Publication date: November 13, 2024
New labelling requirements for medical cannabis as pharmaceutical raw material
Introduction
On 1 July 2024, a new European Pharmacopoeia monograph, Cannabis flos (3028), entered into force. This involves introducing changes to the registration dossiers for pharmaceutical raw materials based on hemp other than fibrous hemp.
Legal basis
In order to discuss the introduced changes, it is necessary to rely on the European Pharmacopoeia prepared by the European Pharmacopoeia Commission, which is a list of quality requirements for medicines, and the Polish Act of 6 September 2001 – Pharmaceutical Law.
Thematic scope of the new monograph
The new monograph addresses the topic of herbal medicines used as raw materials for the production of extracts, or prescribed to patients as medicinal products. Part of it is devoted to the limits of the presence of foreign bodies, impurities and heavy metals such as arsenic, cadmium and lead in herbal medicines prescribed to patients.
New standards in Poland
According to paragraph 1 of Article 25 of the Pharmaceutical Law[1], the basic quality requirements and methods of testing medicinal products and their packaging and pharmaceutical raw materials are specified by the European Pharmacopoeia, or its translations contained in the Polish Pharmacopoeia. This article indicates the primacy of the European Pharmacopoeia over domestic legislation. Therefore, the detailed monograph Ph. Eur. Cannabis flos (3028) upon entry into force will constitute a superior act.
As a result of the changes introduced by Cannabis flos (3028), it is required to include information on the packaging of raw materials that are prescribed to patients as prescription drugs (i.e. in accordance with art. 12 item 12 medicinal product prepared in a pharmacy on the basis of a doctor’s prescription[2]) about their intended use for prescription as a medical product. Additionally, the label should include information on the form (oral or inhalation) of administration of the pharmaceutical raw material.
Summary
A substance that is intended to be prescribed to patients as a prescription drug and meets the requirements set by Cannabis flos (3028) regarding content must be correctly labelled by including the information highlighted above – about the purpose of the substance to be prescribed to patients as a prescription drug and the form of its administration, by inhalation or oral route.
[1]Art. 25 section 1 Act of 6 September 2001 – Pharmaceutical Law (consolidated text: Journal of Laws of 2024, item 686).
[2]Ibid., Article 2, point 12.