Wholesale
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
Registration of medicines, medical devices, food supplements for special medical purposes
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
Notification/registration of food supplements and foods for special medical purposes
Registration of medical devices in the electronic registry of medical devices maintained by the BDA
- 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)
All steps related to changes in the circumstances of a registered price and the removal of products listed in the PDL
General reimbursement policy
Optimization of reimbursement status
Representation before the National Health Insurance Fund (NHIF)
Маркетинг, реклама и промоции на лекарства и медицински изделия
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)
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
Координати
Адрес офис: ул. “Българска легия” №28, офис 1,
Manastirski livadi, Sofia 1618
Адрес склад и адрес за кореспонденция:
ул. “Българска легия” №28, офис 1,
Manastirski livadi, Sofia 1618
GPS координати:
Latitude: 42.660669 | Longitude: 23.276642