On March 11, 2026, the Regulation of the Minister of Health of February 20, 2026 entered into force, amending the regulation of April 29, 2019 regarding the template application for issuing a permit to operate a pharmaceutical wholesale store. The new authorization template for operating a pharmaceutical wholesale store was developed to adapt the document to the guidelines of the European Medicines Agency contained in the publication “Compilation of Community Procedures on Inspections and Exchange of Information”. The change is intended to ensure consistency of data contained in permits with information published by the supervisory authority in the European EudraGMDP database.
Important
The regulation does not impose a mandatory obligation to change permits for operating a pharmaceutical wholesaler issued before March 11, 2026 and based on an earlier template – these permits remain valid. The existing permits will be adapted to the new format gradually and only if the entrepreneur submits an application for a change in the business activity. This also applies to changes in point 3.1. – emphasized the Chief Pharmaceutical Inspectorate in a statement.
Unification of product information with additional requirements
The most important change concerns simplifying and standardizing information regarding the activities indicated in point 3 of the authorization – “Medicinal products with additional requirements”. The new format is intended to be consistent with current regulatory guidelines and ensure greater transparency of the document.
Information on trade in narcotic and psychotropic substances
In point 3.1. permits there should be information about ownership by entrepreneur permits to conduct wholesale trade in narcotic drugs or psychotropic substances. Adding this information will be possible after obtaining appropriate permission in accordance with Art. 40 section 4 point 1 of the Act on Counteracting Drug Addiction (Journal of Laws 2023, item 1939) and after submitting an application for a change to the driving license pharmaceutical wholesaler.
New application template mandatory for new proceedings
Entrepreneurswho submit an application for granting from March 11, 2026 permits for the lead pharmaceutical wholesalerare obliged to use the new form. At the same time, proceedings for issuing or changing permits initiated before the entry into force of the new regulations will be conducted on the basis of the existing regulations.
Application for a permit to operate a pharmaceutical wholesale store (PDF)
Application for a permit to operate a pharmaceutical wholesale store
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