Here you will find the release certificates of all types of medicinal cannabis. Release certificates remain available on the website for a maximum of three months after the expiry date of the product. You can always request deleted certificates via the OMC.
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Clarification regarding the implementation of the new Monograph
We have observed that the implementation of the new Ph. Eur. 07/2024:3028 monograph has raised several questions among clients of the Office of Medicinal Cannabis (OMC). To provide clarity, we hereby offer additional information regarding our products and the corresponding quality requirements.
Consistency in product composition
The OMC applies strict internal specifications for each product variety, which are more stringent than the requirements currently included in the Ph. Eur. 07/2024:3028 monograph. These internal standards are designed to ensure greater consistency in product composition within each variety. Accordingly, the OMC only accepts batches that fall within the following predefined cannabinoid content ranges outlined below. Batches that do not meet these specifications are not released for distribution.
| Variety | Total THC | Total CBD |
|---|---|---|
| Bedrocan (THC-dominant) | 17,6 – 26,4 % | ≤ 1,0 % |
| Bedrolite (CBD-dominant) | ≤ 1,0 % | 6,5 – 9,7 % |
| Bediol (THC/CBD-intermediate) | 5,0 – 7,6 % | 7,0 – 10,6 % |
| Bedica (THC-dominant) | 11,5 – 17,3 % | ≤ 1,0 % |
The exact measured content of THC and CBD — always falling within the ranges outlined above — is specified on the product label and documented in the certificate of analysis. The 10% tolerance margin defined in Ph. Eur. 07/2024:3028 is applied to these measured values.
As outlined above, OMC medicinal cannabis products are categorised based on cannabinoid content.
| Cannabinoid content | Total THC | Total CBD |
|---|---|---|
| THC-dominant | ≥ 5.0% | ≤ 1.0% |
| CBD-dominant | ≤ 1.0% | ≥ 5.0% |
| THC/CBD-intermediate | ≥ 1.0% |
THC/CBD-ratio between 0,2 en 5,0 |
These classifications are now reflected in the updated product specifications and certificates of analysis.
Products with unchanged characteristics
It is important to note that no changes have been made to the cultivation and production processes. The OMC continues to supply medicinal cannabis products with unchanged characteristics and in accordance with the previously established quality standards, which remain in line with earlier OMC monographs and continue to guarantee high product quality.
Please note: The OMC product Bedrobinol® remains an exception and continues to be supplied according to the OMC monograph.