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Q.1 How will a comment be applied which references an image? What will this look like to the applicant, and how will the applicant respond to it?
Q.2 Can we send/receive a PIM submission that is out of sequence?
Q.3 Assuming the Regulator sends submission 0010-r with comments including alternate text. In the case the Applicant accepts the Regulator proposed text, is it needed to refer to the Regulator comment?
Q.4 Is there an issue to insert XML comments into a PIM submission?
Q.5 Does this example of a “pi-leaf” elements lifeline make sense?
Q.6 Is it permitted to populate the “ref-pim” attribute of “pi-leaf” element with the current value of the PIM sequence when “operation” is set to "new" or "replace" ?
Q.7 As PIM data will be stored into databases, is there a limit set to IDs?
Q.8 What Public ID should be used in the PIM XML file?
Q.9 When responding to comments what value should be used for the "department" attribute?
Q.10 There is no Life Cycle Management on the product structure; what needs to be submitted when amending the product structure during the procedure?
Q.11 When generating a document at a certain level, will that document contain all the text contained in the templates referenced from the pi-group nodes of all the elements on and below that level?
Q.12 Is there any guidance on the order of the strength and presentation levels in the EC PDF (or does common sense apply: 10mg before 20mg and 100mg)?
Q.13 Original DES files saved in a Content Management System do not appear to be valid anymore when submitting a PIM sequence. What is happening?
Q.14 During the review process, the regulator might require the removal of sentences about conditional approval or approval under exceptional circumstances. What information should be set in the PIM XML file?
Q.15 In some cases, an applicant comment addresses multiple regulator comments. In this case, is it valid to use more than one ref-id value, separated with commas, e.g. ref-pim="0003-r" ref-id="id8100, id4003"?
Q.16 How can the IDs for levels and templates be handled in a new submission in DES 2.6, if the PRS has already imported submissions of the same product in previous DES versions?
Q.17 Is there a preference regarding the location of virtual documents in the document zone?
Q.18 When the regulator asks an applicant for a merged submission, will the request be simply to merge the latest versions of the product information from two (or more) procedures? Or could the regulator ask the applicant to make additional changes to the content in the merged submission?
Q.19 If the regulator asks an applicant to merge two submissions and the submissions are in DES 2.7, is it mandatory for the merged submission to use the DES 2.7 merge lifecycle information (the “merged” operation and the “pi-merge” element) in order to identify the source of each change?
Q.20 Is there an example of a merged submission using the merge features in DES 2.7?
Q.21 In a DES 2.7 submission, can the free-form part of the filename contain uppercase letters?
Q.22 Are there examples of how to implement the requirement to use permanent IDs for levels, elements, templates, and documents?
Q.23 Is it acceptable to use IDs for XHTML elements within DES elements?
Q.24 Why does the PDVE raise errors and warnings when validating DES submission examples?
Q.25
Q.26 Is it necessary to provide a source or related sequence when submitting translations?
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Q.1 How will a comment be applied which references an image? What will this look like to the applicant, and how will the applicant respond to it?

A. Comments can apply to the PIM submission, PI document, PI section, template or portion of template. In the case the Regulator makes a comment to the image itself (i.e. not to the section for instance), the comment will surround the image tag (img) and no alternate text will be provided.
The applicant then can either:

  • provide an image, clean (i.e. without any comment)
  • provide an image surrounded by a comment tag, that refers to the comment sent by the Regulator, without alternate text

Additional information on the life cycle of images included in submissions can be found in PIM Guidance for Applicants, available on the PIM website.

Q.2 Can we send/receive a PIM submission that is out of sequence?

A. Preferably no.
Business validation rule R3 checks that the submissions exchanged are in sequence (i.e. 0000, 0001, 0002… with no gaps). However, if violated, this rule only throws a warning and should not prevent systems to treat the submission. This means that an exchange of submissions in sequence should be the usual case, and that gaps should remain exceptional. In case an exchange out of sequence is needed, it is advised to inform the receiving side (either Regulator or Applicant) about this exceptional fact. This would assure both parties that no intermediate submission has been lost.

Q.3 Assuming the Regulator sends submission 0010-r with comments including alternate text. In the case the Applicant accepts the Regulator proposed text, is it needed to refer to the Regulator comment?

A. No.
The Applicant submission should refer to the Regulator submission using the “related-sequence” field. At the template level, the Applicant should use the text proposed by the Regulator, without using the comment tag (i.e. clean). The operation to use is “replace”. The verification of the implementation of the comment will be assessed in the Review System using the “related-sequence” field and the comments stored into the Regulator submission.

Q.4 Is there an issue to insert XML comments into a PIM submission?
These XML comments would take the following form: <!--This is just an XML comment and should be ignored-->

A. No.
Such comments are loaded by XML parsers as XML comments, not as elements and therefore, systems will ignore such XML comments.

Q.5 Does this example of a “pi-leaf” elements lifeline make sense?

pim-sequence operation ref-pim Comment

0000-a

new

-

Correct

0001-a

unchanged

0000-a

Correct

0002-a

unchanged

0000-a

Correct

0003-a

replace

0000-a

Incorrect
“ref-pim” is 0003-a
“modified-pim” is “0000-a”

0004-a

unchanged

0003-a

Correct

0005-a

replace

0003-a

Incorrect
“ref-pim” is 0005-a
“modified-pim” is “0003-a”

0006-a

unchanged

0005-a

Correct

0007-a

unchanged

0005-a

Correct

0008-a

delete

0005-a

Correct

0009-a

-

-

 

A. See the comment column.
When the operation attribute of pi-leaf is set to “replace”, the attribute “modified-pim” refers to the PIM instance containing the old template and the attribute “ref-pim” refers to the PIM instance containing the new template.

Q.6 Is it permitted to populate the “ref-pim” attribute of “pi-leaf” element with the current value of the PIM sequence when “operation” is set to "new" or "replace" ?
This is not necessary for the integrity of the PIM file, but this could be helpful for systems to have it.

A. No.
In the cases of “new” and “replace” operation, the “ref-pim” element can usually be omitted. The "ref-pim" needs to be set with an operation "new" or "replace" when the template that is newly attached (or a replacing template) has already been submitted in a previous submission. For instance, when adding a new strength, a text that has already been submitted in the context of the existing strengths, can be attached to the new strength, using the operation "new", and referring to the templates already submitted using the "ref-pim" attribute.If the "ref-pim" attribute is set to the current submission, the PIM Review System will try to check that the referred templates exist, and because they do not (i.e. they belong to the submission being imported), an error will be thrown.

Q.7 As PIM data will be stored into databases, is there a limit set to IDs?

A. In versions of the DES before 2.6, IDs are limited to 32 characters. The length was increased in DES 2.6 to 64 characters so as to support UUID/GUID for PIM IDs

Q.8 What Public ID should be used in the PIM XML file?

A. There is no Public ID attached to the DES. There is only a System ID. There are 3 ways to attach a DTD from an XML instance:

  • inside the XML : this is avoided to clearly separate the data from the standard
  • as System ID: the XML instance refers to the DTD file stored locally
  • as Public ID: the XML instance refers to the DTD file on the web

A Public ID is more convenient to manage centrally but there is an implication for the applicant to be connected to the web at any time. When using XML tools, there might be issues when working behind proxies or firewalls.
A System ID seems therefore appropriate as the submission is self-standing, and does not require to be connected (this also assures to have no security issue). Therefore, it is required that the PIM instance always refers to the DTD using a System ID.

Q.9 When responding to comments what value should be used for the "department" attribute?

A. See DES Specifications, Illustration 3 on Commenting (Section 16.3).

A. When responding to a Regulator comment, the applicant should only refer to the Regulator comment. The Regulator original text should not be re-submitted by the Applicant: only the new desired text should be submitted as part of the "original-text" element.

Q.10 There is no Life Cycle Management on the product structure; what needs to be submitted when amending the product structure during the procedure?

A. During the review of Product Information, there might be a need to add a new level (e.g. a new strength imposed for orphan disease) or remove an existing level (e.g. a strength already identified to be rejected). As no Life Cycle Management covers the Tree Zone, the following guidance must be applied in such case.

  • The addition of a new level during the review process needs to fulfil the following conditions:
    • The id of all the levels must remain identical (i.e. attributes "level_id")
    • The new level must be clearly stated in the cover letter
  • The removal of an existing level during the review process does not require to "delete" all the constitutive templates before the removal of the level itself. The level can be directly removed but this must be clearly stated in the cover letter.

Q.11 When generating a document at a certain level, will that document contain all the text contained in the templates referenced from the pi-group nodes of all the elements on and below that level?

A.See DES Specifications Section 3.8 on Document Zone and Illustration 4 on Document Zone

Q.12 Is there any guidance on the order of the strength and presentation levels in the EC PDF (or does common sense apply: 10mg before 20mg and 100mg)?

A. There is no official guidance on the presentation of strength. The common practice is of course 10mg before 20mg and 100mg. From DES 2.4, the applicant needs to determine the sequence of PI documents in the Document Zone, as stated in the DES Specifications, section 3.8.

Q.13 Original DES files saved in a Content Management System do not appear to be valid anymore when submitting a PIM sequence. What is happening?

A. When saving DES files into a Content Management System (e.g. Documentum), XML files might be reworked by the CMS, like for instance an update in the sequence of attributes. Then, as the content of the file has changed, the computed MD5 value changes as well, and therefore validation rules are violated (e.g. different hash value for headings.xml file). It is recommended to either save DES files into a CMS without allowing the CMS to rework them (for example placing them within a zip file, or similar archiving tool), or to directly use the DES files as published on the PIM website.

Q.14 During the review process, the regulator might require the removal of sentences about conditional approval or approval under exceptional circumstances. What information should be set in the PIM XML file?

A.The element "approval", at product level, is mandatory and thus needs to be provided. To remove the sentences, the attribute "mode" of the element "approval" needs to be set to "complete". The appropriate value, if different from "complete", can be set afterwards, e.g. before opinion or approval.

Q.15 In some cases, an applicant comment addresses multiple regulator comments. In this case, is it valid to use more than one ref-id value, separated with commas, e.g. ref-pim="0003-r" ref-id="id8100, id4003"?

A.No. An applicant response should refer to a single regulator comment. In such a case, the applicant should refer to the most appropriate regulator comment.

Q.16 How can the IDs for levels and templates be handled in a new submission in DES 2.6, if the PRS has already imported submissions of the same product in previous DES versions?

A.It is strongly recommended to apply a minor or major upgrade outside the procedure, i.e. during an upgrade step that precedes the variation. This step should apply the upgrade (including the change of IDs) to the last baseline with no other content changes (i.e. no change for the variation in question). Therefore, it will not be necessary for a DES 2.6 submission in a new procedure to refer to IDs in the format supported by previous DES versions.

Q.17 Is there a preference regarding the location of virtual documents in the document zone?

A. The order of the official documents in the document zone determines their order in the EPAR. Since virtual documents do not appear in the EPAR, their location within the document zone does not matter.

Q.18 When the regulator asks an applicant for a merged submission, will the request be simply to merge the latest versions of the product information from two (or more) procedures? Or could the regulator ask the applicant to make additional changes to the content in the merged submission?

A. A request for additional changes during a merge is not usual but is possible. Also, it may be necessary to make additional changes to resolve conflicts in the text from the submissions being merged (where neither the text from procedure A nor the text from procedure B is right).

Q.19 If the regulator asks an applicant to merge two submissions and the submissions are in DES 2.7, is it mandatory for the merged submission to use the DES 2.7 merge lifecycle information (the “merged” operation and the “pi-merge” element) in order to identify the source of each change?

A. Use of the merge lifecycle information is recommended. Omission of this information means that the submission is theoretically not compliant against the DES. However, the PDVE and the PIM Review System are flexible enough to accept merged submissions without this information, though there is some risk of degraded functionality for reviewers. During the PIM pilot, the EMA will monitor the situation. Based on the experience from the pilot, the EMA will decide whether to later enforce the use of the merge lifecycle information.

Q.20 Is there an example of a merged submission using the merge features in DES 2.7?

A. Yes, click here to download a package containing two examples. The examples use a scenario in which there are two parallel applications, with each application making changes to the “Contraindications” section of the SmPC. The package also contains a document that explains the examples.

Q.21 In a DES 2.7 submission, can the free-form part of the filename contain uppercase letters?

A.The DES Specification requires filenames in lowercase, for consistency with the eCTD Specification. However, Validation Rule F14 allowed uppercase letters in the free-form part of the filename in DES v2.7. To remove this inconsistency, the Validation Rule has been changed in DES v2.7.1 to restrict the filename to lowercase.

Q.22 Are there examples of how to implement the requirement to use permanent IDs for levels, elements, templates, and documents?

A. Yes, click here to download a document containing examples of the use of permanent IDs in several scenarios, such as minor changes to information, reordering information, and splitting information.

Q.23 Is it acceptable to use IDs for XHTML elements within DES elements?

A. The use of IDs for XHTML elements is strongly discouraged. If you do use IDs on XHTML elements, be aware of the following. When the PIM Review System creates a comment, it copies the commented fragment from the <original-text> element to the <alternate-text> element. If a paragraph within the fragment contains an ID, this would result in a duplicate ID. Therefore, the system removes all internal IDs in the <alternate-text> element. The IDs are retained in the <original-text> element.

Q.24 Why does the PDVE raise errors and warnings when validating DES submission examples?

A. The Documentation for the PIM Data Exchange Standard (DES) is available at http://pim.ema.europa.eu/des/docs.html. The Documentation contains submission examples (e.g., EX1.zip which corresponds with the submission sequence 131-pim-a-0031-pimex1.zip). The submission examples can be validated using the PIM Data Validation Engine (PDVE) which is available at http://pim.ema.europa.eu/pdve/index.html. Notice however that:

  • Each submission example should be saved in its own file system directory because the PDVE considers that the files in a directory are sequences of the same submission.
  • The PDVE raises errors and warnings because sequences are missing (e.g., submission sequence 131-pim-a-0031-pimex1.zip refers to sequences 0029-r and 0030-a but those sequences are absent);
  • The PDVE raises some minor errors and warnings that familiarize users with the output of the PDVE.
Q.25 Do the virtual documents that the XSLT generates highlight the differences in headings and standard statements?

A. No. Due to technical limitations, the XSLT PIM Viewer does not take into account the differences in headings/standard statements when generating virtual documents. The following differences between real documents are not detected:

  • Differences in headings/standard statements due to an applicant choice (e.g., the long version of standard statement is selected in one document and the short version of the same standard statement is selected in another document).
  • Differences in headings/standard statements due to a heterogeneous use/non-use of custom headings/standard statements (e.g., the default QRD heading is used in one document and a custom heading is used in another document).
  • Differences in custom headings/standard statements (e.g., a custom heading is used in one document and another custom heading is used in another document).

The Java PIM Viewer (from DES v2.8) will be successor to the XSLT PIM Viewer. The Java PIM Viewer will detect all the differences.

Q.26 Is it necessary to provide a source or related sequence when submitting translations?

A. No. However, in the vast majority of cases, the source and related sequences should be defined when submitting English texts or translations.

When submitting translations for the first time, the source and related sequences can be omitted. The PDVE might generate a warning for this, as rules R23 and R24 have been implemented to cover the vast majority of the cases. The warning should be taken from a cross-check perspective, so as to determine if the absence of source/related sequence is justified in the present case. If the absence is justified, the source/related sequence can be omitted.


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© 1995-2010 European Medicines Agency
Last update: 31-01-2011
Contact: pim@ema.europa.eu