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CANOPY LIFECYCLE SUBMISSION REQUEST FORM
Lifecycle Submission Request (please make one request per submission)
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eCTD Sequence
NeeS Sequence
PIP Submission
Procedure Type
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EU Centralised
EU Decentralised
EU Mutual Recognition
EU National
UK National
Swissmedic
PIP Submission
FDA (NDA)
FDA (ANDA)
FDA (BLA)
FDA (IND)
FDA (PreIND)
FDA (EUA)
FDA (DMF)
AU TGA
Health Canada
GCC
Submission to which Country?
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Product
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Sequence (e.g. 0000, 0001 etc)
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Related Sequence
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EU CP Application Number (e.g. EMEA/H/C/000123)
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EU MRP/DCP/NP/UK/PIP Application Number (e.g. UK/H/0123/001)
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EU Tracking Number (e.g. EMEA/H/C/000123/II/G, UK/H/0123/001/IA/001)
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FDA Application Number (e.g 123456)
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Swissmedic Number (e.g 65432)
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Swissmedic Application Number (e.g 123456789 or pending)
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TGA e-Identifier (e.g e123456)
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ARTG (e.g. 123456 supplied when known)
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Health Canada Dossier Identifier (e.g e999999)
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EU Submission Type
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maa = Marketing Authorisation Application
var-type1a = Variation Type IA
var-type1ain = Variation Type IAIN
var-type1b = Variation Type IB
var-type2 = Variation Type II
var-nat = National variation (e.g. national variation to apply for a pack size that is already registered within an existing MRP/DCP authorisation)
rup = Repeat Use Procedure in decentralised or mutual recognition procedures to include one or more additional member states
extension = Extension
psur = Periodic Safety Update Report (PSUR) which should only be used for PSURs outside of the PSUSA
psusa = PSUR single assessment procedure
rmp = Risk Management Plan (outside any procedure)
renewal = Renewal (yearly or 5-yearly)
pam-sob = Specific obligation related to a post-authorisation measure
pam-anx = Annex II condition related to a post-authorisation measure
pam-mea = Additional pharmacovigilance activity in the risk-management plan related to a post-authorisation measures (RMP) (e.g. interim results of imposed/non-imposed interventional/non-interventional clinical or nonclinical studies)
pam-leg = Legally binding measure related to a post-authorisation measures
pam-sda = Cumulative review following a request originating from a PSUR or a signal evaluation related to a post-authorisation measure
pam-capa = Corrective Action/Preventive Action related to a post-authorisation measure
pam-p45 = Paediatric submissions related to a post-authorisation measure
pam-p46 = Paediatric submissions related to a post-authorisation measure
pam-paes = Submission of a post authorisation efficacy study
pam-rec = Recommendation related to a post-authorisation measures e.g. quality improvement related to a post-authorisation measure
pass107n = Submission of a post authorisation safety study protocol (according article 107n)
pass107q = Submission of a post authorisation safety study report (according article 107q)
asmf = Active Substance Master File
pmf = Plasma Master File
referral-20 = Referral under Article 20
referral-294 = Referral under Article 29(4)
referral-29p = Referral under Article 29 paediatric
referral-30 = Referral under Article 30
referral-31 = Referral under Article 31
referral-35 = Referral under Article 35
referral-5-3 = Referral under Article 5(3)
referral-107i = Referral under Article 107i
referral-16c1c = Referral under Article 16c (1c)i
referral-16c4 = Referral under Article 16c(4)
annual-reassessment = Annual Reassessment
usr = Urgent Safety Restriction
clin-data-pub-rp = Clinical data for publication – Redacted Proposal
clin-data-pub-fv = Clinical data for publication – Final Version
paed-7-8-30 = Paediatric submission related to a paediatric investigational plan according to article 7, 8 or 30 of the Regulation
paed-29 = Paediatric submission post approval once a paediatric investigational plan has been performed
paed-45= Paediatric submission according to article 45 of the Regulation
paed-46= Paediatric submission according to article 46 of the Regulation
article-58 = Article 58 (to be used for an initial application)
notification-61-3 = Notification 61(3)
transfer-ma = Transfer of a marketing authorisation
lifting-suspension = Lifting of a suspension
withdrawal = Withdrawal of a marketing authorisation in regard to a strength or form or entirely. This submission type shall not be used to withdraw a regulatory activity.
cep = Submission that applies to an application on a Certificate of suitability CEP application (EDQM only).
PIP Submission
none = In the exceptional case of reformatting the application no regulatory activity is allowed. Therefore, ‘none’ must be stated. The submission application unit will identify the sub-activity related to the product. In the submission description some information can be provided to e.g. highlight specific modules being reformatted .
EU Submission Unit Type
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initial = Initial submission to start any regulatory activity
validation-response = For rectifying business validation issues.
response = submission unit type that contains the response to any kind of question, validation issues out-standing information requested by the agency
additional-info = Other additional Information (could include, for example, missing files) and should only be used, if validation-response or response is not suitable
closing = Submission unit type that provides the final documents in the centralised procedure following the decision of the European Commission
consolidating = Submission unit type that consolidates the application after several information in the MRP or DCP handled outside the eCTD but that need to be integrated thereafter to maintain the life cycle properly. This submission unit type should also be used when consolidating the dossier in as a result of withdrawing or rejecting a single regulatory activity (not in case of the withdrawal of the entire application).
corrigendum = Correction to the published annexes in the centralised procedure (usually shortly after approval)
reformat = Intended to support the reformatting of an existing submission application from any format to eCTD, i.e. a baseline eCTD submission containing no content change and which will not be subject to review (see example below). This type will always be used together with the submission type ‘none’
FDA Submission Type
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Product Correspondence
Efficacy Supplement
Presubmission
Labeling Supplement
IND Safety Reports
Annual Report
Promotional Labeling Advertising
Periodic Safety Reports
Chemistry Manufacturing Controls Supplement
Original Application
Postmarketing Requirements or Postmarketing Commitments
FDA Submission Sub-Type
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Original
Presubmission
Report
Correspondence
Resubmission
Application
Amendment
Swissmedic Submission Type
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na-nas: New Active Substance
na-bws: Known Active Substance
na-co-marketing: Co-Marketing Medicinal Product
na-pi: Parallel Import
var-type1a = Type Ia variation
var-type1ain = Type Ia variation for immediate notification
var-type1b = Type Ib variation
var-type2 = Type II variation
extension = Extension
renewal = Prolongation, renouncement of prolongation of Marketing Authorisation, notification of no marketing or interruption to distribution
fum = Follow-up Measure
psur = Submission of PSUR
withdrawal = Withdrawal of authorised medicinal products
transfer = Transfer of a Marketing Authorisation, Change of name of applicant, change of address of applicant
dmf = Drug Master File
pmf = Plasma Master File
orphan-fasttrack = Application for recognition of orphan drug status or fast track status
reformat = A baseline eCTD submission containing no content change and which will not be subject to review
supplemental-info = Supplemental information (could include, for example, response to content validation issues, a consolidation
sequence, withdrawal of an application, or answers to question)
corrigendum = Correction of errors detected in a sequence
advice = Used for meetings
TGA Regulatory Activity Lead
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Complementary
Medical Devices
OTC
Pharmacovigilance
Prescription meds-chemical
Prescription meds-biological
TGA Sequence Type
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A - NCE New Chemical Entity
A - NCE New Salt or Ester of Existing Active Ingredient
A - NCE Similar Biological Medicinal Product
B - New Combination
C - Extension of Indication
6 D - New Generic Medicine
seq-type-8 F - Major Variation - New Strength
seq-type-9 F - Major Variation - New Dosage Form
seq-type-10 F - Major Variation - New Route of Administration
seq-type-11 F - Major Variation - Change in Patient Group
seq-type-12 F - Major Variation - Change of Dosage
seq-type-17 J - PI Change requiring evaluation
seq-type-13 G - Minor Variation, New Register Entry - Change of Formulation
seq-type-14 G - Minor Variation, New Register Entry - New Container Type
seq-type-16 H - Minor Variation, Not Resulting in a New Register Entry
seq-type-7 E - Additional Tradename
seq-type-15 Change of Tradename
seq-type-53 9D(1) - Correction of Register Entry
seq-type-54 9D(2) - Safety Related Request
seq-type-55 9D(3) - Change to PI (not J)
seq-type-58 Provisional reqistration - TGA initiated variation
seq-type-59 Notification
seq-type-20 OTC - N1
seq-type-21 OTC - N2
seq-type-22 OTC - N3
seq-type-23 OTC - N4
seq-type-24 OTC - N5
seq-type-60 CN
seq-type-25 OTC - C1
seq-type-26 OTC - C2
seq-type-27 OTC - C3
seq-type-28 OTC - C4
seq-type-30 Ingredient - New
seq-type-31 Ingredient - Variation
seq-type-32 Complementary Medicine - New
seq-type-33 Complementary Medicine - Variation
seq-type-34 Biologicals - Class 1
seq-type-35 Biologicals - Class 2
seq-type-36 Biologicals - Class 3
seq-type-37 Biologicals - Class 4
seq-type-38 Biologicals - Variation
seq-type-40 ASMF / DMF
seq-type-41 Plasma Master File (PMF)
seq-type-42 Tissue Master File (TMF)
seq-type-43 Biological Master File (BMF)
seq-type-44 Pharmacovigilance
seq-type-47 Periodic Safety Update Report
seq-type-48 Risk Management Plan
seq-type-61 Extension of provisional registration
seq-type-56 Change of Sponsor
seq-type-45 Supplementary information
seq-type-46 Baseline
seq-type-62 Duplicate
seq-type-49 Clinical Trial Application
seq-type-57 Product Withdrawal
seq-type-52 Undefined Regulatory Activity*
Health Canada Dossier Type
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Biologic Dossier
Pharmaceutical Dossier
Drug Master File Dossier
Health Canada Regulatory Activity Type
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NDS = New Drug Submission
SNDS = Supplement to a New Drug Submission
SNDS-C = Supplement to a New Drug Submission - Conditional
ANDS = Abbreviated New Drug Submission
SANDS = Supplement to an Abbreviated New Drug Submission
NC = Notifiable Change
CTA = Clinical Trial Application
CTA-A = Clinical Trial Application - Amendment
DINA = Drug Identification Number Application
DINB = Drug Identification Number - Biologics
PDC = Post DIN Change
PDC-B = Post DIN Change - Biologics
PSUR-C = Periodic Safety Update Report - Conditional
PSUR-PV = Periodic Safety Update Report - Pharmacovigilance
UD-PV = Undefined Data Pharmacovigilance
RMP-PV = Risk Management Plan - Pharmacovigilance
Level III = Post-Notice of Compliance Changes - Level III
YBPR = Yearly Biologic Product Report
MPNDS = Pre-NDS Meeting
MPSNDS = Pre-SNDS Meeting
MPNC = Pre-NC Meeting
MPDIN = Pre-DIN Meeting
PRECTA = Pre-Clinical Trial Application Meeting
PRNDS = Priority Request NDS
PRSNDS = Priority Request SNDS
PAND = Pandemic Application
DMF Type I = Drug Master File Type I
DMF Type II = Drug Master File Type II
DMF Type III = Drug Master File Type III
DMF Type IV = Drug Master File Type IV
EU NDS = Extraordinary Use New Drug Submission
EU SNDS = Extraordinary Use Supplement to a New Drug Submission
UDRA* = Undefined Regulatory Activity (*Do not use this regulatory activity without prior discussion with Health Canada)
DSUR = Development Safety Update Report
Health Canada Regulatory Activity Lead
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Pharmaceutical
Biological
Post-Market Pharmacovigilance
Drug Master File
Health Canada Sequence Description
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Administrative (NDS, ANDS, SNDS, SANDS, NC, DINA, DINB, EUNDS, EUSNDS)
Cancellation Letter (All types)
Change to DIN (DINA, DINB)
Comments on Notice of Decision dated mmm. dd, yyyy (NDS)
Drug Notification Form (NDS, SNDS, ANDS, SANDS, DINA, DINB, NC, EUNDS, EUSNDS)
For Period of mmm. dd, yyyy to mmm. dd, yyyy (PSUR-C, PSUR-PV, YBPR INITIAL NDS, ANDS, DINA, DINB, EUNDS)
Minutes of Meeting, mmm. dd, yyyy (All pre-submission meetings)
Pandemic Application (Upon consultation)
Post-Authorization Division 1 Change (PDC, PDC-B)
Post Clearance Data (NDS, SNDS, ANDS, SANDS, NC, EUNDS, EUSNDS, DINA, DINB)
Post NOC Change (SNDS, SANDS, EUSNDS, SNDS-C, NC)
Year, list of change number (for example: 2012, 15, 19a,….) (Level III Changes)
Pre-Submission Meeting Package (NDS, SNDS, NC, DINA, DINB)
Priority Review Request (NDS, SNDS)
Pristine PM (NDS, SNDS, ANDS, SANDS, SNDS-C, NC, EUNDS, EUSNDS, DINA, DINB)
Pristine PM - Second Language (NDS, SNDS, ANDS, SANDS, SNDS-C, NC, EUNDS, EUSNDS, DINA, DINB)
Response to BE Clarification Request dated mmm. dd, yyyy (NDS, SNDS, ANDS, SANDS)
Response to Clinical Clarification Request dated mmm. dd, yyyy (NDS, SNDS, ANDS, SANDS, SNDS-C, EUNDS, EUSNDS, NC, DINA, DINB, PSURC)
Response to e-mail Request dated mmm. dd, yyyy (All types)
Response to Labeling Clarification Request dated mmm. dd, yyyy (NDS, SNDS, ANDS, SANDS, SNDS-C, NC, EUNDS, EUSNDS, DINA, DINB)
Response to NOC/c-QN dated mmm.dd, yyyy (NDS, SNDS, ANDS, SANDS, SNDS-C, EUNDS, EUSNDS)
Response to NOL dated mmm. dd, yyyy (NC)
Response to NOD dated mmm. dd, yyyy (NDS, SNDS, ANDS, SANDS, SNDS-C, EUNDS, EUSNDS)
Response to NON dated mmm. dd, yyyy (NDS, SNDS, ANDS, SANDS, SNDS-C, EUNDS, EUSNDS)
Response to Processing Clarification Request dated mmm. dd, yyyy (All types)
Response to Quality and Clinical Clarification Request dated mmm. dd, yyyy (NDS, SNDS, ANDS, SANDS, NC, EUNDS, EUSNDS, DINA, DINB)
Response to Quality Clarification Request dated mmm. dd, yyyy (NDS, SNDS, ANDS, SANDS, NC, EUNDS, EUSNDS, DINA, DINB)
Response to Screening Acceptance Letter dated mmm. dd, yyyy (NDS, SNDS, ANDS, SANDS, SNDS-C, NC, EUNDS, EUSNDS, DINA, DINB)
Response to Screening Clarification Request dated mmm. dd, yyyy (NDS, SNDS, ANDS, SANDS, SNDS-C, NC, EUNDS, EUSNDS, DINA, DINB)
Response to SDN dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS, SNDS-C, EUNDS, EUSNDS)
Response to Telephone Request dated mmm. dd, yyyy (All types)
Risk communication document (UD-PV)
Post Marketing Surveillance (UD-PV)
Benefit Risk Assessment (UD-PV)
Signal Work Up (UD-PV)
Response to MHPD Requests dated mmm. dd, yyyy (UD-PV)
Notification of Change in benefit-risk profile (UD-PV)
RMP version
dated mmm. dd, yyyy (RMP-PV)
Unsolicited Data,
(NDS, SNDS, SANDS, SNDS-C, NC, EUNDS, EUSND, DINA, DINB, UDRA)
Comments on Summary Basis of Decision dated mmm. dd, yyyy (NDS, SNDS, EUNDS, EUSNDS, NC)
Response to Advisement Letter dated mmm. dd, yyyy (UDRA)
DIN Discontinued (UDRA)
UFRI Generic Pilot (ANDS, SANDS)
Print on Demand (All types)
Variation (Single/Grouped)
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Single Variation
Grouped Variation
Submission Description (e.g. A Variation to Update the SmPC)
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Submission Description
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Reformat
Product Information
Withdrawal
Response to Request for Information - {date:d}
RMP Version {number:l} - {date:d}
Pre-Submission Meeting Package
Provisional approval - rolling data submission - {date: d}
Uncategorised, {description:s}
Pre-Advisory Committee response
Minutes of Meeting - {date:d}
Unsolicited Data, {description:s}
Initial
Risk Communication Document
Patent Certification
Comments on evaluation reports - {date:d}
Notification of a Safety Issue
PSUR for Period of {from-date:d} to {to-date:d}
Working Documents required?
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Yes
No
Please List the Working Documents here:
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Document Plan Upload
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Submission Delivery Method
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Upload via EMA/FDA/CESP/MHRA Gateway
No thanks, please send us the package to submit
Please submit, but also send us a copy
Submission Delivery Method
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CESP
No thanks, CD's only
No thanks, please send us the package to submit
Please submit, but also send us a copy
Submission Delivery Method
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Submit to Swissmedic
No thanks, please send us the package to submit
Please submit, but also send us a copy
Submission Delivery Method
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Submit via FDA Gateway
Submit CD's
No thanks, please send us the package to submit
Please submit, but also send us a copy
Submission Delivery Method
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Submit to TGA
Submit CD's
E-mail
No thanks, please send us the package to submit
Please submit, but also send us a copy
Submit to this Address:
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How many CD's should we send to this address?
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Select Submission Recipients
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We have additional delivery instructions
Reference Member State
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Austria
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Hungary
Ireland
Iceland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom (MHRA)
Select Submission Recipients
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Austria
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Iceland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom (MHRA)
We have additional delivery instructions
Any Country Specific Requirements? (e.g Annex 4 for France)
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Additional Delivery Instructions
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Expected at the Agency (or designated address) on what date?
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Date ONIX expected to receive files
Note: If a submission requires a 48 hour turnaround (2 working days) to the agency from the date files received, the rate charged will be 150% of the standard hourly fee rate set out in SOW.
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