Entering the EU pharmaceutical market requires careful planning across several interconnected steps. Companies must select an appropriate EU marketing authorisation route, establish a European Marketing Authorisation Holder (MAH), fulfil ongoing pharmacovigilance obligations, build GMP- and GDP-compliant manufacturing and distribution, and prepare for country-specific pricing, reimbursement and health technology assessment (HTA) decisions.
This blog outlines the core steps companies should consider when moving from regulatory approval to sustainable commercialisation in Europe.
What needs to be done before the EU marketing authorisation process begins?
The European Economic Area (EEA) consists of the Member States of the European Union (EU) together with three countries of the European Free Trade Association (EFTA) (Iceland, Liechtenstein and Norway; excluding Switzerland). The European Medicines Agency (EMA) collaborates closely with the human and veterinary medicines regulatory authorities of the EU Member states and EEA.
In the EU, a medicinal product must have a marketing authorisation before it can be placed on the market. Before applying for marketing authorisation, companies must establish a legal entity in the EEA to act as the Marketing Authorisation Holder. The MAH is the company or legal entity authorised to market a medicinal product in one, several or all EU Member States and holds overall responsibility for maintaining the authorisation throughout the product lifecycle.
Which EU marketing authorisation pathway is right for the product?
Several marketing authorisation procedures are available within the EU, each suited to different product types and market strategies:
- National procedure: Used when marketing authorisation is sought in a single EU Member State. If a medicinal product has not previously been authorised in any EU country, Norway or Iceland, the application is submitted to the national competent authority of the target country for evaluation.
- Mutual recognition procedure (MRP): Applied when a product already holds a national marketing authorisation in one EU Member State. Other Member States recognise the existing authorisation based on the assessment performed by the Reference Member State (RMS).
- Decentralised procedure (DCP): Used when a product has not yet been authorised in any EU Member State. Applications are submitted simultaneously to several countries, leading to national authorisations granted at approximately the same time. One Member State acts as the Reference Member State, whose assessment is reviewed by the concerned Member States.
- Centralised procedure (CP):Applications are submitted to EMA, which coordinates the scientific evaluation. Following a positive opinion, the European Commission grants a single marketing authorisation valid across all EU Member States as well as Iceland, Liechtenstein and Norway. The centralised procedure is mandatory for certain categories of medicines, such as new biotechnological medicines and other innovative medicinal products.
For more information on the different procedures and dossier components and submission, read our other blog post on how to obtain a marketing authorisation in the EU
How to build a GMP- and GDP-compliant supply chain for the EU/EEA?
Commercialising medicinal products in the EU/EEA is not achieved through marketing authorisation alone. Pharmaceutical companies must operate a fully compliant framework covering GMP-controlled manufacturing and GDP-compliant distribution. Regulatory obligations apply across the entire supply chain, and compliance must be demonstrable at every operational step.
Critical elements include:
- Good Manufacturing Practice (GMP) compliance: To ensure high standards of quality management throughout the development, manufacture, and control of medicinal products, the principles and guidelines of EudraLex Volume 4 – Good Manufacturing Practice must be followed.
- Batch release: A named Qualified Person (QP) must certify each batch before it can be released for sale or supply in the EU/EEA in accordance with EudraLex Volume 4, Annex 16: Certification by a Qualified Person and Batch Release.
- Manufacturing Import Authorisation (MIA): Mandatory for the importation of medicinal products (human, investigational and veterinary) from outside the EU/EEA (EudraLex Volume 4, Annex 21: Importation of medicinal products).
- Good Distribution Practice (GDP) compliance: To ensure that medicines and active substances are authorised under EU legislation and handled, stored, and transported under appropriate conditions throughout the supply chain. It also requires traceability and effective recall systems for all authorised distributors and importers.
- Licensed distribution partners (third-party Logistics, 3PL): Entities performing wholesale distribution activities of medicinal products in the EU/EEA must hold a Wholesale Distribution Authorisation (WDA) and operate in compliance with EU Good Distribution Practice (GDP). The applicability of authorisation requirements is determined by the nature of the distribution activities performed, and all actors involved in the distribution chain are subject to relevant GDP obligations.
A clear understanding of the entire manufacturing, import and distribution chain, from GMP‑compliant production to GDP‑controlled distribution, is essential for regulatory compliance in the EU/EEA. This end‑to‑end oversight is particularly critical when medicinal products are imported from outside the EU/EEA, where Manufacturing Import Authorisation requirements apply and distribution activities must be performed by appropriately licensed partners under defined GDP obligations.
How do pricing and reimbursement decisions affect market access in Europe?
Even after regulatory approval, a medicinal product’s commercial success in Europe depends largely on pricing and reimbursement decisions, which are influenced by health technology assessment (HTA). The HTA summarises and evaluates research evidence on benefits, harms, costs and cost-effectiveness of medicinal products compared to other treatment options.
While marketing authorisation can be obtained through harmonised EU procedures, pricing, reimbursement, and patient access are decided nationally following evaluation by HTA bodies. Each country determines independently whether a medicine will be reimbursed, at what price, and under which conditions, resulting in differences in access timelines across Europe.
As Europe consists of multiple national markets, early planning and a clear market access strategy are essential to support timely and effective commercialisation.
Together, these topics show that entering the EU/EEA pharmaceutical market is a long-term process rather than a single regulatory step. Bringing a medicinal product to the EU/EEA market depends on a series of regulatory and national decisions.
If internal resources or specific expertise are limited, Medfiles’ highly qualified team can support companies throughout the process. By working with Medfiles, companies gain access to customised services tailored to their specific needs. We can support the entire marketing authorisation application process (DCP/MRP/CP/NP) in any EU country, from registration strategy to marketing authorisation.
Global pharma company & Medfiles: Cooperation in obtaining and maintaining marketing authorisations in the EU
“Medfiles has been a valuable partner for us during the registration and maintenance of products in Europe. They consistently provide prompt and accurate responses whenever there are inquiries or concerns related to European approvals.”
This is how a client from outside the EU, who has been working with Medfiles for 7 years, describes the partnership. The company initiated cooperation with Medfiles when they required assistance in entering the European market. The cooperation has involved applying for new marketing authorisations as well as managing products post-approval.
