The Nordic region, renowned for its world-class healthcare, presents unique opportunities and challenges for pharmaceutical companies. Understanding the Nordic pharmaceutical landscape is crucial for the successful launch of your product. This blog outlines key considerations for launching a new pharmaceutical product in the Nordics, helping you navigate the markets of Sweden, Norway, Denmark, Finland, and Iceland. By considering the following information, you can increase the likelihood of a successful launch and secure positive market approval and reimbursement decisions from each of the Nordic health authorities.
Understanding the Nordic Markets
Even though the Nordic region consists of five countries, each with its own regulations and healthcare systems, some launch strategies are similar, such as common EEA regulations and regulatory guidelines. However, other aspects, like national regulatory requirements, pricing, reimbursement, and distribution, are subject to local rules that vary from one country to another. Companies must ensure compliance with both EU-wide directives and country-specific regulations. Failure to do so can result in delays, financial penalties, and even market withdrawal.
Key Considerations for a Successful Launch
Engaging early with experts in regulatory, market access, pharmacovigilance, and quality compliance can help identify specific requirements.
The following key points can be considered for a successful pharmaceutical product launch in the Nordic markets:
Regulatory Compliance
To optimize the market entry, it is important to be familiar with the local requirements and necessary timelines. A regulatory launch strategy is, therefore, crucial for planning a smooth launch, navigating the local-specific complexities and ensuring compliance.
To achieve a successful launch and meet the target date, the strategy should include the following activities, taking the necessary timelines into consideration:
- Local artwork requirements and review for printing.
- Registration with local verification serialization organizations.
- Information regarding accesses and necessary data entry into local regulatory databases.
- Accesses, requirements and procedure for uploading product information into local catalogues.
- In case of planned marketing campaigns, it is essential to ensure that any promotional materials adhere to local regulations and ethical standards.
- Other local specific requirements e.g., pharmaceutical insurance.
Quality Assurance
Launching a pharmaceutical product is a complex and highly regulated process that demands comprehensive and robust Quality Assurance (QA) support at every stage. The QA launch strategy is to guarantee that the product not only meets the highest standards of safety and efficacy but also adheres strictly to all applicable regulatory requirements.
To ensure a successful launch and meet the designated timeline, the strategy should incorporate the following QA activities:
- Implementing a robust, localized Quality Management System (QMS) that aligns with the specific regulatory requirements of the Nordic countries.
- Obtain a Wholesale and Distribution Authorization (WDA) and identify a suitable responsible person.
- Execution of Recall, Complaints & Deviation Management
- Fulfillment of app and personnel qualification for all local staff, ensuring that all staff are qualified and competent to carry out their responsibilities.
- Audits and Inspections: Conducting audits and qualifying suppliers and vendors to ensure compliance with local regulatory requirements.
- Serialization Support, ensuring the products meet regulatory requirements in traceability.
Market access
Reimbursement is a critical function of a drug's development and go-to-market strategy. Reimbursement ensures that patients can afford the drug, which is essential for market access. Without reimbursement in the Nordic markets, even the most effective drugs might not reach the patients who need them the most.
To ensure optimal pricing and reimbursement, and to enable the successful delivery of your product, the following is recommended:
- Proposition of the product’s value – this includes product positioning and landscape assessment.
- Development of a business case and/or value dossier.
- Local reimbursement application.
- Formulation of a price strategy and health economic modelling.
Market Dynamics
Understand the unique market dynamics of each country. For instance, Sweden offers greater opportunities for innovation and competition, while smaller markets like Iceland face challenges in achieving volumes and competitive sales.
Healthcare System Variations
Recognize the differences in healthcare systems. While all Nordic countries have tax-funded systems with universal coverage, the funding and regulations are more decentralized in Sweden, Norway, and Denmark compared to Finland.
Pharmacovigilance support in the Nordics
In the Nordic countries, there are several pharmacovigilance obligations that must be considered when medicines are introduced to the market, such as:
Medical information
Ensure a robust system is in place to receive and respond to medical enquiries from healthcare professionals, patients, and pharmacies.
This system should include:
- A clearly communicated point of contact.
- Personnel with sufficient experience and relevant language capabilities.
- An understanding of local cultures, laws, regulations, and best practices related to medical information inquiries, adverse event reporting, and product complaint handling.
Our Experts Are Here to Help
ProPharma can support with all the above key considerations to ensure a successful launch in the Nordic countries. As a unique partner, ProPharma provide a full range of services and apply a cross-functional approach. These local affiliate services are also provided across Europe, delivered by ProPharma's local experts who possess a deep understanding of both EU and local regulations. By offering end-to-end support, ProPharma helps clients ensure their products meet all necessary requirements throughout the product lifecycle.
For more information on how ProPharma can assist in with your needs across the Nordic market, contact us today.
