CMDh publishes Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs

Occasionally, it may not be possible to finalise an issue (e.g. a signal or a new risk, where additional data is needed before the next PSUR) within a PSUSA procedure, but further scientific assessment of data is warranted. In such exceptional cases, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) may request a follow-up to MAH(s). However, no so-called LED procedure exists for nationally authorised products (NAPs). This Guidance document describes the procedures to be used given the limitations of the existing regulatory tools.