Role of the contact party associated with a submission (e.g. applicant, MAH, regulatory contact). 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)
|
|---|---|---|---|---|
| US Telecom Use | work place phone number |
—
|
FDA | — |
| US Telecom Use | work place fax number |
—
|
FDA | — |
| US Submission Contact Type | United States Agent |
us_submission_contact_type_3
|
FDA | — |
| US Submission Contact Type | Technical Contact |
us_submission_contact_type_2
|
FDA | — |
| US Submission Contact Status | RoleStatusSuspended |
suspended
|
FDA | — |
| US Submission Contact Status | RoleStatusActive |
active
|
FDA | — |
| US Submission Contact Type | Regulatory Contact |
us_submission_contact_type_1
|
FDA | — |
| EU Contact Party Role | Qualified Person in the EEA for Pharmacovigilance |
100000155057
|
EMA | Active |
| EU Contact Party Role | Proposed Marketing Authorisation Holder/Person |
100000155054
|
EMA | Active |
| US Submission Contact Type | Promotional Labeling and Advertising Regulatory Contact |
us_submission_contact_type_4
|
FDA | — |
| EU Contact Party Role | Pharmacovigilance Enquiry Information |
200000017719
|
EMA | Active |
| EU Contact Party Role | Person/Service of the MAH in the EEA (acc. Article 98 of Directive 2001/83/EC) |
100000155058
|
EMA | Active |
| EU Contact Party Role | Person/Company authorised for Communication on behalf of the Applicant during the Procedure |
100000155055
|
EMA | Active |
| EU Contact Party Role | Person/Company authorised for Communication between MAH and Authorities after Authorisation |
100000155056
|
EMA | Active |
| EU Contact Party Role | Person responsible for Product Defects/Recalls |
200000029925
|
EMA | Active |
| EU Contact Party Role | Person (technical or non-technical) responsible for eCTD submissions communication |
200000043407
|
EMA | Active |
| US Telecom Use | mobile contact phone number |
—
|
FDA | — |
Showing 1–17 of 17 terms . Data sourced from public health authority publications and updated periodically.