Regulatory Affairs and Pharmacovigilance

KBM Pharma provides consultation services and support for pharmaceutical industry.

Regulatory Affairs

Regulatory Applications and Maintenance:

  • Preparation and submission of applications for Marketing Authorisation, Renewal and Variation to the Estonian State Agency of Medicines, communication between the State Agency of Medicines and the Applicant
  • Representing the Marketing Authorisation Holder at national level
  • Consulting the Marketing Authorisation Holder regarding local legislation and requirements

Translation and Quality check of Product Information, other medical materials and artworks

  • Preparation/translation/update of Estonian Product Information and other medical materials, quality control of medical translations
  • Review of artworks of product information and Additional risk minimisation materials

Pharmacovigilance support on national level

  • Collecting, translating and reporting pharmacovigilance related information (adverse reactions, quality complaints and other special reportable situations), Pharmacovigilance follow-up
  • Preparation, update and submission of Additional risk minimisation measures
  • Literature search (monitoring medical journals), translation of articles

Support on placing following products on the market: food supplements, medical devices, biocides, food for special medicinal purposes

  • Consulting the Manufacturer or Distributor regarding local legislation and requirements
  • Classification of products
  • Translation of labeling and product information and check of artworks
  • Registration and notification of Authorities about placing products on the market

Review of promotional materials and consulting on local requirements

Preparation of applications for reimbursement

We tailor our services to meet your specific needs and budget.

*We also offer the opportunity for short-term projects (e.g. replacing MAH´s employee during vacation).