PO legal status of supply
The Medicines Act makes it possible to ensure that a medicine is available only on prescription by classifying it as a PO-medicine.
Based on article 57, section 1 of the Medicines Act, the MEB (Medicines Evaluation Board) can decide to classify a medicine as a POM-medicine if:
- even under normal use, it can directly or indirectly pose a risk if used without medical supervision
- when used frequently and very extensively not in accordance with the user instructions, it can pose a direct or indirect risk to health
- it is based on a substance or means of preparing that substance that, due to its being new, requires further study of its effectiveness or side effects
- it is intended for parenteral administration.
The PO (Prescription Only) legal status of supply is assigned if, under normal use (i.e. in accordance with the applicable user instructions), safety risks exist when the product is not used under medical supervision. This includes: direct risk (such as toxicity, interactions, side effects), indirect risk (such as masking underlying diseases, development of resistance), the need for a physician to make a diagnosis, or the need for a medical intervention to administer the agent (injection or infusion).
The PO status is also assigned if there are indications that the medicine will be used improperly on a large scale or if there is insufficient experience with the medicine in actual practice.