State Institute for Drug Control

Start of final sale following the approval of a variation to marketing authorisation 

Final sale of medicinal products following the approval of a variation to marketing authorisation is governed by the provisions of Section 35(2) of the Act on Pharmaceuticals, which reads: “A medicinal product complying with the data and dossier prior to the implementation of the variation to marketing authorisation may continue, unless stipulated otherwise in the decision on the variation to marketing authorisation, to be marketed for a period not exceeding 180 days of the approval of the variation. Such product may continue to be distributed, dispensed, sold where selected medicinal products are concerned, and used in the delivery of healthcare services until the expiry of its shelf life.”

The start of the 180-day period for the marketing of the medicinal product complying with the data and dossier prior to the implementation of the variation to marketing authorisation shall begin to run upon the approval of the variation (see below). For each type of variations (IA, IB, II), the approval of the variation is considered to be a different legal procedure event, in other words, for each type of variation (IA, IB, II), the moment of the approval of the variation is derived from another legal procedure act, with regard to the legal procedure specifics of individual types of variations:

 

a) Type IA, IB, and II variations without affecting texts that do not change the decision on marketing authorisation – the start of the aforementioned 180-day period begins to run upon:

• The delivery of the notification of variation acceptance (national MA variations)
• Approval/End of Procedure from the RMS (MRP MA variations)

 

b) Type IA, IB, and II text variations that do not change the decision on marketing authorisation – the start of the aforementioned 180-day period begins to run upon:

• The delivery of the notification of the wording of the texts (both national and MRP MA variations)

 

c) Type IA, IB, and II text as well as textless variations that do change the decision on marketing authorisation – the start of the aforementioned 180-day period begins to run upon:

• The decision on the MA variation comes into force, unless stipulated otherwise in the decision on the MA variation (both national and MRP MA variations)

 

d) Changes to the labelling of the medicinal product or changes to the package leaflet that are not associated with the summary of the product characteristics – the start of the aforementioned 180-day period begins to run upon:

• The delivery of the notification of the approval of the notified variation to marketing authorisation (both national and MRP MA variations)

 

A change to the decision on marketing authorisation occurs in case the variation to marketing authorisation affects data contained in the decision on marketing authorisation, e.g.:

• The name of the medicinal product is changed
• The classification of the medicinal product for dispensing is changed
• The PSUR submission frequency is changed
• An exception from providing the name of the medicinal product in Braille is granted
• Obligations are imposed upon the MA holder
• Conditions of marketing authorisation are stipulated

Note: In case of the approval of several MA variations, the principle of the final sale is gradual, i.e. the medicinal product complying with the data and dossier valid prior to the implementation of the MA variation shall be limited to the final sale concerning solely the respective MA variation, rather than the final sale following the approval of another MA variation.

 

Start of final sale following a marketing authorisation renewal

The final sale of medicinal products following the approval of the MA renewal is governed by the provisions of Section 34(2) of the Act on Pharmaceuticals, which reads: “A medicinal product complying with the data and dossier prior to the renewal of marketing authorisation may continue, unless stipulated otherwise in the decision on the renewal of marketing authorisation, to be marketed for a period not exceeding 180 days of the approval of the renewal of marketing authorisation. Such product may continue to be distributed, dispensed, sold where selected medicinal products are concerned, and used in the delivery of healthcare services until the expiry of its shelf life.”

The start of the 180-day period for the marketing of the medicinal product complying with the data and dossier valid prior to the MA renewal shall begin to run upon the approval of the MA renewal, i.e. upon the decision on the MA renewal comes into force, unless stipulated otherwise in the decision on the MA renewal (both national and MRP MA renewals).

 

Start of final sale following a marketing authorisation transfer

The final sale of medicinal products following the MA transfer is governed by the provisions of Section 36(4) of the Act on Pharmaceuticals, which reads: “A medicinal product complying with the data and dossier prior to the implementation of the transfer of marketing authorisation may continue, unless stipulated otherwise in the decision on the transfer of marketing authorisation, to be marketed for a period not exceeding 180 days of the date of the transfer of marketing authorisation. Such product may continue to be distributed, dispensed, sold where selected medicinal products are concerned, and used in the delivery of healthcare services until the expiry of its shelf life.”

The start of the 180-day period for the marketing of the medicinal product complying with the data and dossier valid prior to the MA transfer implementation shall begin to run upon the date of the MA transfer, i.e. upon the date when the MA transfer becomes effective (as stated in the application for the MA transfer and in the decision on the MA transfer):

a) MA transfer implemented as of the date when the decision on the MA transfer comes into force – the start of the aforementioned 180-day period begins to run upon:

• The decision on the MA transfer comes into force, unless stipulated otherwise in the decision on the MA transfer (MA transfers concerning medicinal products authorised both nationally and via MRP/DCP)  

 

b) MA transfer implemented on a future date – the start of the aforementioned 180-day period begins to run upon:

• The future date when the MA transfer becomes effective (which is specified also in the decision on the MA transfer), unless stipulated otherwise in the decision on the MA transfer (MA transfers concerning medicinal products authorised both nationally and through via MRP/DCP)

 

Note: In case of an MA transfer with a future date of the implementation, it is not possible to approve and issue texts common with another text procedure at the same time (i.e. it is not possible to apply for common termination of an application for a MA transfer and application for a MA variation), because in respect of the MA variation, the final sale would start to run from the approval of the MA variation, while for the MA transfer only as of the date when the MA transfer becomes effective. Such discrepancy is not acceptable for common texts, and for this reason, these procedures and related texts have to be handled separately, or on a gradual basis as they are being approved.

 

Placement on the market in relation to final sale

Pursuant to section 3a(10) of the Act on Pharmaceuticals, placing the medicinal product on the market shall mean its hand‐over after the manufacture completion or its delivery from another Member State or its import, which are carried out in order to distribute the medicinal product with the exception of its use in clinical trials, i.e. its delivery to the Czech Republic for the purposes of distribution on the market in the Czech Republic.

For a batch of a medicinal product to be considered placed on the market, at least one packaging of the concerned medicinal product from the batch has to be placed on the market in the Czech Republic, which has to be brought to the warehouse of the distributor in the Czech Republic.

Note: Questions and answers regarding the issue of the medicinal product placement onto the market have been published on SÚKL's website.

After the expiry of the 180-day period following the approval of the MA variation or the MA renewal or transfer, SÚKL may not approve the marketing of a batch of a medicinal product complying with the data and dossier valid prior to the implementation of the MA variation, prior to the MA renewal or prior to the implementation of the MA transfer. If the medicinal product has been certified by the manufacturer's qualified person in compliance with the valid MA dossier, it is not a quality defect, and SÚKL therefore cannot initiate an administrative procedure as referred to under Section 13(2)(m) of the Act on Pharmaceuticals.

Note: The process of medicinal product batch release is a manufacturing step; the requirements are stipulated in guideline VYR-32 Amendment 16 – Certification by qualified person and batch release, as last amended.

 

Information on the implementation of variations to marketing authorisation, renewals and transfers of marketing authorisations are provided on SÚKL's website.

 

Marketing Authorisation Section
17 September 2014 (update of 5 November 2021)