The Danish Medicines Agency is set to gradually resume on-site inspections and laboratory controls, including for medical cannabis producers, the regulator said in a statement to Marijuana Business Daily.
“Due to the gradual reopening of the community, the Danish Medicines Agency is gradually resuming on-site inspections and laboratory controls,” according to the emailed statement.
“The planning of the inspections is based on risk assessments that will prioritize new approvals as well as patient and supply security,” the spokesman told MJBizDaily.
“The inspections are planned in dialogue with the companies and are only performed as on-site inspections if it is considered possible that they can be carried out without excessive strain on key functions of the inspected party. The general COVID-19 hygiene recommendations from the National Board of Health must also be complied with during the inspection.”
The Danish Medicines Agency added that it will continue to use office-based assessments and controls in some situations.
“The scope and procedure for these will be agreed for the individual inspection and GXP area, and may include, for example, the submission of relevant documentation for review by the Danish Medicines Agency, access to relevant IT systems, and video conferencing during the inspection.
The Agency issues certificates for medical cannabis producers to confirm compliance with regulations.
A certificate also confirms compliance with Good Manufacturing Practice for medicines, which is needed before a company can export medical marijuana products to other markets in the European Union.
The Agency also issued a press release on the resumption of inspections.
Matt Lamers is Marijuana Business Daily’s international editor, based near Toronto. He can be reached at mattl@mjbizdaily.com.
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