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Product Regulation & Liability

Spain: New public consultation on the regulation of cannabis products

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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.

For more information or in case you need individual advice for your company, please contact our team of experts.

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Author

Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

Author

Damià Triay is an Associate in Baker McKenzie, Barcelona office.

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