EN

cart
Menu
Client area
Log out
Client area
Log in
Menu

Events and news

Blog
Home > Blog > Regulatory Affairs

Accessing the European Pharma Market: becoming a MAH through dossier acquisition.

Accessing the European Pharma Market: becoming a MAH through dossier acquisition.

European Pharma Market

Positioned as the second largest pharmaceutical market in the world and showing a steady and extensive growth pattern, Europe’s pharma market is becoming increasingly attractive, but accessing this market implies both regulatory and technical requirements, so different strategies need to be considered to ensure cost-effectiveness.

One of the options available for companies seeking to capitalize on EU business opportunities is becoming a MAH through the purchasing of a dossier or multiple dossiers of products manufactured in EU facilities.

Accessing the European Pharma Market

It is a must to audit and to ensure that the dossiers already comply with European regulation and after the acquisition, a non-EU company can obtain European MAH status which allows to market medicinal products in one or more EU member states. In terms of manufacturing, the company can transfer the processes of the different products acquired to their own facilities outside Europe by obtaining the European GMP certificate.

Other strategies are also possible to access the European market and can be implemented on an individual basis or alongside each other, depending on the clients needs.

 

At Azierta, we provide global support for accessing the European Pharma Market to Non-European companies. We are experts in Regulatory Affairs, Compliance and EU Requirements Related Services.

For further information, please visit our website European Market Access Support Services, do not hesitate to contact us in case of any doubt.

 

Back

Related posts

Biotechnology: Incentives of the Advanced Medicinal Products...

What are Advanced Therapies? Advanced-therapy medicines are medicines that are made from genes and cells. They may offer...

Read more

Accessing the EU Market: Becoming a suitable CMO for Europe...

In recent years, the volume of generic drug sales has been increasing rapidly in Europe, whereas the outsourcing of branded...

Read more

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

We are at your complete disposal for any inquiry

Thank you for getting in touch! We will contact you as soon as possible to help you out
There has been an error while submitting your form, please try again, or call us at 912 77 10 76
Schedule appointment

Schedule a video call with our field experts

schedule
We use "cookies" to improve your experience on our site. Cookies enable us to tailor messages and display ads to your interests. They also help us understand how our site is being used. By continuing to use our site you consent to use our cookies.