Marketing authorisation and registration

Numerous documents need to be submitted for the marketing authorisation of medicinal products. Every authorisation procedure has its unique requirements. Diapharm is there to help.

Marketing authorisations for medicinal products are subject to very strict overall requirements. Preparing, submitting and maintaining CTD/eCTD dossiers places considerable demands on a company’s human resources.

Marketing authorisation: national / MRP / DCP / CP

We handle and oversee all national and European marketing authorisation procedures for our clients:

  • Centralised procedure (CP) at the EMA
  • Decentralised procedure (DCP) in all EU member states, including application for timely DCP slots
  • Mutual recognition procedure (MRP) in all EU member states
  • National marketing authorisation with the proper regulatory agencies for medicinal products (ANSM, BfArM, DKMA, MHRA, MEB, etc.)

Our regulatory affairs specialists take care of the work that needs to be done – both for human and veterinary medicinal products. We compile information in the required CTD dossier format (or NtA for veterinary medicinal products). We also provide support for the testing and evaluation required for CTD dossiers, such as the environmental risk assessment (ERA).

Our clients benefit from our many years of experience when it comes to choosing an appropriate Reference Member State (RMS) for MRP and DCPs, and we help apply for a timely DCP slot in decentralised procedures (DCPs).

We accompany scientific advice during marketing authorisation procedures, plus we evaluate and process official demands for changes and additional information (“deficiency letter”) throughout the process until the medicinal product is approved.

Well-established use authorisation (WEU)

The authorities have loosened the strict marketing authorisation requirements for medicinal products with a long tradition of well-established use, also known as WEU products (see article 10a of EU Directive 2001/83/EC, or sect. 22, para. 3 AMG in Germany). The applicant may refer to relevant scientific documents, such as findings on the medicinal product published in trade journals, instead of submitting the findings of (its own) pre-clinical and clinical studies. As part of the marketing authorisation process, the applicant also has to provide evidence of the product’s recognised efficacy and safety. The medicinal product must have been in use in the European Union for at least ten years to be granted WEU authorisation.

Traditional registration (THMP)

The European Union has established a simplified “traditional registration” procedure for entirely herbal medicinal products that have been used for decades (see EU Directive 2001/83/EC, art. 16a–16i, or sec. 39a–d AMG in Germany). However, the applicant must instead prove that the product has been in medicinal use for at least 30 years, with at least 15 of them in Europe.

We advise pharmaceutical companies to show them which medicinal products are subject to WEU authorisation or “traditional registration”, prepare the necessary documents and manage the marketing authorisation or registration procedure.

Homeopathic medicinal products

As with all drugs, the marketing of homeopathic medicinal products is subject to regulation. Homeopathic medicinal products are subject either to authorisation (with a therapeutic indication) or registration (without a therapeutic indication).

The rules and regulations governing registration are the same throughout the European Union. However, the framework for authorisation varies greatly from country to country. In Germany and Austria, it is up to applicants to decide whether they would prefer to seek registration or authorisation, provided that they are able to comply with the respective regulations. Switzerland’s ordinance on complementary and herbal medicinal products (KPAV) applies to the special requirements relating to the manufacturing of complementary and herbal medicinal products and defines the conditions that apply to simplified marketing authorisation and authorisation by application procedure for the said drugs.

A homeopathic medicinal product is mainly characterised by its production method. Guidelines on the production of homeopathic preparations can be found in the German Homeopathic Pharmacopoeia (HAB) or the French Pharmacopoeia (Ph. Franc.), for example. The production methods are being increasingly transferred into the European Pharmacopoeia (Ph. Eur.), monograph 01/2011:2371.

Since 2002, the Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies (HMA) has been working on drafting guidelines for the evaluation of homeopathic preparations to achieve European harmonisation for homeopathic medicinal products. The commission has yet to bindingly issue any guidelines or regulations. On its website, the HMPWG has already published a number of guidelines on quality, safety and homeopathic use that are used in all European countries to evaluate homeopathic medicinal products.

Pre-clinical and clinical studies are not required for the registration or authorisation of homeopathic medicinal products. Applicants can use other scientific findings to support their safety claims or potential efficacy claims. In addition, evidence must be provided to support the homeopathic use of a single substance or the plausibility of a combination remedy.

We support pharmaceutical companies in the registration and authorisation of their homeopathic medicinal products – with homeopathic databases, comprehensive knowledge of the Homoeopathic Materia Medica and repertory and therapeutic indications, sound expertise and years of experience in the field of regulatory affairs.

Dr. Christoph Buss
Associate Director Regulatory Affairs & Pharmacovigilance
Dr. Dietmar Riße
Senior Consultant
Mag. pharm. Dr. Siegrun Gerlach

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