2110

Authorization procedure and Trade Register aspects for NACE 2110

Setting up a company with the main activity NACE 2110 (Manufacture of basic pharmaceutical products) requires additional steps compared to standard registration with the Trade Register (ONRC). According to Law 359/2004, the affidavit regarding the fulfillment of legal conditions must confirm that the prior operating authorization from the Ministry of Health and, where applicable, from the National Agency for Medicines and Medical Devices (ANMDM) has been obtained. The name availability check and submission of the constitutive documents are carried out through the electronic system of the Trade Register, and the resolution period is up to 5 working days. Subsequently, notification of the opening of the registered office must be submitted to the Trade Register within 30 days from the sanitary authorization. It is recommended to verify the nomenclature of activities at the county level in advance, as some local authorities require additional urbanism and environmental permits.

Regulatory framework, specific approvals and control institutions

The manufacture of basic pharmaceutical products is strictly regulated at both European and national levels. The main normative acts include Law 95/2006 on healthcare reform, Government Decision 1240/2021 approving the Rules on the authorization of medicine production, and Directive 2001/83/EC. The competent authority is the ANMDM, which issues the manufacturing authorization after a GMP (Good Manufacturing Practice) inspection. An opinion from the Environmental Protection Agency is required for emissions and solid waste, given the toxic substances involved. Additionally, the Labor Inspectorate and the Fire Inspectorate impose rigorous safety and fire prevention conditions. For controlled substances (psychotropic, narcotic), a separate license from the Ministry of Health is required. Failure to comply with the authorization requirement results in the suspension of activity and fines of up to 100,000 lei, according to Government Emergency Ordinance 114/2019.

Tax management, ANAF audit risk and specific accounting

From a fiscal perspective, companies with NACE 2110 are included in the category of large and medium taxpayers, monitored by the General Directorate for the Administration of Large Taxpayers. The tax bases are affected by research and development expenses, which are additionally deductible under the Fiscal Code (Article 21 paragraph 4). VAT applies at the standard rate of 19%, but some intra-Community supplies may be exempt with the right of deduction. The audit risk is high, as the Tax Authority (ANAF) constantly checks import and export documents, since active substances often come from outside the EU. Inventory accounting must be maintained by batches, with strict tracking of serial numbers and expiry dates. The single declaration (D212) is submitted for intellectual property income, if any. The tax vector is set up with ANAF simultaneously with registration, and monthly obligations include D300, D310 and the VAT return. Enrollment in the RO e-Factura system is mandatory for all B2B invoices, under penalty of non-deductibility. Fines for non-compliance with storage and traceability rules can reach 50,000 lei, and in case of chemical accidents, the administrator's criminal liability is direct.