Type of regulatory submission / activity (e.g. initial, variation, renewal). Regionally defined.
|
HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
|
Term
Term Description as defined by the Health Authority
|
Code
Code, if any, associated with the term by the Health Authority
|
Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
|
Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
|
|---|---|---|---|---|
| Submission Type | Periodic Safety Update Report |
100012
|
SwissMedic | — |
| EU Application Submission Type | Periodic Safety Update Single Assessment |
100000155718
|
EMA | Active |
| EU Application Submission Type | Plasma Master File |
100000155701
|
EMA | Active |
| Submission Type | Plasma Master File |
100016
|
SwissMedic | — |
| EU Application Submission Type | Post-Authorisation Measure |
100000155717
|
EMA | Active |
| US Submission Type | Postmarketing Requirements or Postmarketing Commitments |
us_submission_type_7
|
FDA | — |
| US Application Type | Premarket Approval Application (PMA) |
us_application_type_9
|
FDA | — |
| US Application Type | Premarket Notification 510k (510K) |
us_application_type_10
|
FDA | — |
| US Submission Unit Type | Presubmission |
us_submission_unit_type_2
|
FDA | — |
| US Submission Type | Product Correspondence |
us_submission_type_6
|
FDA | — |
| Submission Type | Prolongation, renouncement of prolongation of Marketing Authorisation, notification of no marketing or interruption to distribution |
100010
|
SwissMedic | — |
| US Submission Type | Promotional Labeling Advertising |
us_submission_type_8
|
FDA | — |
| EU Application Submission Type | Recommendation related to a post-authorisation measure |
200000002305
|
EMA | Active |
| EU Application Submission Type | Referral under Article 107i Dir. 2001/83/EC |
200000002311
|
EMA | Active |
| EU Application Submission Type | Referral under Article 16c (1c) Dir. 2001/83/EC |
200000002312
|
EMA | Active |
| EU Application Submission Type | Referral under Article 16c(4) Dir. 2001/83/EC |
200000002313
|
EMA | Active |
| EU Application Submission Type | Referral under Article 20 Reg (EC) 726/2004 |
200000002314
|
EMA | Active |
| EU Application Submission Type | Referral under Article 29 paediatric Reg (EC) 1901/2006 |
200000002318
|
EMA | Active |
| EU Application Submission Type | Referral under Article 29(4) Dir. 2001/83/EC |
200000002315
|
EMA | Active |
| EU Application Submission Type | Referral under Article 30 Dir. 2001/83/EC |
200000002319
|
EMA | Active |
| EU Application Submission Type | Referral under Article 31 Dir. 2001/83/EC |
200000002320
|
EMA | Active |
| EU Application Submission Type | Referral under Article 35 Dir. 2001/83/EC |
200000002321
|
EMA | Active |
| EU Application Submission Type | Referral under Article 5(3) Reg (EC) 726/2004 |
200000002322
|
EMA | Active |
| US Submission Type | REMS Supplement |
us_submission_type_11
|
FDA | — |
| EU Application Submission Type | Renewal |
100000155697
|
EMA | Active |
Showing 51–75 of 97 terms . Data sourced from public health authority publications and updated periodically.