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Medis, the first company in Europe to develop an over-the-counter medicinal product containing essential oil and authorise it under a European registration procedure

The pharmaceutical company Medis was the first in Europe to obtain the authorisation of a medicinal product with rosemary essential oil as the active ingredient under one of the European marketing authorisation procedures simultaneously in 10 European countries. 

The new Rosacta product, intended for effective muscle and joint pain relief, is expected to be available in Slovenia in early 2017.

The entire authorisation procedure for Rosacta was presented as a model of good practice at this year’s International Phytopharmaka Symposium in Bonn, attended by the most important international drug registration experts. For Medis, this was a recognition of excellence and we are sincerely proud of this accomplishment. 

In the European Union, a medicinal product can be authorised at national level by authorisation procedures of individual Member States, or under a standard, centralised procedure at EU level. The latter is generally more difficult as all Member States influence the procedure simultaneously. Since 2012, the process is more complex; the procedures certifying the quality, effectiveness and safety of medicinal products containing essential oil as an active ingredient, have become more comprehensive and lengthy. At all stages of medicinal product manufacture – from cultivation of herbs to extraction of essential oils or other ingredients – and of course in the manufacture of the finished product, meeting extremely high standards is required. This ensures the highest possible level of safety and quality of treatment. Despite the complexity, Medis opted for the centralised European authorisation procedure and completed it with excellence.

»With the development and registration of the new medicinal product, Medis has gained vital knowledge in this segment. Although this is the company’s first own medicinal product, registered under the international procedure, the representative of the European Medicines Agency recognised and presented the authorisation of this medicinal product as an example of good practice

The company invests significantly in the development of medicinal products and medical devices. We liaise with a number of research institutions and development companies in this field and strive to contribute to the breakthrough of innovative projects from the research phase to the phase of manufacture and marketing of finished products that are competitive on the global market. This project also involved the company, Entrapharm and one research institution. The project was to a lesser extent financed from European funds. Due to the fact that smaller companies cannot afford to invest in financially demanding projects for the development of new drugs, it is European funds that facilitate finished products from Slovenian development projects to become available to customers around the world,« said Mateja Štempelj, Director of the Research and Development sector.

»Rosacta is bringing a new, natural approach to pain management, enabling patients to treat pain directly on the location of its origin. The active ingredient in our medical product is integrated in the ointment so that it is rapidly and evenly absorbed into the painful area, alleviating pain with its dual action: it exerts anti-inflammatory effects and also increases blood circulation in the affected area. Anyone with joint or muscle pain, including athletes who experience pain due to excessive exercise or localised injury, will now be able to alleviate pain in a natural way. 

Rosemary oil is an excellent remedy against pain caused by gout and rheumatism, stiff joints and pulled muscles. Medis managed to integrate essential rosemary oil with an innovative technology into the final pharmaceutical formulation which, as the first and only one, has proven the efficacy and safety of the management of this type of pain, which is a remarkable success. Otherwise, rosemary (Rosmarinus officinalis L.) has been hailed since ancient times for its medicinal properties,« explains Martina Brank, Director of Pharmaceuticals at Medis.

The Managing Director of Medis, Tone Strnad, on this occasion said: »I am impressed with how much knowledge and enthusiasm has been brought to Medis with the new generation of associates and how courageous they are! In the past, Medis has already developed, in cooperation with other manufacturers, one generic medicinal product (Aglurab) with our own dossier. However, this time we have accomplished a special breakthrough: this is the first European authorisation of a medicinal product of this kind. This alone is a great achievement. With our own idea, our own dossier and predominantly our own technology we were the first to develop a medicinal product which will be available over the counter, without prescription in pharmacies in ten European countries. This is our second achievement. The third, and in my opinion the greatest achievement is that we dared to tackle this at all!«

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