Explore the requirements for launching your approved medicinal product and discover how PLG can assist with your company’s upcoming product launch.

How the launch of a medicinal product works in the EU

The launch of medicinal products in the European Economic Area (EEA) is subject to a comprehensive regulatory framework governed by the European Medicines Agency (EMA) and EEA member states’ individual national regulatory authorities.

In the EEA, medicinal products can only be placed on the market after they have been authorized by the European Commission or after national authorization by the competent national authorities.

Individual EEA countries have further national regulatory requirements to be considered before launching the medicinal product on the market.

The requirements for a medicinal product launch in the EU

These are the main requirements to be considered before a launch in EEA countries:

  • Local Representative:

Some countries require the appointment of a local representative. This required representative at the local level could be from the Regulatory, Pharmacovigilance, or Scientific Services area.

  • Labelling and Packaging requirements:

Countries have specific requirements for labeling and packaging, including language, font size, and layout. Blue box requirements have to be taken into account for local packages.

  • Serialization:

Serialization regulation requires contracts with European (EMVO) and National Verification Organizations (NMVO). Compliance with serialization requirements (Unique identifier codes and anti-tampering devices on packaging) must be followed.

  • Compendia:

Countries require product information to be included in national compendia. The maintenance of the product information in national compendia is a regulatory requirement. MAH has to ensure that the format and content of SmPC and PIL comply with the compendia’s specific requirements.

  • Waste Management:

Countries’ regulations regarding the management of pharmaceutical waste need to be followed. Contracts with waste management organizations may need to be signed, and the amount of waste must be reported.

  • National code:

The national code must identify the product to ensure communication between all stakeholders, e.g., regulatory authorities, healthcare professionals, MAH, and pharmacies. The requirements for national code requests are different in EEA countries.

  • Notification of launch date:

Some European countries also require a notification of the national launch date for centralized registered products.

  • Registration in local databases:

In some countries, the MAH has to record information on medicinal products and other information in local databases. Some databases are filled automatically by authorities, others are mandatory, and some must only be filled with information from MAH. Therefore, contracts may need to be signed with national organizations.

  • Wholesale Distribution Authorization (WDA):

MAH, which wants to distribute a medicinal product in the EEA, must have a Wholesale Distribution Authorization (WDA).

The WDA is a regulatory approval that authorizes the wholesale distribution of medicinal products and ensures that medicinal products are stored and distributed in a manner that complies with regulatory standards.

  • Pricing & Reimbursement:

Pricing and Reimbursement systems are different in the EEA countries. The national authorities in EEA countries decide on the price of a medicinal product and the level of reimbursement after the MAH has provided the necessary information. P&R dossier needs to be created and submitted to national competent authorities

  • Educational material:

If additional risk minimization measures (e.g., educational material) are required due to authority requests, national approval of the educational material is necessary before launching the medicinal product on the market.

  • Preparation of promotional material:

Local requirements for promotional material (approval by a representative or national authority) must be followed.

Learn how PLG can support your medicinal product launch in the EU

Pharmaceutical companies seeking to launch a medicinal product in EEA countries have to consider the different national requirements in the EEA countries. Knowledge of the requirements and the duration of the necessary activities in the individual countries influence the launch planning. PLG can support pharmaceutical companies during a medicinal product’s registration and launch phase. Contact us for more information.

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