International birth date (IBD)

The date of the first marketing authorisation for any product containing the active substance granted to any company in any country in the world (see GVP Annex IV, ICH-E2C(R2) Guideline).

If a marketing authorisation holder has no information on the actual IBD for a product, it should first refer to listings of birth dates that some regions develop and make publicly available. If the product is not included in any listing, it should propose to the regulatory authority a birth date that is based on the earliest known marketing authorisation of the substance and then obtain the regulatory authority’s agreement (see GVP Annex IV, ICH-E2C(R2) Q&A).