21 Apr Extended EudraVigilance Medicinal Product Dictionary
All pharmaceutical companies with registered products for human use within Europe faced a hugely significant challenge: adaptation of his work to new regulatory requirements. The new EU Pharmacovigilance legislation illustrates this problematic.
The legal framework of Pharmacovigilance for the drugs marketed within the EU is covered under the EU Directive 2001/83/EC and the Regulation (EC) No 726/2004.
The European Medicines Agency (EMA) launched EudraVigilance in 2001 in order to reporting an evaluating suspected drug reactions during the development and post marketing authorization approval of medicinal products for human use in Europe. To ensure accurate updated information, EMA develop constantly new legislation.
In 2012, it became mandatory for Marketing Authorization Holders (MAHs) which maintain products in the European Union, whether centralized, decentralized, Mutual recognition or national to provide detailed structure data within 15 days for all human medicinal authorized products to Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).
The latest changes in the Pharmacovigilance regulation issued on January 31, 2014 with the legal notice on the implementation of article 57(2) of Regulation (EC) No. 726/2004.
MAHs shall electronically notify to the Agency information or any amendments to the terms of the marketing authorizations following variation, transfer, renewal, suspension, revocation or withdrawal no later than 30 calendar days from the date of which the amendments have been authorized. Moreover, more information on medicinal products authorized for human use has to be provided to the Agency. EMA will update tools accordingly.
This new legislation has a huge impact on the strategy of Regulatory Information Management (RIM) use in pharmaceutical company. Many industries have chosen to implement a single, company-wide product license database that support xEVMPD containing both Regulatory and Pharmacovigilance data (example of RIM systems: Samarin RMS®, Liquent inSight®). It brings benefits in terms of visibility of the product portfolio, key timelines and resource planning (cross-department task).
Facing this new regulation, all size of pharmaceutical organization is facing a significant business challenge to improve their compliance. Further enhancement is planned for 2016 with new ISO format named IDMP (International Standards on Identification of Medicinal Product), which implies a new submission format for regulatory data.
Caroline is helping our customers in their xEVMPD data compliance activities by coordinating external data entry activities