The World Health Organization (WHO) is planning a global re-classification of the addictive potential of cannabis. As recently reported in the German Medical Journal, the WHO recommends that United Nations member states re-classify cannabis. This was decided at the 41st meeting of the WHO Expert Committee on Drug Dependence (ECDD) in Geneva in November 2018 and recently communicated in a letter from the WHO to UN Secretary-General António Guterres. It concerns, among other things, a re-evaluation of cannabis and its ingredients THC (Tetrahydrocannabinol) and CBD (Cannabidiol). The experts concluded that the current classification of cannabis in the same group as heroin is not justified. At the same time, a medical benefit of cannabis has been recognized.

According to the WHO recommendations, cannabis flowers and hashish (cannabis resin) should be removed from the list of the most dangerous drugs (Annex IV of the Single Convention) and only remain on the list of less dangerous drugs in Annex I. CBD preparations should be completely removed from the Single Convention as long as the THC concentration does not exceed 0.2 percent. The cannabis API THC is to be moved within the annexes of the international drug conventions in order to facilitate its medical use. Even if this resolution has no direct influence on the assessment of the medical benefit of cannabis, the WHO experts' classification will be considered worldwide. The next step is for the United Nations Commission on Narcotic Drugs (CND) to vote on the recommendations of the ECDD. It meets annually in March, analyses the global drug situation and adopts the content of the international prohibition lists. In the case of cannabis, this is the United Nations Single Convention on Narcotic Drugs of 1961.

In Germany, the legislator has expanded the possibilities for prescription of cannabis with the Act to Amend Narcotic Law and Other Regulations, which came into force on 10 March 2017. According to the requirements of the United Nations Single Convention on Narcotic Drugs of 1961, the law establishes a state agency, the so-called Cannabis Agency at the BfArM. This agency controls and supervises the cultivation of cannabis for medical purposes in Germany.

Cannabis for medical purposes is a medicinal product (in Germany). Therefore, only cannabis fulfilling the following criteria may be used:
    - cultivated according to the Good Agricultural and Collection Practice, GACP,
    - meets the requirements of the current monograph "Cannabis Flowers" (DAB), and
    - the requirements of other relevant pharmacopoeia monographs (e.g. Ph. Eur.) for herbal medicinal products and guidelines, e.g. on GMP (Good Manufacturing Practice).

The Cannabis Agency states that this "ensures the availability of cannabis for medical purposes in reproducible quality in accordance with drug law requirements".

In Germany, medical cannabis is also subject to the regulations of the German Federal Law on Narcotics (Betäubungsmittelrecht = BtM). This law stipulates that, following the provisions of the Single Convention on Narcotic Drugs, the oversight of cannabis cultivation should lie with a cannabis agency. The same goes for compliance with the requirements of Article 23 which, according to Article 28.1, also apply to cannabis.

Until cannabis is available for medical purposes from German cultivation, the demand will be covered by imports (mostly from the Netherlands or Canada), for which the responsibility does not lie with the Cannabis Agency but with the Federal Opium Agency.

Source: www.gmp-compliance.org