Applications for Revocation of Marketing Authorisations of Medicinal Products

SÚKL hereby informs marketing authorisation holders about the aspects of submitting applications for revocation of the medicinal product marketing authorisations, including information on medicinal product recalls following the revocation of their marketing authorisations.  

The marketing authorisation holders or their representatives authorised by Powers of Attorney (information on Powers of Attorney and their specimens are available from here), may submit applications for revocation of the marketing authorisations of their medicinal products. To have the marketing authorisation of a medicinal product revoked, proceed as follows:

  • Submit a cover letter specifying the type of an application.
  • Submit an application for MA revocation, which is to be submitted for one marketing authorisation of a medicinal product at a time (for each MA number separately) using a completely filled-in form REG-72 (its effective version), which is available from here.
  • Prior to the submission of the application for MA revocation, it is mandatory to pay an administrative fee in the amount of 1,000 CZK (code S-003); along with the application, please submit the payment order of the administrative fee specifying the variable symbol necessary for this payment, which should be generated from here.
  • It is recommended to submit the application for MA revocation in the eCTD format; nevertheless, the NeeS format complied with the effective validation criteria is also acceptable.
  • The application for MA revocation must be send officially, i.e. via CESP, data mailbox (in these cases, a scan of a signature of the MA holder or his authorised representative shall be sufficient on the cover letter and on the application form), or via e-mail with a certified electronic signature of the MA holder or his authorised representative sent to posta@sukl_cz.
  • If the MA holder decides to revoke an MRP/DCP marketing authorisation with the Czech Republic as the Reference Member State (RMS), but, at the same time, keep a valid marketing authorisation in the Concerned Member States (CMS), it is necessary for the MA holder to apply for the takeover of the RMS role with one of the CMS (under the conditions stipulated by CMDh guidance).

 

The decision on MA revocation shall be issued within 30 days of the submission of the application for MA revocation.

 

In compliance with Section 34(8) of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended, the MA holder is obliged to recall the medicinal product immediately after the decision on MA revocation comes into force (from the healthcare facility level); the method of the medical product recall and the time necessary to perform the recall are to be provided in the relevant section of the REG-72 form. SÚKL does not publish notifications of medicinal product recalls following MA revocations on its website. Nevertheless, once the decision on MA revocation comes into force, the concerned medicinal product is no longer included in SÚKL´ s updated lists or in its web database of medicinal products, and for this reason, once the decision on MA revocation of this product comes into force, this product may no longer be prescribed, distributed, dispensed or sold. With a view to the aforementioned, MA holders are advised to submit the application for MA revocation only after the sale of the medicinal product is finished. The revocation of the marketing authorisation of a medicinal product also revokes its reimbursement, if applicable.

 

Only in case of an irreplaceable medicinal product whose immediate recall would jeopardise the health of people, it is possible to apply for the gradual recall of the medicinal product. In such a case, the following shall be specified in the relevant section of the REG-72 form:

  • that gradual product recall is being requested;
  • the date until which the gradual recall is being requested (a specific date has to be provided, typically within months of the submission of the application for MA revocation);
  • the facts justifying the gradual recall (particularly the reason why the concerned medicinal product is irreplaceable and how its immediate recall would jeopardise the health of people);
  • where the product replaceability was consulted with a medical association, the expert opinion shall be attached;
  • the payment order covering expenditures shall be attached (prior to the submission of the application, it is necessary to reimburse the costs in the amount of 6,100 CZK (code R-015), the payment order with variable symbol necessary for its reimbursement should be generated from here).

When the aforementioned conditions are met and the gradual recall is approved, after the MA revocation decision comes into force, the concerned medicinal product is labelled with the flag “C” and this medicinal product will be included in SÚKL´s lists and web database of medicinal products until the gradual recall date which is also provided in the MA revocation decision.

 

MA holders are also reminded that as long as the medicinal product is present on the market, their obligations of the MA holder persist also after the revocation of the marketing authorisation of the product.

 

The MA holder shall be obliged to pay the annual maintenance fee for the year in which the marketing authorisation of the medicinal product is valid for at least one day (the annual maintenance fee is not paid only for the calendar year in which the concerned medicinal product was granted marketing authorisation). Therefore, if the decision on MA revocation comes into force in January of the following year, the MA holder shall be obliged to pay the maintenance fee for the following year. The annual maintenance fee is to be paid by the end of the calendar year for the following year; the payment order is available from here. Nevertheless, when the decision on MA revocation comes into force, the MA holder may apply for a refund of the proportionate part of the annual maintenance fee covering the period for which the marketing authorisation has no longer been valid in the concerned year (counted as exact number of days). The application for the refund of the proportionate part of the annual maintenance fee shall be submitted on a form provided in the effective version of Annex 1 to Guideline UST-24 available from here.

 

Marketing Authorisation Section

10 December 2021