Timelines for substantial modifications

Validation

Validation of the substantial modification: 6 days

During these 6 days the rMS (part I modification) or the MSc (part II modification) can request additional documents to complete the application. The member state shall set a maximum of 10 days for the sponsor to respond to this request. Upon receipt of the respons the MS has to notify the sponsor within 5 days whether or not the application complies with the requirements of the CTR. If the MS does not meet its time limits there will be a tacit approval, i.e. the application of the modification is regarded as complete and can be assessed. Where the sponsor does not provide additional information within the period determined by the MS, the application shall be deemed to have lapsed.

Assessment

Assessment of the substantial modification: 38 days (from the validation date).

Between the validation date and the reporting date, a request for additional information can be send to the sponsor. This may extend the above mentioned period with a maximum of 31 days, i.e 12 days for the sponsor to respond to the request, and subsequently 19 days to assess the respons by the MS. Where the sponsor does not provide additional information within the period determined by the MS, the application shall be deemed to have lapsed.

Decision

Decision on the substantial modification: 5 days (from the reporting date or last day conclusion part II).

For a SM part II only there is no decision phase. The date of conclusion of the assessment part II is also the date of the decision regarding part II SM.