Annex 21 to the EU-GMP Guidelines (Importation of medicinal Products) has been published as a draft. It summarises the GMP requirements for importers of medicinal products.
The EMA and its partners are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the EU.
After long discussions, EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders summarizing various MAH GMP-responsibilities.
During the transition period, all EU laws remain applicable in the UK. Does that mean that QP certification by UK QPs will still be valid across the EU? Not really, as a statement by the EQPA explains.
The US Food & Drug Administration (FDA) recently sent a Warning Letter to a US pharmaceutical company criticising batch record design and review and quality oversight.
