Regulatory procedures following the granting of the marketing authorisation

Agency for Medicinal Products and Medical Devices of Croatia (HALMED) organized regulatory and pharmacovigilance conference “Regulatory procedures following the granting of the marketing authorisation”


Changes to the documentation on the most numerous requirements in the life cycle of the drug.They are regulated by the harmonized EU / EEA Regulation for changes that give new opportunities, obligations and responsibilities for holders of authorizations to manage better the life cycle of a drug.

New possibilities for renewal of approval for an unlimited period. Till 2018 is expected that most national drugs will be approved for an unlimited period.


The conference was held in Zagreb on 15th September 2015.


Clinres attended this conference.