Pharmaceutical company "Darnytsia"
General Information
Identification Code: 019584652887-54
Website: [object Object]
Entity Form: PRIVATE JOINT STOCK COMPANY
Registration Category: Companies & groups
Registration Date: 2/15/2024
EP Accredited Number: 0
Mission & Interests
Goals: Pharmaceutical company "Darnytsia" aims to advance public health by researching, producing, and distributing high-quality medicines in Ukraine and beyond. Our goal is to address critical medical needs, particularly in cardiology, neurology, and pain management, through innovative pharmaceutical solutions. We are committed to adhering to the highest standards of quality, compliance, and sustainability in all aspects of our operations.
Interests Represented: Promotes their own interests or the collective interests of their members
Interests:
- Competition
- Public health
- Trade
Levels of Interest:
- european
- sub-national
- global
- national
Activities
Main EU Legislative Proposals: Pharmaceutical company "Darnytsia" is actively engaged in advocating for regulatory harmonization between the European Union (EU) and Ukraine in the pharmaceutical sector. Our main legislative proposals and policies targeted towards the EU include:
Harmonization of EU Law with Ukrainian Legislation: We advocate for the alignment of Ukrainian pharmaceutical regulations with EU standards to facilitate trade and ensure the quality and safety of medicines in both markets. This includes promoting the adoption of EU directives and regulations related to pharmaceutical manufacturing, distribution, and quality control.
Creation of a New Controlling Body: We support the establishment of a dedicated regulatory authority or controlling body in Ukraine modeled after EU agencies such as the European Medicines Agency (EMA). This body would oversee the approval, regulation, and monitoring of pharmaceutical products to ensure compliance with international standards and promote public health.
Mutual Recognition of GMP Certificates with the EU: We propose the mutual recognition of Good Manufacturing Practice (GMP) certificates between Ukraine and the EU. This would streamline the process for Ukrainian pharmaceutical companies to obtain EU GMP certification, facilitating access to the European market and promoting cross-border trade in pharmaceutical products.
Alignment with EU Pharmacovigilance and Clinical Trial Regulations: We advocate for Ukraine to align its pharmacovigilance and clinical trial regulations with EU requirements. This includes enhancing transparency, safety monitoring, and reporting of adverse drug reactions, as well as adopting standardized protocols for conducting clinical trials in line with EU guidelines.
Inter-institutional or Unofficial Groupings: N/A
Head Office
Address: 13 Boryspilska St.
Post Code: 02093
City: Kyiv
Country: UKRAINE
Phone: [object Object]
EU Office
Address: 13 Boryspilska St.
Post Code: 02093
City: Kyiv
Country: UKRAINE
Phone: [object Object]
Financial Data
New Organisation: false
Closed Year: [object Object]
Current Year: [object Object]
Membership Information
Members10 Percent: 0
Members25 Percent: 0
Members50 Percent: 0
Members75 Percent: 3
Members: 3
Members F T E: 2.25
Structure
Structure Type: Structure
Is Member Of: n/a
Organisation Members: Union of Ukrainian Entrepreneurs, European Business Association, London Chamber of Commerce and Industry