Obligations to provide information, supply and manufacture certain medicinal products

26 March 2020

On 24 March, Order SND/276/2020 of 23 March was published in the Official Journal of Spain (abbrev. BOE), laying down obligations to provide information, supply and manufacture certain medicines in the health crisis situation caused by COVID-19.

This piece of legislation, applicable to both manufacturers and marketing authorisation holders, imposes certain obligations on these entities in order to ensure the supply of certain medicinal products considered essential for the fight against the Covid-19 pandemic. These include well-known medicines such as paracetamol, insulin, amoxicillin or omeoprazole and others that are less well known and equally important in this extreme situation, such as epinephrine. The schedule containing the list of medicines can be updated by the Ministry of Health at any time so it is necessary for the industry to keep (as it has been doing) an eye on the daily BOE.

The information obligations are specified in the requirement that within 24 hours (note that the period is extremely short and indicated in hours as permitted by Act 39/2015) from the entry into force of the order, which occurred on the same day of publication, i.e. 24 March, these laboratories must provide information electronically (through the mechanism provided by the Spanish Medicines and Healthcare Products Regulatory Agency) on (i) the available stock, (ii) the quantity supplied in the last twenty-four hours and (iii) the estimated release and receipt of batches (dates and quantities) of all these medicines. This same information must be provided on a daily basis, and the Ministry of Health may extend the scope of these information obligations now set out in Schedule II.

In addition, laboratories must put in place the necessary measures to ensure the supply of these medicinal products, including to health centres and services according to their needs, which may be required at a frequency of once a day.

Finally, the Order establishes the obligation to prioritise the manufacture of these products over any others, allowing the Spanish Medicines and Healthcare Products Regulatory Agency to collect additional information on the planning of manufacture of these products.

Last but not least, infringers will be punished in accordance with the applicable laws (in this case, Royal Legislative Decree 1/2015, of 24 July, approving the recast version of the Medicines and Medical Devices (Guarantees and Rational Use) Act as set out in Art. 10 of the States of Alarm, Exception and Siege Act 4/1981 of 1 June. In this case, infringers could face a penalty for a very serious infringement in failing to comply with the interim and definitive measures concerning medicines determined by the competent health authorities for serious public health reasons.

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