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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 8 terms
All agencies EMA FDA
Term Code Agency Status
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

8 terms shown for EMA. Data sourced from public health authority publications and updated periodically.