Pharmacovigilance most of all

The European Medicines Agency (EMA) has recently published an overview of pharmacovigilance activities that outlines just how strong and reliable a system we have in the EU. The report was prepared by EMA in collaboration with the National Competent Authorities (NCA).  The report includes quantitative data covering the period between 2015 and 2018 and shows that the European regulatory network for medicines is held accountable for the implementation of the pharmacovigilance legislation.

The measurement of impact is based on a strategy and action plan for measuring the impact of pharmacovigilance activities, adopted by EMA’s safety committee (PRAC) in 2017.

It shows that the EU pharmacovigilance system is strong and protects public health.

 Some key outcomes 2015-2018

  • More than 500 new or updated risk management plans were assessed by the PRAC each year, ensuring the safety monitoring and risk minimisation is proportionate and planned. In addition, nearly 7,000 risk management plans were assessed by the Member States for nationally authorised medicines during the reporting period.
  • Enhanced EudraVigilance database of suspected side effects, resulting in improved reporting and greater analytical power;
  • Evaluation of nearly 9,000 potential signals (information about new or changing safety issues potentially caused by a medicine) by EMA’s signal management team over the period covered by the report, and a similar number of potential signals assessed by Member States;
  • Radical simplification and improvement of the way periodic safety update reports are handled, by establishing a common repository with a single portal for access;
  • Development of criteria to determine when a public hearing on issues of medicines’ safety would be of value, and the successful holding of the first such hearings, for valproate-containing medicines in 2017 and for quinolone and fluoroquinolone antibiotics in 2018;
  • Continued development of the ‘Article 57 database’, which now contains information on more than 800,000 medicinal products authorised through central, decentralised, mutual recognition and national procedures across the European Economic Area.

For more details on the report please refer to EMA web page where you can access the press release issued.

The pharmacovigilance legislation established now reinforces the need for and format of various reports, including:

  • Risk Management Plans (RMP);
  • Periodic Safety Update Reports (PSUR);
  • Post-Authorisation Safety and efficacy Studies (PASS);
  • Pharmacovigilance System Master Files (PSMF).

Should you require assistance with respect to setting up a pharmacovigilance system, or the preparation and submission of pharmacovigilance related data we encourage you to contact us.

Written by Alice D’Alton.

Brexit… it’s getting closer…

Ivowen have provided some practical guidance and documents below, which may help you prepare for Brexit for products authorised by the DCP and MRP procedures.

Take our Brexit quiz to see if you are ready.

Do you still need to change your MAH(s) in any of the EU Member States because of Brexit?

If so, refer to the following updated guidance issued in January 2019 which details the documentation and requirements to submit a Marketing Authorisation Holder transfer:

CMDh guidance on Brexit, Jan 2019

If you need any clarification or support to complete a Marketing Authorisation Holder transfer, Ivowen will gladly assist you in a timely manner.  Contact us for more information or to make an enquiry.

 

Is the UK your current RMS?

If so, you need to initiate an RMS switch as soon as possible. The guidance issued in July 2018 along with the template issued in June 2018 is required to complete this process. This template needs to be completed and sent to a specific e-mail address at the proposed new RMS. The list of contacts points to send the completed template is provided below:

Guidance:

CMDh guidance on changing RMS

Template for RMS change

List of RMS contacts can be found in the excel spread sheet in the link Contact Points, which can be found here:

MS contact points

If you need any clarification or support a RMS switch, Ivowen will gladly assist you in a timely manner.  Contact us for more information or to make an enquiry.

 

 

Do you need to change your UK batch release site, etc., if it currently within the UK?

If so, you can refer to the updated guidance document issued in December 2018, which provides information on the type of variation that is required to change functions such as batch release site(s), QC testing site(s), packaging site(s), deletion of site(s) for batch release and changes to the QP for Pharmacovigilance (QPPV) and PSMF where these functions still reside within the UK:

CMDh practical guidance for Brexit & DCP/MRP

If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner.  Contact us for more information or to make an enquiry.

 

Do you supply product to Cyprus?

If so, the Cypriot Competent Authority has issued a newsletter to Stakeholders on the 14 January 2019 which lists 105 products authorised via an exceptional marketing authorisation affected by Brexit which are considered critical. The Drugs Council in Cyprus recommends that pharmaceutical companies register these products via an exceptional marketing authorisation using another reference state other that the UK.

If you need any clarification or support to complete an Exceptional Marketing Authorisation to avoid no supply of these critical products on the Cypriot market, Ivowen will gladly assist you in a timely manner.  Contact us for more information or to make an enquiry.

 

 Written by Marian Winder

marian