The European Commission, the Coordination Group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency have developed a ‘questions and answers’ document in light of the ongoing Covid-19 pandemic. The aim of the document is to provide guidance to Marketing Authorisation Holders on regulatory expectations and flexibility during the Covid-19 pandemic. The document will be updated and amended as the pandemic situation evolves and new questions arise.
Marie Carroll summarises the developments in this area.
Products For Use With Covid-19
The current document answers questions related to marketing authorisation procedures, manufacturing and importation of finished products and APIs, quality variations and product information and labelling. Marketing Authorisation Holders are encouraged to address the EMA for centrally authorised products or the relevant national competent authority with queries related to specific products not addressed in the current document. For queries related to medicinal products intended for use in patients with Covid-19, “CONCERNS COVID-19” should be included in the subject section to ensure prompt assessment of any such requests.
The options for marketing medicinal products for use in Covid-19 patients are outlined. These include:
- the use of zero-day mutual recognition procedure/repeat use procedure,
- authorisation in accordance with Article 126a of Directive 2001/83 EC
- or, authorisation of the distribution of an unauthorised medicine in accordance with Article 5(2) of Directive 2001/83 EC.
Managing Difficulties Caused by Covid-19
Marketing Authorisation Holders facing difficulties in meeting license renewal or renewal of conditional marketing authorisations deadlines due to the pandemic are provided with an option to contact the relevant authority to discuss these difficulties before the renewal deadlines. Any request to postpone the submission of dossiers should be accompanied by a valid justification and commitment to providing dossier at a later stage.
Marketing Authorisation Holders are reminded of the possibility to request exemptions to a sunset clause because of exceptional circumstances and on public health grounds. For centrally authorised products, the Commission may accept sunset clause requests that refer to the pandemic as a reason without the need for any further justification during the pandemic.
Exceptional Change Management Process
An exceptional change management process (ECMP) is being made available to Marketing Authorisation Holders of medicines crucial to the treatment of Covid-19 patients. It is hoped the ECMP will facilitate the rapid implementation of changes to suppliers and/or manufacturing/control sites which might be necessary to reduce the risks of shortages or disruption to supply of these crucial medicines. The procedure for using the ECMP is outlined in the Q and A document.
Quality variations are expected to be carried out in accordance with normal procedures without prejudice to the flexibilities afforded by the ECMP procedure. However, it is recommended, “CONCERNS COVID-19” is placed next to the procedure number when communicating with the relevant authority to ensure prompt assessment of any such variations.
The CMDh has agreed to apply the labelling and packaging flexibilities in accordance with Article 63 (3) of Directive 2001/83 EC for medicines crucial to the treatment of Covid-19 patients in the event of severe problems with the availability of these medicines in Member States. Member states may, therefore, accept product information that has not been translated into the relevant official language, that does not contain the relevant national specific information or is marketed in a different presentation to that authorised for marketing in their state. The Marketing Authorisation Holder must, however, inform the relevant competent authorities in advance and provide links to websites containing the product information in the relevant official language.
Talk To Us
This is an exceptional time for Marketing Authorisation Holders and the issues presented by Covid-19 present additional difficulties for companies. We are currently working with several companies and assisting them with some of the issues referenced above.
Contact us by email: info@acornregulatory.com or complete the form on our Contact Us page and we will get straight back to you.
