Industry Leaders Call For Legal Certainty On Northern Ireland Regulation
The European Commission’s proposals for solving the post-Brexit regulatory problems relating to the Northern Ireland market are welcome but they do not go far enough and risk leaving suppliers in a legal limbo, says the off-patent medicines industry.
You may also be interested in...
Proposals on medicines put forward by the European Commission are part of a package of measures to improve the implementation of the Northern Ireland Protocol by relaxing checks on goods moving across the Irish sea.
Legislation setting out measures to mitigate shortages in Australia has been passed by the country’s senate, incorporating into law key provisions of new five-year pact between the off-patent industry and the government.
While US biosimilar approvals have been thin on the ground in 2021 – with products delayed due to the FDA’s inability to conduct certain facility inspections during the COVID-19 pandemic – the market has nevertheless seen several firsts this year, including two interchangeability designations and the first ophthalmic biosimilar approval.