Via National Procedure:
- Translation and comparison of SmPC to originator for generics
- Translation and labelling of PIL
- Review and completion of dossiers
- Compilation of Module 1
- Liaison with competent authorities
- Advancing process by the procedures in different countries
Via Mutual Recognition Procedure (MRP) / Decentralised Procedure (DCP):
- Application for national MA (MRP part)
- Translation and comparison of SmPC to originator for generics
- SmPC harmonisation
- Translation and labelling of PIL
- Review and completion of the dossiers
- Compilation of Module 1
- Securing the MA (national phase) and applying for the Assessment Report
- Establishing "day 0"
- Preparing the Response Volume
- Steering CMS submissions
- Liaison with competent authorities
- Advancing processes by the procedures in different countries
Variation and renewal applications:
- Renewal applications of a Marketing Authorisation
- Type I-II Variation Applications of a Marketing Authorisation
- Marketing authorisation transfers to a new holder
- The package leaflets and labelling amendments
- Packaging material design correction & proofreading
