eCTD Filing Types for EU
Calyx RIM provides the following filing types for all application types associated with the European Union (EU). This table lists the eCTD code and the applicable DTD or Schema for each Filing Type.
| Filing Type (Display) | Applicable DTD/Schema | eCTD Code | Available for Application Types |
|---|---|---|---|
| Annual Reassessment Filing | eu-1-0 | annual-reassessment | CTA, MAA, MAA-AH |
| Arbitration Filing | eu-1-0 | arbitration | CTA, MAA, MAA-AH |
| Article 58 Filing | eu-1-0 | article-58 | CTA, MAA, MAA-AH |
| ASMF Filing | eu-1-0 | asmf | CTA, MAA, MAA-AH |
| Conditional Specific Obligation Filing | eu-1-0 | cond-specific-obligation | CTA, MAA, MAA-AH |
| Corrigendum Filing | eu-1-0 | corrigendum | CTA, MAA, MAA-AH |
| DMF Filing | eu-1-0 | dmf | CTA, MAA, MAA-AH |
| Extension Filing | eu-1-0 | extension | CTA, MAA, MAA-AH |
| Follow-Up Filing | eu-1-0 | follow-up | CTA, MAA, MAA-AH |
| Follow-Up Measures | eu-1-0 | fum | CTA, MAA, MAA-AH |
| Lifting Suspension Filing | eu-1-0 | lifting-suspension | CTA, MAA, MAA-AH |
| National Variation Filing | eu-1-0 | var-nat | CTA, MAA, MAA-AH |
| Notification 61-3 Filing | eu-1-0 | notification-61-3 | CTA, MAA, MAA-AH |
| Original Filing | eu-1-0 | initial-maa | CTA, MAA, MAA-AH |
| PAED Article 29 Filing | eu-1-0 | paed-article-29 | CTA, MAA, MAA-AH |
| Periodic Safety Update Report | eu-1-0 | psur | CTA, MAA, MAA-AH |
| Referral Filing | eu-1-0 | referral | CTA, MAA, MAA-AH |
| Reformat Filing | eu-1-0 | reformat | CTA, MAA, MAA-AH |
| Renewal Filing | eu-1-0 | renewal | CTA, MAA, MAA-AH |
| Safety Filing | eu-1-0 | safety | CTA, MAA, MAA-AH |
| Specific Obligation Filing | eu-1-0 | specific-obligation | CTA, MAA, MAA-AH |
| Supplement Filing | eu-1-0 | supplemental-info | CTA, MAA, MAA-AH |
| Transfer MA Filing | eu-1-0 | transfer-ma | CTA, MAA, MAA-AH |
| USR Filing | eu-1-0 | usr | CTA, MAA, MAA-AH |
| Variation 1A Filing | eu-1-0 | var-type1a | CTA, MAA, MAA-AH |
| Variation 1B Filing | eu-1-0 | var-type1b | CTA, MAA, MAA-AH |
| Variation 2 Filing | eu-1-0 | var-type2 | CTA, MAA, MAA-AH |
| Annual Reassessment Filing | eu-1-1 | annual-reassessment | CTA, MAA, MAA-AH |
| Arbitration Filing | eu-1-1 | arbitration | CTA, MAA, MAA-AH |
| Article 58 Filing | eu-1-1 | article-58 | CTA, MAA, MAA-AH |
| ASMF Filing | eu-1-1 | asmf | CTA, MAA, MAA-AH |
| Conditional Specific Obligation Filing | eu-1-1 | cond-specific-obligation | CTA, MAA, MAA-AH |
| Corrigendum Filing | eu-1-1 | corrigendum | CTA, MAA, MAA-AH |
| DMF Filing | eu-1-1 | dmf | CTA, MAA, MAA-AH |
| Extension Filing | eu-1-1 | extension | CTA, MAA, MAA-AH |
| Follow-Up Filing | eu-1-1 | follow-up | CTA, MAA, MAA-AH |
| Follow-Up Measures | eu-1-1 | fum | CTA, MAA, MAA-AH |
| Lifting Suspension Filing | eu-1-1 | lifting-suspension | CTA, MAA, MAA-AH |
| National Variation Filing | eu-1-1 | var-nat | CTA, MAA, MAA-AH |
| Notification 61-3 Filing | eu-1-1 | notification-61-3 | CTA, MAA, MAA-AH |
| Original Filing | eu-1-1 | initial-maa | CTA, MAA, MAA-AH |
| PAED Article 29 Filing | eu-1-1 | paed-article-29 | CTA, MAA, MAA-AH |
| Periodic Safety Update Report | eu-1-1 | psur | CTA, MAA, MAA-AH |
| Referral Filing | eu-1-1 | referral | CTA, MAA, MAA-AH |
| Reformat Filing | eu-1-1 | reformat | CTA, MAA, MAA-AH |
| Renewal Filing | eu-1-1 | renewal | CTA, MAA, MAA-AH |
| Safety Filing | eu-1-1 | safety | CTA, MAA, MAA-AH |
| Specific Obligation Filing | eu-1-1 | specific-obligation | CTA, MAA, MAA-AH |
| Supplement Filing | eu-1-1 | supplemental-info | CTA, MAA, MAA-AH |
| Transfer MA Filing | eu-1-1 | transfer-ma | CTA, MAA, MAA-AH |
| USR Filing | eu-1-1 | usr | CTA, MAA, MAA-AH |
| Variation 1A Filing | eu-1-1 | var-type1a | CTA, MAA, MAA-AH |
| Variation 1B Filing | eu-1-1 | var-type1b | CTA, MAA, MAA-AH |
| Variation 2 Filing | eu-1-1 | var-type2 | CTA, MAA, MAA-AH |
| Annual Reassessment Filing | eu-1-2-1 | annual-reassessment | CTA, MAA, MAA-AH |
| Arbitration Filing | eu-1-2-1 | arbitration | CTA, MAA, MAA-AH |
| Article 58 Filing | eu-1-2-1 | article-58 | CTA, MAA, MAA-AH |
| ASMF Filing | eu-1-2-1 | asmf | CTA, MAA, MAA-AH |
| Conditional Specific Obligation Filing | eu-1-2-1 | cond-specific-obligation | CTA, MAA, MAA-AH |
| Corrigendum Filing | eu-1-2-1 | corrigendum | CTA, MAA, MAA-AH |
| DMF Filing | eu-1-2-1 | dmf | CTA, MAA, MAA-AH |
| Extension Filing | eu-1-2-1 | extension | CTA, MAA, MAA-AH |
| Follow-Up Filing | eu-1-2-1 | follow-up | CTA, MAA, MAA-AH |
| Follow-Up Measures | eu-1-2-1 | fum | CTA, MAA, MAA-AH |
| Lifting Suspension Filing | eu-1-2-1 | lifting-suspension | CTA, MAA, MAA-AH |
| National Variation Filing | eu-1-2-1 | var-nat | CTA, MAA, MAA-AH |
| Notification 61-3 Filing | eu-1-2-1 | notification-61-3 | CTA, MAA, MAA-AH |
| Original Filing | eu-1-2-1 | initial-maa | CTA, MAA, MAA-AH |
| PAED Article 29 Filing | eu-1-2-1 | paed-article-29 | CTA, MAA, MAA-AH |
| Periodic Safety Update Report | eu-1-2-1 | psur | CTA, MAA, MAA-AH |
| Referral Filing | eu-1-2-1 | referral | CTA, MAA, MAA-AH |
| Reformat Filing | eu-1-2-1 | reformat | CTA, MAA, MAA-AH |
| Renewal Filing | eu-1-2-1 | renewal | CTA, MAA, MAA-AH |
| Safety Filing | eu-1-2-1 | safety | CTA, MAA, MAA-AH |
| Specific Obligation Filing | eu-1-2-1 | specific-obligation | CTA, MAA, MAA-AH |
| Supplement Filing | eu-1-2-1 | supplemental-info | CTA, MAA, MAA-AH |
| Transfer MA Filing | eu-1-2-1 | transfer-ma | CTA, MAA, MAA-AH |
| USR Filing | eu-1-2-1 | usr | CTA, MAA, MAA-AH |
| Variation 1A Filing | eu-1-2-1 | var-type1a | CTA, MAA, MAA-AH |
| Variation 1B Filing | eu-1-2-1 | var-type1b | CTA, MAA, MAA-AH |
| Variation 2 Filing | eu-1-2-1 | var-type2 | CTA, MAA, MAA-AH |
| Annual Reassessment Filing | eu-1-3 | annual-reassessment | CTA, MAA, MAA-AH |
| Arbitration Filing | eu-1-3 | arbitration | CTA, MAA, MAA-AH |
| Article 58 Filing | eu-1-3 | article-58 | CTA, MAA, MAA-AH |
| ASMF Filing | eu-1-3 | asmf | CTA, MAA, MAA-AH |
| Conditional Specific Obligation Filing | eu-1-3 | cond-specific-obligation | CTA, MAA, MAA-AH |
| Corrigendum Filing | eu-1-3 | corrigendum | CTA, MAA, MAA-AH |
| DMF Filing | eu-1-3 | dmf | CTA, MAA, MAA-AH |
| Extension Filing | eu-1-3 | extension | CTA, MAA, MAA-AH |
| Follow-Up Filing | eu-1-3 | follow-up | CTA, MAA, MAA-AH |
| Follow-Up Measures | eu-1-3 | fum | CTA, MAA, MAA-AH |
| Lifting Suspension Filing | eu-1-3 | lifting-suspension | CTA, MAA, MAA-AH |
| National Variation Filing | eu-1-3 | var-nat | CTA, MAA, MAA-AH |
| Notification 61-3 Filing | eu-1-3 | notification-61-3 | CTA, MAA, MAA-AH |
| Original Filing | eu-1-3 | initial-maa | CTA, MAA, MAA-AH |
| PAED Article 29 Filing | eu-1-3 | paed-article-29 | CTA, MAA, MAA-AH |
| Periodic Safety Update Report | eu-1-3 | psur | CTA, MAA, MAA-AH |
| Referral Filing | eu-1-3 | referral | CTA, MAA, MAA-AH |
| Reformat Filing | eu-1-3 | reformat | CTA, MAA, MAA-AH |
| Renewal Filing | eu-1-3 | renewal | CTA, MAA, MAA-AH |
| Safety Filing | eu-1-3 | safety | CTA, MAA, MAA-AH |
| Specific Obligation Filing | eu-1-3 | specific-obligation | CTA, MAA, MAA-AH |
| Supplement Filing | eu-1-3 | supplemental-info | CTA, MAA, MAA-AH |
| Transfer MA Filing | eu-1-3 | transfer-ma | CTA, MAA, MAA-AH |
| USR Filing | eu-1-3 | usr | CTA, MAA, MAA-AH |
| Variation 1A Filing | eu-1-3 | var-type1a | CTA, MAA, MAA-AH |
| Variation 1B Filing | eu-1-3 | var-type1b | CTA, MAA, MAA-AH |
| Variation 2 Filing | eu-1-3 | var-type2 | CTA, MAA, MAA-AH |
| Annual Reassessment Filing | eu-1-4 | annual-reassessment | CTA, MAA, MAA-AH |
| Arbitration Filing | eu-1-4 | arbitration | CTA, MAA, MAA-AH |
| Article 58 Filing | eu-1-4 | article-58 | CTA, MAA, MAA-AH |
| ASMF Filing | eu-1-4 | asmf | CTA, MAA, MAA-AH |
| Conditional Specific Obligation Filing | eu-1-4 | cond-specific-obligation | CTA, MAA, MAA-AH |
| Corrigendum Filing | eu-1-4 | corrigendum | CTA, MAA, MAA-AH |
| DMF Filing | eu-1-4 | dmf | CTA, MAA, MAA-AH |
| Extension Filing | eu-1-4 | extension | CTA, MAA, MAA-AH |
| Follow-Up Filing | eu-1-4 | follow-up | CTA, MAA, MAA-AH |
| Follow-Up Measures | eu-1-4 | fum | CTA, MAA, MAA-AH |
| Lifting Suspension Filing | eu-1-4 | lifting-suspension | CTA, MAA, MAA-AH |
| National Variation Filing | eu-1-4 | var-nat | CTA, MAA, MAA-AH |
| Notification 61-3 Filing | eu-1-4 | notification-61-3 | CTA, MAA, MAA-AH |
| Original Filing | eu-1-4 | initial-maa | CTA, MAA, MAA-AH |
| PAED Article 29 Filing | eu-1-4 | paed-article-29 | CTA, MAA, MAA-AH |
| Periodic Safety Update Report | eu-1-4 | psur | CTA, MAA, MAA-AH |
| Referral Filing | eu-1-4 | referral | CTA, MAA, MAA-AH |
| Reformat Filing | eu-1-4 | reformat | CTA, MAA, MAA-AH |
| Renewal Filing | eu-1-4 | renewal | CTA, MAA, MAA-AH |
| Safety Filing | eu-1-4 | safety | CTA, MAA, MAA-AH |
| Specific Obligation Filing | eu-1-4 | specific-obligation | CTA, MAA, MAA-AH |
| Supplement Filing | eu-1-4 | supplemental-info | CTA, MAA, MAA-AH |
| Transfer MA Filing | eu-1-4 | transfer-ma | CTA, MAA, MAA-AH |
| USR Filing | eu-1-4 | usr | CTA, MAA, MAA-AH |
| Variation 1A Filing | eu-1-4 | var-type1a | CTA, MAA, MAA-AH |
| Variation 1B Filing | eu-1-4 | var-type1b | CTA, MAA, MAA-AH |
| Variation 2 Filing | eu-1-4 | var-type2 | CTA, MAA, MAA-AH |
| Annual Reassessment Filing | eu-2-0 | annual-reassessment | CTA, MAA, MAA-AH |
| Arbitration Filing | eu-2-0 | arbitration | CTA, MAA, MAA-AH |
| Article 58 Filing | eu-2-0 | article-58 | CTA, MAA, MAA-AH |
| ASMF Filing | eu-2-0 | asmf | CTA, MAA, MAA-AH |
| Conditional Specific Obligation Filing | eu-2-0 | cond-specific-obligation | CTA, MAA, MAA-AH |
| Corrigendum Filing | eu-2-0 | corrigendum | CTA, MAA, MAA-AH |
| DMF Filing | eu-2-0 | dmf | CTA, MAA, MAA-AH |
| Extension Filing | eu-2-0 | extension | CTA, MAA, MAA-AH |
| Follow-Up Filing | eu-2-0 | follow-up | CTA, MAA, MAA-AH |
| Follow-Up Measures | eu-2-0 | fum | CTA, MAA, MAA-AH |
| Lifting Suspension Filing | eu-2-0 | lifting-suspension | CTA, MAA, MAA-AH |
| National Variation Filing | eu-2-0 | var-nat | CTA, MAA, MAA-AH |
| Notification 61-3 Filing | eu-2-0 | notification-61-3 | CTA, MAA, MAA-AH |
| Original Filing | eu-2-0 | initial-maa | CTA, MAA, MAA-AH |
| PAED Article 29 Filing | eu-2-0 | paed-article-29 | CTA, MAA, MAA-AH |
| Periodic Safety Update Report | eu-2-0 | psur | CTA, MAA, MAA-AH |
| Referral Filing | eu-2-0 | referral | CTA, MAA, MAA-AH |
| Reformat Filing | eu-2-0 | reformat | CTA, MAA, MAA-AH |
| Renewal Filing | eu-2-0 | renewal | CTA, MAA, MAA-AH |
| Risk Management Plan Filing | eu-2-0 | rmp | CTA, MAA, MAA-AH |
| Safety Filing | eu-2-0 | safety | CTA, MAA, MAA-AH |
| Specific Obligation Filing | eu-2-0 | specific-obligation | CTA, MAA, MAA-AH |
| Supplement Filing | eu-2-0 | supplemental-info | CTA, MAA, MAA-AH |
| Transfer MA Filing | eu-2-0 | transfer-ma | CTA, MAA, MAA-AH |
| USR Filing | eu-2-0 | usr | CTA, MAA, MAA-AH |
| Variation 1A Filing | eu-2-0 | var-type1a | CTA, MAA, MAA-AH |
| Variation 1B Filing | eu-2-0 | var-type1b | CTA, MAA, MAA-AH |
| Variation 2 Filing | eu-2-0 | var-type2 | CTA, MAA, MAA-AH |
| Additional PV Activity in the RMP Related to PAM | eu-3-0 | pam-mea | MAA, MAA-AH |
| Annex II Condition Related to PAM | eu-3-0 | pam-anx | MAA, MAA-AH |
| Annual Reassessment Filing | eu-3-0 | annual-reassessment | MAA, MAA-AH |
| Article 107i Referral | eu-3-0 | referral-107i | MAA, MAA-AH |
| Article 16c (1c)i Referral | eu-3-0 | referral-16c1c | MAA, MAA-AH |
| Article 16c(4) Referral | eu-3-0 | referral-16c4 | MAA, MAA-AH |
| Article 20 Referral | eu-3-0 | referral-20 | MAA, MAA-AH |
| Article 29 Paediatric Referral | eu-3-0 | referral-29p | MAA, MAA-AH |
| Article 29(4) Referral | eu-3-0 | referral-294 | MAA, MAA-AH |
| Article 30 Referral | eu-3-0 | referral-30 | MAA, MAA-AH |
| Article 31 Referral | eu-3-0 | referral-31 | MAA, MAA-AH |
| Article 35 Referral | eu-3-0 | referral-35 | MAA, MAA-AH |
| Article 5(3) Referral | eu-3-0 | referral-53 | MAA, MAA-AH |
| Article 58 Filing | eu-3-0 | article-58 | MAA, MAA-AH |
| ASMF Filing | eu-3-0 | asmf | MAA, MAA-AH |
| CEP Submission | eu-3-0 | cep | MAA, MAA-AH |
| Clinical Data for Publication – Final Version | eu-3-0 | clin-data-pub-fv | MAA, MAA-AH |
| Clinical Data for Publication – Redacted Proposal | eu-3-0 | clin-data-pub-rp | MAA, MAA-AH |
| Corrective/Preventive Action Related to PAM | eu-3-0 | pam-capa | MAA, MAA-AH |
| Extension Filing | eu-3-0 | extension | MAA, MAA-AH |
| Legally Binding Measure Related to PAM | eu-3-0 | pam-leg | MAA, MAA-AH |
| Lifting Suspension Filing | eu-3-0 | lifting-suspension | MAA, MAA-AH |
| Marketing Authorisation Application | eu-3-0 | maa | MAA, MAA-AH |
| National Variation Filing | eu-3-0 | var-nat | MAA, MAA-AH |
| None | eu-3-0 | none | MAA, MAA-AH |
| Notification 61-3 Filing | eu-3-0 | notification-61-3 | MAA, MAA-AH |
| PAED Article 29 Filing | eu-3-0 | paed-29 | MAA, MAA-AH |
| PAED Article 45 | eu-3-0 | paed-45 | MAA, MAA-AH |
| PAED Article 46 | eu-3-0 | paed-46 | MAA, MAA-AH |
| PAED Related to PIP (Article 7, 8, 30) | eu-3-0 | paed-7-8-30 | MAA, MAA-AH |
| Paediatric Submission Related to PAM (Article 45) | eu-3-0 | pam-p45 | MAA, MAA-AH |
| Paediatric Submission Related to PAM (Article 46) | eu-3-0 | pam-p46 | MAA, MAA-AH |
| PAES Submission Related to PAM | eu-3-0 | pam-paes | MAA, MAA-AH |
| PASS Protocol Submission (Article 107n) | eu-3-0 | pass107n | MAA, MAA-AH |
| PASS Report Submission (Article 107q) | eu-3-0 | pass107q | MAA, MAA-AH |
| Periodic Safety Update Report | eu-3-0 | psur | MAA, MAA-AH |
| Plasma Master File | eu-3-0 | pmf | MAA, MAA-AH |
| PSUR single assessment procedure | eu-3-0 | psusa | MAA, MAA-AH |
| Recommendation Related to PAM | eu-3-0 | pam-rec | MAA, MAA-AH |
| Renewal Filing | eu-3-0 | renewal | MAA, MAA-AH |
| Repeat Use Procedure | eu-3-0 | rup | MAA, MAA-AH |
| Risk Management Plan Filing | eu-3-0 | rmp | MAA, MAA-AH |
| SDA Submission Related to PAM | eu-3-0 | pam-sda | MAA, MAA-AH |
| Specific Obligation Related to PAM | eu-3-0 | pam-sob | MAA, MAA-AH |
| Transfer MA Filing | eu-3-0 | transfer-ma | MAA, MAA-AH |
| USR Filing | eu-3-0 | usr | MAA, MAA-AH |
| Variation 1A Filing | eu-3-0 | var-type1a | MAA, MAA-AH |
| Variation 1AIN Filing | eu-3-0 | var-type1ain | MAA, MAA-AH |
| Variation 1B Filing | eu-3-0 | var-type1b | MAA, MAA-AH |
| Variation 2 Filing | eu-3-0 | var-type2 | MAA, MAA-AH |
| Withdrawal Filing | eu-3-0 | withdrawal | MAA, MAA-AH |
| Additional PV Activity in the RMP Related to PAM | eu-3-0-1 | pam-mea | MAA, MAA-AH |
| Annex II Condition Related to PAM | eu-3-0-1 | pam-anx | MAA, MAA-AH |
| Annual Reassessment Filing | eu-3-0-1 | annual-reassessment | MAA, MAA-AH |
| Article 107i Referral | eu-3-0-1 | referral-107i | MAA, MAA-AH |
| Article 16c (1c)i Referral | eu-3-0-1 | referral-16c1c | MAA, MAA-AH |
| Article 16c(4) Referral | eu-3-0-1 | referral-16c4 | MAA, MAA-AH |
| Article 20 Referral | eu-3-0-1 | referral-20 | MAA, MAA-AH |
| Article 29 Paediatric Referral | eu-3-0-1 | referral-29p | MAA, MAA-AH |
| Article 29(4) Referral | eu-3-0-1 | referral-294 | MAA, MAA-AH |
| Article 30 Referral | eu-3-0-1 | referral-30 | MAA, MAA-AH |
| Article 31 Referral | eu-3-0-1 | referral-31 | MAA, MAA-AH |
| Article 35 Referral | eu-3-0-1 | referral-35 | MAA, MAA-AH |
| Article 5(3) Referral | eu-3-0-1 | referral-5-3 | MAA, MAA-AH |
| Article 58 Filing | eu-3-0-1 | article-58 | MAA, MAA-AH |
| ASMF Filing | eu-3-0-1 | asmf | MAA, MAA-AH |
| CEP Submission | eu-3-0-1 | cep | MAA, MAA-AH |
| Clinical Data for Publication – Final Version | eu-3-0-1 | clin-data-pub-fv | MAA, MAA-AH |
| Clinical Data for Publication – Redacted Proposal | eu-3-0-1 | clin-data-pub-rp | MAA, MAA-AH |
| Corrective/Preventive Action Related to PAM | eu-3-0-1 | pam-capa | MAA, MAA-AH |
| Extension Filing | eu-3-0-1 | extension | MAA, MAA-AH |
| Legally Binding Measure Related to PAM | eu-3-0-1 | pam-leg | MAA, MAA-AH |
| Lifting Suspension Filing | eu-3-0-1 | lifting-suspension | MAA, MAA-AH |
| Marketing Authorisation Application | eu-3-0-1 | maa | MAA, MAA-AH |
| National Variation Filing | eu-3-0-1 | var-nat | MAA, MAA-AH |
| None | eu-3-0-1 | none | MAA, MAA-AH |
| Notification 61-3 Filing | eu-3-0-1 | notification-61-3 | MAA, MAA-AH |
| PAED Article 29 Filing | eu-3-0-1 | paed-29 | MAA, MAA-AH |
| PAED Article 45 | eu-3-0-1 | paed-45 | MAA, MAA-AH |
| PAED Article 46 | eu-3-0-1 | paed-46 | MAA, MAA-AH |
| PAED Related to PIP (Article 7, 8, 30) | eu-3-0-1 | paed-7-8-30 | MAA, MAA-AH |
| Paediatric Submission Related to PAM (Article 45) | eu-3-0-1 | pam-p45 | MAA, MAA-AH |
| Paediatric Submission Related to PAM (Article 46) | eu-3-0-1 | pam-p46 | MAA, MAA-AH |
| PAES Submission Related to PAM | eu-3-0-1 | pam-paes | MAA, MAA-AH |
| PASS Protocol Submission (Article 107n) | eu-3-0-1 | pass107n | MAA, MAA-AH |
| PASS Report Submission (Article 107q) | eu-3-0-1 | pass107q | MAA, MAA-AH |
| Periodic Safety Update Report | eu-3-0-1 | psur | MAA, MAA-AH |
| Plasma Master File | eu-3-0-1 | pmf | MAA, MAA-AH |
| PSUR single assessment procedure | eu-3-0-1 | psusa | MAA, MAA-AH |
| Recommendation Related to PAM | eu-3-0-1 | pam-rec | MAA, MAA-AH |
| Renewal Filing | eu-3-0-1 | renewal | MAA, MAA-AH |
| Repeat Use Procedure | eu-3-0-1 | rup | MAA, MAA-AH |
| Risk Management Plan Filing | eu-3-0-1 | rmp | MAA, MAA-AH |
| SDA Submission Related to PAM | eu-3-0-1 | pam-sda | MAA, MAA-AH |
| Specific Obligation Related to PAM | eu-3-0-1 | pam-sob | MAA, MAA-AH |
| Transfer MA Filing | eu-3-0-1 | transfer-ma | MAA, MAA-AH |
| USR Filing | eu-3-0-1 | usr | MAA, MAA-AH |
| Variation 1A Filing | eu-3-0-1 | var-type1a | MAA, MAA-AH |
| Variation 1AIN Filing | eu-3-0-1 | var-type1ain | MAA, MAA-AH |
| Variation 1B Filing | eu-3-0-1 | var-type1b | MAA, MAA-AH |
| Variation 2 Filing | eu-3-0-1 | var-type2 | MAA, MAA-AH |
| Withdrawal Filing | eu-3-0-1 | withdrawal | MAA, MAA-AH |