Guidance for Industry on Providing Regulatory Information in eCTD Format

Guidance for Industry
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Swissmedic · Hallerstrasse 7 · CH-3000 Bern 9 · www.swissmedic.ch · Tel. +41 31 322 02 11 · Fax +41 31 322 02 12
Guidance for Industry on Providing Regulatory
Information in eCTD Format
Authors: SIMES Working Group “Specification & Best Practice Guidance”
Lead: Susanne Kienberger, Swissmedic
Claudia Zerobin, Swissmedic
Cornelia Bigler, Swissmedic
Damian Schöni, Swissmedic
Rosemarie Sift Carter, Swissmedic
Charles Boyle, Swissmedic
Jörg Schnitzler, Astellas
Caroline Keller, Novartis
Francis Le Monnier, Novartis
Inge Sift, Alpinia
Philippe Karl, Genzyme
Andrew Marr, GlaxoSmithKline
Françoise Fedele, sanofi-aventis (schweiz) ag
Dorothée Alfonso, sanofi-aventis (schweiz) ag
Sibylle Stettler, Rexult AG
Responsible: Support, Marketing Authorisation, Swissmedic
Version / Date: Version 1.2 / 29.11.2010
Document Control
Change Record
Version Date Comments Author(s)
0.92 15.06.2009 Draft version, published on Swissmedic website SIMES Working Group
1.0 30.10.2009 1st
valid version, published on Swissmedic
website
SIMES Working Group
1.09 26.03.2010 Draft for Review SIMES Working Group
1.1 21.05.2010 Update, published on Swissmedic website SIMES Working Group
1.19 05.11.2010 Version for Review SIMES Working Group
1.2 29.11.2010 Version published on Swissmedic website SIMES Working Group
Reviewers
Version Date Organisation
0.92 15.06.2009 Review team SGCI, Review team Swissmedic
1.2 12.11.2010 SIMES Step 3 Working Group

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Distribution
Version Date Name
0.92 15.06.2009 Official publication on Swissmedic website
1.09 26.03.2010 Project team and Review teams SIMES

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Table of Contents
1 Introduction 7
Timelines 7
2 Purpose and scope 8
2.1 Types of products 8
2.2 Types of submissions 8
2.3 Additional information and subsequent submissions 8
2.4 Filing formats of submissions in eCTD format 8
3 Structure and content of submissions in eCTD format 9
3.1 Structure 9
3.1.1 eCTD Identifier........................................................................................................9
3.1.2 Sequence number folder.........................................................................................9
3.1.3 util and dtd subfolders...........................................................................................10
3.1.4 Module 1 subfolder................................................................................................10
3.1.5 Modules 2 to 5 subfolders.....................................................................................10
3.2 eCTD envelope 10
3.3 Metadata 11
3.4 Inclusion of correspondence documentation 12
3.5 Cover Letter 12
4 Technical requirements for submissions 14
4.1 Submission media 14
4.2 Compression and password protection / security settings 14
4.3 PDF files 15
4.4 File naming conventions 16
4.5 Hyperlinks 16
4.6 md5 checksum 17
4.7 Additional files in Word format 17
4.8 Virus check 18
4.9 Technical validation before submission 18
5 Life cycle management 19
5.1 Life cycle management at the “Drug Product” layer (eCTD application) 19
5.2 Life cycle management at the submission layer (i.e. eCTD-sequence) 19
5.3 Life cycle management at the document layer (eCTD leaf) 19
5.4 Life cycle management of specific documents 19
5.5 Responses to “List of Questions” 20
6 Baseline submissions 21
7 Submission of PSURs and E2E / RMP Updates in eCTD Format 23
7.1 PSUR 23
7.1.1 Application type “PSUR” -> please fill in the Form PSUR for Human Medicinal
Products.............................................................................................................................23
7.1.2 Application type “Supplemental Information“ ........................................................23
7.2 E2E / RMP Update 23
7.2.1 Application type “PSUR” if submitted as part of the regular PSUR Program .......23
7.2.2 Application type “Supplemental Information” if not submitted as part of the regular
PSUR Program ..................................................................................................................23
7.3 Structure for a PSUR submission as part of the regular PSUR Program 24

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8 Test eSubmissions 25
9 Shipment 26
10 Appendices 27
Appendix 1: eCTD Reference Documents 27
Appendix 2: Swissmedic types of applications 28
Appendix 3: List of documents requested additionally in paper format 30

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Glossary
A brief glossary of terms (for the purpose of this document only) is indicated below:
Term Definition
Applicant A pharmaceutical company or its agent that is submitting
information in support of an application.
Applicant’s information Regulatory information submitted by an applicant for or to
maintain a marketing authorisation that falls within the scope of
this guidance document
Application A collection of documents compiled by a pharmaceutical
company or its agent in compliance with Swiss legislation and
guidelines in order to seek a marketing authorisation or any
amendments thereof. An application may comprise a number of
submissions.
Application number The application number is assigned to the application by
Swissmedic. It tracks the application at the agency level.
A submission can consist of several application numbers.
eCTD identifier An eCTD identifier is a name, code or number used as the
directory name in the top-level directory.
This can be a proposed trade name, a company internal project
code, or the Marketing Authorisation number.
eCTD-Sequence All files and folders in a submission in eCTD format are to be
placed under the eCTD-Sequence number folder (equivalent to
the term "sequence" used by the EMA)
eCTD-Submission An eCTD-Submission is an electronic-only submission in the
eCTD format that is supported by paper documents (except
some documents from Module 1).
Marketing Authorisation
Number
The Marketing Authorisation Number is the unique identifier for
the medicinal product and the dosage form for the Swiss market.
(Swissmedic Number)
Submission A single set of information and/or documents supplied by the
applicant as a partial or complete, application. In the context of
eCTD, this is equivalent to ‘eCTD Sequence’.
Test-eCTD-Submission A Test-eCTD-Submission is an electronic-only submission by
the applicant prior to the official submission. The objective to test
the technical attributes and suitability of the eCTD. A Test-
eCTD-Submission may differ from the official submission and be
incomplete. A test submission cannot be accepted as the true
submission for review.

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List of Abbreviations
ATC Anatomical Therapeutical Chemical
CCDS Company Core Data Sheet
CL Checklist
CTD Common Technical Document
DMF Drug Master File
DTD Document Type Definition
eCTD electronic Common Technical Document
EMA European Medicines Agency
EU European Union
FO Form
GMO Genetically Modified Organisms
ICH International Conference on Harmonization
INN International Non-proprietary Name
LCM Life cycle management
LoQ List of Questions
NeeS Non-eCTD electronic submission
PDF Portable Document Format
PSUR Periodic Safety Update Report
RMP Risk Management Plan (E2E)
Q&A Questions and Answers document
SIMES Project “Solution for the Implementation and Management of Electronic
Submissions”
SmPC Summary of Product Characteristics
STF Study Tagging Files
Swissmedic Swiss Agency for Therapeutic Products
ToC Table of Contents
TPA Therapeutic Product Act (Federal Law on Medicinal Products and Medical
Devices) of December 15, 2000 / SR 812.21 Bundesgesetz vom 15.
Dezember 2000 über Arzneimittel und Medizinprodukte (Heilmittelgesetz
HMG) in the past known as LTP (Law on Therapeutic Products)
Util Utility folder in the eCTD Sequence. Contains technical files.
VAM Ordinance on Medicinal Products of October 17, 2001 / SR
812.212.21(Verordnung über die Arzneimittel)
XML Extensible Markup Language

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1 Introduction
This document aims to provide guidance on the Swiss Agency for Therapeutic Products
(Swissmedic) plans to implement electronic-only submissions with the electronic Common
Technical Document (eCTD). It is to be used in the preparation and filing of medicinal
product submissions to Swissmedic in the eCTD format established by the International
Conference on Harmonisation (ICH) of Technical Requirements for Registration of
Pharmaceuticals for Human Use.
This Guidance Document reflects the current situation and will be regularly updated to reflect
changes in national legislation and/or ICH regulations together with further experience
gained within different types of submissions submitted in electronic format.
The relevant guidances on the same topic, issued by EMA and Health Canada, have been
considered in the preparation of this document and used as a basis.
The preparation and filing of submissions as well as additional information in eCTD format is
encouraged but remains optional.
Applicants who choose to file a submission in the eCTD format must comply with the
requirements for such submissions, these are
 the requirements defined in this guidance document
 the Swiss M1 Specification for eCTD
 the Electronic Common Technical Document Specification (current Version),
developed by the ICH M2 Expert Working Group (EWG)
 the Swiss eCTD validation criteria
Submissions and additional information in electronic format that do not comply with these
requirements, like non-eCTD electronic submissions (NeeS) will be rejected.
This guidance document is supplemented and actualized by the Questions and Answers
document on the Swismedic website (www.swissmedic.ch), which will be updated on a
regular basis.
Additionally, further eCTD Q&A issued by the ICH can be found at
http://estri.ich.org/eCTD/index.htm
Applicants are also encouraged to consult the list of publications and guidances published by
European Regulatory Authorities. A non exhaustive list is attached as Appendix 1 for
information.
Timelines
Electronic-only submissions for a defined number of application types are accepted since 1
January 2010.

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2 Purpose and scope
The purpose of this guidance document is to integrate the eCTD format within the
Swissmedic registration framework by describing the electronic format requirements for drug
submissions filed pursuant to the Therapeutic Product Act (TPA) and all relevant ordinances.
2.1 Types of products
This guidance document applies to pharmaceuticals, biologicals and vaccines, blood and
blood derivatives as well as products pertaining to complementary medicines for human use.
It does not apply to veterinary medicinal products and transplant products, medical devices
and drug-device combinations where the combination product is classified as a device, as
well as for simplified authorisation procedures for complementary and herbal medicinal
products, especially application procedures for homeopathic and anthroposophic or Asian
medicinal products without indication.
The eCTD format is also encouraged for the drug component of drug and device
combinations, where the primary mechanism of action is drug-related.
2.2 Types of submissions
The currently applicable submissions are listed in Appendix 2.
This guidance document does not currently apply to pre-marketing authorization documents
(e.g. briefing books for scientific advice meetings) or Notification Applications for Clinical
Trials.
2.3 Additional information and subsequent submissions
Once an applicant files a submission in the eCTD format, all additional information and
subsequent submissions for the same drug product should be filed in the eCTD format
(“once eCTD, always eCTD”). Applicants should not revert to the paper-based CTD format
for additional information and subsequent submissions for the same drug product.
2.4 Filing formats of submissions in eCTD format
The filing using eCTD is foreseen as an electronic only submission.
For legal reasons however distinct documents of Module 1 such as listed in Appendix 3 have
to be sent in addition as signed original paper version. The paper version is to be arranged in
the same order as the electronic version. The current Swissmedic practices have to be taken
into account to define which documents are needed for the submission types, and the
documents detailed in Appendix 3 should be provided where applicable.
For any guidance about which documents are needed for which application, please refer to
the TPA and related ordinances and the website of Swissmedic.

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3 Structure and content of submissions in eCTD format
3.1 Structure
The content of information required for submissions in eCTD format is the same as for paper-
based submissions in CTD format. However, the location of files in the submission in eCTD
format may differ from the location of the paper documents in the submission in CTD format.
The eCTD structure reflects the XML backbone that is used for the submission. The eCTD
structure can be graphically displayed by an XML viewing tool. Figure 1 illustrates a portion
of the eCTD structure, as seen using an XML viewing tool.
Sequence Number Folder
Module 2 Subfolder
Leaf Files
Figure 1: eCTD Structure
3.1.1 eCTD Identifier
There is no requirement to use an identifier for the directory name in the top-level directory.
However in order to facilitate the handling of the submissions, Swissmedic recommends to
use the proposed trade name or a company internal project code as an identifier. Once
defined, it should remain unchanged during the whole lifecycle.
3.1.2 Sequence number folder
All files and folders in a submission in eCTD format are to be placed under the sequence
number folder, as described in the ICH Electronic Common Technical Document
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Specification, “File Names and Directory Structure”. The sequence number folder should be
named using a four-digit number. The sequence number for the first submission should be
0000. Applicants are to provide an incremental number, unique within the same application
for each new sequence they provide.
If a submission fails technical validation due to a technical error, the sequence number does
not change when the submission is filed again. If the submission passes technical validation,
but has content deficiencies, resolving these deficiencies requires an increment to the
sequence number.
The sequence number folder includes an m1 subfolder, m2–m5 subfolders (optional), and an
util subfolder (see Figure 1). The eCTD backbone file (index.xml), the checksum file (index-
md5.txt) and the util subfolder should be in the sequence number folder.
3.1.3 util and dtd subfolders
The util subfolders contain a dtd subfolder as well as a style folder and they must only
contain the files that are mentioned in the Swiss Module 1 Specification which define the
regional Module 1 backbone file. The dtd subfolder located under the root folder must only
contain the ICH eCTD DTD that defines the eCTD backbone file. The style folders must
contain the relevant style sheet information.
3.1.4 Module 1 subfolder
The content of the Module 1 is described in detail in the document Swiss M1 Specification for
eCTD.
3.1.5 Modules 2 to 5 subfolders
The structure and content of the Modules 2 to 5 subfolders (m2–m5) are defined in the ICH
Electronic Common Technical Document Specification.
The following points are to be considered:
 Node extensions are allowed but should be used only where necessary
 Node extensions are recommended for each clinical study report. The title element
for the node extension is used to provide the full study title
 The use of Study Tagging Files (STF) is discouraged. If STFs are present, please
liaise with Swissmedic before submission.
3.2 eCTD envelope
The metadata provided by the applicant with the eCTD are extremely important, since it
indicates relationships between individual sequences for effective lifecycle management of
the application. The particular envelope elements used by the review tool for display and
management of submissions are listed in the Swiss Module 1 Specifications for eCTD,
Appendix 2. Applicants must include and present metadata in a manner that unequivocally
ties them to a submission (e.g. applicant name, INN). It is appreciated that there may be
legitimate reasons for the metadata to change over the lifecycle of the product and this is
technically supported. Consistency, quality and accuracy of metadata should always be
assured.
When the Marketing Authorisation number is known, it should be included in the envelope.

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The field <submission description> is a free text field and serves to link the application
number to the application, in case of more than one application per eCTD Sequence.
Using the <application description> element, submissions relating to multiple parallel
variations can be easily identified and grouped together. The contents of the <application
description> element should therefore be concise but clearly indicative of the substance of
the application in question.
The <application description> can also serve to determine the differences between
sequences where the same value for <application type> must be used for multiple
submissions (e.g. ”variation requiring authorization incl. scientific review” due to the fact that
a completely exhaustive set of values for <application type> is not implemented in the eCTD
Swiss M1 specification).
As an example, “new indication” as application type is not descriptive enough for the content
and therefore the description should be supplemented by “application for new indication
breast cancer” in the <application description> field.
3.3 Metadata
The leaf attribute metadata provided by the applicant is considered important, since this
information is displayed by review tools and is used for identifying documents and sections,
and becomes particularly important in managing the lifecycle of the submission. For
example, the ICH eCTD Specification, v3.2 describes 6 eCTD Heading Element Attributes for
use in the eCTD to structure the eCTD content. Five of these attributes are in Module 3:
 Substance
 Drug Product/Drug Substance Manufacturer
 Product Name
 Dosage Form
 Excipient
These attributes correspond to elements in the eCTD that may be repeated, and are used to
define specifically what each repeated section covers.
For example, in an eCTD covering two active ingredient manufacturing sites, the directory
structure for the eCTD may be splitted into two paths which will contain documents for the
different sites, and the XML will be similarly structured (see p6-11 of the ICH eCTD
Specification, v3.2). The extent to which a single eCTD can cover multiple substances,
manufacturers, products and excipients, and the use of these attributes to describe what is
being covered is largely left to the applicant. This means that the eCTD can be structured in
different ways. These potential variations in structure and scope can affect the presentation
of the dossier using eCTD review tools that ‘read’ the XML, and affect eCTD repositories that
are used to store the eCTD files and directory structure.
The structure of an eCTD will affect how the lifecycle of the eCTD can be managed over
time, and, therefore, the structure of the first eCTD for a product or product range needs
careful consideration. For example, if an eCTD is built to cover 100mg and 200mg tablets,
and common documents are submitted for both strengths, if a line extension is introduced to
add a 150mg tablet, then the applicant needs to decide whether to replace 100/200mg
documents with a 100/150/200mg document, or to create a new standalone 150mg
document and introduce another 32p and 23p section to the existing eCTD. Another option
would be to build an entirely different and new eCTD for the 150mg tablets.

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3.4 Inclusion of correspondence documentation
The term ”correspondence” applies to all communications (documents) that are exchanged
between an applicant and a regulator in the context of an authorisation procedure but which
do not have a formal designated placeholder within the eCTD structure. For example,
responses to authority questions are not classified as ‘correspondence’ since the Swiss M1
eCTD DTD includes a designated section for such information.
Not all correspondence should be included in the eCTD. This is because the eCTD exchange
is currently one way only (from the applicant to the agency), and not all correspondence is
directly relevant to the application dossier. Accordingly, only the minimum of correspondence
that relates directly to the content of the dossier should be included in submissions to
Swissmedic. All other correspondence should be exchanged outside the eCTD via the usual
means (letter).
Where correspondence acknowledges the final change to details submitted in the body of the
dossier, the agreement cannot be documented by that correspondence alone. The revised
information should be provided in an accompanying replacement document situated in the
appropriate place in the body of the dossier, with the relevant information contained in a
cover letter.
3.5 Cover Letter
Submissions as well as additional information in eCTD format should be accompanied by an
administrative cover letter in both paper and portable document format (PDF).
The cover letter should always state the context of the submission, e. g. the application type
and the marketing authorization number and the application number (Fill in with “pending” if
not yet known.).
The paper and PDF cover letters should have the same content.
The cover letter in the submission in eCTD format is located in the folder 1.0 of the Swiss
Module 1. The cover letter should be submitted with the document operation attribute “new”.
As eCTD viewing tools will display all "new" leaf elements in a current or cumulative view, it
is recommended that you place additional descriptive text in the leaf title to help you identify
specific cover letters. This will help identify each cover letter leaf and the submission it is in,
rather than having the cover letters named the same in each sequence. Some examples for
the leaf titles could be:
Cover Letter for Sequence 0000
Cover Letter for New Indication AML
The printout of the checksum file (index-md5.txt) should be attached as an annex to the
cover letter (paper version). The annex must be dated and signed.
The letter should at least contain the following information:
 Date
 The applicant’s name and address
 The product (invented) name(s)
 Marketing authorization number (if available)
 Application number (if available)

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 ATC code( if available)
 Dosage form
 Dosage strength(s)
 The International Non-proprietary Name (INN) of the product
 The application type
 A description of the submission
 Attestation concerning mock-ups (if applicable)
 Number of CDs/DVDs provided
 Contact details in case of technical validation issues
The following statements must be included:
 “We confirm that the CD/DVD-burning session is closed and the submission is
checked with an up-to-date and state-of-the art virus checker: [name of the antivirus
software and version of the virus checker]”
 “We confirm that the documents submitted in electronic form and the corresponding
paper version of parts of Module 1 are identical.”
The tracking of the submitted sequences in a tabular format should be included in the cover
letter or as an annex to the cover letter, as per the following example:
Date of
submission
Sequence
number
Related eCTD
sequence
Regulatory activity /
Type of claim
Regulatory status
(submitted / approved /
rejected
The letter (paper version) must be signed.
If there are specificities concerning the eCTD submission about which the reviewers should
be informed, it is highly recommended to include in the cover letter or as an annex to the
cover letter an eCTD ”Reviewer’s Guide” or similar document, that may contain the following
sections if applicable, in addition to those specified above:
 Particularities relating to presentation and delivery of the eCTD (hard media)
 Information on file sizes by module
 Data security/virus scan information
 Legacy documents and scanned pages details
 File formats (if any particularities to report)
 File size (if exceeding 100MB restrictions)
 Files referenced at multiple locations within the backbone
 Specifications adhered to
 Documents with relevance to more than one CTD-module
 Hyperlink appearance and strategy
 Bookmarks
 Particularities of module organisation
 List of documents available on request

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4 Technical requirements for submissions
4.1 Submission media
Hard media (e.g. CDs, DVDs) must be used for the submission of all eCTDs.
CD (CD-ROM) conforming to ISO 9660 or ISO 13346 can be accepted.
Swissmedic will not accept any hardware (laptops, desktops, zip drives, etc.) from applicants
in connection with the submission of information in electronic format. The electronic
information or eCTD should be directly readable and usable on Swissmedic’s hardware (e.g.
CD/DVD drive) using its own software. It is the policy of Swissmedic to maintain desktop
configurations and IT infrastructure in line with common office standards.
In the case of a large application, provision of a single DVD over multiple CDs is strongly
recommended by Swissmedic, as this allows the technical validation and loading into the
repository directly from the hard media, without the need to first recompile the eCTD
submission on a server.
Should the provision of a single CD or DVD not be possible, and if multiple CDs must be
used for large applications, individual modules should not be split over multiple CDs (e.g. if
possible, Module 1 should be contained on a single CD, Module 2 should go onto the next
CD even if this requires CD 1 not to be filled to capacity and so on). Where a split over
multiple CDs is inevitably necessary, subfolders should be distributed in sequence, and
these subfolders should not be split between CDs. In this case the submission of a DVD
should be considered.
The submission media should be packed adequately to prevent damage to the media. All the
contained media units should be appropriately labeled as described below.
Each CD or DVD submitted with an eCTD should include the following label information,
clearly presented and printed on the media:
 The applicant’s name
 The product (invented) name(s)
 The marketing authorisation number (if available)
 The application number (if available)
 The International Non-proprietary Name (INN) of the product
 The sequence number(s) of the eCTD submissions contained on the CD/DVD
 The submission date (YYYY-MM)
 The Number of CDs or DVDs per full set and an indication of the place of the
individual CD/DVD within this set
 The application type of each eCTD submission(s) contained on the CD/DVD, as per
the eCTD envelope information.
 A brief description of each submission type of each eCTD submission(s) contained
on the CD/DVD (e.g. “new sequence following validation”)
4.2 Compression and password protection / security settings
The applicant is required not to apply any compression to the submission or the files inside
the submission. Therefore the data on the media should not be packed into a zip-file, rar-file
or any other file that has been compressed.

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One-time security settings or password protection of electronic submissions for security
purposes is not acceptable during transportation from the applicant to Swissmedic.
Applicants should also not include any file level security settings or password protection for
individual files in the eCTD. The file settings should allow printing, annotations to the
documents, and selection of text and graphics. Internal security and access control
processes in the regulatory authority will maintain the integrity of the submitted files.
Encryption is not considered necessary if the information is sent using a physical media. The
applicant should assume all responsibility for the media until it is delivered to Swissmedic.
The following points should be noted in relation to security:
 The physical security of the submission during transportation/transmission is in the
responsibility of the applicant.
 Once received by Swissmedic, security and submission integrity is the
responsibility of the agency.
The use of, and subsequent validation of the MD5 checksum allows the recipient of the
eCTD to ascertain whether files in the submission have been changed since the checksum
was generated.
4.3 PDF files
Portable Document Format (PDF) is an electronic format that is open, de facto, and
published and created by Adobe Systems Incorporated (http://www.adobe.com). No specific
products from Adobe or any other company are necessary to produce PDF documents.
The following points can be made in relation to PDF files:
 Files should be PDF v1.4 and should be legible with the Acrobat Reader search
plug in or any other freeware viewer; PDF files should be saved as ”Optimized” to
reduce the size and allow faster opening when viewed via an internet connection.
The use of additional software to navigate and work with the files is not acceptable,
unless agreed upon with Swissmedic.
 In exceptional cases other PDF versions can be used (e.g. old documents created
with a previous version of Adobe), provided these can be opened and read by
Swissmedic. The use of other PDF versions needs to be justified in the cover letter.
 PDF files produced from an electronic source document are preferred to PDF files
generated from scanned paper since such 'electronic' PDF files provide the
maximum functionality to the reviewers in terms of search capabilities and copy &
paste functionality.
 Expert Reports and the Overviews/Summaries in the CTD Module 2 should always
be generated from an electronic source document.
 If scanning is unavoidable, readability and file size should be balanced; the
following is recommended: resolution 300 dpi (photographs up to 600 dpi), avoid
grayscale or color where possible, use only lossless compression techniques.
 The maximum individual acceptable file size is approximately 100 MB. The file size
should ensure clarity, speed of download and ease of review. Further guidance
should be sought from Swissmedic regarding individual larger files as to their
acceptability.

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 Fonts should be chosen of a type, color and size such that they allow easy reading
of documents on screen (1024 x 768 pixels) or after printing; examples of such
font-types are:
o Times New Roman, 12-point, black
o Arial, 10-point, black.
 All fonts used in a document (except Times New Roman, Arial and Courier) should
be embedded, including all the characters for the font. Swissmedic advises to limit
the number of fonts used in a document and to avoid customized fonts.If colors
other than black are used, color reproduction after printing should be tested before
submission; the print area for pages should fit on an A4 sheet of paper; margins
should allow binding in multi-ring binders without affecting readability.
Additional details on PDF can be found in the ICH eCTD Specification Document, App. 7.
4.4 File naming conventions
It is recommended to use the eCTD file naming conventions described in the ICH M2 eCTD
Specification and the Swiss Module 1 Specification for eCTD.
If an applicant wishes to submit multiple files in one section, where only one highly
recommended name is available, this can be achieved using a suffix to the filename (e.g.
pharmaceutical-development-container.pdf).
4.5 Hyperlinks
In general, hypertext links are encouraged within the eCTD to facilitate swift navigation within
the dossier, but should not be overused. The eCTD should be structured and links provided
in such a way as to ensure that the reviewer is constantly aware of the overall structure and
narrative flow of the dossier. For example, Module 3 is highly structured and defined to a
relatively low level of granularity in the specification. Therefore, only minimal use of
hyperlinks should be necessary. For example, when the same citation appears on a page
more than once, it is recommended that a link only to the first instance of the citation per
page is provided.
The greater the number of hyperlinks contained in an eCTD dossier, the longer it takes to
technically validate the submission, and the greater the likelihood of non-functioning
hyperlinks. The use of ”obvious” and therefore redundant external links is discouraged with a
view to future lifecycle management.
However, if hyperlinks are only to be included where considered necessary and considered
to add real value, it is important that the way in which the eCTD titles (i.e. the backbone
entries visible as the eCTD “ToC”) are used is consistent with how the documents
themselves are referred to within other documents, for example summary documents. If the
title presented by the review tool in the eCTD ToC and the reference in a summary document
do not match, then this negates the use of the backbone and a hyperlink is needed.
In the Non-clinical/Clinical part of the eCTD, the structure is less well defined. Within
Modules 4 and 5 the localization of studies and references may vary across submissions. For
fast orientation linking from summaries is of benefit. Since changes occur rarely to already-
submitted content in Modules 4 and 5 in contrast to Modules 3 the issue of out-dated links
over the application lifecycle is therefore less critical.

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4.6 md5 checksum
A checksum (MD5) should be included for each file in the eCTD, allowing the recipient to
verify the integrity of physical files in the submission.
An MD5 checksum of the XML eCTD index (index.xml) should also be included. Applicants
should name this checksum file index-md5.txt, and include it as a file (with one line of content
and with no header line) in the same directory as the XML eCTD instance.
An invalid checksum will result in the rejection of an eCTD submission as technically invalid.
4.7 Additional files in Word format
Swissmedic requires Word documents (.doc – no .docx) for the following documents, in
addition to the PDF for the purposes of review and document manipulation:
 Module 2.3 Quality Overall Summary
 Module 2.4 Nonclinical Overview
 Module 2.5 Clinical Overview
 Module 1.3:
o Information for Professionals
o Patient Information
 Module 1 Responses to Swissmedic LoQ
 Module 1.5.1 Swiss Bioequivalence Trial Information Form
 Module 1.2.2.16 Form PSUR for Human Medicinal Products
PDFs (and other accepted file formats) only are to be referenced in the eCTD XML
backbone. Word documents should not be included in the eCTD backbone, as they are
provided merely as an aid to review. An inclusion within the eCTD would result in an
unnecessary management of the lifecycle of these documents in addition to the formal PDF
documents.
Word files should be placed on the same data carrier, alongside the 0000 (or appropriate)
eCTD sequence, not within it. The folder should be called “<eCTD sequence>-workingdocu-
ments” (e.g. 0000-workingdocuments)” with a substructure as follows:
 0000-Product information
 0000-Module 2
- 2.3
- 2.4
- 2.5
 0000-Responses to questions
 0000-Forms
Within this folder, for the following files in Word format, the following naming convention
applies:
 For the information to professionals:
prof_productname_submissiontype_date.doc
 For the patient information:
patient_productname_submissiontype_date.doc

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 For Modules 2.3 to 2.5:
The Word documents should have the same name as the submitted pdf files with the
extension .doc instead of .pdf, and should follow the same granularity where a subdivision
into several documents exists.
 For Responses to Swissmedic LoQ
rtoq_submissiontype_date
 Swiss bioequivalence information trial form
bioequivalence_date.doc
4.8 Virus check
The applicant is responsible for checking the submission for viruses and for informing
Swissmedic of the type of software used for this purpose. Checking should be performed
with at least one, but preferably more, up-to-date virus-checkers and a statement in the cover
letter should be included (see chapter 3.5)
After receipt at Swissmedic, a similar, multiple program, internal virus check will be
performed. A positive check will result in the refusal of the eCTD.
4.9 Technical validation before submission
Swissmedic requires that applicants use a validator that checks the submission for technical
interoperability before submission. (Free-of-charge validation tools for the Swiss eCTD
specification are available. For more detailed information please refer to the Swissmedic
eSubmission website).
To ensure efficient checking for technical correctness in Swissmedic applicants are required
to comment severity B and severity C errors in a separate form provided by Swissmedic.
The form technical validation (English only) is also available on the Swissmedic eSubmission
website.
The form is not part of the eCTD Module 1 and should not be integrated in the eCTD. One
paper copy of the form has to be submitted together with the eCTD sequence to Swissmedic.
Please be aware that a not properly completed form may lead to a rejection of the
submission.
Further details on the validation criteria are described in the document “Swissmedic eCTD
Validation Criteria”.

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5 Life cycle management
5.1 Life cycle management at the “Drug Product” layer (eCTD application)
An initial filing is usually defined as having a sequence number of 0000. There are some
circumstances in which an initial filing might be filled with a sequence number other than
0000.
Each further submission for the corresponding Drug Product will be done with an incremental
eCTD sequence number.
5.2 Life cycle management at the submission layer (i.e. eCTD-sequence)
The related eCTD-sequence-number describes the relationship of additional information to
the original submission or subsequent submissions.
For all new drug submissions types in eCTD format, the related eCTD-sequence-number in
the envelope and in the cover letter (tracking table) should be left empty.
For subsequent submissions, it is mandatory to include a related eCTD-sequence. The
related eCTD-sequence-number should be the sequence-number of the submission to which
the additional information applies. The related eCTD-sequence-number should only be one
single eCTD-sequence number.
See “Example of the use of the Related Sequence” in Appendix 2 of Swiss Module 1
Specification for eCTD.
5.3 Life cycle management at the document layer (eCTD leaf)
The operation attribute describes the relationship between leaf files in submissions
subsequent to the original submission and in additional information related to those
submissions. (For an orginal submission only the operation attribute “new” is applicable).
The four LCM activities (operation attributes) provided by the ICH are new, replace, delete
and append. Further information can be found in the ICH Electronic Common Technical
Document Specification.
The operation “append” should be used with caution in view of future LCM issues.
5.4 Life cycle management of specific documents
Responses to List of Questions and adaptations of product information files are handled with
new eCTD Sequences.
For life cycle management at the document layer, the operation attribute should be treated
as described below for specific documents.
For the cover letter leaf elements provided with all eCTD-sequences, the operation attribute
should always be “New.”
For the form Application / Variation leaf element,
 when provided with all submission types, the operation attribute should be “New”
 when provided as additional information for a correction of an error in the
ZL000_00_003 form in response to Swissmedic List of Questions (LoQ), the
operation attribute should be “Replace”.

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For the Product Information (Information for Professionals, Patient Information, elements of
packaging materials) leaf elements:
 when provided with the initial application (sequence 0000) the operation attribute
should be “New”
 when provided with all other submission types, the operation attribute should be
“Replace” (exception: sequence 0000)
 when provided as additional information in response to the LoQ, the operation
attribute should be “Replace”
 when a new eCTD-sequence, which includes the final Product Information
documents, is provided as additional information the operation attribute should be
“Replace”.
5.5 Responses to “List of Questions”
In the case the original submission is made using the eCTD format, and where a List of
Questions (LoQ) has been issued by Swissmedic, the responses to the LoQ have also to be
provided in eCTD format.
The document which lists all the questions with the corresponding narrative text response for
each question should be placed in the “Responses to Swissmedic LoQ” section of M1.
Where responses also contain new or updated data/documents relating to Modules 3, 4
and/or 5, such data/documents should be placed in the relevant sections of those Modules.
This may also apply to Module 1 (e.g. revised product information), as well as to Module 2 in
cases where extensive data/documents would require inclusion of the relevant summaries
and/or overview sections.
Where new or updated documents are required, hyperlink(s) from an appropriate location(s)
in the consolidated LoQ document to the new or updated document(s) elsewhere in the
eCTD dossier should be included.

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6 Baseline submissions
It is highly recommended that an eCTD baseline submission is submitted in electronic
format, for applications previously managed in paper or other electronic formats. There is no
obligation to submit a full, reformatted eCTD for already authorized products. However, the
Marketing Authorization holder may provide Swissmedic with information reformatted as
eCTD for their already authorized products. In particular Swissmedic encourages the
submission of reformatted quality information in eCTD, in order to facilitate the handling of
variations.
A signed declaration must also be submitted as an annex to the cover letter stating that the
content/data of the submitted quality module in eCTD format is identical to the current
approved quality part and that there have been no changes to the dossier content as a result
of the provision of an eCTD submission.
To start an eCTD product life cycle at a point other than with a new application, such as a
variation or renewal, it is highly recommended to submit a separate initial baseline
submission.
For a baseline submission, the envelope attribute “application type” for a baseline
submission should be “reformat“.
Should the applicant submit additional changes, the envelope element “application type” for a
baseline submission will be that corresponding to the proposed change (see Swiss M1
Specification for eCTD).
In the majority of cases, an eCTD baseline submission will be provided as sequence 0000 for
a product where there has been no previous eCTD submission, however for a product with
an ongoing lifecycle Swissmedic would also accept a baseline submission within the
lifecycle; for example if an applicant has submitted a new indication in eCTD format without
baseline and at a later stage starts some variations of module 3 with a baseline submission.
The theoretical five following options exist for a baseline submission however only options 1
to 4 are allowed as Module 1 as a minimum should be included.
Option to deal with the legacy Legacy sequence(s) no. Variation sequence no.
1 Rebuild of the complete previous
CTD paper life cycle
0000 - 0035 0036
2 Baseline submission of legacy as
“current active view”
0000 0001
3 Partial baseline of Quality legacy
part at the beginning of transition
0000 0001
4 Partial baseline (Quality/CMC part)
in the middle of eCTD lifecycle
-
0035
0000 – 0034
0036
5 No baseline at all n.a. 0000
It is expected that option 1 will rarely occur with products that have a long regulatory history
as this implies a relative high amount of additional work.
When submitting changes to module 3, it will be expected that in most cases the full section
Drug Substance and/or Drug Product will be submitted (option 4). Exceptions (when such
submissions will not be of added value) should be justified in the cover letter.

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Furthermore all the documents of module 1 relevant to the Marketing Authorisation are to be
included into the baseline submission, therefore Module 1 should contain as a minimum and
where applicable:
 Cover Letter of the stand alone baseline submission or of the concommitent variation
 Form Application for Marketing Authorisation/Variation
Annexes - Forms
 Form Full Declaration
 Form Manufacturer Information
 Form Status Marketing Authorisations Abroad
 Form Variations Requiring Notification
 Form Application for Renewal of Marketing Authorisation
 Form Human Blood Components
 Form Substances of Animal and Human Origin
 Form Pharmaceutical Information for Parenteral Preparations
 Form Co-Marketing Confirmation
 Form Import According to Paragraph 14 Section 2 TPA
 Form Safety Changes to Product Information
 Form Change of Marketing Authorisation Holder
 Form Paragraph 13
 Form PSUR for Human Medicinal Products
 Form Declaration Radiopharmaceuticals
 Other Forms
Annexes - Documents on Drug Product Quality
 DMF Letter of Access
 Ph. Eur. Certificate of Suitability for Active Substance
 Ph. Eur. Certificate of Suitability for TSE
 EMA Certificate for Plasma Master File (PMF)
 EMA Certificate for Vaccine Antigen Master File (VAMF)
Annexes - Manufacturing
 GMP Certificate or Other GMP Documents
 Documentation Concerning Manufacturing Authorisation
 Complete Manufacturing Information with Flow Chart
Annexes - Others
 Information for Professionals
 Patient Information
 Packaging Information
Information Relating to Pharmacovigilance
 Pharmacovigilance System
 Risk Management System
Others
 Additional Information

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7 Submission of PSURs and E2E / RMP Updates in eCTD
Format
Applicants who choose to file a PSUR and or an E2E / RMP Update submission in eCTD
format must comply with the following requirements:
7.1 PSUR
7.1.1 Application type “PSUR” -> please fill in the Form PSUR for Human Medicinal
Products
Use this application type when submitted as part of the PSUR Program based on VAM
(Ordinance of Medicinal Products) and TPA (Therapeutic Products Act)
 Art. 34 VAM (authorization received within the last 5 years)
 Art. 34 reference Art. 17 paragraph 2 VAM (major changes within the last 5 years)
 Art. 16 paragraph 1 TPA (commitments)
Product Information Variation (VAR-PI) based on a PSUR submitted as part of the PSUR
Program
When a PSUR, submitted as part of the PSUR Program, serves also as a supporting
document for a Product Information Variation, two sequences are required, one for “PSUR”
and one for “VAR-PI”. Indicate in the Cover Letter and in both forms, the “PSUR” and the
“Application for Marketing Authorisation and Variation Form” that two associated sequences
have been submitted.
7.1.2 Application type “Supplemental Information“
 Use this application type when submitted outside of the PSUR Program (non-VAM
and non-TPA based PSUR) and for other reasons such as: requested by
Swissmedic, to inform about a safety signal, submission of a new version of the E2E /
RMP (see section 7.2).
 Mention the reason for submission in the Cover Letter.
7.2 E2E / RMP Update
7.2.1 Application type “PSUR” if submitted as part of the regular PSUR Program
 Submit only when there are relevant changes to the previous version.
 Mention the differences to the previous version in the PSUR Form.
7.2.2 Application type “Supplemental Information” if not submitted as part of the
regular PSUR Program
 Mention the reason for submission in the Cover Letter.

Version 1.2
7.3 Structure for a PSUR submission as part of the regular PSUR Program
Module /
Requested Documents
Comments Operator
1.0 Cover Letter  operator always new
1.2.2.16 Form PSUR  operator always
 also as working document requested
(word file outside the eCTD structure)
 new design created for eCTD and paper
submission
new
1.2.5.1 Comparison EU-
SmPC vs. CH-FI
 operator always new
1.2.5.2 CCDS  operator first version / eCTD submission
 operator if changes from previous version
 leave section empty if no changes and
mention in the PSUR-Form “Comment
Field” that there are no changes
new
replace
1.3.4 Information for
Professionals
other Countries
(EU SmPC)
 operator first version / eCTD submission
 leave section empty if no changes and
mention in the PSUR-Form “Comment
Field” that there are no changes
new
replace
1.8.2 E2E / RMP
Update
 operator also for attachments
 main document should be listed first if
possible
 leave section empty if no relevant
changes
replace
new or
replace
5.3.6 PSUR  operator always new
24/31

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8 Test eSubmissions
In order to prevent technical errors in eCTD applications, Swissmedic encourages the
submission of test eCTDs, particularly if the applicant has limited experience of submitting
eCTDs. In a test submission, areas of technical concern can be tested. The test submission
process at Swissmedic is an informal process, intended to accord pragmatic assistance to
the applicant.
A test eCTD can be provided on CD or DVD at any time up to 3 weeks prior to the filing date.
It is recommended to do so as early as possible, in particular if the applicant has limited / no
experience with eCTD submission.
Swissmedic cannot guarantee that a test submission will be processed if provided within 3
weeks prior the submission filing date.
The test eCTD should be as representative as possible of the final eCTD submission,
particularly in terms of structure, envelope and metadata used. The individual files of the test
submission will not be reviewed, so “dummy” files can be submitted.
The hard media with the test submission should be appropriately packaged to prevent
damage during transport, and the CDs/DVDs should be appropriately labeled in order to
ensure easy identification of the test submission and its purpose. Here, the applicant name,
invented name if known, INN and type of application and “TEST eCTD” should suffice, as
well as any information relating to the number of media units and submissions contained
therein for organization if appropriate.
The root folder name of the test eCTD should include the word “Test”. The eCTD should be
further accompanied by a brief paper cover letter explaining the purpose of the test
submission, and indicating applicant contact details for feedback on the eCTD. The cover
letter should state the expected filing date for the true submission.
Two copies of the test eCTD should be provided on two sets of CDs/DVDs, in order to be
able to overcome hard media damages and corruptions. The second copy can also be used
to test CD/DVD writer/publishing compatibility with Swissmedic CD/DVD reader hardware if
different versions are under consideration by the applicant. (See also the Swiss eCTD
Validation Criteria about sending a validation report.)
The test eCTD will be checked by a technical sector of Swissmedic. Information will not be
passed on to case management or reviewers for the product unless there are specific
questions arising that relate to business requirements or business issues with the eCTD. The
test eCTD is therefore not subject to a content validation.The tests are exclusively technical.
The test eCTD will be checked using the Swissmedic’s eCTD review system and the
submission will be viewed in order to ascertain that the presentation of the dossier is as
expected, that documents can be accessed, and that correct use of structure and metadata
has been made. Hyperlinks, if provided in documents, may be tested if functioning. Particular
aspects of the eCTD, if highlighted by the applicant may also be checked.
Swissmedic will make every effort to reply to the applicant within 2 weeks of receipt of the
test eCTD. The applicant will be provided with a copy of the technical validation report, and
any particular issues will be highlighted along with a recommendation for resolution. The
applicant will be advised to liaise with the case manager if further business issues need to be
clarified. The hard media containing the test submission will be discarded after testing.

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The process of submission of test eCTDs can be iterative, if considered necessary to ensure
adequate resolution of any issues reported.
Even if the test submission has been tested successfully and the test submission contains
the true data for application, test submissions can not stay with Swissmedic to be accepted
for review.
9 Shipment
The paper copies and the hard media should be submitted jointly.
Two copies of the eCTD on DVD/CD should be submitted to Swissmedic at the following
address:
Swissmedic
Swiss Agency for Therapeutic Products
Hallerstrasse 7
For the attention of: eCTD
P.O. Box
CH-3000 Bern 9
Switzerland

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10 Appendices
Appendix 1: eCTD Reference Documents
Swissmedic reference documents
Guidance for Industry on Providing Regulatory Information in eCTD Format
Swiss Module 1 Specification for eCTD
Swiss eCTD Validation Criteria
Questions and Answers to Swissmedics eCTD implementation
ICH
ICH: http://www.ich.org
ICH electronic Common Technical Document (eCTD): http://estri.ich.org
ICH Specification 3.2 (Modules 2 - 5) (Notice to Applicants Vol 2B):
http://estri.ich.org/eCTD/index.htm
ICH Q&As: http://estri.ich.org/ectd
ICH M4 Granularity: http://www.ich.org/LOB/media/MEDIA554.pdf
ICH ETICS M2 Project: http://www.etics.us
ICH M2 (Q&A or Change Request Form):
http://estri.org/eCTD/eCTD_Change_Request_Form.rtf
eSubmission Links of EU Health Authorities
NTA-TIGes Interlinking (Q&A and Change Request Form):
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/b/ectd_12-
2006/crform.doc
Latest agreed EU Telematics EU eCTD Change Request/Q&A Tracking Table:
http://esubmission.ema.europa.eu/EU_Change_Request_Q&A_Tracking_Table%20v1.1
7.xls
EMA Q&A regarding eSubmission:
http://www.ema.europa.eu/htms/human/resub/q24.htm
EU M1 v1.3 Transition Guidance :
http://esubmission.ema.europa.eu/EU%20M1%20v1.3%20Transition%20Guidance%20-
%20FINAL%20.doc
Question and Answer document relating to practical and technical aspects of EMA eCTD
Implementation for the Centralised Procedure:
http://www.ema.europa.eu/pdfs/human/regaffair/63391908en.pdf
Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD
electronic Submissions
http://esubmission.ema.europa.eu/doc/eCTD%20Guidance%20Document%201.0%20FI
NAL%20FOR%20PUBLICATION.pdf

Version 1.2
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Appendix 2: Swissmedic types of applications
This appendix describes the list of the application types according to the Swissmedic process
map and their acceptability in eCTD format.
For any type of dossier not listed in the table please contact Swissmedic before submission.
Also, should an urgent update to an application (e.g. urgent safety update) be needed before
the approval of sequence 0000, please contact Swissmedic before submission.
ID Type of Applications Acceptability
ZL101 New applications:
NAS: New Active Substance
NGF: New Galenic Form
NKO: New Combination
BWS: Known Active Substance
NA Generikum: Generics
IE: New Indication
NDE: New Dosage Recommendation
NDO: New Dosage Strength
Accepted
Step 3: Paragraph 13 TPA, from
1 January 2011, see standalone
Guidance on applications
according to Paragraph 13 TPA
for eCTD applications
ZL102 Application for Orphan Drug Status/MUMS MUMS not allowed. For Orphan
Drug Status Application only if
submitted simultaneously with
ZL101
ZL103 Notification procedure for complementary
medicine
Not allowed
AA103_20 PSUR Step 3: 1 January 2011
ZL104 Application for Fast Track Procedure Not allowed
ZL105 Meetings with applicants during marketing
authorisation procedure
Not allowed
ZL106 Parallel Import Step 3: 1 January 2011
ZL107 Application for 5 years Data Protection Step 3: 1 January 2011
ZL108 Co-marketing Step 3: 1 January 2011
ZL109 Temporary Authorisation Step 3: 1 January 2011
ZL110 New application for inactivation procedure
(manufacturer)
Not allowed
ZL111 New application for inactivation procedure
(centers)
Not allowed
ZL112 Notification procedure for veterinary
medicinal products
Not allowed
ZL113 Recognition of a product monograph Not allowed
ZL201 Prolongation, renouncement of
prolongation
Step 3: 1 January 2011
ZL202 Renouncement of authorised medicinal
products

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ID Type of Applications Acceptability
ZL301 Variations requiring a notification procedure Accepted
ZL302 Variations requiring authorisation incl.
scientific review
Accepted
ZL303 Variations requiring authorisation without
scientific review
Accepted
ZL304 Variations requiring authorisation of the
product information (SmPC, patient
information)
Accepted
ZL305 Notification procedures for sample
packages
In line with the principle of “once eCTD – always eCTD” applications which are subsequent to an
initial Marketing Authorisation Application will be accepted as soon as the initial Marketing
Authorisation Application (ZL101) is approved, for ZL107 as soon as needed.

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Appendix 3: List of documents requested additionally in paper format
Number
of copies
Name of document in English German document designation/code French document designation/code
1 Cover Letter Begleitbrief Lettre d’accompagnement
1
Form Application for Marketing Authorisation
and Variation
Formular Gesuch Zulassung/Änderung-
Formulaire Demande d'autorisation / de
modification
1 Form Full Declaration Formular Volldeklaration Formulaire Déclaration complète
1 Form Manufacturer Information Formular Herstellerangaben
Formulaire Renseignements concernant les
fabricants
1 Form Status Marketing Authorisations Abroad
Formular Status Zulassungsgesuche im
Ausland
Formulaire Status des demandes d'autorisation
déposées à l'étranger
1
Form Variations Requiring Authorisation
(Quality)
Formular Genehmigungspflichtige Änderung
Qualität.
Formulaire Modification soumise à approbation
relative à la qualité
2 Form Variations Requiring Notification Formular Meldepflichtige Änderungen
Formulaire Modification soumise à l'obligation
d'annoncer
1
Form Application for Renewal of Marketing
Authorisation
Formular Gesuch Verlängerung Zulassung
Formulaire_Demande de prolongation de
l'autorisation
1 Form Human Blood Components Formular Humane Blutbestandteile Formulaire Composants sanguins humains
1 Form Substances of Animal and Human Origin
Formular Stoffe tierischen und humanen
Ursprungs
Formulaire Produits d'origine animale ou
humaine
1
Form Pharmaceutical Information for Parenteral
Preparations
Formular Pharmazeutische Angaben FI und
PI betreffend Parenteralia
Formulaire Renseignements pharmaceutiques –
Informations professionnelle et destinée aux
patients – concernant les préparations
parentérales
1 Form Co-Marketing Confirmation Bestätigung Co-Marketing Attestation de Co-Marketing
1
Form Import According to Paragraph 14 Section
2 TPA
Einfuhr eines Arzneimittels nach Art. 14,
Abs. 2 HMG (Parallelimport)
Importation d'un médicament selon l'art 14, al. 2
LPTh
1 Form Safety Changes to Product Information
Formular Sicherheitsrelevante Änderungen
der Arzneimittelinformation
Formulaire pour les demandes de modification de
l’information

Version 1.2
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Number
of copies
Name of document in English German document designation/code French document designation/code
1 Form Change of Marketing Authorisation Holder Formular Übertragung Zulassung
Formulaire Transfert de l’autorisation /
changement de raison sociale ou de domicile
1 Checklist Content Validation eCTD
Checkliste Formale Kontrolle
Zulassungsgesuche eCTD
Checkliste Contrôle formel eCTD
1
Checklist Content Validation eCTD Paragraph
13 TPA must be filed as Checklist Paragraph 13
(Content Validation)
Checkliste Formale Kontrolle Art. 13 HMG
eCTD muss unter Checkliste Art. 13
abgelegt werden
Checkliste Contrôle formel eCTD Art. 13 LPTh
doit être classer comme Checkliste Contrôle
formel Art. 13 LPTh
1 Form PSUR for Human Medicinal Products Formular PSURs für Humanarzneimittel
Formulaire PSUR pour les médicaments à usage
humain
1 Form Declaration Radiopharmaceuticals Formular Deklaration Radiopharmazeutika
Formulaire Déclaration des produits
radiopharmaceutiques
1 DMF Letter of Access DMF Letter of Access Lettre d’accès au DMF
1 GMP Certificate and Other GMP Documents
GMP-Zertifikat oder andere GMP
Dokumente
Certificat GMP et autres documents GMP
1
Documentation Concerning Manufacturing
Authorisation
Dokumentation Herstellungsbewilligung Documentation Autorisation de fabrication
1 Form Confirmation Substances from GMO Formular Bestätigung Stoffe aus GVO Formulaire Attestation substances à base d’OGM
1 Form DMF for First Authorisation and Variations Formular DMF für Erstzulassung / Änderung
Formulaire DMF première autorisation /
modification
1
Form Information on Product Quality
(Paragraph 13 TPA)
Formular Informationen zur Qualität bei
Antrag Art. 13 HMG
Formulaire Demandes selon art. 13 LPTh :
informations sur la qualité
5 Information for Professionals Fachinformation Information professionnelle
5 Patient Information Patienteninformation Information pour les patients
5 Packaging Information Packmaterial (Faltschachtel, Etikette, Blister) Eléments d’emballage
1 Form Technical Validation eCTD (Form is not available in German) (Form is not available in French)
[End of document]

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Guidance for Industry on Providing Regulatory Information in eCTD Format