Data exclusivity of a centrally authorised medicinal product starts with the publication date in the Community register of medicinal products for human use of the European commission. Thus, not the issuing of the marketing authorisation is crucial for the calculation of the data exclusivity period, but the publication in the register.

Legally, applications for generic/hybrid marketing authorisation can only be accepted if the data protection period has elapsed. Therefore, BfArM has to reject applications submitted before the end of data protection.

If such an application has been withdrawn by the applicant, BfarM will demand fees for the amount of work already spent for the application. The procedure number of the withdrawn application cannot be used for a new application.
For further information please refer to Q&A of the EMA.