Wholesale of drugs
  • NOVUS TRADING PLC holds a licence for wholesale of drugs on the territory of Bulgaria and the European Union and GDP.
Wholesale of medical devices
  • NOVUS PLC holds a licence for wholesale of medical devices on the territory of Bulgaria and the European Union
Registration of drugs and medical devices
  • All steps of the registration procedures of drugs: Certralised procedures (CP), Mutual recognition procedures (MRP), Decentralised procedures (DCP), National procedures (NP)
  • All steps in variations – type I and type II of all types of registrations
  • Transfer of MAH rights
  • Conversion of non-CTD format into CTD drug registration format
  • Conversion of CTD format into e-CTD format
  • Translation of Summary of product characteristics, Patient information leaflet, packages, (from English and French into Bulgarian)
  • Drug packages mock-up preparation (in accordance with the national requirements of BDA)
  • Labeling
  • Preparation of Brail signs on packages (accompanied by a Certificate from the Union of the Blind in Bulgaria)
  • Readability test of the Patient information leaflet in accordance with the National registration procedure
  • Approval of educational materials for medical specialists and patients before BDA (incl. their distribution)
  • Local contact person for Mutual recognition procedures
  • Representation before the Bulgarian Drug Agency (BDA)
  • Launch of medical devices on the market (announcement or registration before BDA, labeling and preparation of patient information)
  • Obtaining a CE marking certificate via BDA
  • Registration of medical devices in the electronic register of medical devices with BDA
Registration of drug price
  • All steps in the registration of a medicinal product price and its maintenance before the National Council on prices and reimbursement of medicinal products (NCPRMP)  (Maximum price or price for the Annexes of the Positive Drug List)
  • All steps in drug price variations and deregistration
  • General price policy consultation
  • Referencing drug prices in the European Economic Space
  • Submission of 6/12-month declarations about drug prices before NCPRMP
Reimbursement of drugs and medical devices
  • All steps in the inclusion of drugs in the Positive Drug List
  • All steps in variations and deregistration from the Positive Drug List
  • General reimbursement policy
  • Optimisation of the reimbursement status
  • Representation before the National Health Fund
Marketing, promotions of drugs and medical devices
  • All marketing stages – strategy, budget, researches, Advisory board
  • Promotions of drugs and medical devices
Advertising of drugs and medical devices
  • Development of an overall advertising strategy (aimed at specialists/aimed at the population)
  • Budgeting
  • PR and media campaigns
  • Representation before the Bulgarian Drug Agency with respect to approval and announcement of a medical device advertisement
Drug related researches

Pre-registration researches

  • A transparent budget from the submission of the registration documents to the launch of the drug on the market
  • Market principles, market trends
  • Market volume (based on IMS Health data)
  • Competitors
  • Price policy (suggestions for successful price positioning)

Post-registration researches

  • Competitors
  • Price policy (suggestions for successful price positioning)
  • Market trends (based on IMS Health data)
Drug related patent rights
  • Full patent status of drugs (expert reports)
  • Patent representation – claims and trade mark registration
  • Consultations with respect to Supplementary Patent Protection (SPC)
  • Representation before the Bulgarian Patent Office (BPO)
Drug safety
  • Consultation in reference to the development of a complete drug safety system for MAHs
  • Expert reports
  • Submission of Periodic safety update reports (PSUR)
  • Hired QPPV, deputy QPPV (including electronic submission of AE/SAE through ew-web)
  • Audit of drug safety systems
  • Local contact person for drug safety before the Bulgarian Drug Agency
Representation before Bulgarian authorities
  • Representation before the Ministry of Health, National Health Fund, the National council on prices and reimbursement of medicinal products (negotiations, direct negotiations etc)
  • Representation before hospitals with respect to tender procedures
  • Representation before Bulgarian branch organisations
Others
  • The full process of publishing medical periodicals
  • The full process of organising medical events
  • Translation of specialised medical literature by doctors/pharmacists
  • Consultation on the full process of licence acquisition for wholesale of drugs and medical devices