A quick guide to Human Medicines Regulations for the Responsible Person.
In October 2017, the EMA and European Commission updated the annex to excipient guidelines for new safety advice of 15 excipients and the three-year timeline to implement the change is nearly over. Excipients are considered to be the ‘inactive’ substances in the medicinal product that are added in addition the drug substance
Legal presence requirements in UK The transition period was not extended at five minutes to midnight on 30 June 2020. In theory the UK and EU may negotiate an agreement which means that all the previously published MHRA requirements listed for a “no deal” Brexit may not be needed at the end of the