R RegData
← eCTD Controlled Vocabularies

Party type

Role of the contact party associated with a submission (e.g. applicant, MAH, regulatory contact). Regionally defined.

eCTD 4.0 Party type 17 terms
HA Controlled Vocabulary Term Code Agency Status
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.