Consideration of application Consideration of application
- 58Consideration of application
- 58APaediatric rewards
- 58BPublication of information relating to paediatric marketing authorisations
- 58CConsideration of applications relating to orphan medicinal products
- 58DOrphan rewards
- 58EConsideration of applications relating to combined advanced therapy medicinal products
- 58FConsideration of applications relating to conditional marketing authorisations
- 58GConsideration of applications in relation to medicinal products containing or consisting of genetically modified organisms
- 59Conditions of UK marketing authorisation or parallel import licence: general
- 60Conditions of UK marketing authorisation or parallel import licence: exceptional circumstances
- 60ACondition as to the submitting of samples and other information to the appropriate authority
- 60BSubmitting of samples and other information: EU marketing authorisations
- 61Conditions of UK marketing authorisation: new obligations post-authorisation
- 62Classification of UK marketing authorisation or parallel import licence
- 63Frequency of periodic safety update reports
- 64Duties of licensing authority in connection with determination
- 64AObligation of licensing authority in case of change of classification