New reporting, supply, manufacturing obligations

According to the Ministry of Health, the COVID-19 crisis makes it necessary to have updated information on the actual availability and manufacturing forecast of certain medicinal products that are considered “essential,” being critical for the public health to guarantee the supply of these medicinal products in health centers and services, which requires daily distribution capable of covering consumption with the necessary agility.

In this sense, on 24 March 2020 a new order came into force in Spain imposing reporting, supply, and manufacturing obligations on manufacturers and MAHs or their local representatives for a total of 347 medicinal products, among which are numerous antibiotics, drugs for the treatment of asthma and COPD (Chronic Obstructive Pulmonary Disease), antipyretics, anesthetics, antiarrhythmic medicinal products, morphine, anxiolytics, insulins, etc. (check the order here, including the full list of the medicinal products affected).

The measures referred to in the order consist of the following:

• reporting on a daily basis as from the 25 March 2020 on available stock, quantity supplied in the last 24 hours, and forecast of release and receipt of batches (dates and quantities);
• obligation to supply any of these 347 medicinal products "to health centers and services in accordance with their needs, which may be required to be supplied on a once-a-day basis," including holidays and weekends; and,
• possibility of requiring pharma companies to "prioritize the manufacture of those medicinal products," as well as to provide information on "planned manufacturing operations.”

The Spanish Agency of Medicinal Products and Medical Devices (AEMPS) has enabled an online platform through its website to allow MAHs and manufacturers to meet their new reporting, supply, and manufacturing obligations. To facilitate the use of the platform, the AEMPS has published some guidelines (check them here) and users can request support by means of the following email address: soporte_aplicaciones@aemps.es.

Placing on the Spanish market of non-CE marked PPE within the context of the COVID-19 threat

Given the shortage issues of CE-marked personal protective equipment (PPE) in Spain, the Ministry of Industry, Trade and Tourism issued a few days ago a decision authorizing the placing on the Spanish market of non-CE marked PPE. Although not expressly referenced to therein, it seems that such decision has taken into account the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.

The decision provides for four different scenarios for acceptance of the following PPE:

• CE-mark with harmonized standard.
• Public purchase of non-CE marked PPE masks meeting certain specifications (NIOSH_USA and KN95_China), prior approval of the health authority. These PPE masks can only be supplied to healthcare professionals.
• Temporary derogation to accept the placing on the market of non-CE marked PPE masks meeting certain specifications (NIOSH_USA and KN95_China), prior assessment by the health authority of the relevant Autonomous Region on a temporary basis while the procedures necessary for affixing of the CE mark are carried out. The aforementioned authorities must verify compliance with the relevant specifications (NIOSH_USA and KN95_China) and that there is a request for assessment referred to a notified body.
• CE mark with a technical specification other than harmonized standards.

The AEMPS informs on the controlled distribution of all hydroxychloroquine/chloroquine stock in Spain

As informed by the AEMPS, on 16 March 2020, the AEMPS began the controlled distribution of hydroxychloroquine and phosphate chloroquine for COVID-19 in hospitals through the online platform for the management of medicinal products under special situations (MSE platform). The supply for patients who were already being treated for chronic diseases such as lupus or rheumatoid arthritis is being carried out through the distribution channel to avoid these patients going to the hospitals for the dispensation of their medication.

According to the AEMPS, given the limited stock of these medicinal products and the growing demand in a variety of situations related to COVID-19, it is necessary to control the entire stock through the MSE platform and implement the following actions:

• Holders of those medicinal products will not place on the channel any more hydroxychloroquine/chloroquine until further notice.
• All the medicinal products in the channel will be made available to the competent authorities of the Autonomous Regions to be used for follow-up dispensations in chronic patients under the authorized indications.
• Based on the actual number of patients/month in this situation, the AEMPS will ensure the monthly treatment stock once the one currently available in the channel is finished.
• The remaining available drug(s) will be distributed by the MSE platform through weekly stock, indicating the number of dedicated packaging for authorized clinical trials and the number of packaging for treatments.

Overall, and until further notice, treatments will be prioritized for:

1. Chronic patients.
2. Clinical trials of all types that include hydroxychloroquine or chloroquine among their treatments.
3. Treatment of patients admitted with pneumonia.

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