Requirements for retail suppliers of medical gases
Companies and hospitals seeking to sell and/or supply medical gases to consumers must have an authorisation for retail sale of gases.
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001, as implemented into Danish law by executive order no. 1318 of 27 November 2007 on medical gases, requires that medical gases be registered as medicinal products.
This means that medical gases may only be distributed to companies holding an authorisation 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 find out whether the requirements of the above-mentioned executive order have been met. Before the expiry of 90 days, we will visit the company in order to assess whether circumstances confirm to the requirements of the executive order. When a company is ready for authorisation, we then issue an authorisation according to section 39 of the Danish Medicines Act.
What are the requirements?
The requirements to retailers of medical gases are described in sections 7 to 17 of the executive order.
The requirements concern:
- documentation on receipt of gases
- staff training and placement of responsibility
- special rules governing prescription-only gases
- reporting of volume sold
Entry into force and transitional provisions
The provisions of this executive order entered into force on 18 November 2006, however, with a transitional provision stating that companies selling gases on this date must submit an application for authorisation of retail sale of medical gases no later than 31 December 2007.
As of 31 March 2008, wholesale distributors and suppliers of medical gases are therefore not allowed to make supplies to retail suppliers or hospitals unless such retail suppliers or hospitals have been granted authorisation according to section 39 of the Danish Medicines Act.