Tina Nørgaard has joined the PharmAdvice team
I am happy to announce that Tina Nørgaard has joined PharmAdvice as Marketing Compliance and QA Manager.
Tina Nørgaard is a pharmacist with a Master in public administration and more than 30 years of experience within the pharma industry.
Simplified renewal application for marketing authorisations
The regulatory procedures for renewal applications for Mutual Recognition Procedures (MRP) and Decentralised Procedures (DCP) have been simplified with the publication of the CMDh update of the Best Practice Guide for renewals in February 2023.
Christina Guiton, MD, joins the PharmAdvice PV Team
I am happy to announce that Christina Guiton has joined the PharmAdvice pharmacovigilance team as QPPV and pharmacovigilance manager.
Christina Guiton is a medical doctor with more than 20 years of experience within the pharma industry.
Extension of pilot period for MAH requirements
On 22 November 2017, EMA launched the new EudraVigilance system. All marketing authorisation holders (MAHs) were required to monitor EudraVigilance data with a start date of 22 February 2018.
In August 2022 EMA and the European Commission agreed to further extend the pilot until the end of 2023.
A new medical product - but for how long?
In all marketing compliance materials, the word "new" or words indicating that a medicinal product is new can only be used for a limited period of time.
OMS and EudraGMPD - a responsibility of your organisation
As of 28 January 2022 organisations must verify that their relevant locations (company name and location address details) are correctly recorded in OMS.
All applications must be in eCTD format as of October first 2019
All submissions must be in eCTD format as of 1 October 2019, according to the Danish Medicines Agency website page.
Good news on search tips for EMA’s website
We have included the link to use for PRAC recommendations and PI translations, listed in chronological order including the option of choosing languages other than English.