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A - GENERAL A01 Empty Folders Checks the sequence folder structure for any empty best online pharmacy for levitra folders (folders without any files or subfolders). Error A02 File and Folder Security Checks the sequence folder structure for any files or folders the user does not have access permission to. Error A03a File Size This rule's implementation checks for files best online pharmacy for levitra that exceed the configured maximum size. Warning for PDF files between 150 MB and 200 MB. Warning for other file types best online pharmacy for levitra larger than 100 MB (excluding SAS XPT).

Warning A03b File Size This rule's implementation checks for files that exceed the configured maximum size(Max. Size. 200 MB for PDF, 1 GB for SAS XPT). Error A05a Sequence Folder Requirements Checks the sequence folder name. Furthermore the rule will report a finding if the sequence seems to be the initial sequence for the application but its name is not 0000.

Error A05b Higher sequences found Reports error if the validated sequence is not the highest in the application folder. Error A06a XML Backbones Identification Identifies all ICH and regional index files found in the sequence folder. Incorrect or invalid index files will be reported as errors. Error A06b STF Identification Identifies all STF files found in the sequence folder. Invalid STF files will be reported as errors.

STF files with an incorrect name will be also reported as errors. Revised Error A07 Sequence numbering Each subsequent transaction provided in the lifecycle of a dossier, must have a sequence number that is consecutively incremented by 1 number (for example 0000, 0001, 0002, 0003, and so on).Skipping numbers is not acceptable for sequence numbers. Validating a transaction with sequence number 0004 will report an error if sequence number 0003 does not exist (even if sequence 0004 does not have any reference to it). Error A09 Corrupt and password protected WORD documents Word document will be reported as corrupted or password protected if one or more of the following situations occur. Document is corrupt or unreadable Document has password protection Document references an attached template located via http or https Document is empty Note.

This rule applies only to Word version 2007 or later (.docx). Revised Error A10 Duplicate transaction This rule checks if the eCTD sequence that is being validated already exists in the eCTD dossier. New Error B - PDF ANALYSIS B01 Corrupt or unreadable PDF documents A PDF document will be reported as corrupt if one or more of the following situations occur. The document cannot be opened because it is damaged. The document appears to have 0 pages.

The document appears to be an application form, but the form content cannot be read. The document contains additional data (more than 1024 characters) after the last %%EOF (End Of File). An example of situation number (3) could be a document appearing to have 1 page only and the page contains the text phrase "Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document."Revised Error B02 Bookmarks - Absolute (Rooted) Retrieves all non-relative bookmarks in PDF documents and prints the total count, including the broken ones. Error B03a Bookmark - External (www, e-mail) Retrieves all web link bookmarks and e-mail bookmarks in PDF documents and prints the total count.

Error B03b Bookmarks - External (other) Retrieves all external bookmarks other than web links and e-mail links from PDF documents and prints the total count. Error B04 Bookmarks - Inactive Retrieves all inactive bookmarks in PDF documents and prints the total count. Error B06 Bookmarks - Inter Application, broken Retrieves all broken inter-application bookmarks in PDF documents and prints the total count. Error B08 Bookmarks - Intra Application, broken Retrieves all broken intra-application bookmarks in PDF documents and prints the total count. Error B10 Bookmarks - Intra Sequence, broken Retrieves all broken intra-sequence bookmarks from PDF documents and prints the total count.

Error B11 Bookmarks - Other Retrieves all unknown bookmarks (links that could not be identified or contain JavaScript code) from PDF documents and prints the total count. Warning B12 Bookmarks - Count Reports the number of bookmarks per document and the total number of bookmarks in the sequence. Information B13 Hyperlinks - Absolute (Rooted) Retrieves all non-relative hyperlinks from PDF documents and prints the total count, including the broken ones. Error B14a Hyperlinks - External (www, e-mail) Retrieves all web links and e-mail links from PDF documents and prints the total count. Error B14b Hyperlinks - External (other) Retrieves all external hyperlinks other than web links and e-mail links from PDF documents and prints the total count.

Error B15 Hyperlinks - Inactive Retrieves all inactive hyperlinks from PDF documents and prints the total count. Error B17 Hyperlinks - Inter Application, broken Retrieves all broken inter-application hyperlinks from PDF documents and prints the total count. Error B19 Hyperlinks - Intra Application, broken Retrieves all broken intra-application hyperlinks from PDF documents and prints the total count. Error B21 Hyperlinks - Intra Sequence, broken Retrieves all broken intra-sequence hyperlinks from PDF documents and prints the total count. Error B22 Hyperlinks - Other Retrieves all unknown hyperlinks (links that could not be identified or contain JavaScript code) from PDF documents and prints the total count.

Warning B23 Hyperlinks - Count Reports the number of hyperlinks per document and the total number of hyperlinks in the sequence. Information B24 PDF Protection Finds PDF documents with password protection. Error B25 PDF version checking Checks all PDF document versions against the list of allowed versions. Warning B32 PDF Protection. Owner password Finds all documents with an owner password set, excluding Health Canada application forms regardless of their location and literature references in subfolders.

33-lit-ref, 43-lit-ref, 54-lit-ref. Revised Warning B33 PDF Protection. Encrypted Finds all encrypted documents. Information B35 Bookmarks - deep destination check For all bookmarks, the named destination or destination page will be verified.Non existing destinations will be reported (i.e. The destination file exists but the page does not).

Error B36 Bookmarks - multi action Finds all bookmarks with multiple actions assigned. Error B37 Hyperlinks - deep destination check For all hyperlinks, the named destination or destination page will be verified.Non existing destinations will be reported (i.e. The destination file exists but the page does not). Error B38 Hyperlinks - multi action Finds all hyperlinks with multiple actions assigned. Error B40 PDF documents with attachments are not allowed This rule is configured to detect attachments and portfolio documents found in PDF documents.

Error B41 All bookmarks and hyperlinks should have a magnification setting of "Inherit Zoom". This rule performs the corresponding checks for bookmarks. Warning B42 Link does not 'Inherit Zoom' All bookmarks and hyperlinks should have a magnification setting of "Inherit Zoom". This rule performs the corresponding checks for hyperlinks. Warning B43 PDF Initial View Checks for PDF documents with an incorrect initial view.

ICH eCTD Specification. Documents with bookmarks must show the bookmarks pane in their initial view. The Magnification and Page Layout should be set as "default". Warning B44 PDF documents with more than 10 pages must have bookmarks PDF documents with more than 10 pages must have bookmarks. Excluded from this check are literature references in sections 3.3, 4.3, and 5.4.

The life cycle management table. And Health Canada application forms. Warning B45 PDF Protection – Printing Finds all documents where printing is not allowed. Error B46 PDF Protection – Content Copying Finds all documents where copying the content is not allowed. Error B47 PDF content restrictions This rule checks for PDF files that contain, dynamic content (e.g., audio, video or special effects), or 3D content.

Health Canada application forms are excluded from this check regardless of their location. Revised Error B48 PDF content restrictions This rule checks for PDF files that contain JavaScript. Health Canada application forms are excluded from this check regardless of their location. New Error C - REFERENCED FILES C01 HREFs to targets outside application Checks for broken links in submission files. Error Hyperlinks targeting files outside the application will be identified.

C02 HREFs to targets outside sequence Checks for broken links in submission files. Information Hyperlinks targeting files outside sequence will be identified. C03 Life Cycle Management Semantics This check option refers to the current sequence. It will perform a general verification of the leaf life cycle properties in this sequence only (no deep history scanning). Error For leaf elements with operation "new", the eValidator verifies that.

Modified file must not exist / title is given / href must exist. For leaf elements with operation "replace", the eValidator verifies that. Modified file must exist / title is given / href must exist. For leaf elements with operation "append", the eValidator verifies that. Modified file must exist / title is given / href must exist.

For leaf elements with operation "delete", the eValidator verifies that. Modified file must exist / title is not required / href must not exist. The eValidator verifies that for initial submissions all leaf elements have the operation "new". The eValidator checks modified files in LCM. Leaf in previous sequence must exist.

It also verifies that when the attribute "modified-file" has been used for a leaf document then the referenced document exists in the previous submission. It is recognized that this attribute is invalid when used for submission sequence number 0000. The eValidator checks that all files referenced in the backbone exist. C04 MD5 Checksum The eValidator regenerates the MD5 checksums for all referenced files and compares the checksums to the values provided in the backbone file. Error C05 Naming Syntax Checks the syntax of all referenced file names (path length, illegal characters, etc.).

The maximum path length is 200 characters. Error C06 Relative References The eValidator checks that only relative references (href and modified file) are used. Also, only forward slashes "/" are allowed (no backslashes). Error Do the file references in the index files (ICH, Regional, STF) use relative paths?. Absolute (i.e.

Rooted) paths are not allowed. C07 Unreferenced Files Searches for files not referenced in an index file (ICH, Regional or STF). Error D - XML ANALYSIS D01 DTD/Schema Checksums Rule compares the checksums of the DTD and schema against the following checksums. Error ich-ectd-3-2.dtd. 1d6f631cc6b6357f0f4fe378e5f79a27 ca-regional-2-2-.xsd.

Ff564d6e69adebd9a9b4f274e65cf5f1 xml.xsd. 382b0a4f7529d2c5f7b0af0aa713b0a5 xlink.xsd. 52d1a3b8596e4fb61d3ec1cde24be16a ich-stf-v2-2.dtd. 0972c10a4dadf3df5d2f41b2026a4a5c D02 Existence of Node extensions The eValidator checks for "node-extension" elements being used and reports them for informational purposes. Information D03 MD5 for Index files MD5 checksums for index files will be calculated and compared against the MD5 checksums provided in the MD5 text files (not case sensitive).

Revised Error D04 Validate against delivered DTD Performs XML validation for ICH Backbone and Regional backbones. Error Uses the DTD or Schema given in the sequence number folder (util/dtd). F - CA REGIONAL 2.2 F01 All files should have one and only one file extension Checks if referenced files have exactly one file extension. Error F03 Element must have leaf Checks for elements not having any leaf child nodes. This only affects elements with a name that starts with 'm'.

Error F04 The folder m1ca must exist. The sequence folder must have a subfolder m1 with a subfolder ca. Error F05 No subfolders in ca-subfolder The folder m1ca must not have any subfolders. Warning F06 Leaf title must not be empty For operations other than 'delete', all leafs must have a 'title' child. The title must be present.

Error F07 Module 1 (regional xml file) exists The regional backbone ca-regional.xml file must exist in folder m1ca. Error F08 Application folder name must match dossier-identifier The element value for the dossier-identifier must match the name of the parent folder of the sequence folder. And the dossier-identifier must start with the letter e or s. Error F09 Element sequence-description Refer to the CA M1 guidance document for the list of valid values for the sequence-description element. Error F10 Cover letter operation attribute Cover letter should have 'new' operation attribute.

Warning F11 Multiple operations on same document in same sequence Checks for documents in the regional backbone, which are used as modified-file more than once. Error F12 File reuse Checks for file reuse scenarios (Same values for xlink:href used multiple times in the regional backbone for this sequence). Information F14 Replace should not provide identical content to the previous file When replacing content, the new content should be different from the previous content. Revised Error F15 Invalid file extension Valid file extensions include. Pdf, .doc, .docx, .xls, .xlsx, .wpd, .ppt, .pptx, .xml, .dat, .inf, .txt, .png, .gif, .svg, .wav, .mp3, .mp4, .wmv, .jpg, .jpeg, .tif, .tiff, .bmp.

Revised Error F17 Detect invalid life cycle. Delete Detect invalid life cycle pattern. Delete operations causing branches. Error F18 Detect invalid life cycle. Replace Detect invalid life cycle pattern.

Replace operations causing branches. Error F19 Detect invalid life cycle. Delete Detect invalid life cycle pattern. Operation on deleted leaf content. Error F21 Element sequence-number The value of the sequence-number element must match the sequence folder name.

Error F22 Operation for Life Cycle Management Table The operation attribute for this leaf element must be “new” when provided for the first time, and “replace”/ “delete” whenever referenced again as part of a subsequent transaction. Revised Error F23 Product Name and Applicant Element values product-name and applicant must not be empty. Error F24 Cover letter Cover letter should not have more than three pages. Error F25 Node extensions in module 1 Node extensions in module 1 backbone (ca-regional.xml) are not allowed, except in 1.2.6 Authorization for Sharing Information heading, 1.2.7 International Information heading, and 1.6.1 Comparative bioavailability Information heading. The validator checks all headings and subheadings in the Canadian regional backbone (ca-regional.xml).

It generates an error when there is (are) node extension(s) found in any subheadings other than those mentioned above This rule does not apply to leaves with operation "delete". Revised Error F26 Node Extensions in 1.2.7 International Information Node extensions are expected in section 1.2.7 International Information heading. Note. There is a mixture of node extensions and leaves allowed in the 1.2.7 International Information heading. A warning is generated when there is a (are) leaf (leaves) added under this heading.

The warning serves the purpose to notify the user to manually verify the leaves added under this heading. Requirements are outlined below and will result in failure of the transaction if not followed. When provided, the International Status document and the Foreign review attestation must be added as leaves directly under 1.2.7 subheading. Any other foreign agency (such as FDA,. EMA) related documents must be provided using node extensions This rule does not apply to leaves with operation "delete".

Revised Warning F27 Node Extension title must not be empty For node extensions, the title child must be present (value must be present). Error F28 Use of operation append The use of operation “append” is not allowed in module 1. New Error G - ICH BACKBONE 3.2 G01 All files should have one and only one file extension Checks if referenced files have exactly one file extension. Error G02 Attribute checksum-type The checksum-type attribute must have the value md5 or MD5. Error G03 Attribute dosage form Checks if the attribute value is present.

Warning G04 Attribute excipient Checks if the attribute value is present. Warning G05 Attribute Indication Checks if the attribute value is present. Error G06 Attribute Manufacturer Checks if the attribute value is present. Applicable only to sections where this attribute is mandatory, otherwise reported as warning. Error G07 Attribute Product-Name Checks if the attribute value is present.

Warning G08 Attribute Substance Checks if the attribute value is present. Applicable only to sections where this attribute is mandatory, otherwise reported as warning. Error G09 Element must have leaf Checks for elements not having any leaf child nodes. This only affects elements with a name that starts with 'm'. Error G10 File index.xml exists The index.xml file must be present.

Error G11 File index-md5.txt exists The MD5 checksum file index-md5.txt must be present. Error G12 Folder m1 exists The m1 folder must be present. Error G13 Folder util exists The util folder must be present. Error G14 Leaf title must not be empty For operations other than 'delete', all leafs must have a 'title' child. The title must be present.

Error G15 m1-administrative element must exist The element m1-administrative-information-and-prescribing information must be present. Error G16 No other files in m1 The m1 folder must not have any other files in addition to the files explicitly allowed. Error G17 No other files in root The root folder (sequence number folder) must not have any other files in addition to the files explicitly allowed. Error G18 Node Extension title must not be empty For node extensions, the title child must be present (value must be present). Error G19 Regional backbone(s) referenced operations Regional backbone(s) referenced (ca-regional.xml) should have 'new' operation attribute.

Warning G20 Multiple operations on same document in same sequence Checks for documents in the ICH backbone, which are used as modified-file more than once. Error G21 File reuse Checks for file reuse scenarios (Same values for xlink:href used multiple times in the regional backbone for this sequence). Information G22 Invalid file extension Valid file extensions include. .pdf, .doc, .docx, .xls, .xlsx, .wpd, .ppt, .pptx, .xml, dat .inf, .txt, .png, .gif, .svg, .sas, .xpt, .xsl, .dtd, .xsd, .wav, .mp3, .mp4, .wmv, .jpg, .jpeg, .tif, .tiff, .bmp. Revised Error G23 Replace or append should not provide identical content to the previous file When replacing or appending content, the new content should be different from the previous content.

Error G24 Leaf count under a node The number of leaves directly under a single node must not exceed 1000. This rule applies only to module 5 when using node extensions and only to leaves with operation attribute "new". Error G25 Detect invalid life cycle. Append Detect invalid life cycle pattern. Append operations causing branches.

Error G26 Detect invalid life cycle. Append Detect invalid life cycle pattern. Append operations not appending to most recent STF leaf. Error G27 Detect invalid life cycle. Delete Detect invalid life cycle pattern.

Delete operations causing branches. Error G28 Detect invalid life cycle. Replace Detect invalid life cycle pattern. Replace operations causing branches. Error G29 Detect invalid life cycle.

Delete Detect invalid life cycle pattern. Operation on deleted leaf content. Error G30 Detect invalid life cycle. Append Detect invalid life cycle pattern. Append on Append.

Warning G31 Strength in dosage form attribute Do not provide strength values in the dosage form attribute in sections 2.3.P, 3.2.P, 3.2.A.1, or 3.2.A.2. Any numeric value found in these attribute values will be reported as an error. If the strength value was already present in a previous sequence, the rule will not report an error for the current sequence. Error G32 Do not relocate content This applies to leaf elements in the ICH sections modules 2-5.When revisions are sent to a regulatory authority, the new leaf element should be submitted in the same location in the backbone as the leaf element being appended, replaced or deleted. Error G33 SAS XPT dataset files (XPORT) This check will examine the SAS XPT dataset files (XPORT).

Files that are corrupt or compressed will be reported as Error. For details about the technical specifications, please refer to the FDA study data technical conformance guide. Error G34 Node extensions in 3.2.R Regional Information Leaf elements in 3.2.R Regional Information heading must be provided using node extensions. PDF files are not allowed as leaf elements directly under 3.2.R Regional Information heading. Acceptable titles of the node extensions are.

3.2.R.1 Production Documentation 3.2.R.2 Medical Devices 3.2.R.3 Lot Release Documentation 3.2.R.4 Yearly Biologic Product Report 3.2.R.5 Assessment of Similarity 3.2.R.6 On Site Evaluation 3.2.R.7 Other Regional Information Warning will be reported if the naming of the title is not followed. Notes:The requirements above apply only to leaves provided using operation attribute "New". They don't apply to leaves provided using operation attribute "Replace". The exact naming convention of the titles of node extensions must be used when the node extension(s) is (are) created for the first time under this heading. If new or replaced leaves are provided when there are already existing node extensions in the 3.2.R Regional information heading, the leaves must be provided under the existing node extensions, even if they don't follow the exact naming convention of the node extension title.

Warning generated during the validation can be ignored. Revised Error H - STF 2.2 H01 Check Index Reference Verifies that the href target exists and has the correct value. Error H02 Check Index Reference (title - match) Verifies that the href target exists and matches the title value. Warning H03 Content Block are not accepted Reports any used content-block element. Warning H04 No backslash in HREF Verifies that href values do not contain backslashes.

Error H05 Study Identifier category must not be empty The value of the study-identifier/category element must not be empty. Warning H06 Study Identifier study-ID must not be empty The value of the study-identifier/study-id element must not be empty. Warning H07 Study Identifier title must not be empty The value of the study-identifier/title element must not be empty. Warning H08 Categories and file tags Checks file tag values and category values against definitions in valid-values.xml file. Accepting values as defined in valid-values.xml v5.

Error H09 STF leaf element must reference other STF leaf upon append STF leaf element must reference other STF leaf upon append. Error Such leaf elements must not reference PDF files as modified files. H10 Category information must be provided for certain STFs Category information must be provided for certain STFs. Warning H12 STF cannot reference another STF Leaf references in STFs must always target content files, not STFs. Warning H13 STF does not relate to any leaf elements STF files must reference at least one leaf.

Warning H14 Study ID for STF must remain constant The STF study IDs must not change in the application life cycle. Warning H15 Invalid STF TOC location STFs should only be associated with certain headings under Modules 4 or 5. Warning H16 STF doc-content file tag count There should be one and only one file tag for each doc-content. Warning H19 Case Report Form(s) structure in 5.3.7 If Study Tagging Files are used in the current sequence being validated, the node 5.3.7 must not be used. The Case Report Forms must be referenced from the Study Tagging Files.

The previous sequences in the same dossier will not be checked. Error H20 Use Study Tagging Files or Node Extensions Leaf elements in module 4 (except those in subsection 4.3), with an operation attribute "new", can use either node extensions, STFs or may be placed directly under the TOC sections.Leaf elements in subsections 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, and 5.3.7, with an operation attribute "new", can use only node extensions or STFs.Although both node extensions and STFs are acceptable for study reports, only one or the other approach should be used consistently throughout the lifecycle of a leaf. Also, in a specific sequence all leaf elements should use the same approach.Note. Previous sequences in the same dossier will not be checked, and neither will leaf elements with operation attributes other than "new". Error I.

Regulatory Enrolment Process* New *ONLY for users of the Regulatory Enrolment Process (REP) I01 Corrupt xml file An XML file will be reported as corrupt if the file cannot be opened because the file is damaged. Error I02 Missing Regulatory Transaction (RT) XML file Checks the 1.2.1 Application Forms node. Generates error if the RT file is missing from the current eCTD sequence and was provided in the previous eCTD sequence. Note. This rule is not based on the presence of the RT file in the current sequence.

This rule is based on the existence of the RT XML file in the previous eCTD sequence. Error must not be generated if there is no RT xml file present in the previous eCTD sequence. Error I03 Placement of the Regulatory Transaction (RT) and Product Information (PI) xml files Verifies the placement of the RT and PI xml files. Generates error if they are placed in a node other than 1.2.1 Application Forms. Error I04 Presence of the Submission Application form (3011) Checks the 1.2.1 Application Forms node.

Generates error if, in addition to the RT xml file, there is a 3011 form named hc-sc-3011-en.pdf or hc-sc-3011-fr.pdf. Revised Error I05 Presence of other xml files in the Application Forms node Checks the 1.2.1 Application Forms node. Generates error if in addition to the RT xml and/or PI xml file there are other xml files Error will also be reported if more than one RT XML file is found in this node. Revised Error I06 Comparison of the RT file with the top level folder (Dossier ID folder) Compares the value in the Dossier ID field in the RT file with the top level folder. Revised Error I07 Operation Attribute Value for the RT XML file The operation attribute value in the leaf element must be “new” when provided for the first time, and “replace” when provided in subsequent transaction.

New Error I08 Dossier ID Naming convention Checks the Dossier ID field in the RT XML file. It must be lower case letter “e” followed by 6 digits. New Error I09 Product Name and company ID in the RT XML file Element values for “product-name” and “company_id” must not be empty. New ErrorA – GENERAL A01 Empty Folders This rule is configured to detect empty folders (folders without any files or subfolders) in the transaction structure. Error TIP.

All empty folders must be deleted before submitting the transaction to Health Canada. A03a File Size This rule is configured to verify the size of the files. A warning will be generated for PDF files between 150 MB and 200 MB. A warning will be generated for other file types (excluding SAS XPT) between 100 MB and 200MB. Warning TIP.

Check the size of each file before submitting to ensure it does not exceed the maximum limits. A03b File Size This rule is configured to verify the size of the transaction. An error will be generated for PDF files greater than 200 MB, SAS XPT files greater than 1GB and other files greater than 200MB. Error TIP. Check the size of each file before submitting to ensure it does not exceed the maximum limits.

A08 File types This rule is configured to verify if the file extensions are valid. The acceptable file extensions are. .pdf, .doc, .docx, .xls, .xlsx, .wpd, .ppt, .pptx, .dat, .inf, .txt, .jpg, .png, .gif, .svg, .wav, .mp3, .mp4, .wmv, .jpeg, .tiff, .tif, .bmp, .sas, .xpt, .xml*. *Applies only to regulatory transaction (rt-*.xml), product information (pi-*.xml) and application information (ai-*.xml) files provided as part of the Regulatory Enrolment Process (REP). Error TIP.

Ensure that the file types for your documents are accepted before submitting. File extensions written in uppercase letters are not accepted. Do not change the file extension manually. A09 Corrupt and password protected WORD documents Word document will be reported as corrupted or password protected if one or more of the following situations occur. Document is corrupt or unreadable Document has password protection Document references an attached template located via http or https Document is empty Note.

This rule applies only to Word version 2007 or later (.docx). Revised Error A10 Duplicate Transaction This rule compares the content of the transaction received with the content of the previous transaction in the same dossier to ensure they are not the same. New Error B - PDF ANALYSIS B01 Corrupt or unreadable PDF documents This rule is configured to detect corrupt or unreadable PDF files within the transaction. An Error will be generated if the document. Cannot be opened because it is damaged.

Appears to have zero number of pages. Appears to be an application form, but the form content cannot be read. The document contains additional data (more than 1024 characters) after the last %%EOF (End Of File). An example of situation number (3) could be a document appearing to have one page only and the page contains the text phrase “Please wait… If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.” Revised Error B24 PDF Protection This rule is configured to detect if the PDF documents are password protected. An error will be generated if there is a password.

Error TIP. Before submitting to Health Canada, ensure PDF documents are not password protected. B25 PDF version checking This rule is configured to verify that if the PDF document versions are valid. The acceptable PDF versions are 1.4, 1.5, 1.6, and 1.7. Warning TIP.

Ensure the PDF documents are created using the acceptable PDF versions. B32 PDF Protection. Owner password Finds all documents with an owner password set, excluding Health Canada application forms regardless of their location in the folder structure. Revised Warning TIP. Ensure that “No Security” is selected for the “Security Method” displayed in “File”, “Properties” and then, “Security”.

B36 Bookmarks - multi action This rule is configured to detect all bookmarks with multiple actions assigned to them. Error TIP. Ensure that all bookmarks have only one action assigned to it. This action should open the destination page. These settings should be verified in the bookmark properties.

B40 PDF documents with attachments are not allowed This rule is configured to detect attachments and portfolio documents found in PDF documents. Error TIP. Ensure that the PDF document does not include attachments or portfolio documents. B44 PDF documents with more than 10 pages must have bookmarks This rule is configured to verify if PDF documents greater than 10 pages have bookmarks. Excluded from this check are.

Literature references in sections 3.3, 4.3, and 5.4. And Health Canada application e-forms. Warning B45 PDF Protection – Printing Finds all documents where printing is not allowed. Error B46 PDF Protection – Content Copying Finds all documents where copying is not allowed. Error B47 PDF Content restrictions This rule checks for pdf files that contain dynamic content (e.g., audio, video or special effects), or 3D content.

Health Canada application forms are excluded from this check regardless of their location. Revised Error B48 PDF Content restrictions This rule checks for PDF files that contain JavaScript. Health Canada application forms are excluded from this check regardless of their location. New Error C - REFERENCED FILES C05 Naming Syntax This rule is configured to verify that the maximum path length including the first level folder of the regulatory transaction must not exceed 200 characters. The file names must not exceed a maximum of 64 characters, including the file extension.

Since non-eCTD transactions do not have sequence numbers, the second level folder must not be a sequence folder named nnnn (four digits). Revised Error TIP. File path length character count starts at the application folder and includes the file name. The correct structure path for non-eCTD transaction is x123456m1. I.

Regulatory Enrolment Process* New *ONLY for users of the Regulatory Enrolment Process (REP) I01 Corrupt xml file An XML file will be reported as corrupt if the file cannot be opened because the file is damaged. Error I06 Comparison of the RT file with the top level folder (Dossier ID folder) Compares the value in the Dossier ID field in the RT file with the top-level folder. New Error I08 Dossier ID naming convention Checks the Dossier ID field in the RT XML file. It must be one of the lower case letters "p", "d", "m", "v", "c" followed by 6 digits. New Error I09 Product Name and company ID in the RT XML file Element values for "product-name" and "company_id" must not be empty.

New Error I10 Presence of the RT file Checks that the transaction has a valid RT XML file based on the root elements TRANSACTION_ENROL or DEVICE_TRANSACTION_ENROL. Error will also be reported if more than one RT is found in the transaction. New Error.

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On January 30, 2020, the World Health Organization (WHO) declared the levitra represents a public health emergency of international best online pharmacy for levitra concern, and on January 31, 2020, the U.S. Department of Health and Human Services declared it to be a health emergency for the United States..

What side effects may I notice from Levitra?

Side effects that you should report to your prescriber or health care professional as soon as possible.

• back pain
• changes in hearing such as loss of hearing or ringing in ears
• changes in vision such as loss of vision, blurred vision, eyes being more sensitive to light, or trouble telling the difference between blue and green objects or objects having a blue color tinge to them
• chest pain or palpitations
• difficulty breathing, shortness of breath
• dizziness
• eyelid swelling
• muscle aches
• prolonged erection (lasting longer than 4 hours)
• skin rash, itching
• seizures

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• flushing
• headache
• indigestion
• nausea
• stuffy nose

This list may not describe all possible side effects.

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Latest Healthy http://reachoutla.com/buy-viagra-with-prescription// Kids News MONDAY, levitra low cost Aug. 31, 2020 (HealthDay News) -- The new erectile dysfunction can be present in children's noses and throats for weeks without causing any symptoms, according levitra low cost to a new study that suggests how the levitra can spread silently.Researchers found that among 91 pre-symptomatic and symptomatic South Korean children diagnosed with erectile dysfunction treatment between Feb. 18 and March 31, 22% never had any obvious symptoms and another 20% didn't have symptoms initially but developed them later, CNN reported.The study was published Monday in the journal JAMA Pediatrics."In this case series study, inapparent s in children may have been associated with silent erectile dysfunction treatment transmission in the community," the researchers wrote."Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of ," levitra low cost Dr.

Roberta DeBiasi and Dr. Meghan Delaney, both of Children's National Hospital in Washington, D.C., wrote in an accompanying editorial."In this study, the authors estimate that 85 infected children (93%) would have been missed using a testing strategy focused on testing of symptomatic patients alone," DeBiasi and Delaney wrote, CNN reported.The levitra low cost study was released shortly after the U.S. Centers for Disease Control and Prevention issued new guidelines saying that some people without erectile dysfunction treatment symptoms may not need to be tested for the new levitra low cost erectile dysfunction, a policy change that's been criticized by many medical experts and groups, including the American Academy of Pediatrics."We know that children often show few or no symptoms of erectile dysfunction treatment.

We also know they are not immune to this levitra, and they can become very sick. Testing exposed individuals who may not yet show symptoms of erectile dysfunction treatment is crucial to contact tracing, which levitra low cost helps identify and support other people who are at risk of ," AAP President Dr. Sally Goza said in a statement, levitra low cost CNN reported.Copyright © 2019 HealthDay.

Latest Healthy best online pharmacy for levitra Kids http://reachoutla.com/buy-viagra-with-prescription// News MONDAY, Aug. 31, 2020 (HealthDay News) -- The new erectile dysfunction best online pharmacy for levitra can be present in children's noses and throats for weeks without causing any symptoms, according to a new study that suggests how the levitra can spread silently.Researchers found that among 91 pre-symptomatic and symptomatic South Korean children diagnosed with erectile dysfunction treatment between Feb. 18 and March 31, 22% never had any obvious symptoms and another 20% didn't have symptoms initially but developed them later, CNN reported.The study was published Monday in the journal JAMA Pediatrics."In this case series study, inapparent s in best online pharmacy for levitra children may have been associated with silent erectile dysfunction treatment transmission in the community," the researchers wrote."Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of ," Dr. Roberta DeBiasi and Dr.

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Current management of calcific aortic valve stenosis (CAVS) is limited to palliation read the article of do you have to have a prescription for levitra end-stage disease with valve replacement to relieve left ventricular outflow obstruction. Rather than treating the mechanical consequences of severe CAVS, identification of causal disease pathways at the tissue level might lead to medical therapies that could actually prevent or delay the pathological changes in the valve leaflets. Serum levels of lipoprotein-associated phospholipase A2 (Lp-PLA2) activity are associated with the presence of CAVS. However, it has been unclear whether this association is due to a cause–effect relationship do you have to have a prescription for levitra.

In this issue of Heart, Perrot and colleagues1 used genetic association studies from eight cohorts to show that CAVS was not associated with any of four single nucleotide polymorphisms that are associated with Lp-PLA2 activity or mass. These findings suggest that although Lp-PLA2 activity is a biomarker for CAVS unfortunately, it is unlikely to be a therapeutic target (figure 1).Higher Lp-PLA2 activity is significantly associated with the presence of CAVS in patients with heart disease, but variants influencing Lp-PLA2 mass or activity are not associated with CAVS in this large genetic association study. CAVS, calcific do you have to have a prescription for levitra aortic valve stenosis. Lp-PLA2, lipoprotein-associated phospholipase A2." data-icon-position data-hide-link-title="0">Figure 1 Higher Lp-PLA2 activity is significantly associated with the presence of CAVS in patients with heart disease, but variants influencing Lp-PLA2 mass or activity are not associated with CAVS in this large genetic association study.

CAVS, calcific aortic valve stenosis. Lp-PLA2, lipoprotein-associated phospholipase A2.In do you have to have a prescription for levitra an editorial, Zheng and Dweck2 discuss this article, summarise current ongoing trials of medical therapy for CAVS (table 1) and comment. €˜Strong evidence points towards elevated Lp(a) levels and its associated oxidised phospholipids (OxPL) as causal risk factors for CAVS, suggesting that targeting this lipid-driven, inflammatory pathway has a real chance to translate into therapy capable of mitigating disease. The current study suggests that this association is not mediated by Lp-PLA2 and underlines the importance of scrutinising whether biological factors within pathophysiological pathways are merely biomarkers or actually represent a feasible and causal target.’View this table:Table 1 Ongoing randomised clinical trials of medical therapies in aortic stenosisRheumatic heart disease (RHD) remains the primary cause of valve disease worldwide and contributes significantly to maternal and fetal morbidity and mortality.

In a study by Baghel and colleagues3 of 681 pregnant women with RHD, adverse do you have to have a prescription for levitra cardiovascular evens occurred in about 15% of pregnancies. Multivariable predictors of adverse outcomes during pregnancy were prior adverse cardiovascular events, lack of appropriate medical therapy, severity of mitral stenosis, valve replacement and pulmonary hypertension. Based on this analysis, the authors propose a risk score from pregnant women with RHD (table 2).View this table:Table 2 New prognostic score (DEVI’s score) to predict composite adverse cardiac outcome in pregnant women with rheumatic valvular heart diseaseCommenting on this paper, Elkayam and Shmueli4 point out that in about one-fourth of women, the diagnosis of RHD was not known prior to pregnancy and that a late diagnosis often was associated with adverse outcomes. Their editorial provides a concise summary of do you have to have a prescription for levitra optimal management of pregnant women with RHD.

They conclude ‘With proper evaluation and risk stratification prior to pregnancy, a close multidisciplinary follow-up during pregnancy, and close monitoring during labour and delivery as well as the early postpartum period most complications can be prevented.’The importance of psychosocial factors in cardiovascular disease (CVD) prevalence and outcomes is increasingly recognised. Using data from the English Longitudinal Study of Ageing, Bu and colleagues5 found that loneliness was associated with CVD, independent of possible confounders and other risk factors, with a 30% higher risk of a new CVD diagnosis in the most lonely people compared with the least lonely people. As O’Keefe and colleagues6 point out, this data is especially important now in the context of social distancing and stay-at-home recommendations and they offer several approaches to mitigating loneliness during the erectile dysfunction treatment levitra.The Education in Heart article7 in this issue do you have to have a prescription for levitra focuses on the clinical use and prognostic implications of echocardiographic speckle tracking measurements of global longitudinal strain to detect and quantify early systolic dysfunction of the left ventricle (figure 2).Left ventricular global longitudinal strain to differentiate between mutation-positive sarcomeric hypertrophic cardiomyopathy and cardiac amyloidosis. (A) Apical four-chamber view of a 66-year-old patient known with mutation-positive hypertrophic cardiomyopathy.

The thickness of the septum was 28 mm and the left ventricular ejection fraction was 55%. (B) The polar map shows markedly impaired do you have to have a prescription for levitra longitudinal strain in the septal mid and basal areas and the global longitudinal strain is impaired (−13.6%). (C) Apical four-chamber view of a 75-year-old patient diagnosed with light chain amyloidosis. There is concentric hypertrophy of the left ventricle and the ejection fraction is 56%.

Based on speckle tracking echocardiography analysis, the left ventricular global longitudinal strain is impaired (−12.2%), with typical sparing of the longitudinal do you have to have a prescription for levitra strain values in the apical segments (D). ANT, anterior. ANT SEPT, anteroseptal. GS, global do you have to have a prescription for levitra strain.

INF, inferior. LAT, lateral. POST, posterior do you have to have a prescription for levitra. SEPT, septal." data-icon-position data-hide-link-title="0">Figure 2 Left ventricular global longitudinal strain to differentiate between mutation-positive sarcomeric hypertrophic cardiomyopathy and cardiac amyloidosis.

(A) Apical four-chamber view of a 66-year-old patient known with mutation-positive hypertrophic cardiomyopathy. The thickness of the septum was 28 mm and the left ventricular ejection fraction do you have to have a prescription for levitra was 55%. (B) The polar map shows markedly impaired longitudinal strain in the septal mid and basal areas and the global longitudinal strain is impaired (−13.6%). (C) Apical four-chamber view of a 75-year-old patient diagnosed with light chain amyloidosis.

There is concentric hypertrophy of the do you have to have a prescription for levitra left ventricle and the ejection fraction is 56%. Based on speckle tracking echocardiography analysis, the left ventricular global longitudinal strain is impaired (−12.2%), with typical sparing of the longitudinal strain values in the apical segments (D). ANT, anterior. ANT SEPT, anteroseptal do you have to have a prescription for levitra.

GS, global strain. INF, inferior. LAT, lateral do you have to have a prescription for levitra. POST, posterior.

SEPT, septal.Our Cardiology-in-Focus article by Hudson and Pettit8 provides a clear-eyed but brief discussion and outstanding graphic of the challenges in reconciling the varying definitions of the ‘normal’ values for left ventricular ejection fraction, as stated in different guidelines (figure 3).Categories of left ventricular ejection fraction. EF, ejection do you have to have a prescription for levitra fraction. HF, heart failure. LVEF, left ventricular ejection fraction." data-icon-position data-hide-link-title="0">Figure 3 Categories of left ventricular ejection fraction.

Current management best online pharmacy for levitra of calcific aortic valve stenosis (CAVS) is limited to palliation of end-stage disease with valve replacement to relieve left ventricular outflow obstruction. Rather than treating the mechanical consequences of severe CAVS, identification of causal disease pathways at the tissue level might lead to medical therapies that could actually prevent or delay the pathological changes in the valve leaflets. Serum levels of lipoprotein-associated phospholipase A2 (Lp-PLA2) activity are associated with the presence of CAVS. However, it has been unclear whether this association is best online pharmacy for levitra due to a cause–effect relationship.

In this issue of Heart, Perrot and colleagues1 used genetic association studies from eight cohorts to show that CAVS was not associated with any of four single nucleotide polymorphisms that are associated with Lp-PLA2 activity or mass. These findings suggest that although Lp-PLA2 activity is a biomarker for CAVS unfortunately, it is unlikely to be a therapeutic target (figure 1).Higher Lp-PLA2 activity is significantly associated with the presence of CAVS in patients with heart disease, but variants influencing Lp-PLA2 mass or activity are not associated with CAVS in this large genetic association study. CAVS, calcific aortic valve stenosis best online pharmacy for levitra. Lp-PLA2, lipoprotein-associated phospholipase A2." data-icon-position data-hide-link-title="0">Figure 1 Higher Lp-PLA2 activity is significantly associated with the presence of CAVS in patients with heart disease, but variants influencing Lp-PLA2 mass or activity are not associated with CAVS in this large genetic association study.

CAVS, calcific aortic valve stenosis. Lp-PLA2, lipoprotein-associated phospholipase A2.In an editorial, Zheng and Dweck2 discuss this article, summarise current ongoing trials of medical therapy best online pharmacy for levitra for CAVS (table 1) and comment. €˜Strong evidence points towards elevated Lp(a) levels and its associated oxidised phospholipids (OxPL) as causal risk factors for CAVS, suggesting that targeting this lipid-driven, inflammatory pathway has a real chance to translate into therapy capable of mitigating disease. The current study suggests that this association is not mediated by Lp-PLA2 and underlines the importance of scrutinising whether biological factors within pathophysiological pathways are merely biomarkers or actually represent a feasible and causal target.’View this table:Table 1 Ongoing randomised clinical trials of medical therapies in aortic stenosisRheumatic heart disease (RHD) remains the primary cause of valve disease worldwide and contributes significantly to maternal and fetal morbidity and mortality.

In a study by Baghel and colleagues3 of 681 pregnant women with RHD, adverse cardiovascular evens occurred in about 15% of pregnancies best online pharmacy for levitra. Multivariable predictors of adverse outcomes during pregnancy were prior adverse cardiovascular events, lack of appropriate medical therapy, severity of mitral stenosis, valve replacement and pulmonary hypertension. Based on this analysis, the authors propose a risk score from pregnant women with RHD (table 2).View this table:Table 2 New prognostic score (DEVI’s score) to predict composite adverse cardiac outcome in pregnant women with rheumatic valvular heart diseaseCommenting on this paper, Elkayam and Shmueli4 point out that in about one-fourth of women, the diagnosis of RHD was not known prior to pregnancy and that a late diagnosis often was associated with adverse outcomes. Their editorial provides a concise summary of optimal management of pregnant women with best online pharmacy for levitra RHD.

They conclude ‘With proper evaluation and risk stratification prior to pregnancy, a close multidisciplinary follow-up during pregnancy, and close monitoring during labour and delivery as well as the early postpartum period most complications can be prevented.’The importance of psychosocial factors in cardiovascular disease (CVD) prevalence and outcomes is increasingly recognised. Using data from the English Longitudinal Study of Ageing, Bu and colleagues5 found that loneliness was associated with CVD, independent of possible confounders and other risk factors, with a 30% higher risk of a new CVD diagnosis in the most lonely people compared with the least lonely people. As O’Keefe and colleagues6 point out, this data is especially important now in the context of social distancing and stay-at-home recommendations and they offer several approaches to mitigating loneliness during the erectile dysfunction treatment levitra.The Education in Heart article7 in this issue focuses on the clinical use and prognostic implications of echocardiographic speckle tracking measurements of global longitudinal strain to detect and quantify early systolic dysfunction of the left ventricle (figure 2).Left ventricular global longitudinal strain to differentiate between mutation-positive sarcomeric hypertrophic cardiomyopathy best online pharmacy for levitra and cardiac amyloidosis. (A) Apical four-chamber view of a 66-year-old patient known with mutation-positive hypertrophic cardiomyopathy.

The thickness of the septum was 28 mm and the left ventricular ejection fraction was 55%. (B) The polar best online pharmacy for levitra map shows markedly impaired longitudinal strain in the septal mid and basal areas and the global longitudinal strain is impaired (−13.6%). (C) Apical four-chamber view of a 75-year-old patient diagnosed with light chain amyloidosis. There is concentric hypertrophy of the left ventricle and the ejection fraction is 56%.

Based on best online pharmacy for levitra speckle tracking echocardiography analysis, the left ventricular global longitudinal strain is impaired (−12.2%), with typical sparing of the longitudinal strain values in the apical segments (D). ANT, anterior. ANT SEPT, anteroseptal. GS, global best online pharmacy for levitra strain.

INF, inferior. LAT, lateral. POST, posterior best online pharmacy for levitra. SEPT, septal." data-icon-position data-hide-link-title="0">Figure 2 Left ventricular global longitudinal strain to differentiate between mutation-positive sarcomeric hypertrophic cardiomyopathy and cardiac amyloidosis.

(A) Apical four-chamber view of a 66-year-old patient known with mutation-positive hypertrophic cardiomyopathy. The thickness best online pharmacy for levitra of the septum was 28 mm and the left ventricular ejection fraction was 55%. (B) The polar map shows markedly impaired longitudinal strain in the septal mid and basal areas and the global longitudinal strain is impaired (−13.6%). (C) Apical four-chamber view of a 75-year-old patient diagnosed with light chain amyloidosis.

There is concentric hypertrophy of the left ventricle and the ejection fraction best online pharmacy for levitra is 56%. Based on speckle tracking echocardiography analysis, the left ventricular global longitudinal strain is impaired (−12.2%), with typical sparing of the longitudinal strain values in the apical segments (D). ANT, anterior. ANT SEPT, anteroseptal best online pharmacy for levitra.

GS, global strain. INF, inferior. LAT, lateral best online pharmacy for levitra. POST, posterior.

SEPT, septal.Our Cardiology-in-Focus article by Hudson and Pettit8 provides a clear-eyed but brief discussion and outstanding graphic of the challenges in reconciling the varying definitions of the ‘normal’ values for left ventricular ejection fraction, as stated in different guidelines (figure 3).Categories of left ventricular ejection fraction. EF, ejection best online pharmacy for levitra fraction. HF, heart failure. LVEF, left ventricular ejection fraction." data-icon-position data-hide-link-title="0">Figure 3 Categories of left ventricular ejection fraction.