Issue 68 of the Health Products Regulatory Authority (HPRA) medicinal product newsletter has been released, covering the latest developments in medicines regulation relevant to Ireland in the first quarter of 2021.
The newsletter details various medicinal product related regulatory updates as they apply to Ireland. The first piece of news explains that the approval date for a package leaflet (PL) is considered to be the date that the case implementing or amending the PL was closed by the HPRA.
The newsletter also explores the latest work by the Committee for Medicinal Products for Human Use (CHMP) in relation to Nitrosamine impurities. The agency highlights the necessary deadlines manufacturers must comply with in relation to conducting risk evaluations, confirmatory testing and submission of relevant variations in line with guidance from the Heads of Medicines Agencies (CMDh).
Following the alignment of the CHMP opinion on angiotensin II receptor antagonists (sartans) containing a tetrazole group with that of nitrosamines, marketing authorisation holders (MAHs) must ensure that the manufacturing processes of the active substances used for their finished products are reviewed for the potential formation of n-nitrosamines. By 20 June 2021, appropriate NDMA and NDEA specifications must be introduced into the finished product specification by the MAH and consequently a variation must be submitted to lift the conditions on the risk assessment and control strategy for the active substance and finished product. When submitting these variations to the HPRA, the MAH must clearly state in the cover letter and ‘scope and background’ section of the variation application form that the variation is being submitted to lift the specified conditions.
As the European Union (EU) Clinical Trial Regulation implementation date edges ever closer, the HPRA has launched initiatives to ensure a smooth transition to the new regulation. The Clinical Trial Regulation-National Collaboration Project (CTR-NCP) launched in conjunction with the National Research Ethics Committee for Clinical Trials of Investigational Medicinal Products essentially mimics the incoming EU regulation. This will help identify any issues and lead to a smooth transition period. In addition, the HPRA is planning to hold several information sessions on the upcoming regulations in late 2021 to provide stakeholders with an insight into the practical aspects of the regulation including the use of the Clinical Trial Information System (CTIS).
The newsletter highlights other key areas in medicinal product regulation along with their relevant guidance documents. Topics covered include the preparation of labelling for joint IE/UK (NI packs), audits of Type IA notifications and updated CMDh Brexit guidance on procedures for medicinal products for human use.
The final section of the newsletter on compliance covers the authenticity verification of authorisations and certificates issued by the HPRA, certificates of free sale for devices approved under the new medical devices regulation and a summary of the annex on technical barriers to trade – 2 (on medicinal products) resulting from the EU and UK Trade and Cooperation Agreement (TCA).
The full newsletter can be found here.