Application for authorisation to retail sale medical gases
Companies and hospitals seeking to sell and/or supply medical gases to consumers must have an authorisation for retail sale of gases pursuant to section 39 of the Danish Medicines Act.
Who are covered by the rules?
The rules apply to all private and public companies, including hospitals, receiving and supplying medical gases.
How to be authorised?
Before a company/hospital may supply medical gases by retail it must apply for an authorisation.
When the Danish Medicines Agency receives an application, we will contact the company to arrange an inspection of the company in order to assess whether circumstances confirm to the requirements of the executive order on medical gases. When a company is ready for authorisation, we then issue an authorisation according to section 39 of the Danish Medicines Act.
Change or termination of an authorisation
The same application form should be used as when a new authorisation is applied for. The Danish Medicines Agency will assess whether the change require an inspection before it can be approved. If so, we will contact the company to arrange the inspection.
The assessment time for a new authorisation or for a change to an authorisation that requires an inspection is 90 days excluding clock stop. If the change of an authorisation do not require an inspection the assessment time is 30 days excluding clock stop. Clock stop is when the Danish Medicines Agency is waiting for information from the applicant.
What are the requirements?
The requirements to retailers of medical gases are described in sections 7 to 25 of the executive order on medical gases.
The requirements concern:
- documentation on receipt of gases
- staff training and placement of responsibility
- special rules governing prescription-only gases
- reporting of volume sold