Are you looking to market pharmaceutical products in Europe? It’s important to understand the basic licensing requirements in order to do so.
This article will give an introduction to the European Union (EU) legislation and explain what licensing is required for pharmaceutical companies to market their products in the European Union.
Marketing pharmaceutical products in Europe is a complex process. The EU’s medicines regulatory system is one-of-a-kind because it coordinates a network of more than 30 regulatory bodies from the 28 EU members, Iceland, Liechtenstein, Norway, the European Medicines Agency (EMA), and the European Commission (EC).
To provide Europeans with high-quality, safe, and effective medicines, they must be authorized before they are available to patients. That permit is known as marketing authorization or product license. The EU has multiple pathways for obtaining that authorization.
One of the possible pathways in all EU member states.
The other pathway is to submit, as is the centralized procedure, where the company submits the application to the EMA. Then, depending on the scientific assessment results, EMA recommends (or not) the EC to grant marketing authorization application to a single Member State. In this case, the competent national authority is responsible for assessing the application. If granted, the marketing authorization is valid just in that Member State.
Irrespective of the authorization route, the rules and requirements in the EU are the same.
No matter where they are based, all manufacturers who wish to supply medicines to the European Union must adhere to European Good Manufacturing Practices (GMP) and licensing requirements. To ensure that companies comply with these regulations, inspections are regularly conducted by a competent national authority of the EU on manufacturers of medicinal products.
Here are the basic licensing requirements to market in Europe:
1) Comply with the European GMP guidelines, which include the following elements:
a) A comprehensive Pharmaceutical Quality Management System.
b) Qualified personnel in current GMP and procedures.
c) Equipment appropriate for the operations carried out.
d) A documentation system that establishes and records all the operations.
e) A production operation that follows defined procedures.
f) A Quality Control department that tests the quality of the product and the used materials.
g) A supplier management system.
h) A system and procedures in place to record, assess, investigate, and review complaints.
i) A self-inspection system.
2) The outer packaging, the direct packaging, and the instruction leaflet must have the necessary information required by the responsible authority of the Member State.
3) Every batch of medication imported from foreign countries must undergo a full qualitative and quantitative analysis of all active substances, as well as any other tests or inspections necessary to verify its quality and meet the standards of the marketing authorization.
4) Pharmacovigilance systems should be established by the marketing authorization holder to monitor the safe use of medicinal products continuously. These systems must be equivalent to the ones put in place by the Member States.
By understanding and complying with these requirements, pharmaceutical companies can successfully market products in Europe and ensure that European patients have access to high-quality, safe, and effective medicines.
To help you navigate the complex European regulatory environment, Qualistery is hosting a webinar titled “Access the European Market: The Steps for a Flawless Product Launch” on April 25th!
During the webinar, a regulatory expert, Charley Maxwell, will provide an overview of the EU regulatory environment and outline how your organization can successfully navigate the system. You’ll also learn about key practical steps you can take now to prepare for marketing your product in Europe.
Don’t miss this opportunity to learn more about European licensing requirements for marketing pharmaceutical products!
