Wholesale of medicines
  • NOVUS TRADING EOOD holds a license for wholesale trade in medicines in the territory of Bulgaria and the European Union and GDP. WL_drugs
Wholesale of medical devices
  • NOVUS TRADING EOOD holds a license for wholesale trade in medical products in the territory of Bulgaria and the European Union and GDP.
Търговия на едро с хранителни добавки, храни със специално медицинско предназначение
  • NOVUS TRADING EOOD holds a license for wholesale trade in food supplements in the territory of Bulgaria and the European Union and GDP.
Регистрация на лекарства, медицински изделия, хранителни добавки, храни със специално мед. предназначение
  • All steps in the procedures for medicinal product registration: Centralized Procedures (CP), Mutual Recognition Procedures (MRP), Decentralized Procedures (DCP), National Procedures (NP)
  • All steps in variations to the marketing authorization – Type I and Type II for all types of registration
  • Transfer of Marketing Authorization Holder (MAH) rights
  • Conversion from non-CTD format to CTD (Common Technical Document) registration format
  • Conversion from CTD format to e-CTD format
  • Translation of the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and packaging (from English and French into Bulgarian)
  • Preparation of mock-ups for medicinal product packaging (in compliance with national requirements of the Bulgarian Drug Agency – BDA)
  • Labeling
  • Preparation of Braille labeling on the packaging (accompanied by a Certificate from the Union of the Blind in Bulgaria)
  • Readability testing of the Patient Information Leaflet, according to the National Registration Procedure
  • Approval of educational materials for healthcare professionals and patients before the BDA (including their distribution)
  • Local contact person for Mutual Recognition Procedures
  • Representation before the Bulgarian Drug Agency (BDA)
  • Market launch of medical devices (notification or registration with the BDA, labeling, and preparation of user information)
  • Obtaining a CE mark certificate through the BDA
  • Registration of medical devices in the electronic registry of medical devices maintained by the BDA
  • Notification/registration of food supplements and foods for special medical purposes
Price registration of medicine devices
  • All steps in the price registration of a medicinal product and its maintenance before the National Council on Prices and Reimbursement of Medicinal Products (NCPRMP) (maximum price or price for inclusion in the Positive Drug List – PDL)
  • All steps related to changes in the circumstances of a registered medicinal product price and its deregistration
  • Consultations regarding overall pricing policy
  • Reference pricing of medicinal products within the European Economic Area (EEA)
  • Submission of 6-/12-month declarations for medicinal product prices to the NCPRMP
Reimbursement of medicine and medical devices
  • All steps related to the inclusion of medicines in the Positive Drug List (PDL)
  • Всички стъпки от промяна на обстоятелства и заличаването на регистрирани в ПЛС продукти
  • General reimbursement policy
  • Optimization of reimbursement status
  • Representation before the National Health Insurance Fund (NHIF)
Marketing, promotions of medicine and medical devices
  • All stages of marketing – strategy, budgeting, research, advisory boards
  • Promotions of medicine and medical devices
Advertising of medicinal products and medical devices
  • Development of a complete advertising strategy (targeted at healthcare professionals or the general population)
  • Budgeting
  • PR and media campaigns
  • Representation before the Bulgarian Drug Agency (BDA) regarding advertising approvals and notifications for medicinal products
Clinical research

Pre-registration studies

  • Transparent budgeting from the submission of registration documents to the product's market launch
  • Market principles, market trends
  • Market volume (based on IMS Health data)
  • Competition
  • Pricing policy (proposals for successful price positioning)

Post-registration studies

  • Competition
  • Pricing policy (proposals for successful price positioning)
  • Market trends (based on IMS Health data)
Drug safety
  • Consultation on building a comprehensive pharmacovigilance system for the Marketing Authorization Holder (MAH)
  • Expert reports
  • Submission of Periodic Safety Update Reports (PSURs) and changes in their submission cycle
  • Contracted QPPV (Qualified Person for Pharmacovigilance), deputy QPPV (including electronic submission of AE/SAE via EV-web)
  • Auditing of pharmacovigilance systems
  • Local contact person for pharmacovigilance before the Bulgarian Drug Agency (BDA)
Representation before Bulgarian institutions
      • Representation before the Ministry of Health, National Health Insurance Fund (NHIF), and National Council on Prices and Reimbursement of Medicinal Products (NCPRMP) (negotiations, direct agreements, etc.)
      • Representation before hospitals regarding tender procedures
      • Representation before Bulgarian industry organizations
Other
      • Full process of publishing medical periodicals
      • Full process of organizing medical events
      • Translation of specialized medical literature by doctors/pharmacists
      • Consulting throughout the entire process of obtaining a wholesale license for medicinal products and medical devices