Access the European Market: The Steps for a Flawless Product Launch

It is not uncommon for organizations to follow a global expansion strategy when commercializing their drug products, i.e., start in their domestic market, then expand to nearby regions before finally launching in international markets. For non-EU companies to expand into Europe, they must apply for the appropriate product, import, and distribution authorizations to get their drug fully commercialized and into these new markets.

There can often be knowledge gaps within the company, and they would need to become more familiar with the EU regulatory landscape and the organizational and QMS requirements to launch in Europe. This webinar will provide an overview of the EU regulatory environment and outline how your organization can navigate this complex system successfully. It will also highlight some key practical steps you can take now to be ready when it comes time to market your product in Europe.

One of the most important things to remember when planning for EU distribution is that it is a complex process and will take time. It cannot be rushed or done without proper planning and preparation. The first step is determining the authorizations needed for your product(s). You may find yourself in this position and have a blockbuster drug or competitive generic, and you feel the time is right to bring it to market in the EU.

There are different authorizations required, and the QMS and organizational structures need to be put in place for each one and an inspection completed by the competent authority in the country of operation.

The authorization types are:

• Manufacturers and Importers Authorisation (MIA) – for the site importing the drug.
• Wholesale Distribution Authorisation (WDA) – For the site and depots distributing the drug in the EU.

Each of these authorizations requires a Pharmaceutical Quality Management system with the personnel, training, and procedures to support each and partner organizations such as third-party logistics providers to warehouse and transport the products. The EU requires that all manufacturers of human medicines have an approved PQMS before they can market their products in the EU.

A competent authority must approve the PQMS as part of an inspection to confirm compliance with EU GMP. While the requirement to have a QMS is universal across all types of pharmaceutical operations, the detail of what that procedure should contain will rarely be identical.

It is important to consider the following when developing your QMS to EU standards:

• What regulatory standard do you need your QMS to deliver operational compliance?
• What Quality Culture do you want our organization to have (top-down or bottom-up)?
• Do you want quality compliance to be policed or embedded in everything you do?
• What resources will you have to manage, implement and embed the QMS into everyday operations?

Once, as a senior management team, you have asked these questions and used them to prepare a quality policy, you can start putting together the various policies and SOPs.

In this 1.5-hour webinar, we will introduce some of the common supply models and the associated Authorisations, partner requirements, organizational structure, and QMS requirements for each one and talk about what it takes to make a scalable, compliant, and sustainable QMS.

Register now and join us on the 25. April 2023 to ensure you are equipped and prepared to manage the quality and regulatory requirements to launch your existing pharmaceutical products in Europe!