Guidelines for authorisation for destruction of euphoriant substances (list ABC)

14 January 2003, revised on 26 March 2008

The application form must be sent to the Danish Medicines Agency, Axel Heides Gade 1, DK-2300 Copenhagen S, Denmark.

The application for obtaining an authorisation for destruction must be in the hands of the Danish Medicines Agency no later than one month before the destruction is to take place.

The authorisation for destruction only covers the amount applied for, i.e. the composition/quantity must not be changed once the authorisation is granted. If the count on the day of destruction is not in accordance with the application, the Danish Medicines Agency must be informed about the adjustments.

No later than one week after the destruction, the Danish Medicines Agency must be informed that the destruction has actually taken place.

If there is applied for destruction of more than one substance/constituent, a form must be filled in for each individual substance/constituent with an indication of the total quantity. No appendices may be enclosed, and all preparations that are to be destructed must be written on the form. The amount must be indicated with three decimals.

NB! Destruction of substances in lists D and E does not require an authorisation from the Danish Medicines Agency. However, destruction must be stated in the company's annual report, which must be submitted to the Danish Medicines Agency once a year.

Instructions for filling in the application form (in Danish only):

• Please state the business name, address, person responsible as well as telephone number (an address for a post office box is not sufficient).
• Names of people participating in the destruction.
• Date of when the company plans to recount and destruct the substances/constituents. It is VERY IMPORTANT that this is stated and complied with, as the Danish Medicines Agency may choose to participate in/monitor the destruction, regardless whether the company is authorised to effect the destruction itself. Recount MUST take place immediately before the destruction, i.e. on the same day and at the same address as where the recount and destruction are to take place.
• Please state substance/constituents, pack size, number and strength (mg or mg/ml) for each product line. (The amount must be indicated with three decimals).If the constituent is a salt, it must be converted into base. The conversions factors are available in the Yellow List and the Green List.
• Please sign the destruction application with date and signature of the person responsible. (This section does not exist in the e-form)
• The Danish Medicines Agency signs the application form, which should subsequently be regarded as a destruction authorisation.

REMEMBER that the destruction must be stated in the company's annual report of euphoriant substances, which must be submitted to the Danish Medicines Agency once a year.