45
For Type IA variations, no linguistic review of the product information Annexes in all other EU
languages (including Icelandic and Norwegian) will be performed and the MAH will be responsible for
ensuring the correctness of the translations.
For Type IB variations, as laid down in Art. 2(5), and Art. 3(2) of Commission Regulation (EC) No.
1234/2008, and affecting the product information, a linguistic review of the product information
annexes in all other EU languages (including Icelandic and Norwegian) will, in general, be required.
The linguistic review will take place in parallel to the scientific assessment. Translations of the product
information in all EU languages (including Icelandic and Norwegian) are to be provided electronically
(in one Eudralink package) to the Member States Contact Points for Translations by Day + 5 (i.e. 5
days after validation) with a copy to the procedure assistant and Product Shared Mailbox.
Translations of the revised Annex A only need to be sent to the procedure assistant with a copy to the
Product Shared Mailbox by Day +5 (i.e. 5 days after validation), if applicable.
Comments will be sent directly by the Member States to the MAH at the latest by Day +19 (i.e. 19
days after validation), with copy to the Agency (Product Shared Mailbox).
The MAH will send the final translations with tracked changes, incorporating the Member States
comments in Word format, as well as in PDF format (clean), electronically (in one Eudralink package)
to the procedure assistant by Day +25 (i.e. 25 days after validation) with a copy to the Product Shared
Mailbox. The Eudralink package should be presented in compliance with the Day +25 Checklist (Annex
7).
The Agency will check if all Member States comments have been implemented before sending the final
translations to the Commission. In order to facilitate and accelerate the check of the implementation of
the Member States’ comments, the MAH should indicate in “QRD Form 2” (Annex 6) for each language
if all comments have been implemented or not. In the latter case, a justification should be provided for
the appropriate language(s) stating why certain comments are not reflected in the final texts. Such
justification(s) and/or alternative proposals should be discussed and agreed with the relevant Member
State(s) before submitting final translations to the Agency.
3.2. Type II variations
For Type II variations affecting the product information, only the EN language version needs to be
provided at submission. Translations of the adopted product information in all other EU languages
(including Icelandic and Norwegian) are to be provided electronically (in one Eudralink package) to the
Member States Contact Points for Translations by Day +5 (i.e. 5 days after adoption of the Opinion)
with a copy to the procedure assistant and Product Shared Mailbox.
For procedures starting on a weekly basis, the linguistic review will continue to follow the monthly
review cycle, starting five days after the conclusion of the next applicable CHMP plenary meeting. The
monthly linguistic review will consolidate all variations affecting the product information annexes
concluded during that month.
For more information on Type II variations starting on a weekly basis or following a monthly timetable,
please consult the Post-authorisation guidance.
Translations of the revised Annex A only need to be sent to the procedure assistant with a copy to the
Product Shared Mailbox by Day +5, if applicable.
The following checks will apply:
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Who
When
Scope
QRD
‘Member State’
Day +5 to +19
Detailed review of highlighted changes in all
translations
Agency
Day +25 to +27
Review of implementation of Member States’
comments
Comments will be sent directly by the Member States to the MAH at the latest by Day +19, with a copy
to the Agency (Product Shared Mailbox).
The MAH will send the final translations with tracked changes, incorporating the Member States’
comments in Word format, as well as in PDF format (clean), electronically (in one Eudralink package)
to the procedure assistant with a copy to the Product Shared Mailbox by Day +25. The Eudralink
package should be presented in compliance with the Day +25 Checklist (Annex 7).
The Agency will check if all Member States’ comments have been implemented before sending the final
translations to the Commission, where applicable. In order to facilitate and accelerate the check of the
implementation of the Member States’ comments, the applicant should indicate in “QRD Form 2”
(Annex 6) for each language if all comments have been implemented or not. In the latter case, a
justification should be provided for the appropriate language(s) stating why certain comments are not
reflected in the final texts. Such justification(s) and/or alternative proposals should be discussed and
agreed with the relevant Member State(s) before submitting final translations to the Agency.
Poor quality translations or a poor implementation of Member States’ comments or absence of a
completed QRD Form 2 may lead to a delay in transmission to the Commission (see also section 6).
Commission Decisions on Type II variations shall be adopted without a Standing Committee procedure.
Consequently, there will be no further revision of the translations of the Annexes after Day +27.
For procedures that will have a Commission Decision adopted within 12 months, the translations
submitted at Day +25 will be considered as final. However, if it is necessary to make (minor)
amendments to the Annexes, all official language versions of the Annexes will be sent to the MAH.
Following receipt of the final translations from the Agency, the Commission will start the Decision
adoption process for variations listed in Article 23(1a)(a) of Regulation (EC) No 1234/2008.
For urgent 30-day Type II variations, in particular for safety issues, the MAH will have to send the
translations to the Member States upon validation of the Type II variation.
The linguistic review will take place in parallel to the scientific assessment in order to accelerate the
final approval of the Type II variation. Such cases will have to be discussed and agreed with the
Agency before the start of the procedure.
3.3. Grouping
MAHs may choose to group the submission of several Types of procedures of the same Marketing
Authorisation. Such grouped submissions will follow the linguistic review process according to the
highest procedure included in the group:
Grouping examples:
a) Extension + Type II variation => will follow the linguistic review process of an Extension.
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•
Pre-opinion: The same principles as for the pre-opinion linguistic review of an Extension apply,
as illustrated by the attached timelines (Annex 1). However, in the EN language version all the
changes from the procedures involved in the group will have to be incorporated in tracked
changes. In this example, the submitted EN language version will include changes from the
Extension + changes from the type II variation.
•
Post opinion: The same principles as for the post-opinion linguistic review of an Extension
apply, as illustrated by the attached timelines (Annex 1). However, at Day 215, the MAH will
submit the English and all other EU languages product information Annexes (including Icelandic
and Norwegian) in tracked changes highlighting all the changes from the procedures involved
in the group.
The MAH will send the final translations with tracked changes, incorporating the Member States’
comments in Word format, as well as in PDF format (clean), electronically (in one Eudralink
package) to the Agency (qrd@ema.europa.eu) with a copy to the Product Shared Mailbox by Day
235. The Eudralink package should be presented in compliance with the Day 235 Checklist (Annex
7).
b) Type II + Type IB variation => will follow the linguistic review process of a Type II variation
•
Post opinion: The same principles as for the post-opinion linguistic review of a Type II variation
apply, as illustrated by the attached timelines (Annex 2). However, at Day +5, the MAH will
submit the product information in English and all other EU languages (including Icelandic and
Norwegian) in tracked changes highlighting all the changes from the procedures involved in the
group. In this example, the English and all other EU languages product information (including
Icelandic and Norwegian) will include changes from the Type II variation + changes from the
Type IB variation.
The MAH will send the final translations with tracked changes, incorporating the Member States’
comments in Word format, as well as in PDF format (clean), electronically (in one Eudralink
package) to the procedure assistant with a copy to the Product Shared Mailbox by Day +25. The
Eudralink package should be presented in compliance with the Day +25 Checklist (Annex 7).
3.4. Worksharing including at least one centrally authorised product (CAP)
MAHs may choose to submit the same Type IB or Type II variation, or the same group of variations
affecting more than one CAP from the same MAH in one submission. Extensions are excluded from
worksharing.
The linguistic review process described below only applies to CAPs as part of the Worksharing
procedure.
The linguistic review will only be performed on one set of Annexes (EN + translations in all other EU
languages [including Icelandic and Norwegian]) for one CAP.
Worksharing submissions follow a 60- or 90-day timetable.
Considering that the same change(s) should in principle apply to all CAPs involved in the worksharing
submission, the linguistic review will only be performed on one set of Annexes of one CAP; if the
changes differ for the products involved in the worksharing procedure, the linguistic review will be
performed on the product containing most of the changes.
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Upon finalisation of the linguistic review, it will be up to the MAH to correctly implement the same
amendments in all the other CAPs, as appropriate.
•
For worksharing submissions including a type II variation:
At submission and for all products involved in the worksharing procedure, the EN language
versions (with tracked changes) of the product information are to be provided.
However, post-opinion, only one set of Annexes (EN + translations in all other EU languages
[including Icelandic and Norwegian]) for one CAP is to be provided electronically (in one Eudralink
package) to the Member States Contact Points for Translations by Day +5 (i.e. 5 days after
adoption of the Opinion) with a copy to the coordinating assistant and Product Shared Mailbox.
Translations of the revised Annex A only need to be sent to the coordinating assistant by Day +5,
if applicable.
Comments will be sent directly by the Member States to the MAH at the latest by Day +19, with a
copy to the Agency (Product Shared Mailbox).
The MAH will send the final translations of all products involved in the worksharing procedure,
with tracked changes, incorporating the Member States comments in Word format, as well as in
PDF format (clean), electronically (in one Eudralink package) to the coordinating assistant with a
copy to the Product Shared Mailbox by Day +25 (i.e. 25 days after adoption of the Opinion). The
Eudralink package should be presented in compliance with the Day +25 Checklist (Annex 7).
•
For Worksharing submissions including only type IB variations:
At submission and for all products involved in the worksharing procedure, the EN language
versions (with tracked changes) of the product information are to be provided.
For worksharing procedures including only type IB variations, the linguistic review will take place at
day +5 after the next available start date as published in the submission dates of Type IB
variations requiring linguistic review.
3.5. Annual re-assessment and renewals
In case the Annual Re-assessment or Renewal affects the SmPC, Annex II, labelling and/or package
leaflet, only the EN language version needs to be provided at submission.
During the scientific renewal assessment, a detailed pre-opinion review of the EN product information
will be performed by the Agency, QRD members and representatives of Patients’ and Consumers’
Organisations. Technical Labeling Review comments will be sent to the MAH by Day 75. When
providing a revised EN version for adoption of the opinion, applicants should inform the Agency if and
why certain Technical Labeling Review comments are not taken into account.
Translations of the adopted product information in all other EU languages (including Icelandic and
Norwegian) are to be provided electronically (in one Eudralink package) to the Member States Contact
Points for Translations by Day +5 with a copy to the procedure assistant and Product Shared Mailbox.
The following checks will apply:
Who
When
Scope
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QRD/CHMP
‘Member State’
Day +5 to +19
Detailed review of (highlighted changes in) all
translations
Agency
Day +25 to +27
Review of implementation of Member States
comments
Comments will be sent directly by the Member States to the MAH at the latest by Day +19, with a copy
to the Agency (Product Shared Mailbox).
The MAH will send the final translations with tracked changes, incorporating the Member States’
comments in Word format, as well as in PDF format (clean), electronically (in one Eudralink package)
to the procedure assistant with a copy to the Product Shared Mailbox by Day +25. The Eudralink
package should be presented in compliance with the Day +25 Checklist (Annex 7).
The Agency will check if all Member States’ comments have been implemented before sending the final
translations to the Commission. In order to facilitate and accelerate the check of the implementation of
the Member States’ comments, the applicant should indicate in “QRD Form 2” (Annex 6) for each
language if all comments have been implemented or not. In the latter case, a justification should be
provided for the appropriate language(s) stating why certain comments are not reflected in the final
texts. Such justification(s) and/or alternative proposals should be discussed and agreed with the
relevant Member State(s) before submitting final translations to the Agency.
Poor quality translations or a poor implementation of Member States’ comments or absence of a
completed QRD Form 2 may lead to a delay in transmission to the Commission (see also section 6).
Following receipt of the final translations from the Agency, the Commission will start the 22-day
Standing Committee consultation, addressing only legal and public health matters (which means in
principle no further linguistic review).
In case the Annual Re-assessment or Renewal affects only the Annex II, no or a shorter post-opinion
translation timetable may be considered by the Agency on a case-by-case basis.
3.6. The linguistic review process for referral procedures (incl. Article 29
paediatric procedures)
The same general principles as for the post-opinion linguistic review of New Applications apply, as
illustrated by the attached timeline (Annex 3):
Only the EN language version of SmPC, labelling and/or package leaflet needs to be provided at
submission
6
.
During the scientific referral assessment, a detailed pre-opinion review of the EN product information
may be performed on an ad-hoc basis by the Agency and QRD members. Technical Labeling Review
comments will be sent to the MAH by Day 30 (for details on the different Referral procedures please
refer to SOP/EMA/0073). When providing a revised EN version for adoption of the opinion, applicants
should inform the Agency if and why certain Technical Labeling Review comments are not taken into
account.
Translations of the adopted Annex I (list of products) and Annex III (SmPC, labelling and package
leaflet text) in all other EU languages (including Icelandic and Norwegian) are to be provided
electronically (in one Eudralink package) to the Member States Contact Points for Translations by Day
6
For referrals according to Art 31 (2), this may be limited to specific parts of the product information only.
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+5 (i.e. 5 days after adoption of the Opinion) with a copy to the procedure assistant and Product
Shared Mailbox.
The following checks will apply:
Who
When
Scope
QRD/
‘Member State’
Day +5 to +19
Detailed review of all translations
Agency
Day +22 to +27
Review of implementation of Member States
comments
Comments will be sent directly by the Member States to the MAH at the latest by Day +19, with a copy
to the Agency (Product Shared Mailbox).
The MAH will send the final translations with tracked changes, incorporating the Member States’
comments, as well as in clean format in Word, electronically (in one Eudralink package) to the
procedure assistant with a copy to the Product Shared Mailbox by Day +22.
The Agency will check if all Member States’ comments have been implemented before sending the final
translations to the Commission. In order to facilitate and accelerate the check of the implementation of
the Member States’ comments, the applicant should indicate in “QRD Form 2” (Annex 6) for each
language if all comments have been implemented or not. In the latter case, a justification should be
provided for the appropriate language(s) stating why certain comments are not reflected in the final
texts. Such justification(s) and/or alternative proposals should be discussed and agreed with the
relevant Member State(s) before submitting final translations to the Agency.
Poor quality translations or a poor implementation of Member States’ comments or absence of a
completed QRD Form 2 may lead to a delay in transmission to the Commission (see also section 6).
Following receipt of the final translations of the product information (Annex III), Annex I (list of
products), Annex II (scientific conclusions) and Annex 127a (conditions) from the Agency, the
Commission will start the 22-day Standing Committee consultation, addressing only legal and public
health matters (which means in principle no further linguistic review).
3.7. The linguistic review process for PSURs and PSUSAs
The CHMP Opinion or CMDh position on a PSUR procedure recommending variation to a Marketing
Authorisation includes the following annexes:
• Scientific conclusions and grounds recommending the variation to the terms of the Marketing
Authorisation;
• Amendments to the product information and, for centrally authorised products, the full product
information (Summary of Product Characteristics, Labelling and Package Leaflet, in English);
• Condition to the Marketing Authorisation, if applicable.
The CHMP Opinion on a PSUSA procedure consists of the following annexes, as applicable:
• Annex A of CAPs;
• Annex B for CAPs: includes Annexes I, II, III and IV (scientific conclusions) for each CAP;
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