GDP and import licensing

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GDP and import licensing

Manufacture, import, wholesale and retail sale of medicinal products are subject to licensing in Ukraine. The competent state authority is the State Service of Ukraine on Medicines and Drugs Control (SMDC).

To obtain the license, the importer should comply with the Licensing Conditions requirements approved by the Resolution of the Cabinet of Ministers of Ukraine No. 929 of 30.11.2019, including implementation and maintaining a pharmaceutical quality system should include applicable GMP and GDP elements. The quality system should be documented.

To comply with the requirements, the importer should have:

trained personnel with the necessary qualification;
appropriate premises and areas;
properly maintained equipment;
approved written methodology (SOP) and instructions;
appropriate means for storage and transportation;

The importer should have a Qualified Person (QP). Such an employee should comply with the education and qualification requirements and work on a full-time basis. QP makes sure that every imported batch of medicinal products undergoes quality control in Ukraine and issues authorization for release (sale).

Cratia offers preparation, development of documentation, and obtaining the import license, including:

preliminary physical audit of the warehouse, analysis of the documentation available;
development of the Importer Dossier;
completion of the available documentation or complete development of the pharmaceutical quality management system documentation, including SOP, CRM, instructions, and other documentation;
personnel training, quality management system implementation;
preparation of the Application and documentation, obtaining the Medicine Import License.

Our services

Since 2006 we support the pharmaceutical business in regulatory affairs, pharmacovigilance, and quality. We are a leading regulatory consultant in Ukraine and 11 countries of the CIS region. Our extensive team has the necessary knowledge, experience, and skills and is proficient in English.

We have provided regulatory services for more than 200 manufacturers of medicines, many of which recommend us as a regulatory partner.

We offer:

consultation, development of registration strategy;
establishment of new registration, renewals, and variations;
establishment and maintaining a pharmacovigilance system, outsourcing the functions of the local contact person;
confirmation of manufacturing conditions with GMP requirements through recognition or inspection.

In addition to the main services, we also offer:

translation of the scientific, medical, technical, and legal documentation;
back-office operations: preparation of the registration dossier or any of its parts without submission;
development and pre-printing verification of labeling artworks and instructions for use;
medical writing of parts of the registration dossier;
development of documentation and import licensing;
writing of documentation for inclusion of the medicinal product in the National List (HTA).

We provide preliminary consultations free of charge, call us by phone +38 (068) 064-78-31, +38 (044) 223-61-67, or write to info@cratia.ua, or come to the meeting directly to our office.