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Changes of the authorisation to operate a pharmacy in light of the amendment of the Pharmacy for Pharmacists Act

2022-05-05

On 24 February 2022. The SAC issued two rulings concerning the amendment of the permits to operate a pharmacy granted prior to the entry into force of the amendment to the Pharmaceutical Law ("PF") referred to as the so-called Apteka dla Aptekarza ("AdA"). 
In both states of facts covered by the judgments of the Supreme Administrative Court, the applicant applied for the change of the permit to operate a pharmacy open to the public as regards the name and personal changes in the company which is the addressee of the permit. The pharmaceutical inspection authorities at both instances took the standpoint that the requested changes would constitute a circumvention of the PF of the amended AdA. WSA dismissed complaints against the GIF decisions. The NSA repealed the appealed judgments of the WSA, indicating that the interpretation of PF amended AdA, both linguistic and logical, as well as systemic or purpose-related interpretation, does not support the interpretation of the provisions adopted by the WSA. Moreover, the AdA indicates the scope of application of the "new" requirements in relation to the entities running community pharmacies, it states explicitly that the so-called "old" permits (permits to run community pharmacies issued before the AdA enters into force) remain valid. 

Below are links to the full judgments:
https://lnkd.in/dwKRybuv
https://lnkd.in/dNedmNpD