The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has released a question and answer guidance outlining how regulatory flexibilities will affect these application procedures due to the pandemic.
“Many pharmaceutical companies are being directly and indirectly affected by this global situation and had to modify their working procedures and/or regulatory activities to respond to the demands.” Regulators and competent authorities are falling under the same pressures.
The guidance explains that products aimed at therapeutic use for COVID-19 are being prioritised, therefore some marketing authorisation applications or post-authorisation procedures may be delayed or frozen if it is in the interest of the applicant or reference member state (RMS).
Marketing authorisation holders (MAHs) should try to submit renewal applications by the legal deadlines, however those impacted by COVID-19 may submit just the renewal application form and cover letter to the reference member state (RMS) and concerned member state(s) (CMS). The cover letter should mention that the full dossier is delayed due to the pandemic. Complete dossiers should then be submitted within six months, and as soon as possible.
The CMDh also recommends that applicants should closely communicate with the RMS/CMS on the steps to be taken in case of delays and unexpected issues arising from COVID-19.
The guidance then addresses questions regarding the Exceptional Change Management Process (ECMP), which is only applicable for products that are critical for the treatment of COVID-19 patients. More information on ECMP can be found in the Notice to Stakeholders.
Other issues included relate to variation procedures for products used to treat COVID-19, qualified person statements and declarations, and the importation of products used to treat COVID-19 at national level.
This CMDh guidance is designed to complement and align with the EU guidance on regulatory expectations for medicinal products during COVID-19.