In the interest of transparency, as of March 2018, the FAMHP will include the subcategories of the legal status of medicinal products with restricted medical prescription in the public database on the FAMHP website. From that date, the subcategory for medicinal products with restricted medical prescription will be offered to the physicians and pharmacists software. Holders of a marketing authorisation for a medicinal product (MA) may verify the legal status of their medicinal products before publication.
Legal status of a medicinal product
The legal status of a medicinal product specifies the conditions under which a medicinal product may be delivered to a patient.
The legal status is a national competence. In Belgium, the competent minister or its representative, determine where and in which conditions a medicinal product is made available to the patient.
There are two classifications for the legal status1 2:
- non-prescription medicinal products (over the counter);
- prescription medicinal products .
1 Article 6, §1bis, from the Law of March 25, 1964 on medicinal products
2 Articles 61-65 from the Royal Decree of December 14, 2006 concerning medicinal products for human and veterinary use
For medical prescription medicinal products , the following categories apply:
- 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.
Based on Article 6, §1bis of the Law on medicinal products of March 25, 1964, medicinal products subject to “restricted” medical prescription are classified into the following subcategories:
- 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.
Combinations of subcategories are also possible.
One example includes individual medication preparation (IMP) for medicines for which the medical prescription must be made by a medical specialist.
Involvement of the sector
The subcategories were established after consultation with the stakeholders: concerned industry, pharmacists associations, hospital pharmacists, nursing staff representatives, the INAMI-RIZIV, academics and patients representatives.
The FAMHP aims to provide medicinal products MA-holders for the opportunity to verify and, if necessary, comment on the legal status of their medicines prior to publication.
The inforamtion have been sent through the professional associations of the MA-holders.
The consultation period runs from 16.11.2017 to 16.12.2017.