An Environmental risk assessment (ERA) of medicines ensures that the potential effects of pharmaceuticals on the environment are studied and that adequate precautions are taken in case specific risks are identified. The EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation. Stakeholders […]
The recent medicinal products newsletter (issue 61) published by the HPRA includes an article about batch-specific requests (BSRs) and safety features. This is an update on the Falsified Medicines Directive safety features information. The Commission Delegated Regulation (EU) 2016/161 with detailed rules for the safety features appearing on the packaging of medicinal products for human […]
The European Union is arguably the world’s most powerful bloc and very soon it’s about to lose the United Kingdom, one of its biggest members. How and when the UK leaves the EU will have further implications that ripple around the globe. So if you’ve heard about Brexit but haven’t been keeping up with every […]
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, […]
With the festive season upon us and 2019 on the horizon, Ivowen are setting our sights on the year ahead. So what’s going on in 2019 and beyond, including and excluding Brexit… What’s happening in early 2019? We will be attending the Medicines for Europe Regulatory and Scientific Affairs and Pharmacovigilance conferences in January and […]
Brexit in: [wpcdt-countdown id=”796″] The Health Products Regulatory Authority (HPRA) of Ireland is geared up and ready to support MA holders as they prepare for Brexit. What happens if UK leaves the EU with no deal? The implications of Brexit with regard to the UK’s role in the licensing of medicines will be determined […]
Brexit in: [wpcdt-countdown id=”796″] Test your knowledge, take our Brexit quiz here What do you want to do next? Do you want to continue to market your product in the EU only, or are you interested in both the EU and UK markets? Read on to find out what you need to do for both […]
Ivowen are pleased to announce that Fellowship of The Organisation for Professionals in Regulatory Affairs (FTOPRA) has been conferred on Majella Ryan. According to TOPRA: “The award of a Fellowship is intended to recognise a contribution in which the individual has used his/her professional knowledge and experience to influence, guide or develop the profession in a proactive […]
As the date for the withdrawal of the UK (also known as Brexit) from the EU approached closer, it pays to hope for the best and prepare for the worst. With this in mind, the EMA have issued a guidance document on “Practical guidance for procedures related to Brexit for medicinal products for human and […]
As of 1st June 2018, Ireland became one of the recognised member states in the Mutual Recognition Agreement (MRA) between the EU and the US FDA. What is the MRA? The Mutual Recognition Agreement (MRA) is an agreement between countries concerning the conformity assessment of regulated products. From the pharmaceutical point of view, this means […]
The updated Annex to “Excipients in the labelling and package leaflet of medicinal products for human use” guideline was published on the 09/10/2017. This updated Annex in all EU languages can be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001646.jsp In addition, Notice to Applicants Volume 2C has been updated in March 2018 to reflect this updated annex. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c/guidelines_excipients_march2018_en.pdf What […]
All good (and bad) things, must come to an end. The NeeS (Non-eCTD electronic submissions) submission format, will no longer be accepted for any Marketing Authorisation applications (MAAs) or submissions in MRP or DCP from 1st January 2018. Centralised Procedure (CP) submissions have been mandatory in eCTD since 2010. All new MAAs submitted using either […]
Dungarvan Enterprise Centre,
Old Friary Building,
Lower Main Street, Dungarvan,
Co. Waterford, X35 FX45,
Ireland.