeing that the holdership of the Certificate of
suitability is passed on to the manufacturer from the date of the
- updated declarations as annex to the application form.
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