OTC vs Rx Medicines in Romania: What You Can Buy Without a Prescription

In Romania, every medicine authorized by ANMDMR (Agenția Națională a Medicamentului — the National Agency for Medicines and Medical Devices, Romania's drug regulator) has a clear status: OTC (Over-The-Counter, no prescription) or Rx (Prescription, prescription-only). The official list is published and updated quarterly on anm.ro. Here is what you can buy straight off the shelf, what you can't, and what has changed in recent years.

The legal framework — who decides what is OTC

Each medicine's status is set out in the Marketing Authorization (APP — Autorizația de Punere pe Piață) issued by ANMDMR or by the European Commission (centralized / mutual recognition / decentralized procedures). The decision is based on Directive 2001/83/EC, transposed into national law through Law 95/2006 (Legea 95/2006 — Romania's health reform act), Title XVIII (“The Medicine”). The criteria for a medicine to receive OTC status are:

• a good safety profile at the recommended dose (low toxicity);
• an indication for minor, self-diagnosable conditions (cold, heartburn, mild pain);
• clear patient-leaflet instructions, understandable without medical staff;
• minimal risk of abuse, dependence or serious interactions.

Moving a medicine from Rx to OTC is called an “OTC switch” and is done through ANMDMR evaluation — in recent years several products have been “switched”: loratadines, paracetamol with low-dose codeine (now back to Rx since 2018), pantoprazole 20 mg, and so on.

OTC categories — what you can buy without a prescription

Analgesics and antipyretics

Paracetamol (up to 500 mg/tablet, no combinations), ibuprofen (200-400 mg), acetylsalicylic acid (up to 500 mg), naproxen 220 mg, metamizole (Algocalmin in tablet form). The OTC pack limit is usually 20-30 units; large packs remain Rx.

Cough suppressants, mucolytics, ENT anti-inflammatories

Ambroxol, bromhexine, acetylcysteine, dextromethorphan (in standard codeine-free syrups), herbal products: Bronchipret, Sinupret, ACC, Mucosolvan.

Second-generation antiallergics

Loratadine, cetirizine, levocetirizine, desloratadine, fexofenadine — all are OTC in standard pediatric and adult doses. First-generation antihistamines (chlorphenamine, promethazine) are Rx.

Antacids and proton pump inhibitors

Algeldrate-magnesium (Maalox, Almagel), ranitidine (where it is still marketed), pantoprazole 20 mg, omeprazole 10 mg for short courses (14 days). Higher PPI doses remain Rx.

Dermatological topicals

Clotrimazole cream (antifungal), aciclovir cream for cold sores, hydrocortisone 0.5-1% cream, diclofenac gel 1%, miconazole cream.

Supplements, vitamins, medical devices

Multivitamins, vitamin D3 up to 4000 IU, magnesium, oral iron, omega-3, probiotics, rapid tests (covid, pregnancy, blood glucose), bandages, masks. All without a prescription.

What you can't buy without a prescription in RO (2026)

• Antibiotics — all of them. Including amoxicillin, azithromycin, ciprofloxacin. Selling them without a prescription is a criminal offence (art. 829 of Law 95/2006).
• Strong non-steroidal anti-inflammatory drugs — systemic diclofenac, ketorolac, indometacin (these are Rx).
• Anxiolytics and hypnotics — diazepam, alprazolam, zolpidem (Schedule 3 narcotics — Lista 3, Rx with a special stamp).
• Antidepressants, antipsychotics — all Rx.
• Antihypertensives, statins, antidiabetics — all Rx, even though they are “ordinary” chronic medicines.
• Oral contraceptives — Rx (exception: levonorgestrel emergency contraceptives, OTC since 2007, but kept behind the counter).
• Codeine — codeine combinations returned to Rx in 2018, after repeated abuse.

How the big pharmacies behave

The chains Catena, Dona, Tei, Dr.Max, Help Net strictly respect Rx status — there is no “under the counter” selling at the chains. At independent pharmacies compliance varies, especially with antibiotics — a 2022 ECDC report placed Romania in the EU top 5 for inappropriate use of antibiotics without a prescription, even though the law forbids it.

ANMDMR plus the College of Pharmacists (Colegiul Farmaciștilor — the professional regulatory body) carry out periodic inspections, and fines for illegal sales start at 5,000 RON and can lead to suspension of the pharmacy's license. At Mattca, Springfarma, Minifarm the situation is similar to the big chains — these are professionalized networks.

Read the leaflet — even for OTC

The official leaflet for every medicine is available on anm.ro → the Nomenclature of human-use medicines — search by INN (DCI — the international non-proprietary, active-substance name) or brand name and download the PDF. Look at: contraindications (what not to take if you have X), interactions (which other medicines react), the maximum daily dose, the maximum duration of treatment without medical advice.

The OTC kit for minor ailments — what to choose

In practice, the Romanian patient buys OTC products for five main scenarios: colds (the common cold, seasonal flu), mild pain (headache, muscle pain, dysmenorrhea), minor digestive upsets (heartburn, bloating, diarrhea from a change in diet), seasonal allergies (rhinitis, mild urticaria) and superficial wounds (scratches, stings, bites). For each there are standard recommendations:

• Cold + fever: paracetamol 500 mg as needed (max 4 doses/day), a nasal decongestant with xylometazoline (max 5 days), seawater spray, throat lozenges with ambazone or chlorhexidine.
• Mild-to-moderate pain: ibuprofen 400 mg every 6-8 hours (max 1200 mg/day without medical advice) or paracetamol 500-1000 mg every 6 hours. Never the two at the same time without medical instruction.
• Reflux + heartburn: an antacid with algeldrate-magnesium (Maalox) as needed, or pantoprazole 20 mg for 14-day courses (longer courses require a consultation).
• Seasonal allergy: loratadine 10 mg or cetirizine 10 mg, once a day, until the symptoms disappear.
• Superficial wound: wash with clean water, povidone-iodine (betadine), a plaster or a sterile dressing.

For all of these, OTC is enough. If symptoms persist beyond 3-5 days, a fever above 39°C appears, or there are alarming signs (sudden pain, bleeding, loss of consciousness), it is time for a medical consultation — not for doubling up on OTC.

RO vs other EU countries — OTC switches

OTC vs Rx status is not identical across all EU countries — even if the marketing authorization is centralized for new molecules, each member state can keep national restrictions. A few differences worth knowing:

• Pantoprazole 20 mg — OTC in RO (2019), OTC in Germany (2009), Rx in France. The difference comes down to national regulatory history, not the safety profile.
• Systemic diclofenac — Rx in RO, Rx in most of the EU after 2013 (when the EMA restricted it due to cardiovascular risk). In Germany it exists but with restrictions.
• Second-generation antihistamines — OTC everywhere in the EU for loratadine, cetirizine, desloratadine.
• Ranitidine — withdrawn from the EU in 2019-2020 (NDMA contamination), no longer available. Replaced by famotidine (OTC) or a PPI such as pantoprazole.
• Codeine — in the UK, Germany, France — OTC in low doses with paracetamol or ibuprofen. In RO — fully Rx since 2018.
• Ibuprofen 400 mg combined with paracetamol 500 mg — in the UK (Nuromol) it is OTC; in RO it is not authorized as an OTC combination product, even though each one separately is OTC.

Bottom line: don't import OTC products from other EU states assuming it is legal — check the RO status on anm.ro first. For travel, you are allowed to carry with you reasonable quantities of OTC for personal use.

Special cases — products that look OTC but are restricted

A few product categories have a complicated legal status in RO 2026:

• Pseudoephedrine (systemic decongestant, e.g. Sinutab) — OTC, but limited to 720 mg per purchase because of its illicit use in the production of methamphetamine. The pharmacy records the purchase in a special register.
• Low-dose codeine — combinations with paracetamol (Solpadeine in the UK) returned to Rx status in RO in 2018, after reports of abuse and dependence.
• Levonorgestrel 1.5 mg (emergency contraception) — OTC, but dispensed “behind the counter” with mandatory pharmacist counseling, per the College of Pharmacists' recommendation.
• Melatonin above 1 mg — in RO it is Rx if it is a medicinal product authorized as a medicine; food supplements with melatonin under 1 mg are freely available. The status is a technicality — check the packaging for “medicine” or “supplement”.
• Cough suppressants with dextromethorphan — OTC in standard doses, but large quantities are monitored (documented recreational use).

How to check the current status of a medicine

1. Go to anm.ro → “Nomenclature of human-use medicines”.
2. Search by brand name or INN (DCI).
3. In the Mode of supply column you will see “OTC” or “PR” (medical prescription).
4. Click on the product line → you will see the APP (Marketing Authorization) and the official leaflet.

It is the only official source. Wikipedia, forums and TV ads may be out of date.