Zero – Day procedure

Zero-day procedure

This is a simplified repeat procedure, during which Lithuania would unconditionally recognize the registration of a medicinal product authorised in other European Economic Area (EEA) countries under the mutual recognition or decentralized procedure, when submitting a marketing authorisation dossier identical to the approved one in reference member state (hereinafter – RMS). In other words, the zero-day procedure would apply to those medicinal products whose quality, safety and efficacy have been assessed by experts from the competent authorities of other EEA (at least two individual) countries and an assessment report has been drawn up.

It should be noted that potential applicants should always contact the State Medicines Control Agency (hereinafter – SMCA) and provide request before initiating any procedure, where the goal is a short procedure, and SMCA will decide in advance on a case by case basis, if this approach is acceptable.

Once the SMCA has confirmed that a zero-day procedure can be initiated, the Applicant should contact the RMS to update an Assessment Report of medicinal product in question, to state the date of submission of application for a zero-day marketing authorization and to initiate a zero-day procedure.

Following these steps, the Applicant shall submit an application for a zero-day procedure. An updated dossier should contain all changes and updates to the data and information, and a declaration that the updated dossier is identical to the updated dossier submitted to RMS. Proposed translations of the Summary of Product Characteristics, labelling and (if available) package leaflet into Lithuanian language should be submitted with the dossier as well.