European Union – 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.
Regulatory Body - EMA
The regulatory body in Europe responsible for the registrations is mainly the European Medicines Agency (EMA)
Pharma Prescription Drugs
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.
Consumer Healthcare Drugs/OTC
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.
Medical Devices
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. On May 5th 2017, new regulations for Medical Devices (MDR) came into effect in the European Union. First of all, there will be only 18 organizations recognised as Notified bodies that would be qualified to certify the different classes of Medical Devices. In order to register a product in any country of Europe, it would be necessary to have an EU Medical Device registration and for this, a notified body among those recognised by the European Commission.
Food Supplements/Nutraceuticals
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 food. Moreover, there is a specific regulation on the nutrition and health claims that can be used.
Cosmetics and Derma
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.
Photo by Christian Lue on Unsplash
Frequently Asked Questions from Clients – Regulatory Affairs
- FAQ - Prescription Products
- FAQ - OTC Products
- FAQ - Medical Devices
- FAQ - FS and Neutraceuticals
- FAQ - Cosmetics and Derma
- 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?
- 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?
- 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?
- 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?
- 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 labelling and packaging rules for cosmetics in Europe?
- Which licenses are required for launching and setting cosmetics in Europe?