TRADITIONAL HERBAL MEDICINAL PRODUCTS MARKET ANALYSIS AND ITS AUTHORIZATION IN ROMANIA

Abstract

t Traditional herbal medicinal products are recognized across the world as the continuation of the old treatments developed by different civilizations in time. This paper is an investigation on how these products are authorized in Romania in comparison to other European countries. Both literature review and secondary analysis are performed in order to identify the trends concerning the authorization of these products. Our study provides results concerning the increased interest concerning these products in Romania and other European Countries. For Romania, the numbers concerning TUR (traditional use registrations) are rather low, but exceeded Lithuania, Estonia and Slovakia. Romania received only 5% of the total CEE countries applications, with only 0,2% of the total CEE countries’ granted applications. Considering the WEU MA (well-established use marketing authorizations) number, Romania showed one of the highest numbers, along with Czech Republic, Poland and Lithuania. Romania received 14% of the total CEE countries applications, with 11% of the total CEE countries’ granted applications. In 2020, both exports and imports of medicinal and pharmaceutical products, including traditional herbal medicinal products, increased in the vast majority of the EU Member States, despite the general decrease in trade due to the restrictive measures taken in response to the COVID-19 outbreak. As the majority of EU countries, Romania registered a general decrease in trade in goods, but reported an increase of imports (approximately +10%) and an increase of exports (approximately +7%) in medicinal and pharmaceutical products, including traditional herbal medicinal products.

Keywords

• traditional herbal medicinal products
• traditional use registrations
• well-established use marketing authorizations
• monocomponent products
• combination products