Romania

Article 6(1) of Legea farmaciei nr. 266/2008 provides that a community pharmacy is established and operates within a company organised under Companies Law 31/1990. Article 6(2) requires only that the company’s object of activity include retail sale of pharmaceutical products. There is no pharmacist-ownership requirement and no chain cap anywhere in the act. That is why Romania supports large national chains where Bulgaria’s statute does not.

What rations entry is demography, and only in towns. Article 12(1) sets one pharmacy per 3,000 inhabitants in Bucharest, per 3,500 in county-seat cities and per 4,000 in other towns, proven by certificate from the local administration. Article 12(2) requires the Ministry to publish which urban localities still have room and the queue of applicants in filing order. Rural areas sit outside the ratio: article 13 lets a pharmacy company open oficine locale de distribuţie in rural localities without pharmaceutical assistance, dissolved within 30 days if a full pharmacy later opens there.

The operational gate is the professional body. Within 15 days of the authorisation the chief pharmacist must ask the Colegiul Farmaciştilor, through the territorial college, to inspect for the Good Pharmacy Practice certificate, issued within 15 working days. Duty rotas set by territorial colleges are binding on all pharmacies contracted with the insurance houses.

OUG 117/2024, in force 26 September 2024, devolved documentation checking and conformity inspection to the 42 county public health directorates, leaving the Ministry to issue the authorisation within 30 days. Its recitals note that pharmaceutical-unit administrative acts grew by over 150% between 2019 and 2024.

Articles 30¹ to 30⁷ of Legea 95/2006 were introduced by O.U.G. nr. 196/2020, in force 19 November 2020, not 2022 as commonly stated. Any 2022 instrument is the implementing norms rather than the primary law.

The definition is unusually favourable. Article 30¹(2) describes telemedicine as medical services provided at a distance, without simultaneous physical presence of clinician and patient, for establishing the diagnosis, indicating the treatment, monitoring conditions or indicating prevention methods. Article 30¹(3) extends it non-discriminatorily to any person and all health professionals. Article 30¹(4) admits any audio or video platform. Article 30² defines teleconsultation as a service where the patient discusses at a distance with the doctor and may be carried out by any means of communication, for establishing the diagnosis, the treatment or preventive measures.

So prescribing after an online-only consultation is within the statutory concept on the face of the primary law. The catch is article 30¹(7): provision is differentiated by specialty and service type, respecting the limits of the medical act and patient safety, under norms approved by Government Decision. That Decision could not be obtained, and it is where any prior-examination requirement, specialty restriction or first-contact prescribing limit would live.

This is the single most commercially decisive unknown for Romania.

Article 2(4¹) of Legea 266/2008 permits sale and dispensing through information society services only of medicines supplied fără prescripţie medicală. Article 21, introduced by Legea 160/2018 in force 14 July 2018, sets the regime: notification to the Ministry of Health naming the company, the unit from which medicines are delivered, the website, the pharmacist responsible for online sale, and the start date, entered as an endorsement on the operating authorisation. Article 21(4) adds that deliveries to other member states must comply with the destination state’s national legislation, which forecloses using a Romanian licence to serve Germany on Romanian terms.

Penalties are meaningful. Article 38(d) and (e) set fines of 20,000 to 50,000 lei, rising to 50,000 to 100,000 lei on repetition, or annulment of the operating authorisation, with withdrawal mandatory for repetition within three years.

On whether the discussed reform to permit online prescription sale has landed: it had not, as at the texts consolidated to September 2024, and OUG 117/2024 does not touch it. Three later health-sector acts, Legea 100/2025, Legea 159/2025 and Legea 163/2025, were not opened. This is recorded as an open question rather than a negative finding.

Romania publishes CANAMED, the Ministry catalogue of approved maximum retail prices. The version in force from 1 August 2026 gives, in lei including VAT:

• Wegovy FlexTouch, one pen of four weekly doses: 773.83 at 0.25 to 1 mg, 900.67 at 1.7 mg, 1,028.13 at 2.4 mg
• Mounjaro KwikPen, one multidose pen: 983.30 at 2.5 mg, 1,156.07 at 5 mg, 1,695.72 at 7.5 and 10 mg, 2,201.90 at 12.5 and 15 mg
• Ozempic: 404.72 for one 0.25 mg pen, 1,078.76 for three 0.5 mg pens, 1,105.27 for three 1 mg pens
• Saxenda three pens: 591.08. Rybelsus 90 tablets: 1,380.38 to 1,383.10

Because the Wegovy and Mounjaro packs carry four weekly doses, these are effectively monthly ceilings: roughly 774 to 1,028 lei a month for Wegovy and 983 to 2,202 lei for Mounjaro.

Two caveats. CANAMED sets maxima, so shelf prices may be lower. And more importantly, presence in CANAMED means an approved price, not reimbursement. Do not read the table as evidence that Wegovy or Mounjaro are covered.

The Programul naţional de diabet zaharat has two subprogrammes, type 1 and type 2 with other types. Ambulatory diabetes medicines are dispensed through ordinary retail pharmacies contracted with the insurance houses, not hospital pharmacies. Treatment is initiated by the specialist in diabetes, nutrition and metabolic diseases, or a doctor with attestation in that field; family doctors appear only in connection with HbA1c evaluation. Separate prescriptions must be written for non-insulin antidiabetics and for insulins with self-monitoring tests. The programme is by a wide margin the largest curative programme line in the financial annex.

The norms are written by activity and eligibility rather than by molecule, so a search for semaglutide, liraglutide, tirzepatide or dulaglutide inside them returns nothing; the molecules are specified in the reimbursement Lista under HG 720/2008 and in the joint Ministry and CNAS therapeutic protocols, neither of which was opened.

So which GLP-1 presentations are reimbursed, in which sublist and at what percentage, is unconfirmed. What is clear is the shape: semaglutide reaches Romanian patients as a type 2 diabetes therapy gated behind a diabetologist, and nothing in the programme extends to obesity without diabetes. That gate is itself the commercial opening, because it channels every non-diabetic patient to self-pay.