On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their joint task force regarding the availability of authorised medicines for human and veterinary use. The HMA-EMA task force was created
The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit: medicines, medical devices and substance of human origin”, which considered the regulatory arrangements needed for the safe and effective supply of medicines and medical devices post-Brexit (see our blog
With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears from a recent letter to the Financial Times (FT) that Government ministers are listening. On 3
The new Health Service Medical Supplies (Costs) Act 2017 came into force on 27 April 2017, giving the Department of Health greater powers to control the cost of medicines supplied to the National Health Service (NHS). The cost of branded medicines supplied to the NHS is regulated through two mechanisms – the Pharmaceutical Price Regulation
The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients in Scotland, published in a report on 14 December 2016. The recommendations aim to further improve the process by which these types of medicines, in particular ultra-orphan products,
From 1 July 2015, any UK-based online retailer that sells medicines to consumers in the UK or any EU or European Economic Area (EEA) country must be registered with the UK competent authority, the Medicines and Healthcare Products Regulatory Agency (MHRA). They must also display the EU common logo for online retailers and pharmacies, together
The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has published new guidance on data integrity in the context of good manufacturing practices (GMP).