Exemption for substitution of pharmaceuticals

Exemptions can be granted from medicaments if the drug concerned cannot be procured, cf. the Danish medicine chest; inventory, control document, user instruction.

When you apply for an exemption from a medicament, you must follow a specific procedure. Below, you can find the application guidelines.

Online application for an exemption

The online application for an exemption makes it possible to apply for an exemption from a drug that cannot be procured or that has a concentration other than that described in the Danish medicine chest. You can apply for exemptions from 3 drugs at a time.

  1. Start by inserting all the standard information in the form.
  2. Choose the relevant drug (Grp.no./name) that you want to be exempted from in the "drop down" menu.
  3. In cooperation with the pharmacy, you can choose known substitute drugs (Grp.no./name) in the subsequent "drop down" menu.
  4. The existing substitutes have prefabricated user guidelines that are available through the "shortcut" at the bottom of the form. Save on the "desktop".
  5. Choose "view" and attach the user guidelines. (Send the form)
  6. A Medical advisor from the Centre of Maritime Health Service will revert to you as soon as possible.

Alternative for valid drugs and known substitutes

  1. When the pharmacy has neither the drug requested nor one of the known substitutes, it is possible to insert alternative drugs in the form, in cooperation with the pharmacy. (Send the form)
  2. A Medical advisor from the Centre of Maritime Health Service will revert to you as soon as possible.

Distribution of responsibility

The Centre for Maritime Health Service is responsible for the granting of exemptions and for the forwarding of guidelines to the applicant on the insertion in the control document. The shipping company is responsible for finding substitutes, having user guidelines drawn up in Danish and English and having labels made in at least English. The master is responsible for inserting the user guidelines and the labels in the control document.

 KONTAKT

Søfartsstyrelsen
Center for det Maritime Sundhedsvæsen (CMS)
+45 72 19 60 04