Brexit took place at 11pm on 31 Jan 2020 as the UK departed from the European Union. A transition period of 11 months began on 01 Feb 2020 until 31 Dec 2020. This transition period allowed for the UK to continue to follow EU rules while both sides worked out what the future EU/UK
The manufacture of pharmaceutical products for the EU, including active substances and medicinal products, frequently occurs outside of the Union. As required by the HPRA “A manufacturer’s authorisation (MIA) is needed if a company is involved in any of the following manufacturing activities: processing of a dosage form, primary packaging, secondary packaging, batch certification,
In July 2021, the European Medicines Agency (EMA) published the final reflection paper entitled "Good Manufacturing Practice and the Marketing Authorisation Holder" after a period of consultation with the relevant stakeholders. The document focuses on and describes the good manufacturing practice (GMP) responsibilities applicable to Marketing Authorisation Holders (MAHs). With the rise in virtual
MIAS has continued exceptional growth and development over 2021. We'd like to thank our Team, Customers and Suppliers for contributing to the continued success of MIAS. We would like to wish you all a very Merry Christmas and we look forward to what will come in 2022. Our offices will close on Friday 24th
We would like to welcome Ciara Kearney, Lisa Evans, Sherry A Calimlim and Olivia McEvoy to the MIAS Pharma Team. They are a very welcome addition to the team and we look forward to a long and fruitful career with MIAS.
The pharmaceutical industry is underpinned by a large amount of documentation to show evidence of the quality, safety and efficacy of the drug product throughout it's life cycle. The integrity of records and data can be breached at any time, by any employee – either intentionally or unintentionally. Data integrity failure may involve omissions,
So are you preparing and filing a Marketing Authorisation Application (MAA) in Europe? What needs to be considered and what timelines do you need to work towards? Active Pharmaceutical Ingredients or APIs must be manufactured in compliance with EU GMP and this compliance is confirmed by the QP declaration, which is submitted with the
A Manufacturer’s/Importation Authorisation (MIA) is required if a company is involved in manufacturing and/or importation activities relating to human, veterinary or investigational medicinal product, within the EU. The term manufacturing and/or importation includes any of the following manufacturing activities as detailed by the HPRA: processing of a dosage form, primary packaging, secondary packaging, batch
Virtual (or Remote) QP Audits have become a key tool in supplier qualification and health authority inspection programs in the Pharma industry during the pandemic. The regulatory authorities have published guidance on how they will perform their inspections by virtual/ remote audits or distant assessments during this restrictive period. There are several elements to
Quality Technical Agreements (QTAs) are not just a nice-to-have; there is a regulatory requirement to have them established! QTAs are established with manufacturers, suppliers and service providers to obtain written agreements of the details of activities to be provided and the associated requirements and controls. Each agreement type should be tailored to address the
