The production of pharmaceuticals at BIOLIK PHARMA LLC is carried out in compliance with the current legislation of Ukraine and in accordance with the terms of GMP and the requirements of international standards on the basis of the current License.

Licenses of BIOLIK PHARMA LLC b/n for carrying out economic activities for the production of medicines, valid from 13.10.2022 and Annex 1 to the license

The company holds the ISO 9001 Certificate No. UA8O072.43415583.1-2024 for the Quality Management System, which is a globally recognized international quality management standard. ISO 9001 certification ensures that the company can produce products at a stable level of quality and constantly improve it. This minimizes the risk of producing products of inadequate quality and makes quality improvement work the foundation of the production process.

BIOLIK PHARMA LLC holds the Certificate of ISO 13485 No. UA8O072.43415583.4-2024 “Medical devices. Quality management systems. Requirements for regulatory purposes”, is an internationally agreed standard that establishes requirements for a quality management system specific to the medical device industry.

BOLOLLK PHARMA has the Certificate of Conformity No. UA.TR.130.1727-24 8O072.43415583. for the medical device “ALVIL Spray”.

Conformity assessment of medical devices should be understood as a set of procedures for conformity of a certain product to the requirements of the technical regulations of Ukraine, where the conformity assessment procedure and the need to involve the designated body is determined by the class and characteristics of the medical device.

The laboratories of QCI “BIOLIK PHARMA LLC” are certified in accordance with the Order of the Ministry of Health “Procedure for Sectoral Certification of Laboratories for Quality Control and Safety of Medicines” and have a Certificate of the right to conduct quality control and safety of medicines No. 513 in accordance with the Scope of Certification issued by the State Service of Ukraine on Medicines and Drugs Control.

Quality control laboratories in accordance with the Scope of Attestation to Certificate No. 513 are certified to perform almost 80 test methods (including microbiological tests and sterility) of the State Pharmacopoeia of Ukraine, which are also listed in the world’s leading pharmacopoeias: European Pharmacopoeia, British Pharmacopoeia and US Pharmacopeia.

The laboratories of the Quality Control Department of BIOLIK PHARMA LLC are accredited according to DSTU ISO 10012 and have the Certificate of Conformity of the Measurement System No. 01-0041/2022. The requirements of the DSTU ISO 10012 standard establish the scope and scope of the measuring instrument control system. Certification to ISO 10012 ensures that the laboratory has a reliable measurement management system that ensures the accuracy and reliability of the analyzes performed. The requirements of the standard are applied along with the metrological rules and regulations of Ukraine.

BIOLEK PHARMA LLC has implemented the HACCP system for food production based on the requirements of the Law of Ukraine “On Basic Principles and Requirements for Food Safety and Quality”, which guarantees the safety of food products. HACCP methods are part of the ISO 22000 system, which is an international system of control and management of food safety based on which the food industry is certified.

BIOLIK PHARMA LLC has ISO 22000 Certificate No. UA8O072.43415583.5-2024 for the Food Safety Management System.

Each individual capacity of the market operator, including a vehicle used as a capacity for the sale of food products to end consumers, is subject to state registration of food production.

In accordance with the Procedure for State Registration of Facilities, the State Service of Ukraine on Food Safety and Consumer Protection registered the facilities of BIOLIK PHARMA LLC by type of activity:

• other type of primary production (extraction of water from a well and water purification); production of beverages, including: non-alcoholic beverages; production of other food products; wholesale trade in food products; storage of food products (registration number r-UA-63-12-1081)
• transportation of food products (registration number r-UA-20-29-10204)