With the aim of harmonising and updating the procedural rules applicable to pharmacies, Ministerial Order No. 375/2025/1 of 4 November has entered into force, introducing significant changes to the procedures for the authorisation of new pharmacies, the relocation of existing pharmacies and the issuance of administrative licences.
This Ministerial Order follows the amendments introduced in 2023 and 2024 to the Legal Framework for Community Pharmacies (RJFO), particularly those relating to pharmacy relocation procedures, and adapts the regulatory framework following the abolition of the Regional Health Administrations.
While some of the provisions now enshrined merely reproduce requirements already set out in the RJFO, the Ministerial Order also introduces noteworthy new rules, including in particular:
- The formal adoption of electronic processing for licence issuance procedures by INFARMED.
- The removal of the express reference to the possibility of launching public tenders for the establishment of new pharmacies in municipalities where relocation procedures from neighbouring municipalities are ongoing.
- The automatic refusal of relocation applications for premises located less than 500 metres from another previously submitted relocation application, irrespective of whether that earlier application has already received a favourable suitability decision.
- The abolition of the possibility of authorising new pharmacies in municipalities with a ratio below 3,500 inhabitants per pharmacy, even where the new pharmacy would be located more than 2 km from the nearest pharmacy, with the municipal ratio becoming the sole determining criterion.
The Ministerial Order also reinforces and clarifies rules already deriving from the RJFO, particularly regarding:
The minimum distance of 500 metres between pharmacies, measured in a straight line between the outer boundaries of the establishments.
- The minimum distance of 100 metres between pharmacies and health extensions, health centres or hospitals, with an exception for parishes with fewer than 4,000 inhabitants.
- The requirement that relocation applications be accompanied by all legally required documentation, including the favourable opinion of the territorially competent Municipality, which must be obtained prior to submitting the application to INFARMED.
It should also be noted that the Ministerial Order does not provide for any transitional regime, meaning that procedures for the opening of new pharmacies or for relocation currently underway must be assessed considering the new regulatory framework.
These amendments enhance the predictability and uniformity of procedures but require increased attention from operators in the pharmaceutical sector, particularly at the planning stage and in the proper preparation of applications.
Belzuz Abogados, S.L.P. – Portuguese Branch has extensive experience in the pharmaceutical sector and provides comprehensive legal advice to operators seeking to establish new pharmacies or relocate existing ones in Portugal, ensuring full compliance with the Legal Framework for Community Pharmacies and the applicable regulations, including procedures before INFARMED.