In response to the significant impact the COVID-19 pandemic is having on European regulatory activity, the European Commission, the European Medicines Agency and the Heads of Medicines Agencies network (EC, EMA and HMA, respectively) have approved a number of measures to help the management of marketing authorisations for human medicinal products considered crucial during the pandemic period.
The objective of these measures agreed at European level is to promote regulatory flexibility, facilitate, simplify and accelerate the administrative procedures, as far as possible, in order to respond more efficiently to emerging needs during this period.
As a result, the EC recently published questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic:
This Q & A document which provides guidance to marketing authorisation holders (MAH) includes the following topics:
- renewal applications
- sunset clause
- an exceptional change management process (ECMP) for crucial medicines for use in COVID-19 patients
- circumstances under which the validity GMP certificates and authorisations to manufacture/import can be extended
- circumstances under which the validity GDP certificates and wholesale authorisations can be extended
- adaptions to the work of a Qualified Person (QP)
- the possibility of adapting quality requirements for medicines intended to be used for the treatment of COVID-19 patients
- the impact on reporting into EudraVigilance of Individual Case Safety Reports (ICSRs)
- flexibility in the labelling and packaging requirements to facilitate the movement of medicinal products within the EU
Further to the European Commission’s Q&A document, the CMDh has agreed additional questions and answers that provide practical information on how to specifically address and apply the provisions determined by the European Commission for MR/DC procedures:
The CMDh document addresses issues such as the impact of COVID-19 on assessment timelines, how to use the ECMP procedure (which is only applicable for products that are crucial for the treatment of COVID-19 patients) and QP declarations based on a desktop audits. It also includes a useful annex that details Member States’ email addresses and links to relevant published guidance on MS websites.
Both documents will be updated and supplemented with additional information, as appropriate during the pandemic.
Everyone at Ivowen is working tirelessly to keep our clients applications on track. We are liaising with the National Competent Authorities all the time to ensure we avoid delays and get the best results possible in these unprecedented times.
If you need any assistance in this regard please don’t hesitate to contact us.
Written by Claire Brown.