Ema Catalyst One Maintenance Agreement

The application must clearly indicate the measures to be taken by the authorised representative (see question 1 « Do I have to notify the cessation of the market, revocation, suspension of my medicinal product/marketing authorisation? ») and the reason for this measure, in particular if it is based on one of the following reasons: Catalyst One – Quality Control Log version 1.0 (10.15) The marketing authorisation for an authorised central medicinal product includes the marketing authorisation and all others. ns (for example. B additional presentations,…) and extensions (for example. B new dosages, new pharmaceutical forms,…) authorised for this specific medicinal product. This term has been used since the beginning of the centralised procedure and is reflected in the way EU numbers are assigned to a centrally authorised medicine and all its presentations. . . .