A risk-based audit should cover governance, risk management and internal controls of all parts of the pharmacovigilance system, as well as pharmacovigilance activities delegated to another organisation such as PharmAdvice, and you should assess risks at both the strategic, the tactical and the operational level.

In this article, you will find a list of the most common ongoing and annual pharmacovigilance activities and the documentation you are required to provide for each activity.

Are you planning for a Good Distribution Practice (GDP) audit, but lack the time or qualifications? At PharmAdvice we act on behalf of our customers as external Responsible Person and regularly perform GDP audits on their behalf.

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.

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.

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.

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.

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.

As of 28 January 2022 organisations must verify that their relevant locations (company name and location address details) are correctly recorded in OMS.

All submissions must be in eCTD format as of 1 October 2019, according to the Danish Medicines Agency website page.

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.