Trend in phytopharmaceuticals: international regulatory extension!

Pharmaceutical companies are increasingly extending the markets for their herbal medicinal products into other EU states, for example using the decentralised procedure (DCP) or mutual recognition procedure (MRP). There is currently particularly high demand for products in the indication areas of women’s health, pain and prevention, and sedation and sleep. No wonder, because the path to new markets is very short – if you are familiar with the regulatory procedures...

Different regulatory routes can be used to bring a new medicinal product to market in a number of EU states. Two of them are particularly suitable for the roll-out of herbal products: the mutual recognition procedure (MRP) and the decentralised procedure (DCP). Both allow marketing authorisations and/or registrations to be achieved in several countries quickly and easily. Where required, both the DCP and MRP can also be extended to further countries at a later stage, by means of a repeat use procedure (RUP).

Short path to market

Both the MRP and DCP involve the central examination and assessment of the dossier by a reference member state (RMS). In the case of the DCP, the applicant determines which country should coordinate the procedure. In the MRP, the coordinating country is determined based on an existing national marketing authorisation or registration. The RMS examines the dossier and passes it and the report on to the concerned member states (CMSs) in which marketing authorisation / registration is sought. The CMSs only have a short period for discussion and statements. The legally defined time limits for the individual stages (see graphic below) make it possible to achieve marketing authorisation in several EU countries in just a few months. The states involved each grant the respective national authorisation.

So check...

Whether an MRP or DCP is the right choice depends on the individual circumstances – for example whether a national marketing authorisation has been granted in an EU state, or if the product is on the HMPC’s EU list (community list).

It is generally possible for any national authority in Europe to take on the role of the RMS. However, we at Diapharm know that certain states take a more formalistic approach, while others are more pragmatic. There are even differences between indication areas, depending on the country’s phytopharmaceutical traditions and the respective authority’s experience with herbal marketing authorisations and registrations.
That makes choosing the right reference member state very important. The regulatory authority in the RMS can, to some extent, help guide the authorities in CMSs through the procedure.

We support clients on their path into European markets. Where required, we conduct feasibility studies for both marketing authorisation procedures, the DCP and MRP, and can compile or update the application dossier accordingly. For clients with registered offices outside the EU, Diapharm can also act as applicant and marketing authorisation holder (MAH). Europe’s OTC markets are attractive – even more so if they are accessed in parallel with limited effort. Contact us!

P.S.: See the Diapharm OTC product list for new product options.

[Translate to English:] Timeline für ein DCP-Verfahren

[Translate to English:] Timeline für ein MRP-Verfahren



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