MARKET SUPERVISION

Compliance with the Requirements of Quality and Safety of Medicines

Medicinal product which does not meet the requirements of technical and regulatory documentation as well as regulatory legal acts, or where previously unknown dangerous properties were detected, are often removed and their circulation in the territory of Ukraine is completely prohibited. In this case, it is possible to carry out the procedure of renewing the circulation of pharmaceutical products, provided that the relevant documentation will be made consistent with the current legislation.

Development and Approval of the Quality Certificate Template for the Manufacturer

Certificate of quality analysis of a pharmaceutical product batch is a document issued by the manufacturer for imported pharmaceutical products certifying conformity of a batch with the requirements of analytical and regulatory documentation or quality control methods established at the time of its registration in Ukraine. Certificate of a pharmaceutical product batch or product must include the summary information in accordance with the requirements to the content. Our recent showing, certificates do not have necessary information, or some information is frequently missing, so we will help to develop a certificate template that will meet all requirements according to the current legislation of Ukraine.

Implementation of Packaging in the Manufacturing Process

Labeling requirements are governed by the current legislation and relevant regulatory legal acts. Information about the pharmaceutical product or any product should be indicated on the label that is applied to packaging, in the supporting documents, etc. Labeling means descriptions, marks for goods and services, graphic images or symbols relating to this product, applied to any packaging, label, sticker, other packaging material. Labeling is the main way to inform the consumer about the product. Thanks to labeling, consumers can learn about the ingredients, indications and usage, manufacturer, expiration date, etc. Labeling shall contain truthful information and not mislead the consumer. Incorrect labeling can cause a number of negative consequences for the manufacturer of the product. Such consequences may include consumer complaints, a temporary ban on the circulation of products, penalties, and compensation for damages in connection with the discovered violations.

Pharmacovigilance

The main function of pharmacovigilance is to improve the treatment and safety of patients when using medications, which is only possible when comprehensive, reliable, high quality and objective information on safety and effectiveness of pharmaceutical products is available. Each applicant, when registering a pharmaceutical product in Ukraine, must implement and maintain a pharmacovigilance system with a quality system in addition to the state pharmacovigilance system, which necessarily ensures that the authorization documentation will be obtained.