When your Marketing authorisation is granted, many local regulatory activities are still required prior to commercial launch. These requirements vary significantly between countries, and we recommend you to carefully plan the marketing in collaboration with local experts.
Below some actions that usually involve Regulatory Affairs:
– Strategy for common packs and serialisation
– Application for Nordic VNR and similar
– Local review and approval of educational materials, when available
– Ensuring PV and GDP functions are in place, in accordance with local requirements
– Review and adaption of promotional material according to local ethical code
– Registration in local data bases and update of compendia such as Fass in Sweden and Felleskatalogen in Norway
At RegFile we are happy to support with the regulatory launch activities for the five Nordic countries. Contact email@example.com for more information.