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