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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
All agencies EMA FDA
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.