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
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- 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
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Other
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- 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
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