Calyx RIM for Registrations

Registration FPP Attachment Attributes

You create a Registration FPP Attachment for a Full Product Presentation (FPP) to include any attached data in the XEVMPD submission for the European Medicines Agency (EMA). The following attributes describe the specific Registration FPP Attachment for a Full Product Presentation.

Attribute Description
Application Code Agency-identified application number (or identifier). Might not be known until submission time. For this reason, it can be the same as the internal code.
Application Name The name of the application.
Attachment Name On the Create Registration FPP Attachment page, Attachment Name launches the Registration Attachment Selection list that displays all Active Registration Attachments that are available in the system and are not associated to the current Full Product Presentation. Is displayed in concatenation of four fields: Internal Name + Attachment Language + Attachment Name + Attachment Version.
Note: On the Modify Registration FPP Attachment page, the Attachment Name field is display only.
Authorisation/Renewal Date The date when the first authorisation was granted by the authorising body or the date when the renewal was granted.
Family Code The company-specific code for the product family.
Family Name The standard name recognized internally and across countries.
Full Product Name The full name of the product. For example: DrugLV Filmtabletten
Full Product Short Name The short name of the product. For example: DrugLV
License Code The code assigned by the regulatory agency. Current value from Package Set Registration.
MAH/Organisation The company to which a license is given to market the product. Current value from Package Set Registration in concatenation of MAH/Development Sponsor/Organisation Name + Address + City + Country Code.
Package Description A brief package description of the pack size(s) corresponding to the referenced authorisation number.
Product Company Name Part of the medicinal product name without any other designations such as trade mark, strength, or pharmaceutical form.
Product INN/Common Name International non-proprietary name. The part of the Full Presentation Name.
Registration FPP Attachment Comments Comments for the Registration FPP Attachment. Available for modifications on the Create/Modify Registration FPP Attachment Attributes pages.
Registration FPP Attachment Concerned Parties Contains email addresses and User IDs for which Notifications can be sent. Concerned parties are anyone who might be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses.
Validity Declaration Validity confirmation that the referenced attachment is the latest version of the documentation. The Validity Declaration field is automatically updated once the XEVMPD Acknowledgement Wizard passes. The automatically assigned value is Previous Copy was sent (1), if:
  • The Registration FPP Attachment is associated to the acknowledged Authorised Product.
  • The Registration FPP Attachment is created from a Registration Attachment that was previously acknowledged.
XEVMPD License Code The current XEVMPD License Code from the Full Product Presentation entity.