On the 27^th of May 2024, the new law of February 29, 2024 on raw materials used by pharmacists was published in the Belgian Official Gazette. The law aims to clarify and replace the current legislative framework for raw materials used by pharmacists. It has an important impact on both pharmacists and manufacturers/suppliers of raw materials. The most important changes are outlined below.

A modernised legal framework for raw materials

Raw materials were previously regulated by the Royal Decree of December 19, 1997 (RD), which was unclear and confusing in several respects, in particular because it regulated raw materials in the same manner as medicinal products. The introduction of the new distinct legal framework for raw materials aims to resolve this commonly cited issue.

In addition, the new law fixes some issues the previous rather outdated RD did not or inadequately regulate. For example, it was not possible to derive from the RD any clear sanctions for marketing raw materials without a valid authorisation number or certificate of analysis, causing the responsibility to not use such materials to shift to pharmacists, which in turn caused many difficulties in the field. The RD furthermore did not provide clear rules for the distribution of raw materials manufactured outside of Belgium and caused problems for several substances that could be considered raw materials within the meaning of the RD, but which because of their limited use (e.g., bacteriophages in antibiotic therapy, radioactive substances or substances used in radiopharmaceutical preparations) could in practice not meet the applicable strict analysis and control requirements. Finally, the new law further addresses the equivalence of lab tests performed in countries outside of Belgium.

Use cascade for raw materials based on quality

Until now, a same type of raw material but of a differing quality could be used in a magistral preparation, without preference or priority. This not only leads to inequality between patients for the same service/treatment, but also legitimises lower quality. To combat this, the new law introduces a quality cascade, whereby pharmacists will have to monitor and verify the availability and quality of raw materials, ensuring that only the highest available quality raw materials are used in preparations.

Ban on unauthorised raw materials whose release is currently based on a monograph

Unauthorised raw materials that are currently released by an approved laboratory based on a monograph will no longer be permitted, subject to a transitional period to be determined by the King(=in Belgium this means the government). The law furthermore stipulates that all monographs currently used by approved laboratories will have to be submitted for evaluation and approval by the Federal Agency for Medicines and Health Products (FAMHP).

Introduction of raw materials for limited use

To ensure the availability of essential raw materials for patients suffering from rare or orphan diseases, the concept of raw materials for limited use is introduced. Such raw materials will be subject to less stringent requirements than regular raw materials so that their availability will not depend solely on the goodwill of manufacturers/suppliers. The FAMHP will be responsible for drafting a minimum analytical reference for such raw materials for limited use, while The King is authorised to set the requirements for such minimum analytical reference.

Ensuring and monitoring the availability of raw materials

Holders of authorisations for raw materials are required to inform the FAMHP of the actual marketing of their raw materials, as well as the unavailability thereof, including the duration. A list of authorised raw materials will be published, as well as a list of authorised raw materials that are currently unavailable or out of circulation. During the transition period, a list of unauthorised raw materials will also be published.

Increased transparency

The law provides for greater publicity and accessibility of information held by the FAMHP. All required publications on raw materials and their relevant actors (manufacturers, distributors, laboratories, etc.) will be made available on the FAMHP website. The publication of this information aims among other things, to enable pharmacists to provide patients with the best quality raw materials available.

Conclusion & next steps

The new law represents a clear improvement on the old RD in that it is clearer and more transparent. It also seems to respond to some important issues currently plaguing the raw materials circuit in Belgium. The law will enter into force on a date to be determined by the King, and no later than the first day of the twenty-fifth month following that in which it is published in the Belgian Official Gazette, i.e., July 1^st, 2026.

Manufacturers/suppliers of raw materials are advised to review their current manufacturing and release setup to check if they can still distribute their products in Belgium, especially when non-Belgian test laboratories are used for the release thereof.

For further questions, please feel free to reach out to our DLA Piper Life Sciences team.