Specification of requirements governing the submission of marketing authorisations in the form of duplicates

SÚKL hereby specifies the requirements governing marketing authorisation of duplicates and documentation to be submitted as part of applications for marketing authorisation of duplicates effective as of 1 January 2018.   

Duplicates are understood to be applications for marketing authorisation of medicinal products meeting the below specified requirements, which are submitted concurrently with the primary marketing authorisation application or in the course of its assessment, if applicable, or are submitted for an authorised medicinal product. The submission of marketing authorisation applications in the form of duplicates shall be governed by the recommendations of the CMDh coordination group published on the CMDh website, taking into account the below provided specific aspects.

 

Requirements governing the documentation of duplicates

Duplicates are defined by reference to the primary application (in case of parallel or subsequent submission of a marketing authorisation application and its duplicate) or by reference to the primary marketing authorisation of the medicinal product (in case of a submission of application for marketing authorisation of a duplicate to a previously authorised medicinal product) and with regard to the primary application/marketing authorisation of the medicinal product, they have:

  • An identical marketing authorisation dossier (i.e. module 1, 2, 3,4 a5), with the below described exceptions;
  • The same legal background;
  • A different name of the medicinal product.

 

The marketing authorisation dossier submitted as part of the application for marketing authorisation in the form of a duplicate may contain the following differences from the dossier of the primary application/marketing authorisation of the medicinal product:

  • Another marketing authorisation holder and the differences implied thereby in:
    • the application form and annexes thereto,
    • the product information (Summary of the Product Characteristics, package leaflet, labelling),
    • mock-ups,
    • module 1.8.1 (PSMF summary) and module 1.8.2 (risk management plan = RMP);
  • A reduced number of pack sizes of the medicinal product within the meaning of omitting some of the pack sizes of the medicinal product from the primary application/marketing authorisation, and the differences implied thereby in:
    • the application form,
    • the product information (Summary of the Product Characteristics, package leaflet, labelling);
  • Different manufacturers/importers responsible for batch release in the EEA and the differences implied thereby in:
    • the application form and annexes thereto,
    • part 2.3.P.3.1 of module 2 and part 3.2.P.3.1 of module 3;
  • A reduced number of manufacturers of the medicinal product within the meaning of omitting some of the manufacturers of the medicinal product from the primary application/marketing authorisation, and the differences implied thereby in:
    • the application form and annexes thereto,
    • part 2.3.P.3.1 of module 2 and part 3.2.P.3.1 of module 3.

 

Note: An application for the marketing authorisation of a duplicate must be submitted with a reference to the primary application (submitted in parallel or subsequently) and it must be submitted by the same applicant as the primary application. An application for marketing authorisation of a duplicate with reference to the primary marketing authorisation (for a previously authorised medicinal product) should be submitted by the same applicant as the application for primary marketing authorisation, or by the holder of this primary marketing authorisation. The same applicant/marketing authorisation holder shall be an identical entity or, in case of mutual recognition procedures (MRP) and decentralised procedures (DCP), it may also be an entity belonging to the same group of companies.

 

The principles of marketing authorisation of duplicates

An application for marketing authorisation in the form of a duplicate may be submitted only in the Member State where the primary application for marketing authorisation was submitted or where the primary marketing authorisation was granted for the medicinal product, upon observance of the principles described below.

 

Any and all applications for marketing authorisation, including duplicates, shall be governed by the requirements stipulated by Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use; Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended (Act on Pharmaceuticals); Decree No 228/2008 Coll., on marketing authorisation of medicinal products, as amended; and the guidance published by the European Commission and by the European Medicines Agency.

 

At the time of submission of the application for marketing authorisation of a duplicate of a previously authorised medicinal product (primary marketing authorisation), the marketing authorisation dossier of this primary marketing authorisation has to be therefore compliant with the effective legislation and effective guidance. Particularly in the case of older primary marketing authorisations it is necessary to update the marketing authorisation dossier – by means of relevant applications for variations to marketing authorisation (such as the risk management plan, product information) – prior to the submission of the application for marketing authorisation of the duplicate. Furthermore, at the time of the submission of the application for marketing authorisation of the duplicate, any applications for variations to the marketing authorisation and marketing authorisation renewals pertaining to the reference primary marketing authorisation must be concluded.

 

Duplicates may be authorised via the mutual recognition procedure (MRP), decentralised procedure (DCP) or national procedure (NAR) in compliance with the rules described in the recommendations of the CMDh coordination group published on the website.

 

Administrative requirements for marketing authorisation of duplicates

When submitting an application for marketing authorisation of a duplicate, the applicant shall:

  • provide data on the primary application/marketing authorisation of the medicinal product, in respect of which the marketing authorisation of a duplicate is being applied for;
  • submit a declaration stating that the submitted marketing authorisation dossier is identical to the one of the primary application/marketing authorisation, describing the exceptions (which must be consistent with the requirements for documentation set forth above).

 

The payment of administrative fees and reimbursement of costs for expert activities conducted upon request applicable to duplicates shall be made as referred to under the effective version of Guideline UST-029 which is available from the website. In the Pricelist of reimbursements of costs of expert activities conducted upon request, the items relevant to duplicates are provided under the following codes: R-003 (national marketing authorisations), R-021 (MRP with the Czech Republic as the RMS), R-031 (MRP/DCP with the Czech Republic as the CMS), and R-045 (DCP with the Czech Republic as the RMS).

 

Marketing Authorisation Branch

23 January 2018