The question was raised by some of the members whether it is needed to decommission commercial packages during (re)-labelling to medical samples, Medical Need Program (MNP) products and Investigational Medicinal Products (IMP).
After verification in the law and confirmed by the BeMVO and the FAMHP, the following can be concluded:
- Free samples: following article 41, the MAH needs to decommission the products => the pharmacist may not scan these products anymore
- IMP: following article 16(2), the MAH needs to decommission the products => the pharmacist may not scan these products anymore
- For MNP products, if the product falls under the FMD regulation in the country where the product is on the market, the packages must be activated by the user (e.g. hospital pharmacists). The FAMHP explained their reasoning more in detail: The idea is here that, since the product is on the market and have been serialized, the product must be decommissioned. The legislation does not provide specific provisions for the distribution circuit, so the logical option is that it must then pass through a pharmacy as no exceptions are foreseen.
=> MNP products may not be decommissioned by the MAH and must be decommissioned by the pharmacist.
Please note that Compassionate Use Program products do not fall within the scope of the FMD regulation since these products are not yet approved and commercialised.