What is the National Procedure(NP)?

The National Procedure (NP) is a pathway used to obtain marketing authorization (MA) for products that do not fall under the centralized procedure or were authorized before the European Medicines Agency (EMA) was established. In this procedure, the competent authorities of respective EU Member States are responsible for reviewing the MA applications made by pharmaceutical companies. Each EU Member State has its own national procedure. Despite streamlined registration options like the Centralized and Decentralized Procedures for multiple member states, the NP route retains its significance for various reasons.

The National Route is beneficial for companies wanting to launch their products in a single market. This allows them to test the market before diving into broader regulatory processes like Mutual Recognition. This process offers a focused approach, suitable for a targeted market entry strategy without having to deal with the complexities of the European market.

National Procedure Timelines

Most Competent Authorities review and grant the MA within 210 days, however, these timelines may vary depending on the Member States. Indeed, even though EU Regulations and Directives provide a general framework, individual member states have their own submission requirements. Due to the variety of regulatory practices, it is essential to have a thorough understanding of local regulations and to work in collaboration with regulatory professionals who are knowledgeable about particular member states.

Pharmaceutical companies using the National Procedure to request market authorization can take advantage of the full range of services offered by regulatory specialists. These include management of the whole National Procedure, communication with Competent Authorities, local requirements dossier preparation, translation services, and support for supply chain management, pricing, reimbursement, and post-approval activities.

DDReg’s Capabilities

Authoring, compilation, and review of MAAs for submission to competent authorities of EU Member States

Preparing responses to agency queries

Preparing responses to agency queries

QPPV support for EEA region

Marketing Authorization Holder (MAH) services for EEA region

Developing robust regulatory strategy for products through centralized procedure

Post approval lifecycle management including variations, change controls, renewals for MAA

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