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5. PRODUCT INFORMATION AND LABELLING

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC

5.1. Is there any flexibility in the labelling and packaging requirements to facilitate the movement of medicinal products within the EU?

It is necessary to facilitate the movement of medicinal products within the EU so that they can be made available in the Member States where are needed the most.

In the current exceptional circumstances, the regulatory flexibilities foreseen in the Directive 2001/83/EC should be fully utilised. Under Article 63(3) of Directive 2001/83/EC Member States may grant full or partial exemptions to certain labelling and packaging requirements to address severe problems in respect of the availability of medicinal products.

During the COVID-19 pandemic, Member States may therefore accept that the product information of products marketed in their territory may not be translated into the relevant official language if there are severe problems of availability of that medicinal product in the Member State.

In these exceptional circumstances, it may moreover be accepted that national specific information does not appear in the packaging/labelling, or that the presentation differs from the presentations authorised in the Member State where the product is marketed.

During the COVID-19 pandemic, the CMDh has agreed to apply the labelling and packaging flexibilities above-referred crucial medicines for use in COVID-19 patients.

MAHs are required to notify the relevant national competent authorities in advance and should also provide a link to a website where the product information in the relevant official language may be obtained. Further guidance on specific national requirements/procedures will be developed by CMDh.

B. ADDITIONAL INFORMATION

The websites of the Commission (https://ec.europa.eu/health/human-use_en) and of the EMA (https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19) provide additional information. For products authorised in decentralised or mutual recognition procedures, additional information will be provided through the websites of the Coordination Group. These pages will be updated with further information, where necessary.

European Commission Directorate-General Health and Food Safety
Heads of Medicines Agencies
European Medicines Agency

12 When in doubt whether a given medicinal product is a crucial medicine for treatment of COVID-19 patients, the MAH may contact the relevant competent authorities (EMA should be contacted for centralised marketing authorisations).