In 2011, the pharmaceutical department “ACE Apotheek” (ACE Pharmacy) was started. As a registered pharmacy, we can supply our medicine to pharmacies, doctors and patients. In the past few years, we have supplied medicines with availability issues.
The reasons for unavailability of medicine through the usual routes are diverse. For example, it involves a medicine that is only available for clinical research and not (yet) as an authorised medicine. On the other hand, some authorised medicine are withdrawn from the market due to manufacturing problems or because of economical considerations. Despite the absence of a marketing authorisation, a medical need can (still) exist for the use of these medicine in the treatment of certain diseases.
The European regulations provide several possibilities to gain access to unlicensed medicine. Examples are named patient programs, compassionate use and temporary authorisations. These programs can only be carried out under strict conditions.
About 20 unlicensed medicine are currently supplied by ACE. The basis for the named patient supply to Dutch (hospital) pharmacies is set out in article 3.17 of the Medicines Act Regulation. One of the conditions is the presence of a written request of the doctor for a (named) patient, a so-called physician’s statement.
We obtain permission from the Dutch Health Inspectorate for our named patient programmes in the Netherlands. These permissions are valid for one year and are extended when necessary.
Would you like to know more about our named patient programs? Or do you have any suggestion(s) for us? Please let us know through our contact form.