Pharmacies Under New Rules – What Has Changed?

Legal Brief by Bruno Magalhães

Legal Brief – Main Changes Introduced by Ordinance No. 375/2025/1 of November 4

Summary
Ordinance No. 375/2025/1 updates and republishes the regime governing the opening and relocation of pharmacies, reinforcing predictability, transparency, and procedural efficiency before INFARMED, I.P.
Key updates include new rules on distances, deadlines, and fees, the standing of local authorities, and procedural simplification through electronic communication.

What Has Changed?

Rules on establishment and distances

• The minimum ratio of 3,500 inhabitants per pharmacy within each municipality after installation remains in force.
• The minimum distance of 500 meters between pharmacies is confirmed, measured “in a straight line” between the outer boundaries of the premises.
• The minimum distance of 100 meters from health centers, extensions, or hospitals also remains (except in parishes with fewer than 4,000 inhabitants).
• The 500 meter distance rule also applies when the opening or relocation occurs near a bordering municipality.

Competitive procedure for new pharmacies

• Local authorities now have standing to request the opening of installation tenders from INFARMED, I.P.
• A pre-selection phase with objective criteria and a public draw is introduced when multiple pre-selected candidates exist.
• A mandatory guarantee of € 25,000 must be provided by the selected applicant within 15 days.
• Technical documentation requirements are strengthened (e.g., 1:2000 scale plans, descriptive report, identification of the technical director, etc.).
• Clear deadlines are set: document review (15 days), inspection (30 days), issuance of the license (10 days after inspection), and opening to the public within 20 days after issuance.

Relocation of pharmacies

• Stricter requirements apply: municipal certificates of distance (origin and destination), favorable municipal opinion, 1:2000 scale plans, and a descriptive report.
• INFARMED, I.P. must issue a suitability decision within 30 days, which is then published on its official website.
• Conflicting requests (submitted on the same day, both deemed suitable, and less than 500 meters apart) are resolved by public draw.
• Inspection of the new premises must occur within 6 months (extendable by up to 120 days); after inspection, the license is issued, and the pharmacy must open to the public within 20 days.
• It is prohibited to request relocation within 5 years from the pharmacy’s initial opening.
• A specific procedure applies for relocation to a neighboring municipality, with adjusted documentation.

Digitalization and simplification

• Applications, document submissions, inspection requests, relocations, and payments can now be made via INFARMED’s website.

Repeals and republication

• Several provisions of Ordinance No. 352/2012 are repealed (e.g., subparagraph e) of paragraph 2 and paragraph 4 of article 4; paragraph 5 of article 19; subparagraph g) of paragraph 1 of article 20; paragraph 6 of article 23; and paragraph 2 of article 32).
• Complete republication of Ordinance No. 352/2012 with the new wording.

The amendments entered into force on November 5. They mark a step toward greater procedural transparency, clarified deadlines, a lottery mechanism for conflicting requests, and fully online applications through INFARMED.
If you are planning to open or relocate your pharmacy, contact us to design a legally secure and efficient process.