Registration of medicines

REMEDIA Regulatory Affairs Team, with a history of over 30 years of expertise and experience in the field, provides support for the following activities:

  • authorisation, re-authorisation and post-authorisation; (maintenance through variations, updates of authorization files, etc.), for medicinal products for human use;
  • notification/registration of food supplements, medical devices and cosmetic products;
  • authorizations through national, decentralized (DCP) and mutual recognition (MRP) procedures;
  • intermediation of readability tests for newly registered medicines;
  • submission of documentation to NAMMDR in order to obtain the advertising authorization;
  • claw back and volume cost services;
  • adverse reactions monitoring services in specialized magazines for informing partners;
  • obtaining import authorizations for psychotropic and narcotic drugs;
  • obtaining authorizations for special needs;
  • pharmacovigilance services;
    notification of external partners regarding legislative changes regarding product registration in Romania.