“Lotysh & Partners” Law Firm assists pharmaceutical companies in auditing their existing business, identifying legal risks and providing recommendations for their elimination. We are also ready to support our clients at the stage of starting a business project or comprehensively support activities on a subscription basis. Our advantage is practical experience in this area of business and the presence of successful cases in servicing national and foreign companies in the field of pharmaceuticals.
What do we offer pharmaceutical companies?
- Consultations on the practical application of legislation in the field of pharmacy, quality control and safety of medicines, price regulation, accreditation of pharmacy institutions, pharmacovigilance and other aspects related to the circulation of medicines.
- Due Diligence of pharmaceutical companies and investment projects, including verification of compliance with anti-corruption and antitrust laws.
- Creation of pharmaceutical companies: pharmacies, pharmacy warehouses, registration of representative offices of foreign pharmaceutical companies.
- Obtaining licenses for the production, import and export, wholesale and retail trade in medicines, including a legal audit of compliance with license conditions.
- Subscription legal services for pharmaceutical companies: comprehensive support for domestic and international investment projects, distributors, wholesale and retail pharmacies, as well as establishments selling cosmetics and dietary products.
- Legal support of representative offices of foreign pharmaceutical companies (i.e. non-residents): preparation of employment contracts with the director and staff, obtaining work permits for foreign citizens, protecting the interests of the parent company in court, contractual work with contractors, etc.
- Preparation of contracts for the sale of medicines, foreign economic supply contracts.
- Representation of interests of pharmaceutical companies in relations with regulatory authorities (in particular, support of license checks) and in court.
Obtaining a license to sell medicines
The licensing authority in this case is the State Service of Ukraine for Medicines and Drug Control.
The general licensing algorithm involves the following steps:
- an appeal to the State Service of Ukraine for Medicines and Drug Control with an application (filled in the form) and the necessary information:
- material and technical base;
- availability of employees with the necessary qualifications;
- field of activity (services) of the company.
- obtaining a decision on issuing a license – such a decision is made public on the website of the State Service for Medicines; information about the decisions made is entered in the appropriate license register (later, at any time, you can check the status of the license in the register).
- payment (state duty) for the license – this must be done within ten days from the date of publication of the decision on the website of the State Service for Drugs.
The team of “Lotysh & Partners” Law Firm has the professional legal skills necessary to solve the complex problems of pharmaceutical companies.
Cooperation with our company is a guarantee of reliability and legal security of business in the field of pharmacy.