Other, containing vitamins or other products of heading 2936

CN code 300450 covers medicines containing vitamins or other products of heading 2936, put up in measured doses or in forms for retail sale. Products classified here are finished medicinal products containing vitamins as active substances, intended for the treatment or prevention of vitamin deficiencies. This includes single-vitamin preparations (such as vitamin D3, vitamin B12, vitamin K) and multivitamin preparations registered as medicines. Pharmaceutical forms include tablets, capsules, injection solutions, oral drops, syrups, and ampoules. The key classification criterion is the product's regulatory status as a medicine (medicinal product) rather than a dietary supplement. Dietary supplements containing vitamins, even when packaged in doses, are classified under Chapter 21 (heading 2106) as food preparations. This distinction is fundamental for correct customs classification and determines both the applicable regulatory requirements and duty rates.

Importing vitamin medicines into the EU requires a marketing authorisation (MA) issued under Directive 2001/83/EC through the centralised (EMA), mutual recognition (MRP), decentralised (DCP), or national procedure. The manufacturer must hold a GMP certificate confirming compliance with Good Manufacturing Practice, and the production facility should be registered in the EudraGMDP database. Prescription vitamin medicines are subject to mandatory serialisation under Directive 2011/62/EU, comprising a unique DataMatrix identifier and anti-tampering device on packaging. The distributor must hold a GDP certificate and a pharmaceutical wholesale distribution authorisation. The pharmacovigilance system requires maintaining adverse reaction registries. Medicines containing high-dose vitamin A may be subject to additional restrictions due to teratogenicity risk.

At customs clearance for vitamin medicines under CN code 300450, complete pharmaceutical documentation is required: marketing authorisation, manufacturer's GMP certificate, Certificate of Analysis (CoA) for each batch, and serialisation documentation for prescription medicines. Most vitamin medicines are transported at controlled room temperature (15 to 25 degrees Celsius) with protection from light and moisture, although some preparations (such as vitamin B12 injection solutions) may require cold chain transport. Duty rates should be verified in TARIC or ISZTAR. During customs classification, authorities may request documentation confirming the product's medicine status (MA) to distinguish it from dietary supplements, which are subject to different duty rates and regulatory requirements. The importer should ensure that the packaging includes a patient information leaflet in the local language.

Importing pharmaceutical products under CN code 3004 50 (Medicines with vitamins in doses) requires authorisation from the national medicines agency. All medicines placed on the EU market must hold a marketing authorisation issued by EMA (centralised procedure) or a national authority. Compliance with Good Manufacturing Practice (GMP) confirmed by a certificate is mandatory. Biological products require cold chain maintenance. Serialisation and authenticity verification (FMD 2011/62/EU) are mandatory for prescription medicines.