Overview

The Spanish pharmaceutical market, despite its modest outset, predicts a consistent demand for medicinal products. Any drug or biological product to be marketed in Spain must be approved by the Spanish Agency of Medicines and Medical Devices (AEMPS). As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:  

• Article 8(3) for New Chemical Entity (NCE) 
• Article 10 for generic, hybrid and similar biological medicinal products  
  • Article 10(1) Generic Application
  • Article 10(3) Hybrid Application
  • Article 10(4) Similar Biological Application
  • Article 10a of Directive 2001/83/EC for well-established use supported by bibliographic literature.
  • Article 10b of Directive 2001/83/EC for new fixed combination of active substances in a medicinal product
  • Article 10c of Directive 2001/83/EC for Informed consent application

Submissions to AEMPS are subject to unique requirements. Applicants having met the centralized regulations of EEA and the European Medicines Agency (EMA) alone, may not suffice, but the Brexit should also be considered while entering the European market. As per the Regulatory guidance, the mutually approved licenses shall be updated for change in Reference Member State (RMS), if UK is the product’s current RMS, change in Market Authorization Holder (MAH) in the EU, batch release and testing sites, changes in the location of Qualified Person (QP), Qualified Person for Pharmacovigilance (QPPV) and PSMF shall be submitted and approved before March 30, 2019.

Freyr’s Regulatory experts assists manufacturers with a clear-cut outline of the specific requirements of AEMPS to market medicinal products in Spain without Regulatory hurdles. In relation with Brexit, Freyr offers a periodic update of EU Regulatory dynamics and provides authoritative intelligence for choosing optimal pathway to act further on compliance.