HD-Guidance document
Formal requirements
List of contents
1
Prologue .............................................................................................................................4
1.1
Terms, definitions, abbreviations .........................................................................................4
1.1.1
Abbreviations .......................................................................................................................4
1.1.2
Definitions............................................................................................................................5
1.1.3
Description of the requirements ...........................................................................................5
1.1.4
Symbols used and their meaning .........................................................................................6
1.2
Purpose of this guidance document .....................................................................................6
1.3
Scope ..................................................................................................................................6
1.4
Legal basis ..........................................................................................................................6
1.5
Structuring of the requirements............................................................................................7
2
General requirements........................................................................................................8
2.1
Submission formats .............................................................................................................8
2.2
Time limits .........................................................................................................................14
2.3
Signatures / Signatory authority .........................................................................................14
2.4
Confirmation of reception ...................................................................................................14
2.5
Module 1 / Part I ................................................................................................................15
2.5.1
Cover letter ........................................................................................................................15
2.5.2
Forms ................................................................................................................................17
2.5.3
Medicinal product information ............................................................................................18
2.5.4
Packaging elements ..........................................................................................................21
2.5.5
Curriculum vitae of the experts ..........................................................................................21
2.5.6
Documentation of Environmental Risk Assessment ...........................................................21
2.5.7
Decisions by foreign authorities .........................................................................................22
2.5.8
PVP / RMP / Pharmacovigilance planning documents (human medicinal products only) ...22
2.5.9
PIP / PDP / Documentation for the paediatric investigation plan (human medicinal products
only) ..................................................................................................................................22
2.5.10
Information on the bioequivalence trial / reference product ................................................22
2.5.11
GMP/Certificates/Establishment licences...........................................................................23
2.5.12
Manufacturing information: flow chart for vaccines and blood products .............................23
2.5.13
Evidence that the obligation to notify pursuant of the Nagoya Ordinance is satisfied .........23
2.6
Modules 2-5.......................................................................................................................24
2.6.1
List of contents and labelling of binders .............................................................................24
2.6.2
References ........................................................................................................................24
2.7
Answers to communications from Swissmedic during the ongoing application process .....25
3
Special requirements ......................................................................................................26
3.1
Scientific Advice meeting ...................................................................................................26
3.2
Pre-Submission meeting....................................................................................................26
3.3
Clarification meeting ..........................................................................................................26
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HD-Guidance document
Formal requirements
3.4
Recognition of important medicinal product status .............................................................26
3.4.1
Recognition of orphan drug status (ODS) (human medicinal products only) ......................26
3.4.2
MUMS status (veterinary medicines) .................................................................................26
3.5
Request for fast-track procedure (human medicinal products only)....................................27
3.6
Request for procedure with prior notification (human medicinal products only) ..................27
3.7
New applications, new APIs and major variations ..............................................................27
3.8
New applications, known APIs ...........................................................................................27
3.9
Similar biological medicinal products (biosimilars) – human medicinal products only .........27
3.10
Applications under Article 13, TPA.....................................................................................28
3.11
Co-marketing .....................................................................................................................28
3.12
Variations requiring notification ..........................................................................................29
3.13
Variations requiring approval with scientific assessment....................................................29
3.14
Variations requiring approval without scientific assessment ...............................................30
3.15
Conditions imposed by Quality Review, Preclinical Review and Clinical Review................31
3.16
Notification procedure for sample packs ............................................................................31
3.17
Extension, no extension, no marketing and interruption to distribution ...............................31
3.17.1
Extension and no extension ...............................................................................................31
3.17.2
Discontinuation of authorised products ..............................................................................32
3.17.3
Discontinuation of dosage strength number .......................................................................32
3.17.4
Notification in accordance with Art. 8a, VAM: No marketing / interruption to marketing and
Placing on the market / Renewed placing on the market ...................................................32
3.18
Complementary and herbal medicinal products .................................................................32
3.18.1
Reduced dossiers ..............................................................................................................32
3.18.2
Asian medicinal products ...................................................................................................33
3.19
Extension of authorisation of homeopathic and anthroposophic medicinal products without
indication by the notification procedure (HOMANT) ...........................................................33
3.20
HOMANT notification procedure ........................................................................................33
3.21
Authorisation / variations, veterinary medicinal products by the notification procedure in
accordance with Art. 39, VAZV / Arts. 10-21, VAM ............................................................34
3.22
Market monitoring ..............................................................................................................34
3.22.1
PSUR/PBRER ...................................................................................................................34
3.22.2
Advertising permission.......................................................................................................34
3.23
DMF/ASMF and Plasma Master Files ................................................................................34
3.23.1
DMF/ASMF ........................................................................................................................34
3.23.2
Plasma Master Files (Human medicinal products only)......................................................36
3.24
Special product types and the corresponding submission ..................................................36
3.24.1
Radiopharmaceuticals .......................................................................................................36
3.24.2
Allergen products...............................................................................................................37
3.24.3
Antidotes ...........................................................................................................................37
3.24.4
Medicinal gases .................................................................................................................37
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HD-Guidance document
Formal requirements
3.24.5
Antivenins ..........................................................................................................................38
3.24.6
Parallel import ...................................................................................................................38
Change history
Version
Valid and
binding as
of:
14
24.05.17
13
Modified
without
version
change
Description, comments (by author)
Section A.3.11.0.4: Based on the new guidance document on the
co-marketing of medicinal products, the “Guidance document –
Formal requirements” will also be corrected.
Section 2.5.3 under A.2.5.3.8 and A.2.5.3.11: Formal requirements
for marking/highlighting changes in manuscripts of medicinal
product information (information for healthcare professionals
and for patients) adapted. Changes in medicinal product
information now only accepted if inserted using Word’s “Track
Changes” function.
14.12.2016
Author’s
initials
vy
wph
Section 3.12 and 3.13: New rules for the joint submission of
variations requiring notification and variations requiring
approval (what are known as “mixed applications”).
12
18.11.16
29.07.16
11
25.07.16
10
13.05.16
09
04.04.16
08
01.03.16
Section A.2.5.12.1: Clarification of requirements
Section A.3.12.0.1: Deletion of duplicated table
cis
Section 2.5.13 “Confirmation of GMP compliance” deleted (duplication
to section 2.5.11)
cis
As a result of the complete revision of the form Manufacturer
information, the requirement in section A.2.5.2.4 on the
subdivision of "Basic form, Part A or Part B" has been deleted.
Section A.2.5.11.1: Adaptation following the introduction of a
template for RP Declaration for foreign manufacturer. Simplified
submission of GMP certificates.
Section 3.23.1: Extension of time limit for submitting Drug Master
Files and Active Substance Master Files before submitting
application
Addition to section 2.1: Tables on document exchange via the
Swissmedic Portal inserted.
Duplications deleted from section A.2.5.3.5 and section A.2.5.3.6.
Section 2.1, "Submission formats" table: linguistic clarification
regarding submission of working documents.
Sections 2.5.3 and 2.5.4: requirements brought into line with
"Submission formats" table in section 2.1.
New chapter 2.5.13: “Evidence that the obligation to notify
pursuant of the Nagoya Ordinance is satisfied”
Explanation in chapter 3.23: Swissmedic must receive the Drug
Master Files (DMF) and Active Substance Master Files (ASMF) no
earlier than seven calendar days before and no later than three
calendar days after it has received the application for first
authorisation or a variation.
Explanation of amendment to change of practice with regard to
processing packaging elements.
Chapter A.2.5.6.1: Reference to biosimilar deleted because no
environmental risk assessment need be submitted for a
biosimilar.
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dts
dts
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HD-Guidance document
Formal requirements
07
01.01.16
06
30.11.15
05
13.11.15
Modifications after evaluation of the pilot phase, including
shortening of the notification period, option to change from an
application for a fast-track authorisation procedure to a
procedure with prior notification (PPN) and option for earlier
preliminary correction of relevant sections in the Information for
healthcare professionals.
There is no need to supply an additional hard copy of entirely
paper-based submissions.
Amendment to change of practice with regard to processing
packaging elements.
Time limit for submitting Drug Master Files and Active Substance
Master Files shortened
Section 3.22.2: Modification Number of copies to be sent
modified: 1 copy instead of 5 copies and explanatory statement
of Submission formats added
Section 2.1 "Summary of submission formats" table adapted in
respect of the "Bioequivalence trials" form and the number of
copies of draft information for healthcare professionals/patient
information texts
Section 2.1 New note stating that published documentation cited
in paper-based applications can be submitted exclusively by
electronic means
Section A.2.1.0.8. Note stating the "Bioequivalence trials" form
no longer needs to be submitted as a Word document
Section A.2.5.1.2 Requirement extended ("forms" replaced by
"documents")
Section A.2.5.1.13 Additional information for applications for
parallel import supplemented and consecutive numbering of the
subsections corrected
Section A.2.5.2.5 If no submission / authorisation for the relevant
preparation exists in other countries, there is no need to submit
the "Status abroad" form
Section 2.5.2 Consecutive numbering of subsections corrected
Section 3.1 Scientific Advice meeting / Section 3.2 PreSubmission meeting: Specify the address of the requesting
company and the procedure with prior notification has been
deleted.
Chapter A.3.10.0.3 Explanatory statement that, for applications
under Art. 13 TPA, the Assessment Report of the Restricted Part,
the LoQ and the company's answers to the Restricted Part must
be submitted by the DMF holder.
Section 3.12 end / Section 3.13 end: The documentation for
collective applications in paper format does not need to be
submitted separately for each authorisation, but only once
(original/copy).
New section 3.24.6: Additional specific requirements added for
section A.2.5.1.13 Applications for parallel import.
04
31.10.15
Section A.3.12.01:
In the event of approval, no official decision is sent for variations
requiring notification. Variations can be implemented unless the
applicant receives information to the contrary within 30 days of
the date of receipt by Swissmedic (cf. Art. 11, para. 2 VAM).
Greater detail provided on the submission of notifications no. 1315 in accordance with Annex 8, section 2 para.1 numbers 13–15
AMZV.
03
01.04.15
Section A.2.5.2.6: The reference to the form
ZL000_00_009e_FO_Human_blood_components has been
deleted
1
Prologue
1.1
Terms, definitions, abbreviations
1.1.1
Abbreviations
ASMF
dts / stb
cis
spb
dts
abe
Active Substance Master File Introduction
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HD-Guidance document
Formal requirements
CCDS
CDS
CEP
CHM
CL
CTD
DMF
DMF/ASMF Holder
eDok
eCTD
Fast-track
GMO
HCP info.
HPC
ICH
Known API
LoA
LoQ
MUMS
NA
New API
NTA
ODS
PBRER
PDP
Patient info.
PIP
PMF
PSUR/PBRER
PVP
RD
RP
RMP
SAP number
SmPC
1.1.2
Definitions
Data carrier
Binder
Loose-leaf binder
Dividers
Cover sheets
1.1.3
Company Core Data Sheet
Core Data Sheet
Certificate of Product
Complementary and herbal medicines
Checklist
Common Technical Document: format for authorisation applications,
divided into Modules Module 1-5
Drug Master File
Holder of the Drug Master File / Active Substance Master File (active
pharmaceutical ingredient manufacturer)
Swissmedic application submission format, paper version + electronic
version (see Swissmedic website)
electronic Common Technical Document
Fast-track authorisation procedure
genetically modified organisms
Product information for healthcare professionals
Healthcare Professional Communication
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use
Known active pharmaceutical ingredient
Letter of Access
List of Questions
Minor Use and Minor Species
New application
New active pharmaceutical ingredient
Notice to Applicants, format for authorisation applications, divided into Parts
I-IV
Orphan Drug Status
Periodic Benefit-Risk Evaluation Report
Pediatric Development Plan, FDA
Product information for patients
Paediatric Investigation Plan, EMA
Plasma Master File
Periodic Safety Update Report/Periodic Benefit Risk Evaluation Report
Pharmacovigilance Plan
Reference document
Responsible Person
Risk Management Plan
Identification number in the Swissmedic's AP business case application,
e.g. for medicinal products, applications, products
Summary of Product Characteristics
CD, DVD, blu-ray disc
A4 rigid ring binder with two sets of holes, 50mm or 80mm spine
Plastic folder for hole-punched documents, A4, two sets of holes
Set of dividers with light cardboard or plastic tabs
The cover sheets made available online by Swissmedic, with the titles and
the bar codes for separating the individual sections within the authorisation
documentation, Modules 1-5 (CTD) and Parts I-IV (NTA) respectively.
Description of the requirements
The requirements are described in tabular form, and are numbered. Only those items defined as
requirements are relevant for the formal control. All of the other text passages are explanations only.
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HD-Guidance document
Formal requirements
Format used for the description of the requirements:
No.
A.1.1.0.1
Subject
Description of the subject
Requirement
Explanation of the requirement
…
…
…
1.1.4
C/O
C=compulsory
O=optional
(C=subject to
objections )
…
Exceptions
Descriptions of special
cases and requirements
…
Symbols used and their meaning
This symbol means "Please note!"
Information marked with this symbol is explanatory and provides additional information.
1.2
This symbol means: "Example / Summary".
Examples and summaries are intended to help clarify the requirements, and serve as additional information.
Purpose of this guidance document
This document is to provide guidance and is intended for administrative entities: it does not therefore
address the rights and duties of individuals. The guidance above all serves to assist Swissmedic in
applying the legal provisions uniformly and equitably. The publication of this document demonstrates
transparency regarding how applications should be structured so that they can be handled efficiently
and completed in accordance with Swissmedic's practices and system. The guidance document
comes into force on 19 May 2014. The previously valid guidance documents will be adjusted by
Swissmedic before the end of 2014.
This document also takes into account all publications on this subject in the Swissmedic Journal in
recent years.
In the case of divergences between the formal requirements specified in previous documents and
those specified in the present guidance document, the present document takes precedence.
1.3
Scope
The guidance document applies to all submissions to Swissmedic. It does not, however apply to:
Requirements related to the content of applications
Medical device
Market monitoring cases
Legal cases
Inspections
Certificates
Clinical trials
Notifications for narcotics
Submission of laboratory orders
1.4
Legal basis
This guidance document is aligned with the following legislation in particular (provisions of Federal
Acts and Ordinances):
Federal Act of 15 December 2000 on medicinal products and medical devices (Therapeutic
Products Act, TPA; SR 812.2)
Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the
requirements for the authorisation of medicinal products (Medicinal products authorisation
ordinance, AMZV; SR 812.212.22)
Ordinance of 17 October 2001 on medicinal products (Medicinal products ordinance, VAM; SR
812.212.21)
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HD-Guidance document
Formal requirements
1.5
Ordinance of the Swiss Agency for Therapeutic Products of 22 June 2006 on the simplified
authorisation of medicinal products and the authorisation of medicinal products by the
authorisation procedure (VAZV; SR 812.212.23)
Ordinance on the fees charged by the Swiss Agency for Therapeutic Products (Ordinance on
Fees for Therapeutic Products, HGebV; SR 812.214.5)
Structuring of the requirements
The requirements stated in this guidance document and those in the table Documents to be submitted
(separate document) are valid with regard to the submission of applications.
The forms and information sheets mentioned under the requirements do not all exist in English, which
is not an official language of the Confederation.
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HD-Guidance document
Formal requirements
2
General requirements
2.1
Submission formats
No.
A.2.1.0.1
Subject
Paper submission
in CTD format
A.2.1.0.2
Paper submissions
in NTA format
Requirement
There are two options:
Entirely paper-based submission:
Module 1-5: One original as hard
The individual sections of Modules 2-5 of
the paper original must be marked by
dividers/tabs.
In addition, the paper original must be
subdivided using the cover sheets
provided electronically by Swissmedic.
In addition, the information for healthcare
professionals / patients / veterinary
medicinal product information / packaging
elements must be submitted electronically
via the Swissmedic Portal or on a data
carrier.
Paper submission with eDok copy:
One paper original for Modules 1-5 plus
an identical electronic copy on a data
carrier
The individual sections must be submitted
as an eDok copy on the data carrier in
accordance with the instructions (see
Guidance eDok)
The paper original (with the modules
submitted separately) must not contain
dividers or cover sheets.
In addition, the information for healthcare
professionals / patients / veterinary
medicinal product information / packaging
elements must be submitted electronically
via the Swissmedic Portal or on a data
carrier.
There are two options:
Entirely paper-based submission:
One original as hard
The individual sections of the paper
original (Parts Ic-IV) must be marked by
dividers/tabs.
In addition, the paper original must be
subdivided using the cover sheets
provided electronically by Swissmedic.
In addition, the information for healthcare
professionals / patients / veterinary
medicinal product information / packaging
elements must be submitted electronically
via the Swissmedic Portal or on a data
carrier.
Paper submission with eDok copy:
One paper original for Parts I-IV plus an
identical electronic copy on a data carrier.
The individual sections must be submitted
as an eDok copy on the data carrier in
accordance with the instructions (see
Guidance eDok)
The paper original (with the modules
submitted separately) must not contain
dividers or cover sheets.
In addition, the information for healthcare
professionals / patients / veterinary
medicinal product information / packaging
elements must be submitted electronically
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C/O
C
Exceptions
-
C
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HD-Guidance document
Formal requirements
No.
Subject
Requirement
via the Swissmedic Portal or on a data
carrier.
A.2.1.0.3
Binding of the
paper documents
A.2.1.0.4
Prioritisation sheet
A.2.1.0.5
Cover sheets
A.2.1.0.6
A.2.1.0.7
Numbering system
CTD / NTA
eCTD
A.2.1.0.8
Additional Word
documents
Paper documents for Modules 1-5 –or Parts I-IV
respectively) must be submitted in binders or
folders, by module
A prioritisation sheet must be placed on top of
each dispatch, and provide information on the
submission format and type of transmission.
Swissmedic will provide the priorisation sheet
electronically.
The priorisation sheet is not part of the
submission (it does not have to be incorporated
into the eCTD or the eDok).
Swissmedic provides cover sheets with the
section titles and barcodes for separating the
individual sections of paper submissions in the
CTD or NTA structure (these cover sheets are
available for download on the Swissmedic
website)
These cover sheets must be printed out by the
applicant and placed in the authorisation
documents, always in front of the corresponding
section
All of the sections must also be separated by
dividers
The priorisation sheet is not part of the
submission (it does not have to be incorporated
into the eCTD or the eDok).
The official structure (CTD, NTA) for the numbering
of the individual sections must remain unchanged
The special requirements for an eCTD submission
are published on the Swissmedic website
The following documents should be taken into
consideration:
Guidance for industry on providing regulatory
information in eCTD Format
Questions and answers by Swissmedic on eCTD
implementation
Swiss Module 1 Specification for eCTD
Swiss eCTD validation criteria
Guidance on applications according to paragraph
13, TPA for eCTD applications
Companies that do not work with the Swissmedic
Portal must submit Word versions of the information
for healthcare professionals and patient or the
information for veterinarians on an electronic data
carrier.
C/O
Exceptions
C
C
C
The cover sheets are
not required for the
submission of an eDok
copy.
C
C
C
Requirements other than those stated in this guidance document with regard to
the forms required (depending on application type) can be found in the table
Documents to be submitted. For further details on the requirements relating to
content, please see the other applicable instructions and documents on the
Swissmedic website.
Entirely paper-based submissions: Staples must not be used for entirely paper-based submissions.
Staples may also be used for paper documents submitted with eCTD or eDok.
No transparent folders may be used.
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HD-Guidance document
Formal requirements
When using the cover sheets, please note:
Paper applications, submission of publications:
In connection with the submission of documentation, the reference documents do not need to be submitted in
paper form if they are publicly available, free of charge, at all times. In this case electronic submission of the
published data alone is sufficient. The applicant should clearly state what references can be found on the CD
and specify the corresponding versions and dates.
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HD-Guidance document
Formal requirements
Summary of submission formats:
eCTD
Module 1
/ Parts
Ia/Ib
Entirely paperbased
submission:
1 copy
1 copy
1 copy
Draft healthcare
professional /
patient information /
veterinary product
information
---
1 copy1
1 copy1
Packaging elements
(mock up)
---
1 copy1
1 copy1
permitted
permitted
Not permitted
-
1 copy
1 copy
1 copy
1 copy
-
-
-
1 cover sheet per
section
Paper documentation
(Modules 2-5 / Parts 1c to IV )
Electronic documentation on
CD/DVD (Modules 1-5 / Parts I to IV)
Cover sheets
(Modules 1-5 / Parts I to IV )
Dividers
Additional word documents
Packaging elements (mock up) (also accepted in
PDF) and / or healthcare professional / patient
information / veterinary product information
Prioritisation cover sheet
1 set of dividers
per section
-
(Modules 2-5 / Parts 1c to IV )
2
Paper original
with eDok copy
Cover letter, forms,
etc. of each
staples
1
Paper
on eCTD data
carrier2
1 copy
On data carrier with
electronic
documentation2
1 copy
on data carrier2
1 copy
For users of the Swissmedic Portal, the information for healthcare professionals / patients / veterinary product information / packaging
elements for answers to preliminary decisions or text correction communications no paper copy is necessary.
For users of the Swissmedic Portal, the information for healthcare professionals / patients / veterinary product information / packaging
elements only have to be uploaded to the Portal. An additional data carrier containing the working documents is not required.
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HD-Guidance document
Formal requirements
Document exchange via the Swissmedic Portal:
The table below regulates the use of electronic document exchange by the companies and
applies to all applications published in the Swissmedic portal. The submission of CDs or working
documents in the case of eCTD applications with product information texts/packaging elements is
therefore unnecessary.
Company
Process step
Format for transmission
Item to be delivered
Paper
Portal
Application form
Information for healthcare professionals/patients
and Veterinary medicine information
Original
-
Original
WORD (1)
Original
PDF or
manuscript
as WORD
(2)
Answer to LoQ
Answer to LoQ
Information for healthcare professionals/patients
(Only if new product
information/packaging and Veterinary medicine information
elements are required
within the framework of Packaging elements
the LoQ)
Original
-
-
WORD
Answer to preliminary decision
Information for healthcare professionals/patients
and Veterinary medicine information
Packaging elements
Original
PDF or
manuscript
as WORD
(2)
-
-
WORD
-
PDF (2)
Answer to text
correction
communication
Answer to text correction communication
Information for healthcare professionals/patients
and Veterinary medicine information
Packaging elements
-
PDF
-
WORD
-
PDF (2)
Communication re. Completion
Information for healthcare professionals/patients
and Veterinary medicine information
Packaging elements
Original
-
Completion of the
labelling phase
-
WORD
-
PDF (2)
Submission of
application
Packaging elements
Answer to preliminary
decision
-
(1) When submitting an application, one copy (exception for eCTD applications) of the information for healthcare
professionals / patients, veterinary medicine information and packaging elements must be sent to Swissmedic as a
paper original. Within 7 calendar days of Swissmedic displaying the application on the portal (company receives
mail notification), the company must submit the electronic version.
(2) To facilitate electronic processing by Swissmedic, the packaging elements should be submitted as PDF graphics
files wherever possible rather than as scanned files. All packaging elements for a product must be uploaded as a
single PDF file with searchable text (OCR) (or as a single Word file, as the case may be).
Table 1: Transmission methods for documentation to be submitted by companies
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HD-Guidance document
Formal requirements
The table below regulates the use of electronic document exchange for Swissmedic (it applies to
all applications included in the Portal by companies that have signed the corresponding usage
contract):
Swissmedic
Format for transmission
Process step
Item to be delivered
Paper
Original
Preliminary decision
Preliminary decision
Information for healthcare professionals/patients
and Veterinary medicine information
Portal
-
-
WORD
Text correction communication
Information for healthcare professionals/patients
and Veterinary medicine information
Packaging elements
-
PDF or
WORD
PDF
-
WORD
Communication
Original
-
Information for healthcare professionals/patients
(for new authorisations, no fast-track auth. or auth.
with prior notification)
Original (1)
WORD (2)
Communication
Original
-
Information for healthcare professionals/patients
(for new authorisations, no fast-track auth. or auth.
with prior notification)
Original (1)
WORD (2)
Packaging elements
Original (1)
PDF (3)
Packaging elements
Text correction
communication
(Input/Output by CM)
Text approval
communication
Official decision
PDF
(1) Version with approval stamp
(2) Issued as a paper version and additionally as an electronic WORD file
(3) Issued as a paper version and additionally as an electronic PDF file
Table 1: Transmission methods for documentation to be submitted by Swissmedic
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HD-Guidance document
Formal requirements
2.2
Time limits
No.
A.2.2.0.1
Subject
General
A.2.2.0.2
Time limits for
resolving
shortcomings
regarding formal
requirements
Extended time limit
to resolve
shortcomings
regarding formal
requirements
A.2.2.0.3
2.3
Requirement
The time limits stated in the Administrative
Ordinance Time limits for authorisation applications
and the Directory of time limits for authorisation
applications (see Swissmedic website)
In the case of objections on the part of Swissmedic,
a target date by which the applicant should resolve
the shortcoming is set. This time limit is
communicated to applicants in writing
C/O
C
The applicant may request an extension of the time
limit
O
Exceptions
C
In the case of
objections regarding
formal requirements for
an application for first
authorisation, the time
limit of 120 days cannot
be extended1
Signatures / Signatory authority
No.
A.2.3.0.1
Subject
Signatory
authorised to
commit the firm
Requirement
Applicants may delegate third parties to submit
applications for authorisation and variations. In such
cases, the corresponding power of attorney must be
provided when the application is submitted
C/O
C
A.2.3.0.2
Signatures
C
A.2.3.0.3
Signatures for
DMF/ASMF
applications
A.2.3.0.4
Eligible authorised
signatory
Cover letters, forms and other documents requiring
an original signature must be submitted in paper
form, with the original signature
The documentation required for a DMF/ASMF
(Form Part B and Letter of Access) must bear the
original signature of the DMF/ASMF holder for each
new application.
It is not mandatory for the signature to be that of the
responsible person or of a person authorised to
sign in accordance with the list of sectorial
responsibilities. It may also be that of a person duly
authorised by the applicant to sign documents for
the corresponding operation.
Exceptions
C
C
Swissmedic does not accept scanned, electronic or printed out signatures.
2.4
No.
A.2.4.0.1
Confirmation of reception
Subject
Confirmation of
reception
Requirement
Swissmedic does not send confirmations of
receptions by post
C/O
C
Exceptions
Swissmedic sends
confirmations of
reception by post for
variations requiring
notification, for job
applications and for
licence applications.
The authorisation holders may consult the application status online on the Swissmedic Portal. For details
of the Portal, see the Swissmedic website and the Guidance for the Swissmedic Portal.
1
Article 3, para. 1, Medicinal Products Ordinance, VAM
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HD-Guidance document
Formal requirements
2.5
No.
A.2.5.0.1
2.5.1
Module 1 / Part I
Subject
Packaging
Module 1 (CTD)/
Part I (NTA)
Subject
Original signature
A.2.5.1.2
Documents not
submitted
A.2.5.1.3
General aspects
A.2.5.1.4
Additional
information for
new applications
for new / known
APIs and major
variations
Additional
information for
similar biological
medicinal
products
(Biosimilars)
A.2.5.1.6
Additional
information for
applications under
Article 13, TPA
A.2.5.1.7
Additional
information for
fast-track requests
(human medicines
only)
Additional
information for
requests for
procedure with
prior notification
(human medicines
only)
A.2.5.1.8
C/O
C
Exceptions
Cover letter
No.
A.2.5.1.1
A.2.5.1.5
Requirement
Module 1 (CTD) / Part I (NTA) must be placed at
the top of a packet or on a pallet. The
corresponding container must be clearly marked
with "Module 1" or "Part 1" on the outside
Requirement
The cover letter must be submitted on paper, with
an original signature
If certain documents required are not submitted, this
must be stated in the cover letter or in the Checklist,
Formal Control, with the reason for the omission
Product name plus appropriate details if other
product designations are used (e.g. other product
names, chemical name, development code no.)
Name of the active pharmaceutical ingredient
If known: ATC / IT group, or ATC vet group
If known: Authorisation number
If known: Application ID
Application type (for applications for variation,
including the type of variation) and short scientific
justification
If no Checklist, Formal Control is included: List of
all administrative documents and other
documentation submitted (for each Module/Part,
with number of binders)
Short presentation of the clinical trials conducted
and if applicable, of the pharmaceutical
characteristics and the manufacturing
For known APIs with bioequivalence trials: state
the foreign comparator product
C/O
C
Justification for requesting an authorisation
process in accordance with the Administrative
Ordinance Instructions for the authorisation of
similar biological medicinal products (biosimilars)
Short presentation of the clinical trials conducted
and if applicable, of the pharmaceutical
characteristics and the manufacturing processes
State where the comparability studies between
the biosimilar and the comparator product can be
found in the documentation
Justification of the divergence if the dosage form,
dosage strength and / or the excipients of the
biosimilar are different from those for the
reference product
Comment if specific requirements are foreseen for
implementing the spontaneous recording of
suspected adverse drug reactions in Switzerland
(e.g. special questionnaires within the framework
of enhanced pharmacovigilance)
Mention authorisation applications or any
questions or decisions on the part of other
authorities, if applicable
Short justification for the request, indicating the
documentation
Possible date for the Pre-submission Meeting or
reason why this is not considered necessary
Planned submission date for the test eCTD
sequence (if applicable)
Planned date of the actual submission of the
application (state within a time frame of +/- 2
calendar weeks)
C
QM-Ident: ZL000_00_001e_WL / V 14 / vy, cis / fua / 24.05.2017
Exceptions
C
C
C
C
C
C
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HD-Guidance document
Formal requirements
No.
A.2.5.1.9
A.2.5.1.10
Subject
Additional
information for
Scientific Advice
and
Pre-submission
Meetings
Additional
information for
Clarification
Meeting
A.2.5.1.11
Additional
information for out
of stock situations
A.2.5.1.12
Additional
information for comarketing
application
Additional
information for
applications for
parallel import
A.2.5.1.13
A.2.5.1.14
Additional
information for
radiopharmaceuticals
A.2.5.1.15
Additional
information for the
simplified
authorisation of
medicinal gases
Additional
information for
changes to the
product
information
requiring approval
A.2.5.1.16
Requirement
Draft agenda with the points to be discussed
Proposed form of the meeting: in person, by
telephone or video conference
Proposal for various possible dates (within a time
frame of 4-8 weeks following reception of the
request for a Pre-Submission Meeting)
Draft agenda with the points to be discussed
Proposed form of the meeting: in person, by
telephone or video conference
Proposal for various possible dates (within a time
frame of 4-8 weeks following reception of the
request for a Clarification Meeting)
Presentation of the problems regarding answers
to the List of Questions, plus presentation of the
outcomes the applicants wish to achieve (on 2–4
pages)
Pharmaceutical form, authorisation holder
Information on the medicinal product to be
imported (foreign authorisation number, product
name, pharmaceutical form, authorisation holder
Name and address of the firm in the country of
export from which the medicinal product to be
imported will be obtained
Name and address of the repackaging company
Contact details for responsible person for
authorisation holder
24-hour emergency number
Name and authorisation of the basic preparation
and any admissible differences compared to the
basic preparation
C/O
C
Information on the medicinal product to be
imported: name and authorisation number of the
medicinal product
Information on the Swiss originator / reference
product (product name, pharmaceutical form and
authorisation number)
Name and address of the company in the country
of export from which the medicinal product will be
obtained
Name and address of the repackaging company
Responsible person who can be contacted in the
event of quality problems (name, address,
telephone and fax numbers, e-mail address, 24hour contact phone number).
Name of the active pharmaceutical ingredient or
the radionuclide (if possible, use the INN)
Area(s) of use in diagnostics and / or treatment.
For kits, the marker nuclide must also be stated
Dosage form(s)
See Administrative Ordinance Authorisation of
medicinal gases, (available in French and German)
C
Version on which the text submitted is based (i.e.
the latest version approved by Swissmedic)
For changes to the texts and corrections in an
ongoing procedure (e.g. answer to preliminary
decision or answer to the text correction
communication), confirmation that all changes are
clearly marked as such.
For safety-relevant changes:
In the subject line: "Safety-relevant change to
the product information"
C
QM-Ident: ZL000_00_001e_WL / V 14 / vy, cis / fua / 24.05.2017
Exceptions
C
C
C
C
C
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HD-Guidance document
Formal requirements
No.
2.5.2
Subject
Requirement
Discussion regarding enhanced measures
(e.g. HPC)
State the justification for the safety relevance
in the text
If the safety-relevant changes are in
connection with a national or international
safety signal, mention this in the cover letter
C/O
Exceptions
Forms
No.
A.2.5.2.1
Subject
Form Application
for authorisation /
variation
A.2.5.2.2
Form Application
for authorisation /
variation for
collective
applications
A.2.5.2.3
Form
Full declaration
A.2.5.2.4
Form Manufacturer
information
A.2.5.2.5
Form
Status of
authorisation
applications
abroad
A.2.5.2.7
Form
Requirement
Use the corresponding form depending on
whether the application is for human or veterinary
medicinal products
The original of the form Application for
authorisation / variation must be submitted for
each authorisation number and for each
application type
Only one application type box may be checked
Dosage strength number: state the various
dosage strengths
Under "Additional documents", the attachments
that can be submitted for the application are
listed: check the appropriate box to show whether
or not they are submitted ("yes" or no")
Complete once per authorisation number, original
copy
Section "Authorisation number". State one of the
authorisation numbers concerned by the
collective application per form
Section "Collective application": state all of the
authorisation numbers concerned by the
collective application on each form
The complete qualitative and quantitative
composition of the medicinal products must be
stated
For herbal medicinal products, the information on
declaring extracts in the Information Sheet
Extract declaration, herbal medicinal products
should be taken into consideration
Information on the various manufacturers
For medicinal products with herbal active
pharmaceutical ingredients, the special
requirements in accordance with the Information
Sheet Details required regarding manufacturers
of herbal active substances must be met
For homeopathic and anthroposophic medicinal
products without indication, with reduced dossier,
the requirements stated in the Information Sheet
Simplification of the information to be provided on
the manufacturer information form for the
authorisation of homeopathic and anthroposophic
medicinal products without indication, with
reduced dossier (available in German and
French) must be taken into consideration
If the status changes during an ongoing application,
Swissmedic must be notified accordingly by means
of a newly completed form. This can take place in
conjunction with the answer to the List of Questions
or the answer to the preliminary decision
If a product contains no substances of animal or
human origin, the "no" box for the corresponding
QM-Ident: ZL000_00_001e_WL / V 14 / vy, cis / fua / 24.05.2017
C/O
C
Exceptions
C
C
C
C
If no submission /
authorisation for the
relevant preparation
exists in other
countries, there is no
need to submit the
"Status abroad" form.
The non-submission
should be justified in the
cover letter.
C
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HD-Guidance document
Formal requirements
No.
Subject
Substances of
animal and human
origin
A.2.5.2.8
Form
Pharmaceutical
information:
product
information,
parenteral
preparations
(human medicinal
products only)
Form
Site Master File for
foreign
manufacturing
sites
Form
Declaration of
radiopharmaceutic
als
A.2.5.2.10
A.2.5.2.11
Requirement
question must be checked in the form Application
for authorisation / variation
In this case, it is not necessary to submit the form
Substances of animal and human origin
This form must be submitted for all first
authorisations of parenterals and any variations to
parenterals
C/O
Exceptions
C
Only vaccines and blood products
C
The form must be submitted for all applications for
radiopharmaceuticals for which a full declaration is
also submitted
C
Form Application for authorisation / variation for collective applications:
A collective application for authorisation numbers x, y and z.
a) Form for authorisation number x: Under "authorisation number", enter authorisation number x in the
upper part. Enter all of the authorisation numbers concerned (x, y and z) in the section "Collective
application".
b) Form for authorisation number y: Under "Authorisation number," enter authorisation number y in the
upper part. Enter all of the authorisation numbers concerned (x, y and z) in the section "Collective
application".
c) Form for authorisation number z: Under "Authorisation number" enter authorisation number z in the
upper part. Enter all of the authorisation numbers concerned (x, y and z) in the section "Collective
application".
The form Manufacturer information may only be submitted for application types that require this form to be
processed. If the form is submitted for other application types, Swissmedic will neither check it nor
approve it.
The currently valid versions of the forms are available on the Swissmedic website for download. Only
these versions must be used for the application to be submitted. If forms are submitted that are no longer
valid, Swissmedic will issue a formal objection after the corresponding transitional period stated expires.
Old versions of forms are usually valid for 3 months following the entry into force of newer versions.
If so required, the forms must be signed. Unsigned forms (e.g. the form Confirmation of substances from
GMOs) are not accepted.
2.5.3
Medicinal product information
Mandatory submission
No.
A.2.5.3.1
Subject
Submission is
mandatory for
dispensing
categories A and B
(human medicinal
products only)
Requirement
Information for both
healthcare
professionals and
patients is required
QM-Ident: ZL000_00_001e_WL / V 14 / vy, cis / fua / 24.05.2017
C/O
C
Exceptions
Patient information is not required for
Dosage forms in accordance with Art. 14, para. 2,
AMZV that are exclusively administered by doctors
or dentists (e.g. products for injection or infusion).
For these products, the information for healthcare
professionals is inserted in the packaging;
Veterinary medicinal products
No medicinal product information is required for
homeopathic and anthroposophic medicinal products
without indication, for individual treatment, in
accordance with Art. 17, para. 1 and Art. 19 et. seq.,
KPAV
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HD-Guidance document
Formal requirements
No.
Subject
Requirement
A.2.5.3.2
Submission is
mandatory for
products of
dispensing
categories C and D
(human medicinal
products only
Information for both
healthcare
professionals and
patients is required
C
A.2.5.3.3
Submission is
mandatory for
products of
dispensing
category E (human
medicinal products
only
Veterinary product
information
Information for
healthcare
professionals or
patients is not
required
C
A.2.5.3.4
Veterinary product
information must
be included for
every veterinary
medicinal product
QM-Ident: ZL000_00_001e_WL / V 14 / vy, cis / fua / 24.05.2017
C/O
Exceptions
No information for healthcare professionals is required
for homeopathic and anthroposophic medicinal
products in accordance with Art. 16, Art.17 and Art. 19
et. seq., KPAV or for Asian medicinal products without
indication for individual treatment in accordance with
Art. 27 et. seq., KPAV
Patient information is not required for
Dosage forms in accordance with Art. 14, para. 2,
AMZV that are exclusively administered by doctors
or dentists (e.g. products for injection or infusion).
For these products, the information for healthcare
professionals is inserted in the container;
Medicinal products for which the required
information is placed on the container.
Veterinary medicines
No medicinal product information is required for
homeopathic and anthroposophic medicinal products
without indication, for individual treatment, in
accordance with Art. 17, para. 1 and Art. 19 et. seq.,
KPAV
On application, information for healthcare
professionals need not be included for the following
groups of medicinal products:
Baby foods
Bath additives and compresses (healing clay,
poultices)
Disinfectants
Dietary supplements
Intimate hygiene products
Products for sensitive skin
Tear substitutes
Nasal products (with secretolytic and moistening
effect)
laxatives (only bulking and filling agents)
Vitamin products (only those with water-soluble
vitamins)
Dental products (products for the gingiva and the
other oral mucosa, products with fluoride, products
to prevent tooth decay, tooth surface and to
desensitise the dentine)
Homeopathic and anthroposophic medicinal
products in accordance with Art. 16, KPAV
Asian medicinal products in accordance with Art.
25, KPAV
No information for healthcare professionals is required
for:
Homeopathic and anthroposophic medicinal
products in accordance Arts. 16 and 17 and Art. 19
et. seq., KPAV or for Asian medicinal products
without indication, for individual treatment in
accordance with Art. 27 et. seq. KPAV
Herbal medicinal products with the exception of
laxatives containing anthrachinone and products
containing St. John's wort
With the approval of Swissmedic, and if all the
required information is placed on the container used
for dispensing, product information is not required
(Art. 15, paras. 1 and 2, AMZV). The requirements for
the information and texts on containers and packaging
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HD-Guidance document
Formal requirements
No.
Subject
Requirement
C/O
Exceptions
material must comply with Art. 12, in connection with
Annex 1, AMZV)
Requirements
No.
A.2.5.3.7
Subject
References in the
medicinal product
information
A.2.5.3.8
Marking of
changes
A.2.5.3.9
Safety-relevant
changes to the
medicinal product
information
A.2.5.3.10
Information for
healthcare
professionals from
other countries,
EU-SmPC
Requirement
Statements made in the medicinal product
information must be scientifically justified and
proved. Suitable references are study reports,
publications, or other scientific documentation
For references to study reports, publications,
other scientific documentation, a summary or an
overview, the corresponding page number must
always be stated
Example: Study xyz, binder 3, page 736.
Or Binder 2, Reference 38: Müller et al, title etc.,
page 13
Reference to the firm's internal Core Data Sheet
(CDS) of the Company CDS (CCDS) or the
Summary of Product Characteristics (SmPC) is
not permitted, since these are not scientific
references
All changes compared to the last approved
version must be clearly marked as such
The marking must be shown in the manuscripts
throughout the entire application process.
Changes must be marked/highlighted using
Word’s “Track Changes” function. No other forms
of marking/highlighting will be accepted.
If changes to several applications that are still
pending are summarised in a single manuscript, it
is necessary to show which adjustments apply to
each application, e.g. by using different editor
IDs.
If an application for a variation contains changes
to texts that take place during several rounds of
text corrections, and if the text has not yet been
approved, confirm that the corrections suggested
by Swissmedic in the previous version have been
made. Corrections by Swissmedic that have not
yet been agreed upon must be clearly marked as
corrections made to the text by Swissmedic, e.g.
by inserting a comment.
The application requires either a Health
Professional Communication (HPC) or a
justification for not submitting an HPC
Within the framework of an application for safetyrelevant changes, no further changes to the last
approved text may be made in addition to the
justified, safety-related changes. Other changes
must be applied for separately
The content of safety-relevant changes mainly
concerns new, more restrictive statements in the
sections "Dosage / use", "Contraindications",
"Warnings and precautionary measures",
"Pregnancy / breast feeding" and "adverse
reactions"
If the patient information is also concerned, the
corresponding changes must be submitted at the
same time as those concerning the information
for healthcare professionals
For EU-SmPCs: submit the last version approved
in the EU, stating the date on which the approval
was granted
For products or changes that have not yet been
approved: the applicant's proposals for the SmPC
QM-Ident: ZL000_00_001e_WL / V 14 / vy, cis / fua / 24.05.2017
C/O
C
Exceptions
Veterinary medicinal
products: Reference to
EU-SmPC is possible in
exceptional cases
C
Veterinary medicinal
products:
As of the answer to the
preliminary decision,
only those changes that
do not correspond to
the proposed
corrections by
Swissmedic must be
marked.
C
Veterinary medicinal
products:
Only changes
concerning serious and
life-threatening
reactions or irreversible
damage are considered
to be safety-relevant
O
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HD-Guidance document
Formal requirements
No.
Subject
Requirement
in the EU must be clearly marked as the
applicant's draft
A.2.5.3.11
Composition of the
medicinal product
information for
medicinal products
with known active
pharmaceutical
ingredients
(without
innovation) and
biosimilars
It must be confirmed that the medicinal product
information corresponds to the currently
published texts of the information for healthcare
professionals and for patients for the originator
product … (name of the originator product),
product information version dated … (month /
year) and that only the following authorised
differences or deletions (state only as applicable)
compared with the originator product have been
made and are marked accordingly in the
medicinal product information.
C/O
Exceptions
C
For medicinal products that are authorised exclusively for export, a manuscript for the basic information is
checked and approved. Depending on the requirements (according to dispensing category), this basic
information can be for healthcare professionals or patients, or can be information on the outer packaging.
2.5.4
Packaging elements
No.
Subject
Submission
methods for
packaging
elements (folding
boxes, labels,
sachets, etc.)
2.5.5
No.
A.2.5.5.1
2.5.6
No.
A.2.5.6.1
Requirement
The format and number of copies to be
submitted are as specified in the "Submission
formats" table in section 2.1.
Colour laser printouts, in the original format,
may be submitted instead of original prints of
the packaging elements (folding boxes, labels,
sachets, etc.)
In addition, packaging elements must be
submitted on a digital data carrier via the
Swissmedic Portal as a single file with
searchable text (OCR).
C/O
C
Exceptions
No paper copies are
required for
submission in eCTD
format.
Swissmedic Portal
users do not need to
submit an additional
electronic data carrier
for the packaging
elements.
C/O
C
Exceptions
C/O
C
Exceptions
For applications for
major variations or
known APIs, the
submission of an ERA
is only required if the
impact on the
environment is
expected to increase
For Art. 13 applications,
an ERA is only required
if the authorisation was
granted in a non-EU
country. If an ERA is
not submitted, the
omission must be
justified.
Curriculum vitae of the experts
Subject
Curriculum vitae of
the experts
Requirement
Required for:
The overview (CTD: Module 2.3, 2.4, 2.5))
Statement by an expert
The original of the document is not required
Documentation of Environmental Risk Assessment
Subject
Environmental
Risk Assessment
(ERA)
Requirement
Human medicinal products: required for
applications for new APIs. If an ERA is not
submitted, justification for the omission must be
provided
Veterinary medicinal products: An ERA (at least
a Phase I assessment) is a part of every new
authorisation
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HD-Guidance document
Formal requirements
2.5.7
Decisions by foreign authorities
No.
A.2.5.7.1
Subject
All applications
A.2.5.7.2
Applications under
Article 13, TPA
2.5.8
No.
Requirement
Assessment reports and decisions by foreign
authorities that are available should be submitted
Final assessments reports and decisions by foreign
authorities must be submitted.
For details, see Instructions: Authorisation of
human medicinal products already authorised in
foreign countries (Art. 13, TPA), and the Checklist,
Formal Control, authorisation applications for
human medicinal products, Art.13, TPA
C/O
O
Exceptions
C
PVP / RMP / Pharmacovigilance planning documents (human medicinal products
only)
Subject
General aspects
Requirement
Documentation on pharmacovigilance planning
should be submitted in accordance with ICH E2E.
This constitutes a Risk Management Plan (RMP)
in accordance with EU directives or comparable
documents.
Swissmedic prefers that if an EU RMP is
available, it should be submitted
To be submitted:
For all first authorisations of vaccines (including
known APIs)
Use of a product on a new target population
If so requested by Swissmedic: e.g. in the case
of relevant safety problems
C/O
C
Exceptions
The US REMS format (Risk Evaluation and Mitigation Strategy) is not accepted as implementation
of the ICH Guideline.
2.5.9
PIP / PDP / Documentation for the paediatric investigation plan (human medicinal
products only)
No.
A.2.5.9.1
Subject
PIP
A.2.5.9.2
PDP
2.5.10
Requirement
If a Paediatric Investigation Plan approved by the
EMA is available, it must be submitted
The FDA Pediatric Development Plan may be
submitted
C/O
C
Exceptions
O
Information on the bioequivalence trial / reference product
No.
A.2.5.10.1
Subject
Information on the
bioequivalence trial
(human medicinal
products only)
A.2.5.10.2
Information on the
reference product
(human medicinal
products only)
A.2.5.10.1
Veterinary
medicinal
Requirement
If the proof of the transferability of the test results
for the reference product is based on
pharmacokinetic bioequivalence trials, it is
necessary to submit a fully completed
Swissmedic Bioequivalence Trial Information
Form) both as a printed version and as an
electronic document
A signed statement confirming that the test
product used in the bioavailability trial is identical
to the product submitted to Swissmedic for
authorisation must be submitted
Information required:
Product name, name and address of the
authorisation holder of the reference product,
country of origin, authorisation number, batch
number and expiry date of the packs used for the
bioequivalence trial
If the proof of the transferability of the test results
for the reference product is based on
QM-Ident: ZL000_00_001e_WL / V 14 / vy, cis / fua / 24.05.2017
C/O
C
Exceptions
Alternative:
Corresponding
information as
described in Appendix
IV of the Guideline on
the Investigation on
Bioequivalence
(CPMP/EWP/QWP/140
1/98 Rev.1) may be
submitted in Module 1
C
C
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HD-Guidance document
Formal requirements
No.
2.5.11
No.
A.2.5.11.1
2.5.12
No.
A.2.5.12.1
2.5.13
No.
A.2.5.14.1
Subject
products:
Information on the
bioequivalence trial
and the reference
product
Requirement
pharmacokinetic bioequivalence trials,
confirmation must be provided that the test
product used in the bioavailability trial is identical
to the product submitted to Swissmedic for
authorisation
Documents concerning the reference product
must be submitted with Part 1 of the application
documentation (product name, name and
address of the authorisation holder of the
reference product, country of authorisation,
source country, authorisation number, batch
number and expiry date of the packs used in the
bioequivalence trial)
C/O
Exceptions
C/O
C
Exceptions
GMP/Certificates/Establishment licences
Subject
Proof of GMP
compliance,
certificates and
establishment
licences
Requirement
For foreign manufacturer, to be submitted in
accordance with: Information sheet: GMP
compliance by foreign manufacturers of active
pharmaceutical ingredients and / or ready-to-use
medicinal products
Manufacturing information: flow chart for vaccines and blood products
Subject
Presentation of the
manufacturing
steps for vaccines
and blood
products
Requirement
Clear, summarised presentation of the
manufacturing steps and sites asa flow chart
C/O
O
Exceptions
Evidence that the obligation to notify pursuant of the Nagoya Ordinance is satisfied
Subject
Evidence that the
obligation to notify
pursuant of the
Nagoya Ordinance
is satisfied
Requirement
According to Art. 3 para. 1bis TPO, a new
application for authorisation of a medicinal
product whose development is based on the
utilisation of genetic resources or related
traditional knowledge must include the
registration number pursuant to Art. 4 para. 3 or 8
para. 5 of the NagO. The registration number is
issued by the Federal Office for the Environment
(FOEN) and provides the applicant with proof of
compliance with the obligation to notify according
to Articles 4, 5 or 8 of the NagO, and is a
prerequisite for authorisation under Art. 7
paragraph 1bis of the TPO.
The requirements of the NagO as well as Arts. 3
and 7 of the TPO must be satisfied for all new
authorisation applications that involve substances
(active substances or excipients) whose
development is based on a genetic resource, if
access to the genetic resource was gained after
12 October 2014 (see Art. 25d NCHA). If the
utilisation of traditional knowledge relating to
genetic resources pursuant to Article 23p NCHA
is involved, the obligation to notify according to
Article 4 is similarly applicable. If the use of a
genetic resource from Switzerland pursuant to
Art. 8 NagO is involved, evidence that the
obligation to notify has been met is to be provided
once Art. 8 NagO has taken effect from 1 January
2017.
Further information on the Nagoya Protocol and
its implementation in Switzerland can be found on
the homepage of the responsible authority and
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C/O
C
Exceptions
Access to the genetic
resource or related
traditional knowledge
took place prior to 12
October 2014.
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HD-Guidance document
Formal requirements
No.
Subject
Requirement
the National Focal Point for the Nagoya protocol
at the FOEN.
2.6
Modules 2-5
2.6.1
List of contents and labelling of binders
No.
A.2.6.1.1
Subject
List of contents
A.2.6.1.2
Labelling of the
binders
A.2.6.1.3
List of contents of
the binders
Requirement
To be submitted for all paper submissions, for the
documentation supplied (Modules 2-5)
The Overall CTD Table of Contents“ (Section 2.1)
is the table of contents for the entire CTD
(Modules 2–5)
Each module has its own list of contents
The level of detail of the list of contents is defined
in the Granularity Document” (Annex to the ICH
documents Organisation of The Common
Technical Document for the Registration of
Pharmaceuticals for Human Use M4)
Labelling on the binder spines:
Product name
If available: Authorisation number
Module concerned by the documentation
Separate numbering of all volumes per module
or for all volumes within the entire
documentation (always stating the overall
number of binders)
If appropriate, reference numbers and / or page
numbers
Applicant's name
The individual studies must be separated using
the cover sheets provided by Swissmedic
If there are several binders for a single study, the
cover sheet for the first binder must be placed at
the top of every subsequent binder
Every binder must contain a list of contents.
An overall list of contents of the studies must be
submitted. It must show exactly which pages are
contained in each binder, e.g. Study xyz, binder
3, pages 632 to 895
Voluminous annexes should be given their own
list of contents. Cover sheets must be included in
every binder, as described above
C/O
Exceptions
C/O
C
Exceptions
C
C
Documentation sent to Swissmedic spontaneously and that does not fall within the framework of an
application will be returned to the authorisation holder, at the expense of the latter (e.g. update to
Module 3).
2.6.2
References
No.
A.2.6.2.1
Subject
A.2.6.2.2
Type of crossreferencing
Extent of crossreferencing
Requirement
A fundamental concept regarding the CTD is to
avoid repeating information that is presented in
Modules 3, 4 and 5 in the summaries and
overviews of Module 2. For that reason,
comprehensive cross-referencing of the
documents in Module 2 to the other parts of the
CTD, in accordance with the ICH guidelines, is
mandatory
The use of the CTD/NTA chapter numbers
("cross strings" according to the ICH) serves as
the basis for the cross referencing
The chapter numbers are not sufficient to provide
the reviewers with an efficient way of accessing
the sources of information. Swissmedic strongly
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C/O
C
Exceptions
O
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HD-Guidance document
Formal requirements
No.
Subject
A.2.6.2.3
Referencing in
Modules 3.3; 4.3;
5.4 (references to
literature)
A.2.6.2.4
References to
literature in the
overviews for
Module 2
Requirement
encourages applicants to expand these chapter
numbers in line with the ICH guidelines with a
short additional text, e.g. stating the volume, the
page numbers or "see study xyz"
The references must be numbered consecutively
A list of contents must be submitted, and must
state the exact binder for each references and
their numbers, e.g.
Binder 2, references 38 to 89
Reference 38: Müller et al, title, etc. (Pages within
this reference 1 to 13)
Reference 39: Wang et al, title, etc. (Pages
within this reference 1 to 45)
If several binders are used for the references, the
cover sheet for the first binder must also be
inserted at the top of each binder
Every binder must also contain a list of contents
for the references that are contained in it
In the information for healthcare professionals /
patients, reference must be made to the
corresponding module, the reference number, the
page number and the binder number (e.g. Module
5.4, reference 22, page 5, binder 2)
The references contained in the overviews
(Module 2.3 – 2.5) constitute an integral part of
the submission and must be submitted in the
corresponding modules. For eCTD applications,
the references must be linked either from the
body text or from the list of references in the
overview
C/O
Exceptions
Referencing that cannot be found, that is incorrect or that is not sufficiently comprehensive, or
that is based on a complex cascade structure with various lists of contents (more than two
intermediate steps) will not be accepted and a formal objection will be issued.
2.7
Answers to communications from Swissmedic during the ongoing application
process
No.
A.2.7.0.1
Subject
Incomplete submission
of answers to
communications from
Swissmedic
Requirement
Missing documents will be requested by
Swissmedic
The processing of the application will only
continue once all documents requested by
Swissmedic, plus any test samples requested,
have been received by Swissmedic
A.2.7.0.2
Stance / Answer to the
preliminary decision
The time limit for the stance / answer to the
preliminary decision is 90 calendar days
The conditions that are imposed on the
authorisation must be fulfilled within the time
limit specified and submitted collectively
QM-Ident: ZL000_00_001e_WL / V 14 / vy, cis / fua / 24.05.2017
C/O
O
Exceptions
Answers to the List of
Questions: If no
complete answer or no
justified written
application for the time
limit to be extended is
received by the date
stated in the List of
Questions, the
corresponding
questions are
considered to be
unanswered. Under
certain circumstances,
this can lead to a
negative preliminary
decision or a negative
official decision, and
costs will be applied.
O
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HD-Guidance document
Formal requirements
No.
Subject
Requirement
The submission of a separate stance may be
dispensed with
3
Special requirements
3.1
Scientific Advice meeting
No.
3.2
No.
3.3
No.
Subject
Address
Requirement
The requesting company must have a registered
office in Switzerland or a legal representative with a
registered office in Switzerland.
C/O
Exceptions
C/O
C
Exceptions
C/O
C
Exceptions
C/O
-
Exceptions
Pre-Submission meeting
Subject
Address
Requirement
The requesting company must have a registered
office in Switzerland or a legal representative with a
registered office in Switzerland.
Clarification meeting
Subject
(none)
Requirement
-
3.4
Recognition of important medicinal product status
3.4.1
Recognition of orphan drug status (ODS) (human medicinal products only)
No.
A.3.4.1.1
Subject
General
A.3.4.1.2
For assessment in
accordance with
Art. 4, para. 1,
letter b) VAZV
(recognition by a
country with
comparable
medicinal product
control)
3.4.2
Requirement
The applicant must at least have an address for
correspondence in Switzerland
If no Swissmedic establishment license has been
granted, Swissmedic requires advance payment.
The application is only processed once the
payment is received
A separate application for ODS recognition must
be submitted for each individual orphan indication
Additional proof demonstrating that the medicinal
product submitted for recognition of ODS and the
medicinal product authorised abroad as an
orphan drug are identical (Art. 4, para. 4, VAZV).
This must be integrated in the cover letter or take
the form of a separate confirmation (dated and
signed)
Copy of the official decision from the foreign
authority granting ODS
All administrative and scientific documentation
that was submitted to the foreign authority for
recognition of ODS
C/O
C
Exceptions
C
MUMS status (veterinary medicines)
No.
A.3.4.2.1
Subject
General
A.3.4.2.2
Documents to be
submitted
Requirement
The applicant must at least have a delivery
address in Switzerland
If no Swissmedic establishment license has been
granted, Swissmedic requires advance payment.
The application is only processed once the
payment is received
Minor use: a separate application for recognition
must be submitted for each individual indication
Minor species: for the treatment of animal species
or categories other than cattle, pigs, horses,
dogs, cats, sheep (not including milk ewes) and
poultry (not including laying hens)
Minor use: Form, cover letter, and normally,
scientific documentation
Minor species: Form, cover letter
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C/O
C
Exceptions
C
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HD-Guidance document
Formal requirements
3.5
No.
3.6
No.
A.3.6.0.1
Request for fast-track procedure (human medicinal products only)
Subject
None
Requirement
None
C/O
-
Exceptions
Request for procedure with prior notification (human medicinal products
only)
Subject
Request for
procedure with
prior notification
Requirement
To be submitted in writing, at the earliest 6 months
and at the latest 3 months prior to the planned
submission of the application.
C/O
M
Exceptions
Requests for the procedure with prior notification may only be submitted for new APIs and additional
indications.
A procedure with prior notification can only be carried out if the authorisation application is
subsequently submitted in the CTD format, as an eCTD application or as a paper version with an
eDok copy.
If a submission in eCTD format is planned, it is strongly recommended that applicants with no
experience or limited experience with eCTD submit a test sequence at least 3 weeks prior to
submitting the application. In that way, it is possible to avoid the risk of exceeding time limits as a
result of technical shortcomings.
3.7
No.
A.3.7.0.1
3.8
No.
A.3.8.0.1
3.9
New applications, new APIs and major variations
Subject
Modules 2-5/
Parts Ic-IV
Requirement
For additional requirements, see the
Administrative Ordinance / Instructions for the
authorisation of human medicinal products with
new active pharmaceutical ingredients and major
variations
C/O
C
Exceptions
C/O
M
Exceptions
New applications, known APIs
Subject
Modules 2-5 /
Parts Ic-IV
Requirement
For additional requirements, see the Administrative
Ordinance / Instructions for the authorisation of
human medicines with known active pharmaceutical
ingredients
And the information sheet Authorisation
applications for veterinary medicines with known
active pharmaceutical ingredients
Similar biological medicinal products (biosimilars) – human medicinal
products only
No.
A.3.9.0.1
Subject
Modules 2-5
A.3.9.0.2
RMP/ PVP
Immunogenicity
Requirement
Additional requirements relating to applications for
biosimilars, see the Administrative Ordinance /
Instructions for similar biological medicinal products
(biosimilars)
The particularly important aspect of demonstrating
immunogenicity must be given appropriate
significance in the RMP. Here, the underlying
interdisciplinarity must be taken into account.
Activities with a view to obtaining additional
immunogenicity data must be discussed
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C/O
C
Exceptions
C
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HD-Guidance document
Formal requirements
3.10
Applications under Article 13, TPA
No.
A.3.10.0.1
Subject
Documentation to
be submitted
A.3.10.0.2
Swiss Modules 1 1
(for complementary
and herbal or
veterinary
medicines, Parts 1A
and 1B),
product information
and packaging
elements
A.3.10.0.3
Drug Master File
(DMF/ASMF)
3.11
Requirement
The complete documentation in CTD format
(Modules 2-5 plus the country-specific Module 1)
or NTA format (Parts I-IV), as it was submitted to
the reference authority
Results of the assessment by the reference
authority, including additional documentation
(final assessment report and additional test
results)
Submit in an official language of Switzerland
(information for healthcare professionals / patient)
in German or French
C/O
C
If a DMF/ASMF was submitted to the reference
authority for the application in question, the
DMF/ASMF holder must submit an identical copy
of the Restricted Part, including the Letter of
Access, the Assessment Report of the Restricted
Part, the LoQ and the company's answers to the
Restricted Part.
If the DMF/ASMF (Applicant's Part and
Restricted Part) has undergone changes in the
meantime, the approved changes with the
corresponding assessment report must be
submitted separately.
C
Requirement
It is not possible to submit an authorisation
application for a co-marketing preparation before
the basic preparation has been authorised. In
such cases, the application will not be processed
If the basic preparation is authorised for the
Swiss market, either a marketing authorisation for
Switzerland or a marketing authorisation for
abroad only may be applied for.
An authorisation for marketing the basic
preparation abroad only or for parallel import
excludes the possibility of market authorisation of
a co-marketing medicinal product in Switzerland.
Such applications will not be processed.
A confirmation is required that the medicinal
product information for the co-marketing medicinal
product is in line with the last version of the
medicinal product information for the basic
preparation that was approved by Swissmedic on
… (day/month/year) and that only the following
authorised differences or deletions were carried
out. These must be shown in the manuscript and
clearly marked
Documents to be submitted:
Complete authorisation documentation, identical
to the documentation for the basic preparation
Confirmation that the documentation submitted is
identical to that for the basic preparation
(including any additional material that was
approved in the meantime; eCTD: all documents
(i.e. all the modules concerned for the basic
C/O
C
Exceptions
C
Co-marketing
No.
A.3.11.0.1
Subject
Authorisation
status
Basic preparation
A.3.11.0.2
Medicinal product
information
A.3.11.0.4
Converting co-
marketing
authorisations to
normal
authorisations
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Exceptions
C
C
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HD-Guidance document
Formal requirements
No.
3.12
Subject
Requirement
preparation) must be submitted with a new
sequence
C/O
Exceptions
Variations requiring notification
Variations requiring notification and variations requiring approval can also be submitted together (what are
known as “mixed applications”) providing the cover letter gives reasons for the joint submission and the
individual variations are clearly attributed to the relevant part of the submitted documentation
Collective applications (see Annex 8, AMZV) are possible. Here, the identical variation for all medicinal
products must be submitted simultaneously. All of the medicinal products concerned must be listed on the
form. For changes to the product information for healthcare professionals / patients, collective applications
are only possible if the information for healthcare professionals is the same for all the products.
The documentation for collective applications in paper format does not need to be submitted separately for
each authorisation, but only once (original/copy). For eCTD submissions of collective applications, the
documentation should be submitted individually for each preparation.
For complementary and herbal medicines, the conditions to be fulfilled and the documents to be submitted
apply by analogy, taking into consideration the specific characteristics of these products.
In the event of approval, no official decision is sent to the applicant. The applicant can implement the
variation unless Swissmedic issues a decision to the contrary within 30 days (post office franking mark on
the decision) of receipt of the variation (date as per confirmation of receipt) by the agency (cf. Art. 11, para.
2 VAM).
3.13
No.
A.3.13.0.1
Variations requiring approval with scientific assessment
Subject
Updates to the
documentation
Requirement
Updates (e.g. to Module 3/Part II) may not be
submitted independently but only in connection
with one or more applications for variations
If updates to entire modules contain variations
requiring notification or approval, these must be
submitted separately, as applications for
variations
An index of changes with a tabular comparison
(old / new) following the variation and indicating
the page number where the documents can be
found must be included in the corresponding
documentation
Editorial changes to Module 3 (incl. additions
such as adding validation documents without
changes to the test method, updated stability
results or change to the shelf life or retest period)
are neither variations requiring notification nor
variations requiring approval. For that reason, the
procedure is as follows:
If an updated Module 3 exists, e.g. as the result of
a variation requiring approval and several
independent editorial changes, the variation
requiring approval must be submitted with the
form Quality variation requiring approval, and the
editorial changes must be indicated in the cover
letter and in the index of changes.
If an updated Module 3 consists exclusively of
editorial changes (including additions), the
updated Module 3 cannot be submitted
independently.
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C
Exceptions
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HD-Guidance document
Formal requirements
No.
Subject
A.3.13.0.2
Completing the
form Quality
variations requiring
approval
A.3.13.0.3
Quality variation
requiring approval:
consequential
change
A.3.13.0.6
"Other quality
variations"
Collective
applications
A.3.13.0.5
Requirement
Documents submitted spontaneously or updates
without an application for a variation are returned
to the applicant at the cost of the latter.
The variation applied for must be categorised either
as a "major quality variation" or a "minor quality
variation". If several values will change within one
type of variation (e.g. specifications for the finished
product), proceed as follows (example)::
One major and one minor variation: check the
"major" box only.
Three small variations: check the "minor" box only
once.
Only one box may be checked ("major" or
"minor") but not both.
The text fields "Description / justification for the
variation" and "Previously approved – applied for"
must be completed. A reference to the
documentation or internal company codes is not
sufficient.
If needed, a table can also be copied into the text
fields.
Several applications for quality variations
requiring approval can be submitted using the
same form. The title sheet of the form must be
submitted together with all the completed pages
for the variations applied for.
Sections of the template for variations that are not
needed (parts of the form) need not be completed
Other variations that are directly related to a
variation requiring approval that is applied for (EU
term "consequential change") must be stated as
such in the corresponding text field, and justified
For the precise identification of this consequential
changen, the SAP product number must be used
for variations requiring approval, and the number
in accordance with Annex 8, AMZV (nos. 1-48)
must be used for variations requiring notification
When stating the type of consequential change, it
should be noted that on an application for a
"minor quality variation regarding approval", only
a "minor quality variation" or a variation requiring
notification may follow, but not a "major quality
variation"
This may only be used if the variation cannot be
associated with any of the application types listed
For collective applications (Annex 7, no. 1, AMZV),
only those variations relating to the collective
application may be submitted.
C/O
Exceptions
C
C
C
C
Variations requiring notification and variations requiring approval can also be submitted together
(what are known as “mixed applications”) providing the cover letter gives reasons for the joint
submission and the individual variations are clearly attributed to the relevant part of the submitted
documentation.
The documentation for collective applications in paper format does not need to be submitted
separately for each authorisation, but only once (1 original/1 copy). The documentation for collective
applications in the eCTD format the documentation should be submitted individually for each
preparation.
3.14
No.
Variations requiring approval without scientific assessment
Subject
(None)
Requirement
-
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-
Exceptions
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HD-Guidance document
Formal requirements
3.15
No.
Conditions imposed by Quality Review, Preclinical Review and Clinical
Review
Subject
(None)
Requirement
-
C/O
-
Exceptions
Conditions that are imposed in the official decision and apply to a collective application may also be
submitted as a collective application.
A separate application must be made for each condition imposed in the official decision.
3.16
No.
Notification procedure for sample packs
Subject
(None)
Requirement
-
C/O
-
Exceptions
Applications for variations for sample packs authorised by the notification procedure are not provided for.
If changes are made to the sample packs of medicinal products authorised by the notification procedure, a
new application for authorisation by the notification procedure must be submitted
3.17
Extension, no extension, no marketing and interruption to distribution
3.17.1
Extension and no extension
No.
A.3.17.1.1
Subject
Regular extension
A.3.17.1.2
Application for
renewed
authorisation (new
authorisation)
Requirement
In accordance with the regulatory time limit
specified in Art. 9, para. 2, VAM, the application
must be submitted to Swissmedic at the earliest 1
year and at the latest 6 months before the
authorisation expires
Swissmedic will not process applications for
extension that are submitted too late, i.e. less
than 6 months before the authorisation expires
Submission of the administrative documents for
Module 1 in accordance with the table Documents
to be submitted, with the confirmation that all the
information is in line with that for the product
concerned
C/O
C
Exceptions
Does not apply to the
extension of temporary
authorisations
C
If no application for authorisation is submitted to Swissmedic before six months prior to the expiry of
the authorisation, an official decision is issued to cancel the authorisation for the product once the
current authorisation period expires. The cancellation is automatically published in the Swissmedic
Journal.
If the authorisation holder has missed the deadline for submitting the application for extension, it is
possible to submit an application for renewed authorisation.
The renewed authorisation is published in the Swissmedic Journal in the month following the official
authorisation decision, with the comment "Renewed authorisation after the expiry of the currently
authorisation period".
An interruption to the marketability of the product concerned cannot always be prevented by an
application for renewed authorisation. This is only possible if there is sufficient time for Swissmedic
to assess the above-mentioned documents.
Extensions may not be submitted as collective applications.
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HD-Guidance document
Formal requirements
3.17.2
Discontinuation of authorised products
No.
A.3.17.2.1
Subject
Discontinuation of
product
(notification)
Requirement
Cover letter
For eCTD submission, submit the cover letter in a
new eCTD sequence
C/O
C
A.3.17.2.2
Discontinuation of
product with
deferred
withdrawal
(application)
Only for products distributed in Switzerland, i.e.
not possible for "export authorisations"
Documents to be submitted:
Cover letter with justification
If eCTD: new eCTD sequence
Form Application for authorisation /
variation
Maximum deferral period that can be applied for:
1 year (not beyond the expiry date of the
authorisation certificate)
C
Exceptions
In the case of collective medicinal product information texts, a variation requiring approval without
scientific assessment (depending on the requirements to the application) must be submitted for the
products not concerned by the discontinuation.
3.17.3
No.
Discontinuation of dosage strength number
Subject
None
Requirement
-
C/O
-
Exceptions
If the entire dosage strength number is cancelled as the result of discontinuing a pack size, this may
not be submitted as a variation requiring notification no. 3, but as a discontinuation of a dosage
strength number.
If the cover letter concerns the discontinuation of several dosage strength numbers at once, this must
be considered as an application
3.17.4
No.
A.3.17.4.1
Notification in accordance with Art. 8a, VAM: No marketing / interruption to
marketing and Placing on the market / Renewed placing on the market
Subject
Documents to be
submitted
Requirement
A separate form must be submitted for each
notification
3.18
Complementary and herbal medicinal products
3.18.1
Reduced dossiers
No.
Subject
(None)
Requirement
-
C/O
C
Exceptions
C/O
-
Exceptions
Note the information sheet: Reduced documentation requirements on the form Manufacturing
information for the authorisation of homeopathic and anthroposophic medicinal products without
indication with reduced dossier
Note the information sheet: Reduced requirements regarding the submission of GMP certificates
for the reduced dossier
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HD-Guidance document
Formal requirements
Note the form: Modification of reduced dossier
3.18.2
No.
Asian medicinal products
Subject
(None)
Requirement
-
C/O
-
Exceptions
Note the information sheet: Requirements relating to quality documents on Asian medicinal
products
www.swissmedic.ch/kpa
3.19
Extension of authorisation of homeopathic and anthroposophic medicinal
products without indication by the notification procedure (HOMANT)
No.
A.3.19.0.1
Subject
Timing
A.3.19.0.2
Documents to be
submitted
Requirement
The applications must be submitted at the earliest 1
year and at the latest 6 months prior to the expiry of
the authorisation procedure
Completed form (incl. number of the products to
be extended and the number of products to be
discontinued).
Copies of the product lists with the corresponding
official decision concerning first authorisations,
with the official stamp of the authorisation holder.
Those products for that the applicant does not
wish to have extended must be crossed out by
hand. In order for these crossed out parts to be
easily found by Swissmedic, we request the
authorisation holders to use appropriate marking
(for example using a highlighter pen)
C/O
C
Exceptions
C
The authorisation holders are responsible for submitting the applications for extension within the
time limit. Swissmedic does not issue reminders.
Extensions cannot be submitted as a collective application.
3.20
No.
HOMANT notification procedure
Subject
(None)
Requirement
-
C/O
-
Exceptions
For the requirements regarding the entering of data and labelling the CD-ROM, see the
HOMANT user manual.
Note the information sheet: "Information sheet, authorisation procedure for homeopathic and
anthroposophic medicinal products" and the HOMANT information sheet
www.swissmedic.ch/kpa
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HD-Guidance document
Formal requirements
3.21
No.
Authorisation / variations, veterinary medicinal products by the notification
procedure in accordance with Art. 39, VAZV / Arts. 10-21, VAM
Subject
(None)
Requirement
-
C/O
-
Exceptions
Note the information sheet: Authorisation / variations, veterinary medicinal products by the notification
procedure in accordance with Art. 39, VAZV / Arts. 10 – 12, VAM
www.swissmedic.ch/Zulassungen/Tierarzneimittel
Note the form: Authorisation / Variation, notification procedure
3.22
Market monitoring
3.22.1
PSUR/PBRER
No.
Subject
(None)
Requirement
-
C/O
-
Exceptions
If available, the routine submission of the RMP update takes place together with the periodic report
(PSUR/PBRER), with the appropriate box checked in the PSUR/PBRER form.
For veterinary medicinal products, no PSUR/PBRER form is required.
3.22.2
No.
Advertising permission
Subject
(None)
Requirement
-
C/O
-
Exceptions
One copy in paper form must be submitted with the advertising (e.g. advertisements or storyboards,
etc.).
The definitive version of electronic media should always be submitted on a CD/DVD.
3.23
DMF/ASMF and Plasma Master Files
3.23.1
DMF/ASMF
No.
A.3.23.1.1
Subject
General
Requirement
The Applicant's Part of the DMF/ASMF must be
submitted in Part II of the NTA format for
veterinary medicinal products. The entire DMF
(Applicant's and Restricted Part) must also be
submitted separately
The authorisation holder is responsible for
ensuring that the manufacturer of the active
pharmaceutical ingredient submits the currently
valid version of the DMF / ASMF (Applicant's Part
and Restricted Part), synchronised with the
authorisation application (see instructions)
The outcome of the formal control of authorisation
documentation will only be possible if the full
DMF/ASMF (Applicant's Part and Restricted Part)
and the Letter of Access and the fully completed
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C
Exceptions
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HD-Guidance document
Formal requirements
No.
Subject
A.3.23.1.2
Form DMF/ASMF
First authorisation
/ Variation
A.3.23.1.3
Letter of Access
Requirement
for DMF/ASFM First authorisation / variation are
submitted
The form consists of parts A and B. The
authorisation holder completes part A and sends
a copy of the entire form (parts A and B) to the
DMF / ASMF holder. The original, signed by the
authorisation holder, is submitted together with
each application for first authorisation or variation
The DMF/ASMF holder completes part B. The
fully completed, signed form (copy of part A and
the part B signed by the DMF/ASMF holder is
submitted directly together with the cover letter,
Letter of Access, and the Applicant's Part and
Restricted Part
The DMF/ASMF must always be accompanied by
a Letter of Access from the manufacturer in
accordance with Annex 2 of the EU Guideline on
Active Substance Master File Procedure
The Letter of Access must contain the name of
the medicinal products and the name of the
authorisation holder
The Letter of Access must be submitted by both
the DMF/ASFM holder (original) and the applicant
(copy)
C/O
Exceptions
C
C
DMF/ASMF may only be submitted in connection with an application for authorisation or variation or
within the framework of a periodic review procedure.
Swissmedic must receive the DMF/ASMF – including the form DMF for first authorisation/variation
(parts A and B), Letter of Access and covering letter – no earlier than eleven calendar days before
and no later than three calendar days after it has received the application for first authorisation or a
variation. If there is no application for a DMF/ASMF, a reminder will be sent to the authorisation
holder.
If no application is received within 120 calendar days of the reminder being sent to the authorisation
holder, Swissmedic will return the DMF/ASMF at the sender's cost if the DMF/ASMF was sent from
Switzerland. If the DMF/ASMF was sent from abroad, it will be disposed of in a controlled manner at
the end of the 120 days.
If is only possible to omit the paper copy of the DMF/ASMF documentation if the DMF/ASMF is
submitted in eCTD format.
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HD-Guidance document
Formal requirements
3.23.2
No.
A.3.23.2.1
Plasma Master Files (Human medicinal products only)
Subject
Annual updates
and corresponding
variations
Requirement
The cover letter must describe whether this is
(a) An annual update, or
(b) A quality variation requiring approval,
without annual update, or
(c) An annual update with quality variation
requiring approval
An annual update (without variation requiring
approval) must be noted as a PMF annual update
on the form Application for authorisation /
variation in the section "Other applications /
Other"
The form Quality variations requiring approval
must not be submitted
Changes to the Plasma Master File (e.g.
additional donor centres, different country of
origin of the plasma, modified test kits, etc.) must
be submitted as quality variations requiring
approval with scientific assessment, using the
form Application for authorisation / variation and
the form Quality variation requiring approval
If an annual updated is submitted together with
variations to the Plasma Master File requiring
approval, it is necessary to submit two separate
forms: Application for authorisation / variation and
Quality variation requiring approval. If only
updates are submitted (e.g. epidemiological data,
information on inspections / audit status of donor
centres, etc.), this constitutes compliance with
regard to conditions imposed on an authorisation
and not a quality variation requiring approval.
C/O
C
Exceptions
The submission of PMF annual update is considered to be compliance with regard to conditions
imposed on an authorisation.
3.24
Special product types and the corresponding submission
3.24.1
Radiopharmaceuticals
No.
A.3.24.1.1
Subject
Establishment
licences
A.3.24.1.2
Information for
healthcare
professionals
Packaging
elements
A.3.24.1.3
Requirement
Permission from the Federal Office of Public Health
regarding the handling of radioactive substances:
Copy of the original or the application (see
Radiological Protection Ordinance, RPO)
Draft: see other valid document Requirements
relating to the information for healthcare
professionals, radiopharmaceuticals
For primary containers, lead shielding, folding
boxes, labels for the market product, etc. in
accordance with Annex 3, AMZV
The documentation must be submitted separately
for each pharmaceutical form
C/O
C
C
C
A.3.24.1.4
Module 3 CTD /
Part II: Chemical,
pharmaceutical
and biological
assessment
A.3.24.1.5
Module 5 CTD /
Part IV: Clinical
assessment
The scintigrams / scans may also be submitted in
electronic form (on DVDs)
C
A.3.24.1.6
Documentation
The native images of the scans or scintigrams
must be submitted in electronic form (on CD or
C
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C
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HD-Guidance document
Formal requirements
No.
3.24.2
Subject
Subject
Cover letter and
forms in the case
of more than five
allergen products
concerned
A.3.24.2.2
Modules 2-5
Subject
Module 1
A.3.24.3.2
Module 3
No.
-
Exceptions
Requirement
If more than five allergen products are concerned
by an application, a list of the allergens – possible
summarised by allergen groups) – must be
included
The cover letter and all the necessary forms
(Application for authorisation / variation, Full
declaration, TSE, etc.) must be submitted in one
copy in this case, referring to the allergens or
allergen groups in the list
Additional requirements relating to applications for
allergen products are provided in the Instructions,
simplified authorisation of allergen products
C/O
C
Exceptions
Requirement
Draft of the information for healthcare
professionals and, if appropriate, of the patient
information (e.g. for use outside the hospital)
Products manufactured in Switzerland: Drafts
texts in accordance with Swiss requirements
Products manufactured abroad: the texts
approved abroad (in a national language of
Switzerland or in English
Packaging texts
Products manufactured in Switzerland: Draft
texts in accordance with Swiss requirements
Products manufactured abroad:
Copies of the texts approved abroad and
drafts of the additional adhesive labels (in
German and French) that will be placed on
the foreign packaging and that show the
authorisation number and packaging code,
plus the approval mark A, the area of
application (short form), the contact data for
the Swiss Toxicological Information Centre
(STIC) and the note: "ANTIDOTE: only use in
emergencies and with medical supervision.
The indication is defined by the professional
prescribing this product".
Confirmation from the STIC stating the average
annual figure for cases of intoxication in
Switzerland
Confirmation from the Military Pharmacy of the
Swiss Confederation stating the estimated number
of critical cases
Additional requirements can be found in the
Instructions, authorisation of important, rarely used
antidotes
C/O
C
Exceptions
Requirement
-
C/O
-
Antidotes
No.
A.3.24.3.1
3.24.4
C/O
Allergen products
No.
A.3.24.2.1
3.24.3
Requirement
DVD). The image data must be provided both in
the original format (e.g. DICOM) and in a
commonly-used image format that can be read
by PCs using Windows
The anonymised patient data and the modalities
of the imaging must be provided
C
Medicinal gases
Subject
(None)
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Exceptions
-
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HD-Guidance document
Formal requirements
3.24.5
No.
A.3.24.5.1
3.24.6
No.
A.3.24.6.1
A.3.24.6.2
Antivenins
Subject
Application
documentation
Requirement
See
Administrative
Ordinance
authorisation of antivenins
Instructions,
C/O
C
Exceptions
-
Parallel import
Subject
Additional
documents to be
submitted in
respect of section
2.5.1 Cover letter,
section A.2.5.1.13
Additional
information for
applications for
parallel import"
Medicinal product
information /
sample pack
Requirement
Form: Import of a medicinal product according to
Art. 14 (2) TPA
GMP/GDP certificate for the company from which
the medicinal product was procured abroad
according to Art. 9 Annex 2 MPLO (no older than
3 years) or some other evidence to show that the
company satisfies GMP/GDP requirements.
GMP certificate for the repackaging company if in
another country; no older than 3 years
C/O
C
1 sample pack of the preparation to be imported
incl. information for healthcare
professionals/patient information/veterinary
medicinal product information in the original
language and, if applicable translation into D / F / I
or E (1 copy incl. certification of the translation of
the medicinal product information from the country
of parallel import, if a language other than D / F / I
/ E is used
Electronic draft of information for healthcare
professionals/patient information/veterinary
medicinal product information/ Packaging
elements (via Swissmedic portal or CD)
Colour photocopy of the primary container (blister
pack / labels etc.)
C
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