Data Administration Updates: Ennov InSight 7.2.12
Running the migration script updates Data Administration with latest changes. The changes must be reviewed, and updated, as necessary.
EU v3.1 Updates
| Country Code | Country Name | Health Authority Name | Health Authority Abbreviation | Health Authority eCTD Code | Health Authority Website |
|---|---|---|---|---|---|
| AT | Austria | Austrian Federal Office for Safety in Health Care / Austrian Medicines and Medical Devices Agency | BASG | AT-BASG | www.basg.gv.at |
| BE | Belgium | Federal agency for medicines and health products | FAMHP | BE-FAMHP | http://www.fagg-afmps.be/ |
| HR | Croatia | Agency for Medicinal Products and Medical Devices of Croatia | HALMED | HR-HALMED | http://www.halmed.hr/ |
| CY | Cyprus | Pharmaceutical Services - Ministry of Health | PHS | CY-PHS | http://www.moh.gov.cy/ |
| CZ | Czech Republic | State Institute for Drug Control | SUKL | CZ-SUKL | www.sukl.eu |
| DK | Denmark | Danish Medicines Agency | DKMA | DK-DKMA | www.lmst.dk |
| EE | Estonia | State Agency of Medicines | SAM | EE-SAM | ravimiregister.ravimiamet.ee/en/default.aspx |
| FR | France | National Agency for the Safety of Medicines and Health Products | ANSM | FR-ANSM | http://ansm.sante.fr/ |
| DE | Germany | BfArM - Federal Institute for Drugs and Medical Devices | BfArM | DE-BFARM | http://www.bfarm.de/ |
| GR | Greece | Greek National Organization for Medicines | EOF | EL-EOF | http://www.eof.gr/ |
| HU | Hungary | National Institute of Pharmacy and Nutrition | OGYI | HU-OGYI | www.ogyei.gov.hu |
| IS | Iceland | Icelandic Medicines Agency | IMCA | IS-IMCA | http://www.ima.is/ |
| IE | Ireland | The Health Products Regulatory Authority | HPRA | IE-HPRA | http://www.hpra.ie |
| IT | Italy | Italian Medicines Agency | AIFA | IT-AIFA | www.aifa.gov.it |
| LV | Latvia | State Agency of Medicines | ZVA | LV-ZVA | http://www.zva.gov.lv |
| LI | Liechtenstein | Office of Health / Medicinal Products Control Agency | LLV | LI-LLV | http://www.llv.li/ |
| LT | Lithuania | State Medicines Control Agency | SMCA | LT-SMCA | http://www.vvkt.lt/ |
| LU | Luxembourg | Ministry of Health | MINSANT | LU-MINSANT | www.ms.etat.lu |
| MT | Malta | Medicines Authority | MRU | MT-MEDAUTH | http://www.medicinesauthority.gov.mt/ |
| NL | Netherlands | Medicines Evaluation Board | MEB | NL-MEB | http://www.cbg-meb.nl/ |
| NO | Norway | Norwegian Medical Products Agency | NOMA | NO-NOMA | https://www.dmp.no/ |
| PL | Poland | Office for Registration of Medicinal Products, Medical Devices and Biocidal Products | URPL | PL-URPL | http://www.urpl.gov.pl/ |
| PT | Portugal | National Authority of Medicines and Health Products, IP | INFARMED | PT-INFARMED | http://www.infarmed.pt/ |
| SK | Slovakia | State Institute for Drug Control | SIDC | SK-SIDC | http://www.sukl.sk/ |
| SI | Slovenia | Agency for Medicinal Products and Medical Devices of the Republic of Slovenia | JAZMP | SI-JAZMP | http://www.jazmp.si/ |
| ES | Spain | Spanish Agency for Medicines and Health Products | AEMPS | ES-AEMPS | http://www.aemps.gob.es/ |
| SE | Sweden | Medical Products Agency | MPA | SE-MPA | http://www.lakemedelsverket.se/ |
Assembly - Assembly DTD/Schema Type
If the 'EU-3-1' Assembly DTD/Schema type already exists in the Assembly - Assembly DTD/Schema Types section in Data Administration, it will be activated (if inactive) and updated to have the code value 'EU-3-1'. Otherwise, the 'EU-3-1' Assembly DTD/Schema will be added.
Sequence Maintenance - Filing Type Values
Filing Type values will be added to the Sequence Maintenance – Filing Type values section in Data Administration, if they do not already exist. List of new values can be found in table below:
| Filing Type | Display Name | Countries |
|---|---|---|
| Article 18 Filing | Article 18 Filing | Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Undefined, United Kingdom |
Submission Maintenance - Sub Filing Type Values
Sub Filing Type values will be added to the Submission Maintenance – Sub Filing Type values section in Data Administration, if they do not already exist. List of new values can be found in table below:
| Sub Filing Type | Countries |
|---|---|
| Initial | Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Undefined, United Kingdom |
| Closing Information | Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Undefined, United Kingdom |
| Validation Response | Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Undefined, United Kingdom |
| Response | Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Undefined, United Kingdom |
| Additional Information | Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Undefined, United Kingdom |
| Consolidating | Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Undefined, United Kingdom |
| Corrigendum | Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Undefined, United Kingdom |
| Reformat | Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Undefined, United Kingdom |
| Re-examination | Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Undefined, United Kingdom |
Submission Maintenance - Filing Type eCTD Codes
The Filing Type eCTD Codes values will be added to the section in Data Administration if they do not already exist. If they exist, the eCTD Code for eu-3-1 DTD/Schema is added to them. The list of new values includes the following:
| Filing Type (Display Name) | Applicable DTD/Schema | eCTD Code | Available for Filing Type |
|---|---|---|---|
| Marketing Authorisation Application | eu-3-1 | maa | MAA, MAA-AH |
| Variation 1A Filing | eu-3-1 | var-type1a | MAA, MAA-AH |
| Variation 1AIN Filing | eu-3-1 | var-type1ain | MAA, MAA-AH |
| Variation 1B Filing | eu-3-1 | var-type1b | MAA, MAA-AH |
| Variation 2 Filing | eu-3-1 | var-type2 | MAA, MAA-AH |
| National Variation Filing | eu-3-1 | var-nat | MAA, MAA-AH |
| Extension Filing | eu-3-1 | extension | MAA, MAA-AH |
| Repeat Use Procedure | eu-3-1 | rup | MAA, MAA-AH |
| Periodic Safety Update Report | eu-3-1 | psur | MAA, MAA-AH |
| PSUR single assessment procedure | eu-3-1 | psusa | MAA, MAA-AH |
| Risk Management Plan Filing | eu-3-1 | rmp | MAA, MAA-AH |
| Renewal Filing | eu-3-1 | renewal | MAA, MAA-AH |
| Specific Obligation Related to PAM | eu-3-1 | pam-sob | MAA, MAA-AH |
| Annex II Condition Related to PAM | eu-3-1 | pam-anx | MAA, MAA-AH |
| Additional PV Activity in the RMP Related to PAM | eu-3-1 | pam-mea | MAA, MAA-AH |
| Legally Binding Measure Related to PAM | eu-3-1 | pam-leg | MAA, MAA-AH |
| SDA Submission Related to PAM | eu-3-1 | pam-sda | MAA, MAA-AH |
| Corrective/Preventive Action Related to PAM | eu-3-1 | pam-capa | MAA, MAA-AH |
| Paediatric Submission Related to PAM (Article 45) | eu-3-1 | pam-p45 | MAA, MAA-AH |
| Paediatric Submission Related to PAM (Article 46) | eu-3-1 | pam-p46 | MAA, MAA-AH |
| PAES Submission Related to PAM | eu-3-1 | pam-paes | MAA, MAA-AH |
| Recommendation Related to PAM | eu-3-1 | pam-rec | MAA, MAA-AH |
| PASS Protocol Submission (Article 107n) | eu-3-1 | pass107n | MAA, MAA-AH |
| PASS Report Submission (Article 107q) | eu-3-1 | pass107q | MAA, MAA-AH |
| ASMF Filing | eu-3-1 | asmf | MAA, MAA-AH |
| Plasma Master File | eu-3-1 | pmf | MAA, MAA-AH |
| Article 20 Referral | eu-3-1 | referral-20 | MAA, MAA-AH |
| Article 29(4) Referral | eu-3-1 | referral-294 | MAA, MAA-AH |
| Article 29 Paediatric Referral | eu-3-1 | referral-29p | MAA, MAA-AH |
| Article 30 Referral | eu-3-1 | referral-30 | MAA, MAA-AH |
| Article 31 Referral | eu-3-1 | referral-31 | MAA, MAA-AH |
| Article 35 Referral | eu-3-1 | referral-35 | MAA, MAA-AH |
| Article 5(3) Referral | eu-3-1 | referral-5-3 | MAA, MAA-AH |
| Article 107i Referral | eu-3-1 | referral-107i | MAA, MAA-AH |
| Article 16c (1c)i Referral | eu-3-1 | referral-16c1c | MAA, MAA-AH |
| Article 16c(4) Referral | eu-3-1 | referral-16c4 | MAA, MAA-AH |
| Annual Reassessment Filing | eu-3-1 | annual-reassessment | MAA, MAA-AH |
| USR Filing | eu-3-1 | usr | MAA, MAA-AH |
| Clinical Data for Publication – Redacted Proposal | eu-3-1 | clin-data-pub-rp | MAA, MAA-AH |
| Clinical Data for Publication – Final Version | eu-3-1 | clin-data-pub-fv | MAA, MAA-AH |
| PAED Related to PIP (Article 7, 8, 30) | eu-3-1 | paed-7-8-30 | MAA, MAA-AH |
| PAED Article 29 Filing | eu-3-1 | paed-29 | MAA, MAA-AH |
| PAED Article 45 | eu-3-1 | paed-45 | MAA, MAA-AH |
| PAED Article 46 | eu-3-1 | paed-46 | MAA, MAA-AH |
| Article 58 Filing | eu-3-1 | article-58 | MAA, MAA-AH |
| Notification 61-3 Filing | eu-3-1 | notification-61-3 | MAA, MAA-AH |
| Transfer MA Filing | eu-3-1 | transfer-ma | MAA, MAA-AH |
| Lifting Suspension Filing | eu-3-1 | lifting-suspension | MAA, MAA-AH |
| Withdrawal Filing | eu-3-1 | withdrawal | MAA, MAA-AH |
| CEP Submission | eu-3-1 | cep | MAA, MAA-AH |
| None | eu-3-1 | none | MAA, MAA-AH |
| Article 18 Filing | eu-3-1 | article-18 | MAA, MAA-AH |
Submission Maintenance - Sub Filing Type eCTD Codes Values
Sub Filing Type eCTD codes values will be added to the Submission Maintenance – Sub Filing Type values section in Data Administration, if they do not already exist. If they already exist, the eCTD Code for ZA-3-0 DTD/Schema is added to the value. List of new values can be found in table below:
| Sub Filing Type (Display Name) | Applicable DTD/Schema | eCTD Code | Available for Filing Type |
|---|---|---|---|
| Initial | eu-3-1 | initial | Marketing Authorisation Application,Variation 1A Filing,Variation 1AIN Filing, Variation 1B Filing, Variation 2 Filing, National Variation Filing, Extension Filing, Repeat Use Procedure, Periodic Safety Update Report, PSUR single assessment procedure, Risk Management Plan Filing, Renewal Filing, Specific Obligation, Related to PAM, Annex II Condition Related to PAM, Additional PV Activity in the RMP Related to PAM, Legally Binding Measure Related to PAM, SDA Submission Related to PAM, Corrective/Preventive Action Related to PAM, Paediatric Submission Related to PAM (Article 45), Paediatric Submission Related to PAM (Article 46), PAES Submission Related to PAM, Recommendation Related to PAM, PASS Protocol Submission (Article 107n), PASS Report Submission (Article 107q), ASMF Filing, Plasma Master File, Article 20 Referral, Article 29(4) Referral, Article 29 Paediatric Referral, Article 30 Referral, Article 31 Referral, Article 35 Referral, Article 5(3) Referral, Article 107i Referral, Article 16c (1c)i Referral, Article 16c(4) Referral, Annual Reassessment Filing, USR Filing, Clinical Data for Publication - Redacted Proposal, Clinical Data for Publication - Final Version, PAED Related to PIP (Article 7, 8, 30), PAED Article 29 Filing, PAED Article 45, PAED Article 46, Article 58 Filing, Notification 61-3 Filing, Transfer MA Filing, Lifting Suspension Filing, Withdrawal Filing, CEP Submission, None, Article 18 Filing. |
| Validation Response | eu-3-1 | validation-response | Marketing Authorisation Application,Variation 1A Filing,Variation 1AIN Filing, Variation 1B Filing, Variation 2 Filing, National Variation Filing, Extension Filing, Repeat Use Procedure, Periodic Safety Update Report, PSUR single assessment procedure, Risk Management Plan Filing, Renewal Filing, Specific Obligation, Related to PAM, Annex II Condition Related to PAM, Additional PV Activity in the RMP Related to PAM, Legally Binding Measure Related to PAM, SDA Submission Related to PAM, Corrective/Preventive Action Related to PAM, Paediatric Submission Related to PAM (Article 45), Paediatric Submission Related to PAM (Article 46), PAES Submission Related to PAM, Recommendation Related to PAM, PASS Protocol Submission (Article 107n), PASS Report Submission (Article 107q), ASMF Filing, Plasma Master File, Article 20 Referral, Article 29(4) Referral, Article 29 Paediatric Referral, Article 30 Referral, Article 31 Referral, Article 35 Referral, Article 5(3) Referral, Article 107i Referral, Article 16c (1c)i Referral, Article 16c(4) Referral, Annual Reassessment Filing, USR Filing, Clinical Data for Publication – Redacted Proposal, Clinical Data for Publication – Final Version, PAED Related to PIP (Article 7, 8, 30), PAED Article 29 Filing, PAED Article 45, PAED Article 46, Article 58 Filing, Notification 61-3 Filing, Transfer MA Filing, Lifting Suspension Filing, Withdrawal Filing, CEP Submission, None, Article 18 Filing. |
| Response | eu-3-1 | response | Marketing Authorisation Application,Variation 1A Filing,Variation 1AIN Filing, Variation 1B Filing, Variation 2 Filing, National Variation Filing, Extension Filing, Repeat Use Procedure, Periodic Safety Update Report, PSUR single assessment procedure, Risk Management Plan Filing, Renewal Filing, Specific Obligation, Related to PAM, Annex II Condition Related to PAM, Additional PV Activity in the RMP Related to PAM, Legally Binding Measure Related to PAM, SDA Submission Related to PAM, Corrective/Preventive Action Related to PAM, Paediatric Submission Related to PAM (Article 45), Paediatric Submission Related to PAM (Article 46), PAES Submission Related to PAM, Recommendation Related to PAM, PASS Protocol Submission (Article 107n), PASS Report Submission (Article 107q), ASMF Filing, Plasma Master File, Article 20 Referral, Article 29(4) Referral, Article 29 Paediatric Referral, Article 30 Referral, Article 31 Referral, Article 35 Referral, Article 5(3) Referral, Article 107i Referral, Article 16c (1c)i Referral, Article 16c(4) Referral, Annual Reassessment Filing, USR Filing, Clinical Data for Publication - Redacted Proposal, Clinical Data for Publication - Final Version, PAED Related to PIP (Article 7, 8, 30), PAED Article 29 Filing, PAED Article 45, PAED Article 46, Article 58 Filing, Notification 61-3 Filing, Transfer MA Filing, Lifting Suspension Filing, Withdrawal Filing, CEP Submission, None, Article 18 Filing. |
| Additional Information | eu-3-1 | additional-info | Marketing Authorisation Application,Variation 1A Filing,Variation 1AIN Filing, Variation 1B Filing, Variation 2 Filing, National Variation Filing, Extension Filing, Repeat Use Procedure, Periodic Safety Update Report, PSUR single assessment procedure, Risk Management Plan Filing, Renewal Filing, Specific Obligation, Related to PAM, Annex II Condition Related to PAM, Additional PV Activity in the RMP Related to PAM, Legally Binding Measure Related to PAM, SDA Submission Related to PAM, Corrective/Preventive Action Related to PAM, Paediatric Submission Related to PAM (Article 45), Paediatric Submission Related to PAM (Article 46), PAES Submission Related to PAM, Recommendation Related to PAM, PASS Protocol Submission (Article 107n), PASS Report Submission (Article 107q), ASMF Filing, Plasma Master File, Article 20 Referral, Article 29(4) Referral, Article 29 Paediatric Referral, Article 30 Referral, Article 31 Referral, Article 35 Referral, Article 5(3) Referral, Article 107i Referral, Article 16c (1c)i Referral, Article 16c(4) Referral, Annual Reassessment Filing, USR Filing, Clinical Data for Publication - Redacted Proposal, Clinical Data for Publication - Final Version, PAED Related to PIP (Article 7, 8, 30), PAED Article 29 Filing, PAED Article 45, PAED Article 46, Article 58 Filing, Notification 61-3 Filing, Transfer MA Filing, Lifting Suspension Filing, Withdrawal Filing, CEP Submission, None, Article 18 Filing. |
| Closing Information | eu-3-1 | closing | Marketing Authorisation Application,Variation 1A Filing,Variation 1AIN Filing, Variation 1B Filing, Variation 2 Filing, National Variation Filing, Extension Filing, Repeat Use Procedure, Periodic Safety Update Report, PSUR single assessment procedure, Risk Management Plan Filing, Renewal Filing, Specific Obligation, Related to PAM, Annex II Condition Related to PAM, Additional PV Activity in the RMP Related to PAM, Legally Binding Measure Related to PAM, SDA Submission Related to PAM, Corrective/Preventive Action Related to PAM, Paediatric Submission Related to PAM (Article 45), Paediatric Submission Related to PAM (Article 46), PAES Submission Related to PAM, Recommendation Related to PAM, PASS Protocol Submission (Article 107n), PASS Report Submission (Article 107q), ASMF Filing, Plasma Master File, Article 20 Referral, Article 29(4) Referral, Article 29 Paediatric Referral, Article 30 Referral, Article 31 Referral, Article 35 Referral, Article 5(3) Referral, Article 107i Referral, Article 16c (1c)i Referral, Article 16c(4) Referral, Annual Reassessment Filing, USR Filing, Clinical Data for Publication - Redacted Proposal, Clinical Data for Publication - Final Version, PAED Related to PIP (Article 7, 8, 30), PAED Article 29 Filing, PAED Article 45, PAED Article 46, Article 58 Filing, Notification 61-3 Filing, Transfer MA Filing, Lifting Suspension Filing, Withdrawal Filing, CEP Submission, None, Article 18 Filing. |
| Consolidating | eu-3-1 | consolidating | Marketing Authorisation Application,Variation 1A Filing,Variation 1AIN Filing, Variation 1B Filing, Variation 2 Filing, National Variation Filing, Extension Filing, Repeat Use Procedure, Periodic Safety Update Report, PSUR single assessment procedure, Risk Management Plan Filing, Renewal Filing, Specific Obligation, Related to PAM, Annex II Condition Related to PAM, Additional PV Activity in the RMP Related to PAM, Legally Binding Measure Related to PAM, SDA Submission Related to PAM, Corrective/Preventive Action Related to PAM, Paediatric Submission Related to PAM (Article 45), Paediatric Submission Related to PAM (Article 46), PAES Submission Related to PAM, Recommendation Related to PAM, PASS Protocol Submission (Article 107n), PASS Report Submission (Article 107q), ASMF Filing, Plasma Master File, Article 20 Referral, Article 29(4) Referral, Article 29 Paediatric Referral, Article 30 Referral, Article 31 Referral, Article 35 Referral, Article 5(3) Referral, Article 107i Referral, Article 16c (1c)i Referral, Article 16c(4) Referral, Annual Reassessment Filing, USR Filing, Clinical Data for Publication - Redacted Proposal, Clinical Data for Publication - Final Version, PAED Related to PIP (Article 7, 8, 30), PAED Article 29 Filing, PAED Article 45, PAED Article 46, Article 58 Filing, Notification 61-3 Filing, Transfer MA Filing, Lifting Suspension Filing, Withdrawal Filing, CEP Submission, None, Article 18 Filing. |
| Corrigendum | eu-3-1 | corrigendum | Marketing Authorisation Application,Variation 1A Filing,Variation 1AIN Filing, Variation 1B Filing, Variation 2 Filing, National Variation Filing, Extension Filing, Repeat Use Procedure, Periodic Safety Update Report, PSUR single assessment procedure, Risk Management Plan Filing, Renewal Filing, Specific Obligation, Related to PAM, Annex II Condition Related to PAM, Additional PV Activity in the RMP Related to PAM, Legally Binding Measure Related to PAM, SDA Submission Related to PAM, Corrective/Preventive Action Related to PAM, Paediatric Submission Related to PAM (Article 45), Paediatric Submission Related to PAM (Article 46), PAES Submission Related to PAM, Recommendation Related to PAM, PASS Protocol Submission (Article 107n), PASS Report Submission (Article 107q), ASMF Filing, Plasma Master File, Article 20 Referral, Article 29(4) Referral, Article 29 Paediatric Referral, Article 30 Referral, Article 31 Referral, Article 35 Referral, Article 5(3) Referral, Article 107i Referral, Article 16c (1c)i Referral, Article 16c(4) Referral, Annual Reassessment Filing, USR Filing, Clinical Data for Publication - Redacted Proposal, Clinical Data for Publication - Final Version, PAED Related to PIP (Article 7, 8, 30), PAED Article 29 Filing, PAED Article 45, PAED Article 46, Article 58 Filing, Notification 61-3 Filing, Transfer MA Filing, Lifting Suspension Filing, Withdrawal Filing, CEP Submission, None, Article 18 Filing. |
| Reformat | eu-3-1 | reformat | Marketing Authorisation Application,Variation 1A Filing,Variation 1AIN Filing, Variation 1B Filing, Variation 2 Filing, National Variation Filing, Extension Filing, Repeat Use Procedure, Periodic Safety Update Report, PSUR single assessment procedure, Risk Management Plan Filing, Renewal Filing, Specific Obligation, Related to PAM, Annex II Condition Related to PAM, Additional PV Activity in the RMP Related to PAM, Legally Binding Measure Related to PAM, SDA Submission Related to PAM, Corrective/Preventive Action Related to PAM, Paediatric Submission Related to PAM (Article 45), Paediatric Submission Related to PAM (Article 46), PAES Submission Related to PAM, Recommendation Related to PAM, PASS Protocol Submission (Article 107n), PASS Report Submission (Article 107q), ASMF Filing, Plasma Master File, Article 20 Referral, Article 29(4) Referral, Article 29 Paediatric Referral, Article 30 Referral, Article 31 Referral, Article 35 Referral, Article 5(3) Referral, Article 107i Referral, Article 16c (1c)i Referral, Article 16c(4) Referral, Annual Reassessment Filing, USR Filing, Clinical Data for Publication - Redacted Proposal, Clinical Data for Publication - Final Version, PAED Related to PIP (Article 7, 8, 30), PAED Article 29 Filing, PAED Article 45, PAED Article 46, Article 58 Filing, Notification 61-3 Filing, Transfer MA Filing, Lifting Suspension Filing, Withdrawal Filing, CEP Submission, None, Article 18 Filing. |
| Re-examination | eu-3-1 | re-examination | Marketing Authorisation Application,Variation 1A Filing,Variation 1AIN Filing, Variation 1B Filing, Variation 2 Filing, National Variation Filing, Extension Filing, Repeat Use Procedure, Periodic Safety Update Report, PSUR single assessment procedure, Risk Management Plan Filing, Renewal Filing, Specific Obligation, Related to PAM, Annex II Condition Related to PAM, Additional PV Activity in the RMP Related to PAM, Legally Binding Measure Related to PAM, SDA Submission Related to PAM, Corrective/Preventive Action Related to PAM, Paediatric Submission Related to PAM (Article 45), Paediatric Submission Related to PAM (Article 46), PAES Submission Related to PAM, Recommendation Related to PAM, PASS Protocol Submission (Article 107n), PASS Report Submission (Article 107q), ASMF Filing, Plasma Master File, Article 20 Referral, Article 29(4) Referral, Article 29 Paediatric Referral, Article 30 Referral, Article 31 Referral, Article 35 Referral, Article 5(3) Referral, Article 107i Referral, Article 16c (1c)i Referral, Article 16c(4) Referral, Annual Reassessment Filing, USR Filing, Clinical Data for Publication - Redacted Proposal, Clinical Data for Publication - Final Version, PAED Related to PIP (Article 7, 8, 30), PAED Article 29 Filing, PAED Article 45, PAED Article 46, Article 58 Filing, Notification 61-3 Filing, Transfer MA Filing, Lifting Suspension Filing, Withdrawal Filing, CEP Submission, None, Article 18 Filing. |
WHO v1.0 Updates
Application Maintenance – Region Values
If the WHO region already exists in the Application Maintenance – Region Values section in Data Administration, it will be updated to have the code value ‘WHO’ in the database. Otherwise, the WHO region is added with the values:
| Region Abbreviation | Region Name | Active Flag |
|---|---|---|
| WHO | World Health Organization | Active |
Application Maintenance - Country Values
New WHO country in the Application Maintenance – Country values in Data Administration, must be changed or added, if absent, with the following values:
| Country Code | Country Name | eCTD Code | Region | Active Flag |
|---|---|---|---|---|
| WHO | World Health Organization | whopqt | World Health Organization | Active |
Application Maintenance - Health Authority Name
Health Authority name for WHO country, in the Application Maintenance – Country values in Data Administration under the Health Authority tab, must be changed or added, if absent, to those listed in the following table:| Country Name | Health Authority Name | Health Authority Abbreviation | Health Authority eCTD Code | Health Authority website |
|---|---|---|---|---|
| World Health Organization | World Health Organization | WHO | whopqt | https://extranet.who.int/prequal/ |
Assembly - Assembly DTD/Schema Type Values
If the 'WHO-1-0' Assembly DTD/Schema type already exists in the Assembly - Assembly DTD/Schema Types section in Data Administration, it will be activated (if inactive) and updated to have the code value 'WHO-1-0'. Otherwise, the 'WHO-1-0' Assembly DTD/Schema will be added.
Application Maintenance - Procedure Type Values
The ‘National’ Procedure Type in the Application Maintenance - Procedure Type values section in Data Administration, it will be activated (if inactive) and updated to include WHO country, in addition to already added countries.
Application Maintenance - Application Type Values
The
Application Type Values list will be added to the
section if it does not already exist. The list includes the following values:
The Finished Pharmaceutical Product Application Type gets Default Flag set to Yes upon associating it with WHO country.
| Application Type | Name | Display Name | Entity XML Type Name | Application Category | Countries |
|---|---|---|---|---|---|
| FPP | Finished Pharmaceutical Product | Finished Pharmaceutical Product | New Drug Application | Finished Pharmaceutical Product | World Health Organization |
| FVP | Finished Vaccine Product | Finished Vaccine Product | New Drug Application | Finished Vaccine Product | World Health Organization |
| APIPQ | Active Pharmaceutical Ingredient | Active Pharmaceutical Ingredient | New Drug Application | Active Pharmaceutical Ingredient | World Health Organization |
| APIMF | Active Pharmaceutical Ingredient Master File | Active Pharmaceutical Ingredient Master File | New Drug Application | Active Pharmaceutical Ingredient Master File | World Health Organization |
Application Maintenance - Application Category Values
Application Category Values will be added to the Application Maintenance – Application Type Values section in Data Administration if they do not already exist. List of new values can be found in table below:
| Application Category Name | Active Flag |
|---|---|
| Finished Pharmaceutical Product | Active |
| Finished Vaccine Product | Active |
| Active Pharmaceutical Ingredient | Active |
| Active Pharmaceutical Ingredient Master File | Active |
Application Maintenance - Application Type eCTD Codes
The Application Type eCTD Codes values will be added to the list in Data Administration if they do not already exist there. If they exist, the eCTD Code for who-1-0 DTD/Schema will be added to them. The list of new values includes the following:
| Application Type (Display Name) | Application DTD/Schema | eCTD Code | Agency Abbreviation | Limit to Cross Application Only |
|---|---|---|---|---|
| Finished Pharmaceutical Product | who-1-0 | FPP | No | |
| Finished Vaccine Product | who-1-0 | FVP | No | |
| Active Pharmaceutical Ingredient | who-1-0 | APIPQ | No | |
| Active Pharmaceutical Ingredient Master File | who-1-0 | APIMF | No |
Sequence Maintenance - Filing Type eCTD Codes
The Filing Type eCTD Codes values will be added to the list in Data Administration if they do not already exist. If they exist, the eCTD Code for who-1-0 DTD/Schema is added to them. The list of new values includes the following:
| Filing Type (Display) | Applicable DTD/Schema | eCTD Code | Available for Application Types |
|---|---|---|---|
| Annual Report (FVP) | who-1-0 | AR | Finished Pharmaceutical Product, Finished Vaccine Product, Active Pharmaceutical Ingredient, Active Pharmaceutical Ingredient Master File |
| APIMF Procedure | who-1-0 | APIMF | Finished Pharmaceutical Product, Finished Vaccine Product, Active Pharmaceutical Ingredient, Active Pharmaceutical Ingredient Master File |
| New Emergency Use Listing (EUL) Application (FPP, FVP) | who-1-0 | EUL | Finished Pharmaceutical Product, Finished Vaccine Product, Active Pharmaceutical Ingredient, Active Pharmaceutical Ingredient Master File |
| Post-PQ Change (API, FFP, FVP) | who-1-0 | PPQC | Finished Pharmaceutical Product, Finished Vaccine Product, Active Pharmaceutical Ingredient, Active Pharmaceutical Ingredient Master File |
| New Prequalification Application (API, FFP, FVP) | who-1-0 | PQP | Finished Pharmaceutical Product, Finished Vaccine Product, Active Pharmaceutical Ingredient, Active Pharmaceutical Ingredient Master File |
| Reassessment (FVP) | who-1-0 | REAS | Finished Pharmaceutical Product, Finished Vaccine Product, Active Pharmaceutical Ingredient, Active Pharmaceutical Ingredient Master File |
| Requalification Application (FPP) | who-1-0 | RQAP | Finished Pharmaceutical Product, Finished Vaccine Product, Active Pharmaceutical Ingredient, Active Pharmaceutical Ingredient Master File |
Submission Maintenance - Sub Filing Type eCTD Codes
The Sub Filing Type eCTD Codes values will be added to the section in Data Administration if they do not already exist. If they exist, the eCTD Code for who-1-0 DTD/Schema is added to them. The list of new values includes the following:
| Sub Filing Type (Display Name) | Applicable DTD/Schema | eCTD Code | Available for Filing Type | |
|---|---|---|---|---|
| Annual Notification (FPP) | WHO-1-0 | AN | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Abridged | WHO-1-0 | PQA | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Immediate Notification (API) | WHO-1-0 | AIN | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Annual Notification (API) | WHO-1-0 | AAN | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Conversion | WHO-1-0 | CONV | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| eCTD Baseline | WHO-1-0 | eCTDB | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| EUL-Full (Emergency Use Listing) | WHO-1-0 | EULF | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Full | WHO-1-0 | Full | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Immediate Notification (FPP) | WHO-1-0 | IN | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Major | WHO-1-0 | Major | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Minor | WHO-1-0 | Minor | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Parallel | WHO-1-0 | Parallel | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Product Extension | WHO-1-0 | PEX | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Standard | WHO-1-0 | STD | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Type A (Approval Before Implementation)(Major)(FVP) | WHO-1-0 | AMAJ | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Type N (Immediate Notification)(Minor) (FVP) | WHO-1-0 | NMI | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| Update | WHO-1-0 | UPD | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
| no Application Sub Type | WHO-1-0 | none | Annual Report (FVP), APIMF Procedure, New Emergency Use Listing (EUL) Application (FPP,FVP), Post-PQ Change (API, FFP, FVP), New Prequalification Application (API, FFP, FVP), Reassessment (FVP),Requalification Application (FPP) | |
Submission Maintenance - Regulatory Activity Lead Values
The Regulatory Activity Lead Values will be added to the list in Data Administration if they do not already exist. The list of new values includes the following:| Region | Applicable DTD/Schema | eCTD Code | Regulatory Activity Lead |
|---|---|---|---|
| WHO | who-1-0 | initial | Initial |
| WHO | who-1-0 | validation-response | Validation Response |
| WHO | who-1-0 | response | Response |
| WHO | who-1-0 | additional-info | Additional Info |
| WHO | who-1-0 | reformat | Reformat |
Submission Maintenance Submission Product Type Values
Submission Product Type values will be added to the Submission Maintenance > Submission Product Type Values section in Data Administration if they do not already exist. List of new values can be found in table below:
| Region | eCTD Code | Product Type | Applicable DTD/Schema |
|---|---|---|---|
| WHO | BTP | Biotherapeutic Product | WHO-1-0 |
| WHO | FPP | Finished Pharmaceutical Product | WHO-1-0 |