MedicinalProductAuthorization

The regulatory authorization of a medicinal product.

MedicinalProductAuthorization
identifier
Business identifier for the marketing authorization, as assigned by a regulator
subject
The medicinal product that is being authorized
country
The country in which the marketing authorization has been granted
jurisdiction
Jurisdiction within a country
status
The status of the marketing authorization
statusDate
The date at which the given status has become applicable
restoreDate
The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
validityPeriod
The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format
dataExclusivityPeriod
A period of time after authorization before generic product applicatiosn can be submitted
dateOfFirstAuthorization
The date when the first authorization was granted by a Medicines Regulatory Agency
internationalBirthDate
Date of first marketing authorization for a company's new medicinal product in any country in the World
legalBasis
The legal framework against which this authorization is granted
jurisdictionalAuthorization
Authorization in areas within a country
identifier
The assigned number for the marketing authorization
country
Country of authorization
jurisdiction
Jurisdiction within a country
legalStatusOfSupply
The legal status of supply in a jurisdiction or region
validityPeriod
The start and expected end date of the authorization
holder
Marketing Authorization Holder
regulator
Medicines Regulatory Agency
procedure
The regulatory procedure for granting or amending a marketing authorization
identifier
Identifier for this procedure
type
Type of procedure
date[x]
Date of procedure
application
Applcations submitted to obtain a marketing authorization