This content applies to human and veterinary medicines.
Guidance is available for marketing authorisation holders, wholesalers, distributors and manufacturers to help ensure continuity in the supply of human medicines, prevent shortages and reduce the impact of any shortages that occur.
It includes the following recommendations:
The HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use developed the guidance in consultation with industry associations. It complements the Guidance for patients and healthcare professionals published in 2022.
Guidance is available for marketing authorisation holders for human and veterinary medicines on detecting and reporting medicine shortages, based on a harmonised definition of a shortage agreed upon by all national competent authorities and EMA.
When a shortage occurs, or is expected to occur, in one or more EU Member States, the marketing authorisation holder should report it to the national competent authorities concerned. If the shortage concerns a centrally authorised product, the marketing authorisation holder should also notify EMA.
The guidance contains a reporting template for use if none is provided by the country in question.
It aims to facilitate the early notification of shortages to national competent authorities, allowing them sufficient time to make contingency arrangements where necessary. It covers:
It does not cover issues such as withdrawals of marketing authorisations, which can also affect a medicine's availability.
EMA and HMA published the guidance in July 2019.
Marketing authorisation holders for all authorised human medicines in the EU are required to appoint a so-called industry single point of contact (i-SPOC) who can provide information directly to EMA about the supply and availability of critical medicines identified in the context of a major event or a public health emergency.
They needed to register an i-SPOC by 2 September 2022.
EMA uses the i-SPOC contact list for rapid, two-way communication with the marketing authorisation holders of medicines included in a list of critical medicines by EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) during a public-health emergency or major event.
This aims to enable the European medicines regulatory network to detect, report, and prevent or manage issues related to the supply and availability of these medicines.
The Agency is setting up the i-SPOC system in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). It is based on the former enhanced monitoring system for medicines used in COVID-19 patients that EMA and pharmaceutical companies put in place in April 2020.
For more information, see Crisis preparedness and management.
Marketing authorisation holders need to identify their i-SPOC via EMA's IRIS platform.
They can log in to IRIS using their EMA account credentials.
Guidance on how to register an i-SPOC is available in the demo video below, and in the IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants.
Marketing authorisation holders without an EMA account must create one first via EMA's Account Management portal. This could take 5-10 working days.
For technical support, they should contact the EMA Service Desk.
Between March 2021 and August 2022, marketing authorisation applicants for orphan medicines and medicines to treat cancer were invited to participate in a pilot project by declaring their market launch intentions on a voluntary and confidential basis.
This aimed to help regulators understand why delays may occur in marketing of certain medicines in EU Member States after receiving a marketing authorisation.
EMA invited marketing authorisation applicants to share this information via an online survey during validation or when they received the CHMP opinion. They were also asked to provide feedback on challenges and limiting factors they face in ensuring the availability of their medicines in the EU.
The European Commission, EMA and the national competent authorities ran this pilot in the context of the Pharmaceutical strategy for Europe.
More information is available on the European Commission's website and in the question-and-answer (Q&A) document below.