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Medicines stockpiling obligation to be introduced

From 1 January 2023, medicine manufacturers and wholesalers will be obliged to stockpile medicines to prevent shortages. As such, marketing authorisation holders will be obliged to maintain stocks for at least six weeks. A step-by-step build-up will apply for wholesalers, starting with a stockpile obligation for at least two weeks with effect from 1 January 2023 building up to a stock obligation of at least four weeks with effect from 1 July 2023.

This "stockpiling obligation" is established by the Dutch Minister of Care in a policy rule (Dutch language) that has been published in the Dutch government gazette (Staatscourant). Pursuant to the Dutch Medicines Act, marketing authorisation holders and wholesalers are already obliged to maintain a "sufficient stock" of medicines to meet the needs of patients. This follows from Articles 36 (2) and 49 (9) of the Dutch Medicine Act, which implement Article 81 of Directive 2001/83/EC. To prevent further shortages of medicines, the definition of "sufficient" has now been concretised in the policy rule and will be determined by a calculation method: the forecasted amount of medicines that will need to be stockpiled shall be calculated by dividing the sales of the previous year (that is, all deliveries of the past 52 weeks) by 52 and then multiplying that number by six weeks for market authorisation holders or two, and then four, weeks for wholesalers. The policy rule also provides for deviating calculation methods in specific circumstances, such as in case of strongly fluctuating demands or for new market introductions.

The stockpiling obligation only applies to medicines that are available on prescription, and does not apply to self-care medicines, personalised medicines, and medicines with a shelf life of less than one year (provided that for these types of medicines the aforementioned basic obligation to maintain "sufficient stock" following Article 36 (2) and Article 49 (9) of the Dutch Medicine Act, still applies). In addition, the stockpiling obligation will apply to all individual marketing authorisations that belong to a specific product range: in case of a medicinal product that is marketed in different strengths or dosage forms, the stockpiling obligation will apply to each of the individual strengths and dosage forms.

The policy rule will be periodically evaluated for feasibility and enforceability and will be updated if necessary. The first evaluation will take place one year after entry into service (that is, 1 January 2024).

This article was first published on Thomson Reuters Practical Law.