Spain: New public consultation on the regulation of cannabis products

In brief

In order to set the regulatory framework for a products containing cannabis, the Ministry of Health has launched a public consultation on a draft Royal Decree establishing the conditions for the preparation and dispensing of magistral formula based on standardised preparations of these substances. In this regard, the interested parties will be able to present allegations until 4 March 2024.


In more detail

The Ministry of Health has opened the prior public consultation process for the Draft Royal Decree establishing the conditions for the preparation and dispensation of magistral formula based on standardised cannabis preparations ("Draft Royal Decree"). In this regard, citizens and organisations that are affected by this Draft Royal Decree will be able to express their viewpoints until 4 March 2024.

The origin of this initiative is a report issued by the Health and Consumer Affairs Committee of the Congress of Deputies making recommendations to the Spanish Agency of Medicines and Medical Devices for it to adopt measures to enable access to medicinal products containing this substance in the form of magistral formulae.

This Draft Royal Decree aims, among other considerations, to evaluate and supervise the quality of cannabis preparations in order to ensure its effectiveness and safety. In the development of the regulatory framework for cannabis preparations, the legislator has taken into account the benefit-risk ratio of these products in relation to the indications for which they are used. In this sense.

The objectives of the Draft Royal Decree can be summarised as follows:

  • To establish the procedure for assessing the quality of cannabis preparations
  • To establish the indications for use of these medicinal products
  • To establish the conditions under which magistral formulae prepared with cannabis may be prescribed, prepared and dispensed, limiting such magistral formulae to those with a monograph in the National Formulary.

In conclusion, this Draft Royal Decree aims to open up a new avenue for exploring and using cannabis from a medicinal perspective, in line with the regulations already approved on this matter in other countries. In this way, the legal loophole in which cannabis products have found themselves until now in Spain would be closed.

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