FAMHP

The Federal Agency for Medicines and Health Products (FAMHP) calls on Marketing Authorization Holders (MAHs) to verify the delivery status of their medicinal products.

Prescription medicinal products are classified into following categories:

  • medicinal products on medical prescription for non-renewable delivery;
  • medicinal products on medical prescription for renewable delivery (oral contraceptives);
  • medicinal products subject to special medical prescription (psychotropic substances and narcotics);
  • medicinal products subject to “restricted” medical prescription, for example, those reserved for treatments that may only be followed in hospital environments or due to the fact that the diagnosis of the disease for which they are being used must be made in a hospital environment or because a prescription drawn up by a specialist is required.

The “restricted” medical prescription medicines are further classified into subcategories as established by the concerned industry, pharmacist associations, hospital pharmacists, nursing staff representatives, the INAMI-RIZIV, academics, and patients’ representatives. These subcategories are as follows:

  • medicinal products intended for individual medication preparation (IMP);
  • medicinal products for which delivery is reserved for hospital pharmacists;
  • medicinal products for which the first medical prescription must be made by a medical specialist and for which delivery may occur in a retail pharmacy;
  • medicinal products for which the prescription and/or administration are reserved for medical specialists and for which delivery may occur in a retail pharmacy;
  • medicinal products subject to specific legislation.

FAMHP now provides the opportunity for MAHs to verify and, if necessary, comment on the legal status of their medicines prior to publication.

More information can be found on the FAMHP website.

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