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Order refusal copies

Pursuant to Article 36z(7) of the Pharmaceutical Law Act (Journal of Laws of 2019.499, as amended) a copy of a refusal to perform an order for medicinal products, foodstuffs for particular nutritional uses, and medical devices specified in the Announcement of the Minister of Health containing a list of products facing potential shortages within the Republic of Poland, referred to in Article 37av(14) of the Pharmaceutical Law Act, should be given to the Chief Pharmaceutical Inspector.
 
How to give copies of order refusals?

As of 31 August 2016, copies of order refusals need to be sent via the order refusal report system, which is available at: https://odmowy.gif.gov.pl

Does the system allow sending order refusal copies in different ways?

Yes, the system allows sending a report in several different ways:

  • using the web service;
  • via electronic mail;
  • by loading a file to the system or by manually filling in a form.

(The first three methods require generating an XML file in a proper format via the system of the entity issuing the refusal.)

The system allows enclosing to the .XML file an attachment in any format, which is a document file received from the entity issuing the refusal. The purpose of this is allowing the refusal files to be given automatically even if they are not consistent with the schema required by the order refusal report system. In such a situation, the obligation to generate a file consistent with the schema required by the order refusal report system lies on the software of the entity reporting the refusal.

How to access the system?

In order to use the order refusal report system, you need to create an account. You can do this by sending a request to create an account to: zorz.klient@gif.gov.pl.

The request should include:

  • name and surname of the user;
  • pharmacy/wholesaler identifier from the registers available at: http://www.rejestrymedyczne.csioz.gov.pl  and
  • e-mail address where the account activation link will be sent.

Who is the data controller for the personal data of the users of the order refusal report system?

The data controller of the users of the order refusal report system is the Chief Pharmaceutical Inspector (00-082 Warszawa, ul. Senatorska 12). Personal data are collected for the purposes of keeping the order refusal report system. Using the order refusal report system and providing the personal data is voluntary. Each person has the right to review and correct their personal data.

Inquiries from system users/integrators:

Users – any inquiries from users relating to the order refusal report system are to be sent via electronic mail only to zorz.klient@gif.gov.pl and contain the user’s contact details.

Integrators – reports from software producers (integrators) are accepted at: zorz.integrator@gif.gov.pl.

 

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