Utilization of exception for distribution and dispensing of medicinal product without verification

The Czech Medicines Verification Agency would like to inform MAHs and also ask them to make use of the statutory option of granting an exception from verification in the interests of the system’s functionality and, primarily, in the interests of end users. The Ministry of Health grants this exception and it concerns batches where it is not possible to have the unique identifier verified by end users, so they are the source of unnecessary alerts. They are usually packages whose unique identifier could not be correctly uploaded into the system or subsequently corrected.

This option will continue to apply after 1 January 2020, when the transition period ends, with the option of issuing a medicine even without successful verification in good faith that it is not a forgery (for example from a tried-and-tested distributor).

The proposed procedure is based on the Medicines Act (amendment dated 30 January 2019) – annexed.

All information and instructions for the granting of an exception from verification, i.e. Information for Holders and an Annex to a Request, are available at the website of the Ministry of Health of the Czech Republic:

 http://www.mzcr.cz/Odbornik/dokumenty/informace-pro-drzitele-rozhodnuti-o-registraci-o-moznosti-podani-zadosti-k-vydan_16876_1952_3.html

 Procedure for Preparation of Request

A request must contain:

1. Identification data of the applicant;
2. Information about the medicinal product—SIDC code, name of medicinal product, supplement to the name, batch (in the annex state one batch on one line), expiry date
3. Reasoning for the request
4. Remedial measures taken by the applicant
5. An annex with the relevant information in the table—quantity, batch number, number of packages, expiry date.
6. Analytical certificate and release sheets for each batch

Marketing authorisation holders then submit a request marked with the words “Application for Measure in accordance with Section 11(r) of the Medicines Act”, electronically through the electronic filing room of the Ministry of Health of the Czech Republic (mzcr@mzcr.cz) with a qualified electronic signature or through the data box (pv8aaxd).

A copy of a request containing an annex with information about the medicinal product will be sent to the e-mail addresses: opatreni11r@mzcr.cz and opatreni11r@sukl.cz 

A decision is usually issued within a few business days.

• MZ Informace_pro_držitele_20190312.pdf (285 KB)
• Zákon o léčivech_výjimka.pdf (85 KB)