Marketing authorisation of pharmaceuticals

  • Registration research
  • Assessment of the feasibility of the registration procedure
  • Calculation of costs and the time required for the registration procedure
  • Support for the creation of the required information for each module of the Common Technical Document (CTD)
  • Technical and regulatory support
  • Bibliographic approval
  • Creation of documents for the proof of traditional usage
  • Compiling of Common Technical Document dossiers
  • Preparation of the required expert opinions
  • Compiling of complete application documents
  • Registration of traditional herbal medicinal products according to EU Directive 2001/83 / EC, 2004/24 / EC and §39a-d AMG

Marketing authorisation of pharmaceuticals

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 fields of application correspond exactly to the traditional medicinal usage of the drugs
  • The medicinal product is intended for use without prescription, according to its composition and intended use
  • The medicinal product has to be administered only with a specific strength and dosage
  • The medicinal product has been used for at least 30 years and 15 years in the European Union
  • The data on the traditional use, including the safety and plausibility of the efficacy can be adequately proven. The proof can be in the form of bibliographical data or in the form of a report by an expert. Evidence is not required if a plant monograph of the Committee for Herbal Medicinal Products is referred to.
  • For combinations with vitamins and minerals or when the medicinal product contains more than one active substance (for example several plants, with several active substances), the information on the combinations shall be provided. If the traditional application is used for the combination, but not for the individual active substances, the information shall be provided for each individual active substance
  • Evidence of the pharmacovigilance responsibilities, proof of the necessary infrastructure, description of the pharmacovigilance system and scope of the risk management system
  • Applicant and holder of the registration must be registered in the EU
  • Manufacturers must be certified according to European GMP.

Registration procedure

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.

Structure of the Common Technical Document-Dossier
Structure of the Common Technical Document-Dossier