Action plan for concrete solutions and recommendations in the event of temporary unavailability of a medicinal product
As part of the search for structural solutions to the unavailability of medicinal products, a test phase began in January 2018 concerning an action plan for alternative medicinal products or alternative treatments in the event of temporary unavailability.
A medicinal product may be temporarily unavailable for a wide range of reasons. At the FAMHP, a working group was created in collaboration with INAMI and representatives of pharmacists, hospital pharmacists, doctors, insuring bodies (mutuals), pharmaceutical companies and distributors to search for structural solutions to this problem.
The notification of temporary supply problems is important not only for the patient but also for all persons involved in healthcare.
An action plan for an alternative medicinal product or an alternative treatment
One of the new measures is to create an action plan to offer, if necessary, an alternative medicinal product or an alternative treatment. A test phase, during the course of which this action plan will be evaluated in practice, was launched in January 2018.
In order to test the action plan as optimally as possible, the FAMHP must acquire a realistic idea of the scale of the problem. It is therefore necessary that pharmaceutical companies systematically notify any temporary supply problems.
How to notify the temporary unavailability of a medicine?
The pharmaceutical company in question notifies the temporary unavailability of a medicinal product by filling in the electronic form via the single contact point.
In order to evaluate the impact of the problem correctly, it is necessary to indicate a predicted date for the end of unavailability. You can amend this date at any time by submitting a new form.
When to notify the temporary unavailability of a medicine?
The pharmaceutical company concerned notifies the temporary unavailability of a medicinal product when this is expected to last for at least two weeks.
It is very important that you notify any unavailability as soon as possible; preferably before the medicinal product effectively becomes unavailable.
Why is it important to notify the unavailability in a timely manner?
Notifying unavailability in a timely manner enables the FAMHP to analyse the issue as soon as possible and to look for alternative solutions so that patients are affected as little as possible by this unavailability.
You will find more information on temporary unavailability on the specific pages of the FAMHP website or via the medicinal product data banks on the websites of the FAMHP, the CBIP (non-profit), and the Source authentique de médicaments (Authentic medicines source - SAM).
Notifying unavailability in a timely manner enables these data banks to be kept constantly up to date.
How to notify the temporary unavailability of a medicinal product correctly when a temporary import exception has been granted for this medicinal product?
A temporarily unavailable medicinal product for which an import exception has been granted by the advisory committee is considered temporarily unavailable.
The pharmaceutical company notifies the temporary unavailability as it would for other medicinal products and before an exemption is requested.
Additional information on the exemption granted and the alternative treatment is included in the data bank and is available to third parties via the sources mentioned above.