Zero Day Procedure: Request for New Marketing Authorisation in the Czech Republic with a Shortened Timetable

The zero day procedure is an exceptional tool that allows accelerated marketing authorisation of essential, critical, or long-term unavailable medicinal products in the Czech market. Only medicinal products that are already nationally authorized in another country of the European Economic Area (EEA) or authorized in multiple EEA countries via a decentralized procedure (DCP) or mutual recognition procedure (MRP, or RUP – Repeat Use procedure) can be authorized through this procedure, provided that the standard procedure is not suitable – namely in urgent cases where the standard MRP/RUP timeline does not allow authorisation within the required timeframe. Within the zero day procedure, SÚKL will approve the dossier as it has already been approved in another member state / states of the EEA, without comments. The same applies to the Product Information (Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and Information on the packaging (LAB)). A prerequisite for SÚKL’s consent to the authorisation of a medicinal product through the zero day procedure is that the medicinal product will be placed on the market in the Czech Republic without delay.

More information can be found in the CMDh document Procedural Advice on Zero day MR procedure.

Process for Submitting an Intention to Submit a Zero Day Procedure with the Czech Republic as CMS (Concerned Member State)

Who Applies for Zero Day Procedure

It is expected that in most cases, SÚKL will initiate negotiations with the marketing authorization holder of the relevant medicinal product, considering the current situation on the Czech market.

However, in exceptional cases, the marketing authorization holder of the medicinal product authorised in another member state / states of the EEA can also contact SÚKL with the intention to submit an application for the authorisation of a medicinal product with the Czech Republic as CMS within a zero day procedure.

When to Apply for Zero Day Procedure

This procedure should only be used if the relevant procedure with a standard timetable (MRP/RUP) is not suitable due to the need for the earliest possible authorisation of the medicinal product in the Czech Republic. In the case of the marketing authorization holder’s intention to submit a zero day procedure, SÚKL should be contacted well in advance (optimally 1-2 months) before the proposed date of the actual application submission via the zero day procedure.

How to Apply for Zero Day Procedure

The applicant fills in the SÚKL questionnaire: “Zero Day Procedure – dotazník (questionnaire)” and sends it via email to mrp@sukl.gov.cz, including attachments. The questionnaire includes a commitment from the applicant that the product will be placed on the market in the Czech Republic, including the expected start date of supply and the number of packages. It is essential to attach the SmPC, Flow-chart (Annex 5.8 of the application form), and Finished product specification (module 3.2.P.5.1 documentation in eCTD).

After evaluation, the applicant will be contacted by the relevant SÚKL employee.

Only after receiving SÚKL’s consent for authorisation via the zero day procedure can the applicant contact RMS (reference member state) and proceed further according to the RMS instructions.

SÚKL may decide to reject the intention to submit an application for authorisation of the product via the zero day procedure. In such cases, the application for the authorisation of the medicinal product can always be submitted via the standard procedure (MRP/RUP).

Process for Submitting Applications for Zero Day Procedure with the Czech Republic as RMS

In this case, the medicinal product is already authorized in the Czech Republic and involves extending the authorisation to other member states of the EEA through the zero day procedure.

In the case of the intention to submit this type of procedure, it is necessary to inquire in advance about the possibility of submission at the email address mrp@sukl.gov.cz. The applicant has to provide evidence of the new CMS’s consent to this application, preferably in English.

Documentation Submitted within the Zero Day Procedure

• The sequence (following the last sequence before the zero day procedure) should include a cover letter, eAF (application form), proof of payment of cost reimbursement, annexes, the last approved Product Information in English, and any other documents relevant to the given CMS.
• This sequence is submitted to both RMS and CMS.
• The “Request for MRP/RUP” form is not submitted as part of the zero day procedure.