Danish regulators remove expiry dates from company authorisations
The move – announced on the Danish Health and Medicines Authority’s website – will mean that all authorisations issued to drug and pharmaceutical intermediate manufacturers and importers after September 1 will be considered valid until changed or terminated.
The change will also be applied to the authorisations issued to EU/EAA drug wholesalers, firms that veterinary drugs, blood banks and companies that conduct preclinical toxicology and pharmacological testing.
The organisation said that: “We are changing this practice to ease the administrative burdens related to the renewal of company authorisations. The change does neither impact the contents of the authorisation nor our monitoring of companies that have been granted an authorisation."
"If a company makes changes to any of the activities approved on the authorisation without prior approval by the Danish Health and Medicines Authority, we may suspend the authorisation, impose a fine on the company or may, in exceptionally grave circumstances, change or withdraw the authorisation."
Spokeswoman Mette Elstrom reiterated the benefits of the move, telling in-pharmatechnologist.com the change “will ease the regulatory burden for both the companies and us,” adding that the organisation’s inspection activities will not be affected.
She also rejected the idea that removing expiry dates increases the risk that once compliant companies which subsequently fall short of standards will be able to operate for longer than if they held finite authorisations.
“We do not expect that to happen,” Elstrom said, adding that the organisation intends to introduce precautionary control measures whereby facilities authorised for long periods will be subject to review.