2120
Manufacture of pharmaceutical preparations
This code covers the manufacture of medicinal products and pharmaceutical preparations for human or veterinary use, including active substances, vaccines, antibiotics and finished pharmaceutical forms. The processes include chemical, biological and phytotherapeutic production, as well as primary packaging. It is intended for companies that hold a GMP manufacturing authorization and supply pharmacies, hospitals or distributors.
Entrepreneur Profile
Producători de medicamente (SRL, SA) care dețin sau intenționează să obțină autorizație de fabricație GMP de la Agenția Națională a Medicamentului. De asemenea, fabrici de produse farmaceutice veterinare, producători de substanțe active pentru export sau contract manufacturing organizations (CMO).
Who should avoid:
Avoid the exclusive use of code 2120 if the main activity of your company shifts towards other commercial or related branches not specified in the official description. See the excluded activities section below.
Authorization procedure and Trade Register aspects for CAEN 2120
When establishing a company that will carry out the activity of manufacturing pharmaceutical preparations (CAEN 2120), prior registration with the Trade Register (ONRC) is mandatory. The registration file must include the constitutive documents, the affidavit according to Law 359/2004 and, essentially, evidence of obtaining the preliminary approvals from the National Agency for Medicines and Medical Devices (ANMDM). Pharmaceutical manufacturing activities fall under the restrictions on the object of activity, requiring specific authorization before starting production. In case of subsequent modification of the object of activity to include CAEN 2120, an application for registration of the mention with the ONRC is submitted, accompanied by the authorizations issued by the health authorities. I recommend prior consultation of the ONRC endorsement structure to avoid suspension of registration and extension of processing deadlines.
Regulatory framework, specific approvals and control institutions
The manufacture of pharmaceutical preparations (CAEN 2120) is strictly regulated by Law 95/2006 on healthcare reform, supplemented by the Good Manufacturing Practice (GMP) rules transposed from European directives. The main mandatory approval is the manufacturing authorization issued by the ANMDM, certifying compliance with requirements regarding premises, equipment, qualified personnel and the quality assurance system. Also, the National Environmental Protection Agency (ANPM) issues the environmental permit, necessary for obtaining the operating authorization. Operational control is exercised by the ANMDM and the State Sanitary Inspectorate, which periodically verify compliance with GMP and the management of hazardous waste. Failure to comply with authorization procedures entails contraventional sanctions and even suspension of activity.
Tax management, ANAF audit risk and specific accounting
From a fiscal point of view, companies operating under CAEN 2120 are subject to the general rules of the Fiscal Code, with particularities regarding VAT deduction for purchases of raw materials and specialized equipment. Registration for VAT purposes and submission of periodic declarations (D300, D390, D100) are mandatory. I recommend correct classification of finished products in the customs nomenclatures and application of the standard VAT rate (19%), except for situations where medicines are included in the list of those with regulated prices. In accounting, pharmaceutical production requires strict inventory management according to the standard cost or actual cost method, with periodic adjustments for technological losses. The risk of ANAF audit is high, especially regarding deductions of research and development expenses and transfer pricing in the case of intra-group transactions. For tax optimization, facilities regarding the exemption from profit tax for reinvested profit in technological equipment can be used, provided that the deadlines for commissioning and the preservation of supporting documents are met.
Included Activities
- ✅ Manufacture of active pharmaceutical ingredients (API)
- ✅ Manufacture of finished pharmaceutical preparations (tablets, capsules, syrups, injectables)
- ✅ Manufacture of vaccines, toxins and biological products
- ✅ Manufacture of antibiotics
- ✅ Manufacture of homeopathic and phytotherapeutic medicines
- ✅ Manufacture of oral contraceptives
- ✅ Manufacture of infusion solutions
- ✅ Primary packaging of medicinal products (blisters, vials, ampoules)
- ✅ Manufacture of veterinary pharmaceutical products
Excluded Activities
- ❌ Wholesale or retail trade of medicinal products (code 4646, 4773)
- ❌ Pharmaceutical research and development (code 7211)
- ❌ Manufacture of laboratory products (code 2059)
- ❌ Manufacture of cosmetic products (code 2042)
- ❌ Manufacture of food supplements (code 1089)
- ❌ Manufacture of plastic packaging materials (code 2222)
Similar or Related CAEN Codes:
From the same category of economic activities:
Întrebări Frecvente
What authorizations are required to start production under CAEN 2120?
It is mandatory to obtain the GMP Manufacturing Authorization from the National Medicines Agency (ANM), as well as registration with the Ministry of Health. An environmental permit and compliance with fire safety regulations are also required.
Can I produce food supplements under this CAEN code?
No, food supplements are classified under CAEN code 1089 (Manufacture of other food products n.e.c.). Code 2120 is strictly for medicines and pharmaceutical products with therapeutic effect.