Type of regulatory submission / activity (e.g. initial, variation, renewal). Regionally defined.
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HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
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Term
Term Description as defined by the Health Authority
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Code
Code, if any, associated with the term by the Health Authority
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Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
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Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
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|---|---|---|---|---|
| EU Application Submission Type | Withdrawal |
100000155711
|
EMA | Active |
| Submission Type | Withdrawal |
100013
|
SwissMedic | — |
| EU Application Submission Type | WHO Cooperation acc. Article 58 |
100000155707
|
EMA | Active |
| EU Application Submission Type | Variation Type II |
100000155693
|
EMA | Active |
| EU Application Submission Type | Variation Type IB |
100000155692
|
EMA | Active |
| EU Application Submission Type | Variation Type IAIN |
100000155691
|
EMA | Active |
| EU Application Submission Type | Variation Type IA |
100000155690
|
EMA | Active |
| EU Application Submission Type | Urgent Safety Restriction |
100000155704
|
EMA | Active |
| Submission Type | Type II Variation |
100008
|
SwissMedic | — |
| Submission Type | Type IB Variation |
100007
|
SwissMedic | — |
| Submission Type | Type IA Variation for immediate notification |
100006
|
SwissMedic | — |
| Submission Type | Type IA Variation |
100005
|
SwissMedic | — |
| Submission Type | Transfer of Marketing Authorisation, Change of name of applicant, change of address of applicant |
100014
|
SwissMedic | — |
| EU Application Submission Type | Transfer of a marketing authorisation |
100000155709
|
EMA | Active |
| EU Application Submission Type | Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC). |
200000002310
|
EMA | Active |
| EU Application Submission Type | Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC). |
200000002308
|
EMA | Active |
| EU Application Submission Type | Submission of a post-authorisation efficacy study |
200000002303
|
EMA | Active |
| EU Application Submission Type | Specific Obligation |
100000155699
|
EMA | Active |
| EU Application Submission Type | Risk Management Plan |
100000155713
|
EMA | Active |
| US Submission Unit Type | Resubmission |
us_submission_unit_type_5
|
FDA | — |
| US Submission Unit Type | Report |
us_submission_unit_type_6
|
FDA | — |
| EU Application Submission Type | Repeat Use Procedure |
200000002323
|
EMA | Active |
| EU Application Submission Type | Renewal |
100000155697
|
EMA | Active |
| US Submission Type | REMS Supplement |
us_submission_type_11
|
FDA | — |
| EU Application Submission Type | Referral under Article 5(3) Reg (EC) 726/2004 |
200000002322
|
EMA | Active |
Showing 1–25 of 97 terms . Data sourced from public health authority publications and updated periodically.