The European Commission has published a questions and answers document on regulatory expectations for medicinal products for human use during the COVID-19 pandemic (revision 3, 1 July 2020), which details regulatory expectations and flexibilities available to MAHs to maintain medicines on the EU market during the COVID-19 pandemic.
To interpret the practical aspects of the EC document for MR/DCP products, CMDh has published practical guidance for facilitating the handling of processes during the COVID-19 response. It provides further direction on how to request and apply the provisions described in the EU Commission document.
Applicants who consider that they have a need for regulatory flexibility in relation to the COVID-19 pandemic should carefully consult these documents and send their further requests to the contact points detailed below, ensuring they include the prescribed headings for MR/DCP applications as per CMDh practical guidance (also detailed below).
Exceptional Change Management Process (ECMP)
In particular, the EC Q&A introduces a specific procedure in order to quickly implement new starting materials/reagents/active substance/intermediate/finished product manufacturing/packaging sites/suppliers or control sites, without having to submit a variation before implementation, called the Exceptional Change Management Process (ECMP). This is intended for crucial medicines relating to treatment of COVID-19 patients. The Q&A also specifies exclusions from this process, which applicants are recommended to carefully consider. The CMDh practical guidance provides further detail on procedural aspects. For MR/DCP procedures where IE is RMS, and for purely national procedures where an applicant wants to apply for ECMP, the following applies:
Step 1: Submit ‘initial request for ECMP’ using the CMDh ECMP submission template for both national and MR/DCP submissions, confirming the specific supporting commitments and summary description of changes as outlined in the EC guidance, to the mailbox firstname.lastname@example.org. The email heading should state ‘COVID-19, ECMP’ and the MR/DCP procedure number, where applicable. In MR/DCP where IE is not the RMS, the applicant should send the initial ECMP request solely to the RMS, and the RMS will communicate their acceptance or not, of the ECMP request within two working days to the MAH and CMS (Step 2).
Step 3: Submit the ‘notification of implementation’ as outlined in the EC guidance including the summary description of changes to both the RMS and CMS within 48 hours of implementing the change. For API manufacturer changes, the name and address of the manufacturer and details of ASMF number and version or CEP number details should also be provided, as outlined in CMDh guidance. In IE this should be done through email@example.com and we will respond with details of the associated case number.
Step 4: The final variations, which are required as soon as possible and no later than 6 months from implementation, should be sent as usual via CESP, however the applicant should take care to include a reference to the associated ECMP Step 3 case number (and include the heading ‘COVID-19, ECMP’ and MR/DCP procedure number where relevant) to avoid future queries.
Applicants are reminded that in case any of the commitments as mentioned in the “Notice to stakeholders” are not fulfilled, or any critical findings in respect of the quality of the product are identified, the agreed ECMP will immediately cease to be valid.
Use of Existing Regulatory Routes
Applicants are also reminded of existing regulatory routes to maintain supply such as Batch Specific Requests, and Exempt Medicinal Product, guidance for which is available on the HPRA website, and zero-day mutual recognition/repeat use procedures, and we remain available for further discussion as necessary.
Please e-mail firstname.lastname@example.org including the heading ‘COVID-19, ECMP’ and the MR/DCP procedure number where applicable.
Ongoing Renewals, variations, ongoing new application procedures should use the usual contact points as summarised below, and the case administrator where applicable:
Variations (excluding ECMP queries)
Requests for expedited procedures should include the email heading ‘COVID-19 shortened variation TT’ and the procedure number TT and any agreements between MAH and MS in communication beforehand should be summarised in the cover letter of the application.
Ongoing / New Applications
Requests for expedited procedures, including mutual recognition/repeat use day zero procedures should include the email heading ‘COVID-19 expedited MRP/RUP’ and the procedure number, and any agreements between MAH and MS in communication beforehand should be summarised in the cover letter of the application.
Batch Specific Requests (including label / leaflet issues) and submission requests
Requests for COVID related queries e.g. regarding labelling should include the heading ‘COVID-19’ in the email heading.
Other regulatory queries relating to COVID can be e-mailed to email@example.com