4773

Authorization procedure and Trade Register aspects for CAEN 4773

Opening a pharmacy or a point of sale for pharmaceutical products involves going through a rigorous procedure at the Trade Register (ONRC). First, you must set up a company (LLC, SA, etc.) with the main activity code CAEN 4773. The registration application includes the founding documents, the affidavit according to Law 359/2004, and for pharmacies, the prior approval of the College of Pharmacists and the Public Health Directorate is mandatory. Without these approvals, ONRC rejects the registration. You must also provide proof of the registered office that meets hygiene, health, and fire safety standards. After registration, you obtain the unique registration code and request tax registration with the Tax Authority (ANAF), including the tax vector for monthly/quarterly payments.

Regulatory framework, specific approvals, and control institutions

The retail sale of pharmaceutical products is strictly regulated. The main normative acts include Law 95/2006 on healthcare reform, Order MS 1192/2016 approving the operating rules for pharmacies, legislation on narcotics (Law 339/2005), and EU Regulation on distance selling of medicines. Control institutions are: the Ministry of Health, the County Public Health Directorates, the College of Pharmacists, ANAF (for fiscal and anti-fraud inspections), and for controlled substances, the Police (IGPR) also intervenes. Specific approvals include: operating authorization from the Public Health Directorate, approval from the College of Pharmacists, a license to trade pharmaceutical products (including online for e-pharmacies), fire safety authorization, and environmental approval (if hazardous waste is managed). Any lack of approval leads to fines or suspension of activity.

Tax management, ANAF audit risk, and specific accounting

From a fiscal perspective, CAEN 4773 activity is subject to the general rules of the Fiscal Code, but with particularities. VAT on medicines is 9% for prescription and 19% for supplements or cosmetics. Separate records by rate are mandatory. Monthly/quarterly declarations (300, 394, D406 SAF-T) must be correctly submitted. The risk of an ANAF audit is high due to regulated margins and drug stocks with expiry dates. ANAF checks: compliance with the capping of trade margins (maximum 20% for reimbursed medicines), stock management (mandatory IT system), accurate declaration of income (avoiding underreporting). Specific accounting requires analytical records for each product, warehouse cards, periodic inventory, and for controlled substances, special registers (Law 339/2005). The use of the RO e-Factura system is mandatory for all B2B invoices. Any error in reporting risks a complaint to ANAF and a tax inspection. Collaboration with a certified accountant specialized in pharmacies is recommended.