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.  

Freyr Expertise 

  • Initial submissions (MAAs) via various procedures- National, Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) and Centralized Procedure (CP) for innovator, hybrid and generic products 
  • Regulatory consultation and strategic support on submission roadmaps, and procedures 
  • Pre-submission administrative activities such as interaction with Health Authorities (HAs), slot booking for submissions, selection of the RMS and CMS, request to HA to work as RMS 
  • Evaluation of the product and source data from R&D and manufacturing site (executed data) for the Spain and EU-specific Regulatory and submission requirements 
  • Compilation and submission of the dossiers to HAs in eCTD format in line with Spanish Agency of Medicines and Medical Devices (AEMPS) requirements 
  • Consultation during developments and manufacturing of the medicinal products 
  • Initial submissions for APIs - ASMF/ CEP submissions  
  • Qualified Person (QP), Qualified Person for Pharmacovigilance (QPPV) in Spain
  • Evaluation of change controls, preparation of submission strategy, preparation and submission of variation package to Health Authorities
  • Impact analysis of Brexit and submission of the relevant changes to HA(s) like- change in Reference Member State (RMS), changes to MAH, addition/ replacement of the batch release and testing sites, changes to the QP, QPPV and Pharmacovigilance system master file (PSMF) (Article 57 notification) 
  • Life cycle maintenance by submission of renewal applications 
  • Support in handling AEMPS’ deficiencies with Regulatory strategy and preparation and submission of the response