Clarification on the Covering Expenditures for Worksharing and Supergrouping Procedures

On January 1, 2025, Commission Delegated Regulation (EU) 2024/1701 entered into force, amending Regulation (EC) No. 1234/2008 regarding the evaluation of variations to the registration of human medicinal products (“Variation Regulation”). This regulation introduces the possibility of submitting applications via supergrouping (including nationally authorized products) and mandates the submission of identical variations in multiple Member States via the worksharing procedure.

The payment method for supergrouping and worksharing procedures, including the calculation methodology, remains unchanged. However, due to received inquiries, the Institute provides the following clarification regarding applicable payment categories:

• For worksharing and supergrouping procedures where the Czech Republic is the reference member state, covering expenditures apply as for RMS variations of type IA, IB, or II (i.e., codes R-023 – R-025, R-051) for all products in the application authorised in the Czech Republic, regardless of whether they are national, RMS, or CMS authorisations.
• For worksharing and supergrouping procedures where the reference member state is not the Czech Republic, i.e., the reference authority is another Member State or the European Medicines Agency (EMA), covering expenditures apply as for CMS variations of type IA, IB, or II (i.e., codes R-032 – R-034, R-052) for all products in the application authorised in the Czech Republic, regardless of whether they are national, RMS, or CMS authorisations.

Methodology for Calculating of Covering Expenditures for Variation Applications

The amount of covering expenditure for individual variations is calculated in full for the first registration number. For each additional registration number within the same application, a 50% discount is applied to the total amount calculated for the first registration number.

Calculation formula:

Amount of covering expenditures (in CZK) = (IA*m_IA) + (IB*m_IB) + (II*m_II) + (n-1)*0,5*((IA*m_IA) + (IB*m_IB) + (II*m_II))

Where:
IA, IB, II = amount of covering expenditures for the respective type of variation
m_IA, m_IB, m_II = number of changes of the respective type for the first registration number
(n – 1) = number of additional registration numbers in the application

The online form for paying covering expenditures is designed so that all changes for the first registration number must be entered, followed by the number of additional registration numbers. The total amount of covering expenditure is then automatically calculated. One summary form is generated per application.

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Example 1 – Worksharing (CZ is not the reference state)

Application includes 2 registration numbers:

• 1 national registration
• 1 RMS registration

Variations:

• Type IA – A.7
• Type IB – B.I.a.2e

Covering Expenditures Form input:

• IA variation → code R-034 (CZK 4,000), number of changes: 1
• IB variation → code R-033 (CZK 10,000), number of changes: 1
• Number of additional medicinal products: 1

Covering expenditures calculation:

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Example 2 – Supergrouping (CZ is the reference state)

Application includes 3 registration numbers:

• 1 national registration
• 1 CMS registration
• 1 RMS registration

Variations:

• Type IA – A.7
• Type IA – A.1

Covering expenditures form input:

• IA variations → code R-025 (CZK 12,000), number of changes: 2
• Number of additional medicinal products: 2

Covering expenditures calculation: