Editing Properties for Market Authorizations and Market Authorization Changes

You can many details associated with a market authorization or market authorization change. Typically, you enter country and authorization details on the market authorization change, and when that is approved, Market Registration copies those details to the market authorization.

Required access role: Regulatory User

Before you begin: View the properties page for the required market authorization or market authorization change.
  1. Click Edit .
  2. Edit these details as needed:

    SectionField NameDescription
    TitleThe descriptive name for the market authorization.
    DescriptionDescription for the market authorization.
    CountryMarket Authorization HolderThe organization that is responsible for holding the market authorization for any product in this country. Click to open the Properties page for the organization.
    Regional Country RepresentativeThe organization that acts as the company's regional representative in this country. Click to open the Properties page for the organization.
    DistributorThe organization that distributes the product in this country. Click to open the Properties page for the organization.
    Prescription SpecificationThe prescription details of the product for this country.
    Registered Product NameThe registered name of the product for this country.
    AuthorizationNumberThe authorization number for the product.
    Approval DateThe date of the approval of the market authorization.
    Start Effectivity DateThe effective state date of the market authorization.
    Expiration Date RequiredYes or No indicating if an expiration date is required for this market authorization.
    Expiration DateThe expiration date of the market authorization.
    Sunset Clause Date RequiredYes or No indicating if a sunset clause date is required for this market authorization.
    Sunset Clause DateThe date by which if the company does not commercialize the product, the market authorization might be lost.
    Sunset Clause Notification IntervalThe number of days between notifications that the date for the sunset clause is approaching.
    Renewal Notification IntervalThe number of days between notifications that the market authorization needs to be renewed.
    Restricted AuthorizationQuantity of UnitsOnly shows for restricted authorizations.

    The number of units that can be used in this country granted by this restricted authorization.

    Clinical ProductOnly shows for restricted authorizations.

    The name of the clinical product authorized by this restricted authorization.

  3. Click Done.