The EU Affiliate landscape... A complex web

ProductLife Group (PLG) is a leading regulatory and scientific solutions provider for the life sciences industry, with over 25 years of experience helping pharmaceutical, biotech, and medical device companies navigate the complex regulatory landscape. PLG offers a comprehensive suite of services to support pharmaceutical companies, from regulatory affairs and pharmacovigilance to clinical development and medical writing and has a truly global presence.

From the outside, the European Union (EU) and European Economic Area (EEA) can appear like a harmonized community guided by common Directives and Legislation. However, peel back the surface and it can become a complex space. With national interpretation of legislation and localized requirements creating a divergence between different countries and many Local Health Authorities with their own specific guidance, it can become a minefield of requirements!

Consider the registration of a new Marketing Authorization Application (MAA), as a Marketing Authorization Holder has many different registration routes available and how these map to the commercial goals of the company all need to be considered;

1. Centralized Procedure: This procedure results in a single marketing authorization (MA) granted by the European Commission (EC). The MA allows a medicine to be marketed in all EEA (European Economic Area) countries (EU member states and the three EEA EFTA States: Iceland, Liechtenstein, and Norway).
2. MRP/DCP: a registration resulting in MAs granted in more than one EEA-MS (MRP must start with an initial national registration adding to the timing and complexity).
3. National Procedure: a registration resulting in a single MA valid for a country/EEA-MS (and the pre-cursor for the MRP )

On top of this, those other countries, such as the UK and Switzerland, are equally important to a Company’s commercial strategy and must also be considered in the overall RA strategy. The plot can quickly thicken! Behind this are somewhat ‘hidden elements’, activities and items that are required ‘behind the scenes’, those national nuances and affiliate activities that must be understood and run in parallel to support Regulatory activities and guarantee market success. Activities such as;

• Identified Local Representatives.
• Local Health authority notifications, e.g. for launch, changes in marketing status, discontinuations, supply chain issues etc.
• Promotional/non-promotional material review and compliance against national requirements, including Educational materials.
• Specific Labelling, Blue Box, national codes and Shared pack requirements
• Serialization requirements.
• Local Database completion and upload.

PLG has more than 70 Regulatory Experts positioned in markets across the EU and EEA, with expert knowledge of these local nuances and specifics. They are expertly positioned to guide clients and customers through this complex web to ensure that all local requirements are understood and met.