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Europe – Regulatory Affairs

The European Union is a unique economic and political union between 27 EU countries that together cover much of the continent. It is the largest trade block in the world. It is the world’s biggest exporter of manufactured goods and services, and the biggest import market for over 100 countries. Free trade among its members was one of the EU’s founding principles. This is possible thanks to the single market, which enables most goods, services, money, and people to move freely. The pharmaceutical market in the EU is the second biggest one in the world and the harmonized regulations across the Member States of the EU facilitates market entry into the whole region.


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Pharma/Prescription Drugs

Consumer Healthcare Drugs/OTC Drugs

Medical Devices

Food Supplements/Nutraceuticals

Cosmetics & Derma


Our Services & experience

We have more than 20 years of experience in Europe, we would gladly guide you through the maze of the regulatory affairs with our local network. We will also make sure that the whole registration process of your product in Europe is very clear to you.

We do not have a standard approach to regulatory affairs, but rather tailor our services to the expectations and needs of our clients.

Some examples: 
1. A very detailed yet easy to understand flow chart with thepharma/prescription drug registration process in Mexico
2. A full overview of Medical Devices registration timeline and costs in Mexico

1. Europe Registration Process – Tips & Tricks
2. Europe Registration Process – Fast Track Time & Cost

European Commission

The regulatory body in Europe responsible for the registrations is mainly the European Commission. Click here to go to the official website of the European Commission

Contact us to get answers to all your individual product and situation questions!


Pharma/Prescription Drugs

Overview

All pharma products must be authorised at national or EU level before launch on the EU market. The EC has established the European Medicines Agency (EMA) to support in this process by coordinating the scientific evaluation of the quality, safety, and efficacy of medicinal products undergoing an authorisation procedure.

Below we have listed the questions that our clients usually have regarding Pharma drug registrations in Europe:

  • Can my home company act as a MAH in Europe?
  • If I register a pharma product in one Member State, can I sell it in any country in Europe?
  • What is the difference between the four?
    • Centralised procedures (CP)
    • Mutual recognition procedures (MRP)
    • Decentralised procedures (DCP)
    • National marketing authorisation procedures
  • What are the pharma/prescription drug registration costs and registration time in Europe? 
  • How and where do I receive European GMP for my production plant?

Contact us about your questions on your Pharma and medicine registration in Europe!


Consumer Healthcare Drugs/OTC

Overview

Europe is the second biggest pharmaceutical market in the world. It accounts for around 20% of the entire global pharmaceutical market. With changing demographics and consumers being more focused on wellness and prevention, the European region is attractive for pharmaceutical companies with innovative products that can bring value to the patients. In addition, the harmonization of the European regulations facilitates the registration of products across all Member States of the European Union.

Please see below the questions that our clients usually have on the Consumer Healthcare & OTC drugs registration process in Europe:

  • Should I consider registering my OTC drug as a Herbal Remedy?
  • What are the Consumer Healthcare Drugs/OTC registration costs and registration time in Europe? 
  • Can my home company act as a MAH in Europe?
  • If I register a pharma product in one Member State, can I sell it in any country in Europe?
  • What is the difference between the four and what is the best option for my product?
    • Centralized procedures (CP)
    • Mutual recognition procedures (MRP)
    • Decentralized procedures (DCP)
    • National marketing authorization procedures
  • How and where do I receive European GMP for my production plant?
  • How to organize an Rx to OTC switch?
  • What are the regulations and limitations of online selling and pharmacy vs. drugstore?

Contact us to learn more about Consumer Healthcare Drug/OTC registration in Europe!


Medical Devices

Overview

Europe is one of the three largest markets for medical devices in the world and is very attractive for companies with innovative and effective products that can compete in this dynamic segment. The medical devices market is tightly regulated in Europe by laws that ensure the safety and performance of these products. In the near future, the current law will transition to two new ones, which will be a big change to all companies in the sector.

The questions that our clients usually ask about Medical Device Registration in Europe:

  • How is product classified regarding the European Medical Devices Regulations vs. other countries?
  • Are local clinical trials necessary in Europe?
  • What are the Medical Devices registration costs and registration time in Europe? 
  • Do I have to address my dossier to a Notified Body first?
  • What changes are coming up with the new European Medical Device law?
  • How to apply for reimbursement process for my Medical Device product?
  • What claims am I allowed to use and how to understand the limitations?

Contact us to learn more about Medical Devices registration in Europe!


Food Supplements/Nutraceuticals

Overview

The European Directive on food supplements provides a list of the minerals and vitamins that can be used in food supplements, and the sources from which they can be derived. The European Food Safety Authority (EFSA) provides scientific advice on the risks associated with foodstuff. Moreover, there is a specific regulation on the nutrition and health claims that can be used.

The questions that our clients usually ask about the Food Supplement registration in Europe:

  • How to register claims for Food Supplements in Europe?
  • What are the restrictions regarding the quantities of minerals and vitamins in Europe?
  • What if one of my product ingredients is not considered a food supplement in Europe?
  • When a food supplement does becomes a drug? Borderline products.
  • What are the specific labeling and packaging rules for food supplements in Europe?
  • Which licenses are required for launching and setting food supplements in Europe?

Contact us to learn more about Food Supplements/Nutraceuticals registration in Europe!


Cosmetics & Derma

Overview

Europe is the largest cosmetics market in the world. The growth of standard cosmetic products has slowed down, however innovative concepts and products showing good growth in Europe. The size of the European market represents an attractive opportunity for international companies with innovative products. In addition, the harmonized regulations across the Member States of the EU facilitates market entry into the whole region.

In general, the cosmetic product registration in Europe is well structured, however many exceptions on a local country level can be found.

The questions that our clients usually ask us about cosmetic and derma registrations in Europe are the following:

  • How to register claims for Cosmetics in Europe?
  • What are the restrictions regarding the quantities of different ingredients, e.g. Urea % content?
  • What are the special requirements for Cosmetics containing nanomaterials?
  • When a cosmetic does becomes a derma drug? Borderline products.
  • What are the specific labeling and packaging rules for cosmetics in Europe?
  • Which licenses are required for launching and setting cosmetics in Europe?

Contact us to learn more about Cosmetics registration in Europe!