Regional Factbooks

Vitamins are extremely popular in Romania but consumption frequency tends to be low. The main reason for consumption is a result of the relatively low per capita income of the Romanian population. Vitamins are supposed to provide biological strength and enable the individual to cope better with fatigue, stress, illness, malnutrition, and mental and physical efforts. The Romania's vitamin market size reached US$ 19.5 mil. in 1999.

The National Medicines Agency (ANM) and the Ministry of Health have stipulated that high dosage vitamins be classified as pharmaceuticals, thus requiring importers to obtain import licenses and requiring local manufacturers to obtain product registration.

The National Drug Institute has proposed to reclassify vitamins to conform with regulations in the US, Germany, and France. Single vitamins will be classified as food products and only high dosage vitamins A, D, E, and K will be classified as prescription drugs.

Market Information:

The largest selling products in the market are low cost Romanian vitamins produced by Eurofarm and Sicomed as well as imported products manufactured by such companies as Glaxo Wellcome, Sanofi, UPSA, Novartis, Walmark, Bristol Meyers, and Liner Health. Hoffmann La Roche vitamins are intended for urban areas with average and high incomes.

During the period of 1996-98, the vitamin and pharmaceuticals market recorded an upward trend in sales and revenues. However, in 1999 the depreciation of the local currency against the US dollar was reflected in a decrease sales figure of all major international producers. The lower purchasing power compelled vitamin consumers to buy Romanian products because of their lower price. Thirty-five to forty percent of Romanians used vitamin C, multivitamins, calcium, and magnesium produced by local firms. 57.70% used vitamin C, 47.90% used multivitamin, 42.80% used calcium, and 23.10% used magnesium. The most popular foreign multivitamin are: Magne B6, Plusssz, and Supradyn. B complex and minerals share a large portion of the market.

Food supplements don't need any special approval for registration. They are found in supermarkets, the most popular ones being: Kruger, Pluzz, and Pez . For food supplements, the importer must obtain an approval of the Institute of Hygiene.

It is worth underscoring that there is no educational program. Products need to be designed to provide consumers with answers to simple questions such as: what are the vitamins? When do we need them? When do we use them?

Market Access:

Romania's pharmaceutical vitamin manufacturers include foreign-owned, Romanian – owned and joint-venture firms. The foreign-owned firms are also major importers. Most of the locally owned firms are small to medium size enterprises with low level production technology, focusing on few vitamins. There is a remarkable difference between the registration of dietary supplements and registrations/OTCs, the first ones needing approximately five months for registration, while drugs and OTCs are registered in a period of approximately two years from the moment of submission. This amount of time are considered only if all registration related documents are in good order.

Summary of the Application Requirements for Drug Registration:

• request for registration (2), asking for sanitary approval for one specific product
  
• sanitary approval from the country of origin, stating that the product is fitted for consumption
  
• content of specification
  
• quality certificate
  
• description of the analysis methods (including data on raw materials and preparations)
  
• description of the manufacturing process
  
• stability studies
  
• four samples from the specific product
  
• outer/inner packaging sample with labeling
  

On an average, it takes 12-18 months for the ANM to review new drug applications. There are no registration differences between the foreign products and the generics.

Vitamin dosages that are less than, or equal to the following standards are classified as Food:

For children, the concentrations have to be half of the ones described above. The maximum admitted dose for one-a-day multivitamin is twice the above dose for liposoluble vitamins, and three-times the above dose for hydrosoluble vitamins.

Trade Procedures:

There are no known barriers imposed on imports of vitamins to Romania. Currently, there are no known forthcoming regulations or legislation that would impede imports.

Demographics & Economic Situation

Source: Factbook.net