On 31 March 2004 Directive 2004/24 / EC on traditional herbal medicinal products was adopted by the European Parliament and the Council of the European Union. The Directive provides a simplified registration procedure for traditional herbal medicinal products for the authorization of these medicinal products on the EU market.
The simplified registration procedure is a great opportunity for TCM products to be authorized for the EU market. No separate clinical trials are required for the simplified registration procedure for Traditional Herbal Medicinal Products.
The prerequisites for the registration of TCM products via the simplified registration procedure are as follows:
The applicant can choose between the following four registration procedures:
A: Centralised Procedure (CP）
The registration will be applied directly to the EMA, which means that admission is valid for the whole EU.
B: Decentralised Procedure (DCP）
Identical applications are submitted simultaneously to all countries and one State is selected as a reference Member State. If the medicinal product is authorized in a member state of the EU, the approval for other countries may take place through the mutual recognition procedure.
C: Mutual Recognition Procedure (MRP)
The Mutual Recognition Procedure (MRP) enables a medicinal product which has already been approved nationally in a Member State of the EU to be authorized in other Member States on the basis of the general assessment and assessment of the quality, efficacy and safety of that State. The MPR procedure is mandatory if an authorization for the medicine already exists in a European Member State.
D: National Procedure (NP）
The National Registration Procedure is applied if the medicinal product is to be marketed exclusively in one country. If the medicinal product is to be authorized in several countries of the European Economic Area, the European approval procedures, such as the Mutual Recognition Procedure (MRP), the Decentralized Approval Procedure (DCP) or the Central Approval Procedure (CP), must be applied.