Do you Know the about IRIS?

The European Medicines Agency (EMA) has launched a new secure online portal for orphan designation applications.

The portal, named 'IRIS', provides a single space where applicants can submit and manage the information and documents related to their applications for orphan designation. This is expected to reduce the time needed to prepare and submit the applications. During the review process, applicants can check the status of their applications from any device and receive automatic notifications when the status of the application changes.

Iris is part of a longer-term programme that aims to make the handling of product-related applications easier and utilises the domains of master data in pharmaceutical regulatory processes (SPOR).

Applicants will still be able to use the existing submission process until 19 September 2018. However, the Agency strongly encourages companies to start using the new portal from 19-06-18.

You can use this portal for the following activities relating to orphan medicines:

·         Apply for an orphan designation

·         Request a pre-submission meeting

·         Track the progress of your application

·         Respond to requests from EMA for supplementary information

·         View your historic applications

·         Change the name or address of a sponsor

·         Request an Appeal

·         Remove or transfer an orphan designation to a new sponsor

Reference: Modernising the orphan designationprocess

Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU

On 29 March 2017, the United Kingdom (UK) decided to leave the European Union (EU) and the UK government triggered Article 50 of the Treaty on the EU, officially starting the two-year period of negotiation before the exist. The process, known as ‘Brexit’, will presumably lead to profound changes to the broadly harmonised field of medicinal products. At present, it is widely reported that the UK government intends to pursue a ‘hard break’ from the EU, which would consider the UK outside of the single market.

The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).

Updates to the questions-and-answers document  include information on how the UK’s withdrawal will affect the status of inspection outcomes by the UK national competent authority and batch release processes for medicines that are subject to Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR). The document also clarifies how scientific opinions of the Committee for Medicinal Products for Human Use (CHMP) for ancillary medicinal substances in medical devices requested by UK notified bodies will be affected. In addition, it includes new information on back-up arrangements for Qualified Persons for Pharmacovigilance (QPPVs) and on marketing multi-country packs of medicines, where one of the countries in which the packs will be sold includes the UK.

The Agency has also published an updated version of its practical guidance for industry which outlines the steps that companies should follow to make sure that necessary changes to their marketing authorisation are made by the end of March 2019, to allow for the continued marketing of their medicine in the Union after Brexit.