Extensions

Group

Name

Class

Reference

Group

Name

Class

Reference

Group

Name

Class

Reference

Group

Name

Class

Reference

Group

Name

Class

Reference

Group

Name

Class

Reference

Group

Name

Class

Reference

Group

Name

Class

Reference

Group

Name

Class

Reference

eSubmission

Identifier

The value should consist of the small EN letter and 6 digits ([a-z]([0-9]

{6})

Identifies the type of activity that is being submitted with the sequence, either the

regulatory activity type

if it is the first

sequence of the regulatory activity, or supplementary

information if it is a follow-up to information already submitted for the regulatory activity.

Australian

Approved

Name(s)

Product

Name

The name or proposed product (trade) name to be used on the Certificate of

Registration. Multiple comma-separated values can be provided.

The Australian

Register of Therapeutic Goods number should be provided if available.

The ARTG can be a

four, five, or six digit number

eCTD Code value from Data Administration >

Sequence

Description Values

Sequence Code

(without prefix "P")

Related

Sequence

Number

Identifies the group within the TGA which is expected to take the lead in the review process.

The regulatory activity lead defined list of codes and values is managed at <http:// apps.tga.gov.au/ downloads/regactivity-lead.xml>. Applicants should

refer to this list for current list values.

eCTD Code value from Data Administration >

Regulatory Activity

Lead Values

Identifies the type of activity that is being submitted with the sequence: either the

regulatory activity type

if it is the first

sequence of the regulatory activity, or supplementary

information if it is a follow-up to information already submitted for the regulatory activity.

The sequence type defined list of codes and values is available from <http:// apps.tga.gov.au/ downloads/sequencetype.xml>.

eCTD Code value from Data Administration >

Filing Type Values

> Filing Type eCTD

Code

<extensions>

<extension type="m1-au"

version="0.9">

<field

name="sequenceDescription" type="string" >seq-desc-0000</

field>

</extension>

</extensions>

There are four types of additional parameters:

1. date
2. date range (i.e. two dates, "from date" and "to date")
3. number and date
4. description

If a customer selects the 1st type of additional parameter, the system yields the sequenceDescription field and date (see example):

<extensions>

<extension type="m1-au"

version="0.9">

<field

name="sequenceDescription" type="string" >seq-desc-22</

field>

<field name="xValue1" type="date" >1487887200000</

field>

</extension>

</extensions>

©Ennov 2024

Ennov

sequenceDescription 531 fieldEnnov InSight Adminis and date range

(see example):

eSubmission

Identifier

Identifies the type of activity that is being submitted with the sequence: either the regulatory activity type if it is the first sequence of the regulatory activity, or supplementary

information if it is a follow-up to information already submitted for the regulatory activity.

Australian

Approved

Name(s)

Product

Name

The Australian

Register of Therapeutic Goods number should be provided if available.

The ARTG can be a

four, five, or six digit number.

eCTD Code value from Data Administration >

Sequence

Description Values

Sequence Code

(without prefix "P")

Related

Sequence

Number

Identifies the group within the TGA which is expected to take the lead in the review process.

The regulatory activity lead defined list of codes and values is managed at <http:// apps.tga.gov.au/ downloads/regactivity-lead.xml>. Applicants should

refer to this list for current list values.

eCTD Code value from Data Administration >

Regulatory Activity

Lead Values

Identifies the type of activity that is being submitted with the sequence: either the regulatory activity type if it is the first sequence of the regulatory activity, or supplementary

information if it is a follow-up to information already submitted for the regulatory activity.

The sequence type defined list of codes and values is available from http:// apps.tga.gov.au/ downloads/sequencetype.xml.

eCTD Code value from Data Administration >

Filing Type Values >

Filing Type eCTD

Code

<extensions>

<extension type="m1-au"

version="3.0">

<field

name="sequenceDescription" type="string" >seq-desc-0000</

field>

</extension>

</extensions>

There are four types of additional parameter:

1. date
2. date range (i.e. two dates, "from date to date")
3. number and date
4. description

If a customer selects the 1st type of additional parameter, the system yields the sequenceDescription field and date (see example):

<extensions>

<extension type="m1-au"

version="3.0">

<field

name="sequenceDescription" type="string" >seq-desc-22</

field>

<field name="xValue1" type="date" >1487887200000</

field>

</extension>

</extensions>

eSubmission

Identifier

The value should consist of the small EN letter and 6 digits ([a-z]

([0-9]{6})

Identifies the type of activity that is being submitted with the sequence, either the regulatory activity

type if it is the first sequence of the regulatory activity, or supplementary

information if it is a follow-up to information already submitted for the regulatory activity.

The name of the active ingredients that are accepted for inclusion in the Australian

Approved Name

list. Multiple

comma-separated values can be provided.

ARTG

Number(s)

The Australian

Register of Therapeutic Goods number should be

provided if available.

The ARTG can be

a four, five, or six digit number

Submission of

Application

Number(s)

The submission number(s) or application number(s) applicable to the sequence being

submitted. Multiple comma-separated values can be provided.

Sequence Code

(without prefix

"P")

Related

Sequence

Number

Identifies the group within the TGA which is expected to take the lead in the review process. The regulatory activity lead defined list of codes and values is managed at <http:// apps.tga.gov.au/ downloads/regactivity-lead.xml>. Applicants should

refer to this list for current list values.

eCTD Code value from Data Administration >

Regulatory

Activity Lead

Values

Submission

Mode

One of "single",

"work-sharing",

"work-grouping"

Identifies the type of activity that is being submitted with the sequence: either the regulatory activity

type if it is the first sequence of the regulatory activity, or supplementary

information if it is a follow-up to information already submitted for the regulatory activity.

The sequence type defined list of codes and values is available from <http:// apps.tga.gov.au/ downloads/ sequencetype.xml>.

eCTD Code value from Data Administration >

Filing Type

Values > Filing

Type eCTD Code

Content description for the submitted sequence should be one of the values from the defined list. Codes have been implemented to help provide consistency of input and reduce validation issues based on semantics of values.

The sequence description defined list of codes and values is available from <http:// apps.tga.gov.au/ downloads/ sequencedescription.xml>.

eCTD Code value from Data Administration >

Sequence

Description

Values

 <extensions>
  <extension type="m1-au" version="3.1">
   <field name="sequenceDescription" type="string" >seq-desc-19</field>
   <field name="xValue3" type="map"> <!-- it is predefined value -->
    <value key="999__uniqueSuffix__0" value="24-Feb-2017" /> <!-- number/date pair -->
   </field>
  </extension>
 </extensions>

Where:

999__uniqueSuffix__0 - it is xValue3_text, "999" is number and "__uniqueSuffix__0" is predefined suffix

24-Feb-2017 - it is xValue3_date

 <extensions>
  <extension type="m1-au" version="3.1">
   <field name="sequenceDescription" type="string" >seq-desc-0004</field>
   <field name="xValue4" type="string">description for sequenceDescription</field> <!-- description -->
  </extension>
 </extensions>

The value must represent a valid e-mail, the validation mask is ^([\sa-zA-

Z0-9._%-]+@[azA-Z0-9.-]+\.[azA-Z]{2,4})$

The value should consist of the small EN letter and 6 digits ([a-z]

([0-9]{6})

ARTG

Number(s)

The Australian Register of Therapeutic Goods number should be

provided if available.

The ARTG can be a four, five, or six digit number

The submission number(s) or application number(s) applicable to the sequence being submitted. Multiple comma-separated values can be provided.

Sequence Code (without prefix "P")

Related

Sequence

Number

Identifies the group within the TGA which is expected to take the lead in the review process. The regulatory activity lead defined list of codes and values is managed at <http:// apps.tga.gov.au/ downloads/regactivity-lead.xml>. Applicants should

refer to this list for current list values.

eCTD Code value from Data Administration > Regulatory Activity Lead Values

Submission

Mode

"Identifies the type of activity that is being submitted with the sequence, either the regulatory activity type if it is the first sequence of the regulatory activity or supplementary information if it is a follow-up to information already submitted for the regulatory activity.

Content description for the submitted sequence should be one of the values from sequence-description.

Refer to the sequence description for the current list of values. Please be aware that additional attributes for sequence description cannot be specified in workgrouping submission mode.

The examples listed below are a subset of the overall list and show how to handle the different approaches.

Multiple Sequence Type/Sequence description pairs are used if Submission Mode is set to work-grouping"

Belongs to sequenceDescription field.

In UI sequenceDescription field is a list with values, some values have or do not have additional parameters.

If a customer selects a value with no additional parameter, then the system yields the following XML (see example):

seq-desc-0000

There are four types of additional parameter:

1. date
2. date range (i.e. two dates, "from date to date")
3. number and date
4. description

If a customer selects the 1st type of additional parameter, the system yields the sequenceDescription field and date (see example):

seq-desc-221487887200000

If a customer selects the 2nd type of additional parameter, the system yields the sequenceDescription field and date range (see example):

seq-desc-20 xValue1 date Belongs to sequenceDescription field. In UI sequenceDescription field is a list with values, some values have or do not have additional parameters. If a customer selects a value with no additional parameter, then the system yields the following XML (see example):seq-desc-0000 There are four types of additional parameter:

1. date
2. date range (i.e. two dates, "from date to date")
3. number and date
4. description

If a customer selects the 1st type of additional parameter, the system yields the sequenceDescription field and date (see example):

seq-desc-221487887200000

If a customer selects the 2nd type of additional parameter, the system yields the sequenceDescription field and date range (see example):

seq-desc-2014878872000001487973600000

If a customer selects the 3rd type of additional parameter, the system yields the sequenceDescription field and number/date pair (see example):

seq-desc-19

Where:

999__uniqueSuffix__0 - it is xValue3_text, "999" is number and "__uniqueSuffix__0" is predefined suffix

24-Feb-2017 - it is xValue3_date

If a customer selects the 4th type of additional parameter, the system yields the sequenceDescription field and description (see example):

seq-desc-0004description for sequenceDescription

The value must represent a valid e-mail, the validation mask is ^([\sa-zA-

Z0-9._%-]+@[azA-Z0-9.-]+\.[azA-Z]{2,4})$

eSubmission

Identifier

The value should consist of the small EN letter and 6 digits ([a-z]

([0-9]{6})

Identifies the type of activity that is being submitted with the sequence, either the regulatory activity

type if it is the first sequence of the regulatory activity, or supplementary

information if it is a follow-up to information already submitted for the regulatory activity.

The name of the active ingredients that are accepted for inclusion in the Australian

Approved Name

list. Multiple

comma-separated values can be provided.

The name or proposed product (trade) name to be used on the Certificate of Registration.

Multiple commaseparated values can be provided.

ARTG

Number(s)

The Australian

Register of Therapeutic Goods number should be

provided if available.

The ARTG can be

a four, five, or six digit number

Submission of

Application

Number(s)

The submission number(s) or application number(s) applicable to the sequence being

submitted. Multiple comma-separated values can be provided.

Sequence Code

(without prefix

"P")

Related

Sequence

Number

Identifies the group within the TGA which is expected to take the lead in the review process. The regulatory activity lead defined list of codes and values is managed at <http:// apps.tga.gov.au/ downloads/regactivity-lead.xml>. Applicants should

refer to this list for current list values.

eCTD Code value from Data Administration >

Regulatory

Activity Lead

Values

Submission

Mode

One of "single",

"work-sharing",

"work-grouping"

Identifies the type of activity that is being submitted with the sequence: either the regulatory activity

type if it is the first sequence of the regulatory activity, or supplementary

information if it is a follow-up to information already submitted for the regulatory activity.

The sequence type defined list of codes and values is available from <http:// apps.tga.gov.au/ downloads/ sequencetype.xml>.

eCTD Code value from Data Administration >

Filing Type

Values > Filing

Type eCTD Code

Content description for the submitted sequence should be one of the values from the defined list. Codes have been implemented to help provide consistency of input and reduce validation issues based on semantics of values.

The sequence description defined list of codes and values is available from <http:// apps.tga.gov.au/ downloads/ sequencedescription.xml>.

eCTD Code value from Data Administration >

Sequence

Description

Values

<extensions>

<extension type="m1-aunees" version="2.0">

<field

name="sequenceDescription"

type="string" >seqdesc-0000</field>

</extension>

</extensions>

There are four types of additional parameters:

1. date
2. date range (i.e. two dates, "from date" and "to date")
3. number and date
4. description

If a customer selects the 1st type of additional parameter, the system yields the sequenceDescription field and date (see example):

<extensions>

<extension type="m1-aunees" version="2.0">

<field

name="sequenceDescription"

type="string" >seqdesc-22</field>

<field name="xValue1"

type="date"

>1487887200000</field>

</extension>

</extensions>

If a customer selects the 2nd type of additional parameter, the system yields the sequence

The value must represent a valid e-mail, the validation mask is ^([\sa-zA-

Z0-9._%-]+@[azA-Z0-9.-]+\.[azA-Z]{2,4})$

Field

Name

at, be, bg, common, cy, cz, de, dk,

ee, el, emea, es, fi, fr, hu, ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk

Field

Name

at, be, bg, common, cy, cz, de, dk,

ee, el, emea, es, fi, fr, hu, ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk

Field

Name

Field

Name

Field

Name

Matching

UI Field

Show all EU countries, plus EMEA and Common. List of countries: at, be, bg, common, cy, cz, de, dk,

edqm, ee, el, es, ema, fi, fr, hr, hu, ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk, xi.

Matching UI

Ffield

Related

Sequence

Number

Sequence Code

(without prefix

"P")

Date format -

Unix

Timestamp.

Submission

Identifier

Application

Code

The Filing type of the submission. Based on the Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

— CTA

— CTA-A

— IND

— NDS

— SNDS

— ANDS

— ABNDS

— SANDS

— ABSNDS

— NC

— DIN

— ADMIN

The high-level type of the

Application.

— Biologic Dossier

— Drug Master File

Dossier

— Pharmaceutical Dossier

The Filing type of the submission.

Based on the

Sequence's

Filing Type eCTD

Code in Ennov InSight , otherwise blank.

NDS, SNDS, SNDS-C,

ANDS, SANDS, NC, CTA,

CTA-A, DINA, DINB, PDC,

PDC-B, PSUR-C, PSURPV, UD-PV, RMP-PV, Level

III, YBPR, MPNDS,

MPSNDS, MPNC, MPDIN,

PRECTA, PRNDS,

PRSNDS, PAND, DMF type

I, DMF type II, DMF type

III, DMF type IV, EU NDS,

EU SNDS, UDRA, DSUR

— Pharmaceutical

— Biological

— Post-Marketed Pharmacovigilance

— Drug Master File

The description of the

Submission to be included in the XML.

Note: The numeric values

are not supported.

Related

Sequence

Number

Application

Number

Invented

Name

The invented name of the Product being

submitted. Multiple comma-separated values can be provided.

Identifies the submission as

Paragraph 13 TPA.

— yes

— no

Sequence Code

(without prefix

"P")

The Filing type of the submission. Based on the Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

na-nas, na-ngf, na-nko, na-bws, na-gen, na-ie, nande, na-ndo, notification, varauthorisationscientific, varauthorisationadmin, renewal,

psur, pi, eas, comarketing, withdrawal, varpi, transfer, dmf, pmf, reformat,

supplementalinfo-to,

corrigendum

Application

Number

Invented

Name

Identifies the submission as

Paragraph 13 TPA.

— yes

— no

Sequence Code

(without prefix

"P")

The Filing type of the submission. Based on the Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

na-nas, na-ngf, na-nko, na-bws, na-gen, na-ie, nande, na-ndo, notification, varauthorisationscientific, varauthorisationadmin, renewal,

psur, pi, eas, comarketing, withdrawal, varpi, transfer, dmf, pmf, reformat, supplementalinfo, corrigendum

Application

Number

Invented

Name

Identifies the submission as

Paragraph 13 TPA.

— yes

— no

Sequence Code

(without prefix

"P")

The Filing type of the submission. Based on the Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

eas, co-marketing, corrigendum, dmf, na-gen, na-bws, na-nas, na-nko, na-nde, na-ndo, na-ngf, na-ie, orphan-fasttrack, pi, psur, pmf, reformat, renewal, supplemental-

info, transfer, varpi, varauthorisationscientific, notification, varauthorisationadmin, withdrawal

Application

Number

Invented

Name

— yes

— no

Sequence Code

(without prefix

"P")

The Filing Type of the submission. Based on the Sequence's Filing Type eCTD Code in Ennov

InSight , otherwise blank.

eCTD Code value from Data Administration >

Filing Type

Values > Filing

Type eCTD Code

Application

Number

Application

Code

The Drug Master File

Holder for the Product the submission is for.

The Drug Master File

Number for the Product the submission is for.

Invented

Name

The invented name of the Product being

submitted. Multiple comma-separated values can be provided.

Identifies the submission as

Paragraph 13 TPA.

— yes

— no

The Plasma Master

File Holder for the Product the submission is for.

The Plasma Master

File Number for the Product the submission is for.

Sequence Code

(without prefix

"P")

eCTD Code value from Data Administration >

Filing Type

Values > Filing

Type eCTD Code

Application

Number

Application

Code

Application

Code

DMF

Number

Invented

Name

Article 13

TPA

— yes

— no

PMF

Number

Plasma Master File

Number for the Product the submission is for.

Sequence Code

(without prefix

"P")

eCTD Code value from Data Administration >

Filing Type

Values > Filing

Type eCTD Code

Matching

UI Field

Galenic

Form Name

The name

of the galenic form.

The number

for the galenic form from the SwissMedic agency.

Galenic

Language

Name

— de

— fr

— it

— en

Example: <field name="galenicNameLanguage" type="map"><value key="en" value="english" /></field>

Galenic Form

Name

Example:

"12345", or

"pending"

Galenic

Language Name

— de

— fr

— it

Galenic

Language Text

The Galenic

Language Text.

Application

Number

Application

Type

— cnapt1

— cnapt2

— cnapt3

Defaults based on Application Type from the parent

Application.

— cnprt1

— cnprt2

Original

Number

The basic and permanent number given to a drug entering the registration approval process. The original number is assigned by the regulatory agency and is used as the

unique

identification code to identify the applicant, active ingredient (API) and dosage form.

The sequence

first submitted in a regulatory activity is called the related sequence of all sequences submitted in the regulatory activity.

Regulatory

Activity

Type

The type of regulatory

activity: i.e. the regulatory purpose the filing is addressing.

— cnrat1

— cnrat2

— cnrat3

— cnrat4

— cnrat5

— cnrat6

— cnrat7

Defaults based on Filing Type from the parent Sequence,

for initial

Sequence

Assembly.

— cnsqt1

— cnsqt2

— cnsqt3

— cnsqt4

A brief

description of the sequence purpose, which is used to distinguish the sequence of similar type.

Unicode symbols for all text values must be encoded using numeric character reference, for example:

&#26679;&#26412.

Sequence

Contact

Name

Sequence

Contact

Telephone

Number

Sequence

Contact

Email

Drug Product

Name

Drug Product

Name

The manufacturer of

the Active

Ingredient.

Drug Substance

Name

Matching

UI Field

at, be, bg, common, cy, cz, de, dk, edqm, ee, el, ema, es, fi, fr, hr, hu, ie, is, it, li, lt,lu, lv, mt, nl, no,

pl, pt, ro, se,si, sk,

uk

Agency

Name

Application

Number

Defines which country the envelope information is related to. Defaults based on the Application's Country. Show all EU

countries, plus

EMEA and common.

Invented

Name

The procedure type being used to submit. Based on the

Application's Procedure Type.

— centralised

— national

— mutual-recognition

The related sequence number as well as the country for the specific relation.

Country values

include all of

Europe,

Common, and EMEA.

The Filing type of the submission. Based on the

Sequence's Filing Type eCTD Code in Ennov InSight , otherwise blank.

— arbitration

— cond-specific-obligation

— dmf

— follow-up

— initial-maa

— psur

— renewal

— safety

— sepcific-obligation — supplemental-info

— var-type1a

— var-type1b

— var-type2

The description of the

Submission to be included in the XML.

Agency

Name

Application

Number

The Application Number

provided by the agency.

Defines which country the envelope information is related to. Defaults based on the Application's Country. Show all EU

countries, plus EMEA and Common.

Invented

Name

The procedure type being used to submit. Based on the

Application's Procedure Type.

— centralised

— national

— mutual-recognition

The related sequence number as well as the country for the specific relation.

Country values

include all of

Europe,

Common, and EMEA.

The Filing type of the submission. Based on the

Sequence's Filing Type eCTD Code in Ennov InSight , otherwise blank.

— arbitration

— cond-specific-obligation

— dmf

— follow-up

— initial-maa

— psur

— renewal

— safety

— sepcific-obligation — supplemental-info

— var-type1a

— var-type1b

— var-type2

The description of the

Submission to be included in the XML.

Agency

Name

Application

Number

Defines which country the envelope information is related to. Defaults based on the Application's Country. Show all EU

countries, plus

EMEA and common.

Invented

Name

The procedure type being used to submit. Based on the

Application's

Procedure Type

— centralised

— national

— mutual-recognition

The related sequence number as well as the country for the specific relation.

Country values

include all of

Europe,

Common, and

EMEA

The Filing type of the submission. Based on the

Sequence's Filing Type eCTD Code in Ennov InSight , otherwise blank.

— arbitration

— cond-specific-obligation

— dmf

— follow-up

— initial-maa

— psur

— renewal

— safety

— sepcific-obligation — supplemental-info

— var-type1a

— var-type1b

— var-type2

The description of the

Submission to be included in the XML.

Agency

Name

AT-AGES, BE-FAMHP, BG-

BDA, BG-NVS, CY-VS, CZ-

SUKL, CZ-USKVBL, DEBFARM, DE-BVL, DE-PEI,

DK-DKMA, EE-SAM, ELEOF, ES-AGEMED, FINAM, FR-AFSSAPS, FR-

ANMV, HU-IVMP, HUOGYI, IE-IMB, IE-DAFF,

IS-IMCA, IT-AIFA, IT-LMV,

IT-SPV, LI-LLV, LT-SMCA,

LT-VVPI, LT-VMVT, LUMINSANT, LV-ZVA, MTMRU, MT-MEDAUTH, NLMEB, NO-NOMA, PL-URPL,

PT-DGV, PT-INFARMED,

RO-ANM, SE-MPA, SI-

JAZMP, SK-SIDC, SKUSKVBL, UK-MHRA, UKVMD, EU-EMEA

The name of the company

submitting the Application.

Application

Number

Defines which country the envelope information is related to. Defaults based on the Application's

Country. Show all

EU countries, plus EMEA and Common.

at, be, bg, cy, cz, de, dk,

ee, el, emea, es, fi, fr, hu, ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk

Invented

Name

— centralised

— national

— mutual-recognition

The related sequence number as well as the country for the specific relation. Country values include all of

Europe, Common, and EMEA.

The Filing type of the submission. Based on the

Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

— initial-maa

— supplemental-info

— fum

— specific-obligation

— var-type1a

— var-type1b

— var-type2 — extension

— psur

— renewal

— asmf

— referral

— annual-reassessment

— usr

— article-58

— notification-61-3

— transfer-ma,

— corrigendum

— lifting-suspension

— withdrawal

— paed-article-29

— var-nat

— reformat

Agency

Name

AT-AGES, BE-FAMHP, BG-

BDA, BG-NVS, CY-VS, CZ-

SUKL, CZ-USKVBL, DEBFARM, DE-BVL, DE-PEI,

DK-DKMA, EE-SAM, ELEOF, ES-AGEMED, FINAM, FR-AFSSAPS, FR-

ANMV, HU-IVMP, HUOGYI, IE-IMB, IE-DAFF,

IS-IMCA, IT-AIFA, IT-LMV,

IT-SPV, LI-LLV, LT-SMCA,

LT-VVPI, LT-VMVT, LUMINSANT, LV-ZVA, MTMRU, MT-MEDAUTH, NLMEB, NO-NOMA, PL-URPL,

PT-DGV, PT-INFARMED,

RO-ANM, SE-MPA, SI-

JAZMP, SK-SIDC, SKUSKVBL, UK-MHRA, UKVMD, EU-EMEA

The name of the company

submitting the Application.

Application

Number

Defines which country the envelope information is related to. Defaults based on the Application's Country. Show all

EU countries, plus

EMEA and common

at, be, bg, cy, cz, de, dk,

ee, el, emea, es, fi, fr, hu, ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk

Invented

Name

— centralised

— national

— mutual-recognition

The related sequence number as well as the country for the specific relation. Country values include all of

Europe, Common, and EMEA.

The Filing type of the submission. Based on the

Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

— initial-maa

— supplemental-info

— fum

— specific-obligation

— var-type1a

— var-type1b

— var-type2 — extension

— psur

— renewal

— asmf

— pmf

— referral

— annual-reassessment

— usr

— article-58

— notification-61-3

— transfer-ma,

— corrigendum

— lifting-suspension

— withdrawal

— paed-article-29

— paed-article-46

— var-nat

— reformat

Agency

Name

AT-AGES, BE-FAMHP, BG-

BDA, CY-PHS, CZ-SUKL,

DE-BFARM, DE-PEI, DK-

DKMA, EE-SAM, EL-EOF,

ES-AEMPS, FI-FIMEA, FR-

ANSM, HR-HALMED, HU-

OGYI, IE-IMB, IS-IMCA,

IT-AIFA, LI-LLV, LT-SMCA,

LU-MINSANT, LV-ZVA,

MT-MEDAUTH, NL-MEB,

NO-NOMA, PL-URPL, PT-

INFARMED, RO-ANMMD, SE-MPA, SI-JAZMP, SKSIDC, UK-MHRA, EU-EMA

The name of the company

submitting the Application.

Application

Number

Defines which country the envelope information is related to. Defaults based on the Application’s

Country. Show all

EU countries, plus EMEA and Common.

at, be, bg, cy, cz, de, dk, ee, el, ema, es, fi, fr, hu, hr, ie, is, it, li, lt, lu, lv, mt,

nl, no, pl, pt, ro, se, si, sk,

uk

Invented

Name

— centralised

— national

— mutual-recognition

The related sequence number as well as the country for the specific relation. Country values include all of

Europe, Common, and EMEA.

The Filing type of the submission. Based on the

Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

— initial-maa

— supplemental-info

— fum

— specific-obligation

— var-type1a

— var-type1b

— var-type2 — extension

— psur

— renewal

— asmf

— pmf

— referral

— annual-reassessment

— usr

— article-58

— notification-61-3

— transfer-ma,

— corrigendum

— lifting-suspension

— withdrawal

— paed-article-29

— paed-article-46

— var-nat

— reformat

— rmp

Defines which country the envelope information is related to. Defaults

based on Application's Country.

at, be, bg, cy, cz, de, dk, ee, edqm, el, ema, es, fi, fr, hu, hr, ie, is, it, li, lt, lu, lv, mt, nl, no,

pl, pt, ro, se, si, sk,

uk

A UUID as specified by ISO/IEC 11578:1996 and

ITU-T Rec X.667 |

ISO/IEC

9834-8:2005. The

same UUID must be

used for all sequences of an eCTD application. Defaults based on the UUID from the parent Application.

The UUID must be in the form of

xxxxxxxx-xxxxMxxx-Nxxxxxxxxxxxxxxx, where:

— x is a hexadecimal number

— M is 1-5

— N is 8, 9, a or b

The Filing type of the submission. Based on the

Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

eCTD Code value from Data Administration >

Filing Type Values

> Filing Type eCTD

Code

Submission

Mode

— single

— grouping

— worksharing

High Level/

Worksharing

Submission

Number

The high level submission number for the specific submission, used when the

submission mode is Grouping or

Worksharing.

Application

Tracking

Number

— initial

— validationresponse — response

— additional-info

— closing

— consolidating

— corrigendum

— reformat

Agency

Name

AT-BASG, BEFAMHP, BG-BDA,

CY-PHS, CZ-SUKL,

DE-BFARM, DE-

PEI, DK-DKMA,

EE-SAM, EL-EOF,

ES-AEMPS, FIFIMEA, FR-ANSM,

HR-HALMED, HU-

OGYI, IE-HPRA,

IS-IMCA, IT-AIFA,

LI-LLV, LT-SMCA,

LU-MINSANT, LV-

ZVA, MT-

MEDAUTH, NLMEB, NO-NOMA,

PL-URPL, PTINFARMED, ROANMMD, SE-MPA,

SI-JAZMP, SKSIDC, UK-MHRA,

EU-EMA, EUEDQM

— centralised

— national

— mutual-

recognition

— decentralised

Invented

Name

Sequence Code

(without prefix

"P")

This is the sequence number of previous submission(s) to which this submission relates, for example the responses to questions to a particular variation. If value of submissionUnit field is ‘initial’ and ‘reformat’ then value of relatedSequence

field is identical to the value of sequence field. Multiple commaseparated values can be provided.

Defines which country the envelope information is related to. Defaults based on the Application’s

Country. Show all EU countries, plus EMA and EDQM.

at, be, bg, cy, cz, de, dk, ee, edqm, el, ema, es, fi, fr, hu, hr, ie, is, it, li, lt, lu, lv, mt, nl, no,

pl, pt, ro, se, si, sk,

uk

A UUID as specified by ISO/IEC 11578:1996 and

ITU-T Rec X.667 |

ISO/IEC

9834-8:2005. The

same UUID must be

used for all sequences of an eCTD application. Defaults based on the UUID from the parent Application.

The UUID must be in the form of

xxxxxxxx-xxxxMxxx-Nxxxxxxxxxxxxxxx, where:

— x is a hexadecimal number

— M is 1-5

— N is 8, 9, a or b

The Filing type of the submission. Based on the

Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

eCTD Code value from Data Administration >

Filing Type Values

> Filing Type eCTD

Code

Submission

Mode

— single

— grouping

— worksharing

High Level/

Worksharing

Submission

Number

The high level submission number for the specific submission, used when the

submission mode is Grouping or

Worksharing.

Application

Tracking

Number

— initial

— validationresponse — response

— additional-info

— closing

— consolidating

— corrigendum

— reformat

Agency

Name

AT-BASG, BEFAMHP, BG-BDA,

CY-PHS, CZ-SUKL,

DE-BFARM, DE-

PEI, DK-DKMA,

EE-SAM, EL-EOF,

ES-AEMPS, FIFIMEA, FR-ANSM,

HR-HALMED, HU-

OGYI, IE-HPRA,

IS-IMCA, IT-AIFA,

LI-LLV, LT-SMCA,

LU-MINSANT, LV-

ZVA, MT-

MEDAUTH, NLMEB, NO-NOMA,

PL-URPL, PTINFARMED, ROANMMD, SE-MPA,

SI-JAZMP, SKSIDC, UK-MHRA,

EU-EMA, EUEDQM

— centralised

— national

— mutual-

recognition

— decentralised

Invented

Name

Sequence Code

(without prefix

"P")

This is the sequence number of previous submission(s) to which this submission relates,

e.g. the responses to questions to a particular variation. If value of submissionUnit field is ‘initial’ and ‘reformat’ then value of relatedSequence

field is identical to the value of sequence field. Multiple commaseparated values can be provided.

Defines which country the envelope information is related to. Defaults based on the Application’s

Country. Show all

EU countries, plus EMA and EDQM.

Show all EU countries, plus EMA and EDQM.

The list is: at, be, bg, cy, cz, de, dk, edqm, ee, el, es,

ema, fi, fr, hr, hu,

ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk, xi.

A UUID as specified by ISO/IEC 11578:1996 and

ITU-T Rec X.667 |

ISO/IEC

9834-8:2005. The

same UUID must be

used for all sequences of an eCTD application. Defaults based on the UUID from the parent Application.

The UUID must be in the form of

xxxxxxxx-xxxxMxxx-Nxxxxxxxxxxxxxxx, where:

— x is a hexadecimal number

— M is 1-5

— N is 8, 9, a or b

The Filing type of the submission. Based on the

Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

eCTD Code value from Data Administration >

Filing Type Values

> Filing Type eCTD

Code

Submission

Mode

— single

— grouping

— worksharing

High Level/

Worksharing

Submission

Number

The high level submission number for the specific submission, used when the

submission mode is Grouping or

Worksharing.

Application

Tracking

Number

— initial

— validationresponse — response

— additional-info

— closing

— consolidating

— corrigendum

— reformat

Agency

Name

AT-BASG, BEFAMHP, BG-BDA,

CY-PHS, CZ-SUKL,

DE-BFARM, DE-

PEI, DK-DKMA,

EE-SAM, EL-EOF,

ES-AEMPS, FIFIMEA, FR-ANSM,

HR-HALMED, HU-

OGYI, IE-HPRA,

IS-IMCA, IT-AIFA,

LI-LLV, LT-SMCA,

LU-MINSANT, LV-

ZVA, MT-

MEDAUTH, NLMEB, NO-NOMA,

PL-URPL, PTINFARMED, ROANMMD, SE-MPA,

SI-JAZMP, SKSIDC, UK-MHRA,

EU-EMA, EUEDQM

— centralised

— national

— mutual-

recognition

— decentralised

Invented

Name

Sequence Code

(without prefix "P")

This is the sequence number of previous submission(s) to which this submission relates, e.g. the responses to questions to a particular variation. If value of submissionUnit field is ‘initial’ and ‘reformat’ then value of relatedSequence

field is identical to the value of sequence field. Multiple commaseparated values can be provided.

Electronic

Document ID.

EDoc

Reference Id

Electronic

Document ID of the document the current document is referred to.

Registration

Number Id

— 01 – mutual recognition: MRP.

— 02 - decentralized:

DCP.

Solvent

Manufacturer

Application

Number

The name of the

applicant filing the submission

BH-MOH, KWMOH, OM-MOH,

QA-NHA, YEMOPHP, SA-SFDA,

AE-MOH

The Filing type of the submission. Based on the Sequence's Filing

Type eCTD Code in Ennov InSight , otherwise blank.

— new-gen — new-nce

— new-bio

— new-rad — new-her

— new-hea

— new-vet

— renewal

— var-type1

— var-type2

— transfer-ma

— withdrawal

— responses

— psur

— gcc

— national

Invented

Name

Sequence Code

(without prefix

"P")

Application

Number

BH-MOH, KWMOH, OM-MOH,

QA-NHA, YEMOPHP, SA-SFDA,

AE-MOH

eCTD Code value from Data Administration >

Filing Type Values

> Filing Type eCTD

Code

— gcc

— national

Invented

Name

Sequence Code

(without prefix

"P")

Application

Tracking

Number

The name of the company

submitting the Application.

Agency

Name

— HR-AZLMP

— HR-VET

The Filing type of the submission. Based on the

Sequence's Filing Type eCTD Code

in Ennov InSight , otherwise blank.

— initial-maa

— supplemental-info

— fum

— specific-obligation

— var-type1a

— var-type1b

— var-type2 — extension

— psur

— renewal

— asmf

— pmf

— referral

— annualreassessment

— usr

— article-58

— notification-61-3

— transfer-ma

— corrigendum

— lifting-suspension

— withdrawal

— paed-article-29

— paed-article-46

— var-nat

— reformat

Submission

Mode

The mode of the submission, either Single, Grouping, or

Worksharing.

— single

— grouping

— worksharing

High Level

Submission

Number

The procedure type being used to submit. Based on the

Application's

Procedure Type.

— centralised

— national

— mutual-

recognition

— decentralised

Invented

Name

Sequence Code

(without prefix "P")

The related sequence number as well as the country for the specific relation. Country values include all

of Europe,

Common and

EMEA

The description of the

Submission to be included in the XML.

Field

Name

Matching

UI Field

Field

Name

Matching

UI Field

Field

Name

Matching

UI Field

Field

Name

Matching

UI Field

Field

Name

Matching

UI Field

at, be, bg, common, cy, cz, de, dk, edqm, ee, el, ema, es, fi, fr,

hr, hu, ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk

Field

Name

Matching

UI Field

Show all EU countries, plus EMEA and Common. List of countries: at, be, bg, common, cy, cz, de, dk, edqm, ee, el,

es, ema, fi, fr, hr, hu, ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk, xi.

Field

Name

at, be, bg, common, cy, cz, de, dk,

ee, el, emea, es, fi, fr, hu, ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk

Field

Name

— spc

— annex2

— outer

— interpack

— impack

— other

— pl

— combined

— spc

— annex2

— outer

— interpack

— impack

— other

— pl

— combined

— spc

— annex2

— outer

— interpack

— impack

— other

— pl

— combined

Matching

UI Field

Show all EU countries, plus EMEA and Common. List of countries:

at,be,bg,common,cy,cz,de,dk,edqm,ee,el,es,ema,fi,fr,hr,hu,ie,is,it,li,l

The language used for

submission in the defined country.

Application

Reference

Number

eCTD Code value from Data Administration >

Filing Type

Values > Filing

Type eCTD Code

— jo

— national

Invented

Name

Invented name of the

Product being submitted.

Sequence Code

(without prefix

"P")

Description of the

Submission to be included in the XML. Multiple related sequence numbers may be entered as comma-separated values.

— ae

— common

— bh

— kw

— om

— qa

— sa

— ye

— ar

— en

— ae

— common

— bh

— kw

— om

— qa

— sa

— ye

— ae

— common

— bh

— kw

— om

— qa

— sa

— ye

— ar

— en

— spc

— label

— pil