4646

Authorization procedure and Trade Register aspects for NACE 4646

Setting up a company with the main activity '4646 - Wholesale trade of pharmaceutical and medical products' involves going through the standard registration stages with the Trade Register (ONRC), but with particularities related to prior approvals. According to Law 359/2004, when submitting the registration application, a declaration on own responsibility regarding the fulfillment of operating conditions is attached. For this field, it is necessary to obtain the operating authorization from the Ministry of Health or, as the case may be, from the National Agency for Medicines and Medical Devices (ANMDMR) prior to registration. The company must have a suitable registered office, with storage spaces compliant with GMP (Good Manufacturing Practices) or GDP (Good Distribution Practices) standards, verified by the inspectors of the Public Health Directorate. I recommend legal consultants to check the NACE code 4646 in the certificate of registration issued by ONRC, ensuring that there are no authorization restrictions for specific products (e.g., narcotic drugs or medical devices with special regime).

Regulatory framework, specific approvals and control institutions

Economic operators classified under NACE 4646 are subject to permanent control by ANMDMR, the Ministry of Health and, through thematic controls, the Tax Authority (ANAF). Law 95/2006 on healthcare reform, correlated with Order of the Ministry of Health no. 1.382/2010, establishes the obligation to hold a license for the wholesale distribution of medicines. The authorization process takes between 60 and 120 days and includes an inspection of the storage unit. Without this license, wholesale trade activity is prohibited. Furthermore, for medical devices, Regulation (EU) 2017/745 applies, and for biocidal products, additional approvals from the National Commission for Biocidal Products are required. The company must have a distribution manager qualified as a pharmacist or chemist, according to legal requirements. Contraventions may attract substantial fines or suspension of activity.

Tax management, ANAF audit risk and specific accounting

The wholesale trade of pharmaceutical products involves a complex tax regime. According to the Romanian Fiscal Code, income from this activity is taxed at the standard rate of 16% (corporate income tax) or 1% (micro-enterprise, if conditions are met). The applicable VAT is regulated by Title VII of the Fiscal Code; intra-Community supplies of medicines may be exempt with the right of deduction, based on art. 294 para. (1) letter a) of the Fiscal Code. It is mandatory to issue invoices in the RO e-Factura system for all transactions with partners in the EU, and for stocks, management through the e-Transport application applies for movements of goods with high tax risk. ANAF focuses on checking commercial margins and transfer prices, as medicines have regulated prices through the Order of the Ministry of Health. Specific accounting requires separate recording of pharmaceutical products, medical devices and food supplements, respecting expiration dates and storage conditions. I recommend preparing a complete tax file and consulting a certified accountant for drafting monthly (D300, D390, D394) and annual (D101, D100) declarations.