Just before the European Council decided, in agreement with the UK, to postpone Brexit until 31 October, the European Commission offered an optimistic report on Wednesday on the preparedness of the drug and medical device sectors.
“Based on available information, the majority of medical products concerned by the UK withdrawal should be compliant with EU legislation on the withdrawal date,” the commission said.
Still, the commission noted that some medicines and medical devices may not be compliant in time and could be at risk of shortages if they do not act swiftly to remedy the situation. “The Commission and Member States will continue to monitor closely the progress of ongoing preparedness actions and provide support to affected stakeholders,” an annex published Wednesday says.
The commission also points out how Member States can use certain exemptions in the directives on human and veterinary medicines “to allow marketing authorisation holders to rely on quality control testing performed in the United Kingdom for a limited period of time.”…