Complying with regulations on herbal medicines according to EU GMP guidelines will bring development opportunities and help traditional medicines expand their international market share.
Complying with regulations on herbal medicines according to EU GMP guidelines will bring development opportunities and help traditional medicines expand their international market share.
Method to bring herbal medicinal products to the EU market
EU countries have advantages in technology and modern machinery lines to produce high quality pharmaceuticals and cosmetics. Vietnam exports to EU countries mainly phone products, electrical components, household appliances, and processed fashion. Meanwhile, in the opposite direction, Vietnam mainly imports high-tech machinery and pharmaceuticals.
Currently, not many Vietnamese medicinal products are exported to the EU market. Herbal medicines are our traditional medicine. However, in order to export traditional medicines to EU countries, products need to meet EU GMP standards.
According to Directive 2001/83/EC, Products made from herbal ingredients that want to be registered as traditional medicines when circulating in EU countries, businesses need to apply at the competent authority of 1 EU member country, and must meet one of the following criteria:
Medicinal products from medicinal plants with sufficient safety data and proven effectiveness, must be used for at least 30 years and have at least 15 years of use in the EU, products without prescription and without injection use.
Medicinal products from medicinal herbs have documents proving that the active ingredients in the product have effectiveness in EU countries, at least 10 years are used safely; no unwanted effects available; safe and effective data are evaluated for the active ingredients in the product.
Products with efficacy and safety data from the company’s own development or separate studies from outside organizations with attached data documents..
- Medicinal products from medicinal plants with sufficient safety data and proven effectiveness, must be used for at least 30 years and have at least 15 years of use in the EU, products without prescription and without injection use.
- Medicinal products from medicinal herbs have documents proving that the active ingredients in the product have effectiveness in EU countries, at least 10 years are used safely; no unwanted effects available; safe and effective data are evaluated for the active ingredients in the product.
- Products with efficacy and safety data from the company’s own development or separate studies from outside organizations with attached data documents..
Conditions for herbal medicinal products in the EU GMP
According to EU Law, drugs produced from traditional medicinal herbs contain ingredients consisting of 1 or more active ingredients or herbal preparations or a combination of both. Traditional medicines from medicinal herbs to be circulated in the EU need to meet their standards. EU GMP and standards on active, medicinal ingredients are regulated in Decision 2008/911/EC.
GMP EU standard herbal medicinal products are certified by EMA. In particular, the unit manufacturing traditional medicine needs to meet the rules of good manufacturing practice, according to the regulations of the European Union.
- The human resources involved in the production and research of drugs are qualified and knowledgeable about the list of active ingredients and preparations established based on the opinions of the Committee on Herbal Medicinal Products – HMPC. At the same time, he has knowledge about manufacturing pharmaceutical products that meet GMP EU standards.
- GMP EU standardized factory, production lines. Design, build and arrange a clean production system, minimizing risks in the process of manufacturing drugs from medicinal herbs.
- Medicinal materials used to manufacture drugs are on the list of drugs and preparations approved by HMPC. Herbal medicinal products should have medicinal ingredients that are used for 30 years, without harmful effects under normal conditions.
- Conditions of efficacy, effectiveness and safety of the product has been proven or proven to be effective in the EU, for a minimum of 10 years.
- Storage conditions, packaging meet GMP standards, avoid environmental agents, biological agents that affect the quality of traditional medicines.
Advantages of having a herbal medicines factory that meet GMP EU standards
Enterprises who want to access the European market or bid for medicinal products to hospitals and clinics, the EU GMP certificate will be an advantage. Traditional products from medicinal herbs meeting GMP EU standards will be approved and licensed by EMA for circulation in the EU. Or, the enterprise’s herbal medicinal products will be more appreciated when registering to market herbal products from companies.
Traditional drugs in the EU GMP will also have the opportunity to compete when bidding for drugs in group 1 or group 2, with multinational companies; with good manufacturing practices and tested safe herbal ingredients.
Therefore, enterprises need to clearly understand the regulations on drugs from medicinal herbs in the EU GMP, in order to build a standardized production process, increase competitiveness, and gain effective market access. Immediately contact GMP EU for advice on design and construction of a pharmaceutical factory meeting GMP EU standards.