Information regarding medicinal product authorisation

> Updated results – Assessment of medicinal product authorisation
> Indications of medicinal products protected by patent law

PARALLEL IMPORT AUTHORISATIONS

> Parallel import authorisations

AUTHORISATIONS FOR SPECIAL NEEDS

> Authorisations for special needs

MRP / DCP / NATIONAL PROCEDURE

> Authorisation – Renewal
> Variations
> National step
> Procedural guidelines
> Notice to applicants
> E-mail addresses used in the authorisation of medicinal products through European MRP/DCP procedure and MRP/DCP variations

CENTRALISED PROCEDURE

All information regarding the centralised procedure are available online: – Centralised procedure | European Medicines Agency (europa.eu)

> CENTRALISED PROCEDURE – Procedural guidelines
> CENTRALISED procedure – Forms
> CENTRALISED procedure – Fees
> CENTRALISED procedure – Blue-Box