Ukraine is a country with high-level demands to the quality of medicinal products. In order to prevent the circulation of falsified, substandard and unregistered medicinal products, the mechanism of state quality control operates in Ukraine.
The concept of "quality management" in Ukraine implies the following:
- assignment of a contact person in Ukraine responsible for handling claims for defective products;
- receipt of a Conclusion or a Certificate of Compliance of the manufacturing of medicinal products with GMP requirements, performing routine actions for maintenance such Conclusion or Certificate;
- registration and updating of the layouts of primary and secondary packaging of medicinal products in the Unified Automated Information System (UAIS) of the State Service of Ukraine on Medicines and Drugs Control (SMDC);
- control of the implementation of the requirements of the national legislation to the certificates of analysis (certificates of quality) that accompany each batch of imported medicinal products, the alignment of English and Ukrainian information in the certificates of quality (analysis) of the batch;
- checking the identity of information in all regulatory documents that may have an impact on the quality of the medicinal product:
- registration certificate,
- methods of quality control,
- instructions for the medical use of medicinal products,
- original layouts,
- Conclusion on recognition / GMP certificate,
- certificate of quality (certificate of analysis);
- interaction with the competent authorities for quality control of medicinal products when conducting incoming quality control at importation;
- activities with complaints about quality.
The applicant has the right to refer any issues related to quality management to the third party under the agreement.
Recognition / certification of compliance of manufacturing to GMP requirements
Since 2011 Ukraine is a member-country of PIC/S (https://www.picscheme.org/), an international instrument for interaction between countries and competent authorities in the field of quality control of medicinal products (national pharmaceutical inspectorates), which collectively provide an active and constructive cooperation on compliance with the requirements of good manufacturing practices (GMP) by inspecting and licensing the manufacturing conditions.
The conclusion on the recognition (or certificate) of compliance with GMP requirements is required during the state registration of medicinal products, and also the copy thereof is submitted each time while receiving a conclusion regarding the quality of the imported batch.
Procedure of confirmation of the compliance of manufacturing of medicinal products with GMP requirements is conducted by one of two ways:
- either by recognizing the GMP certificate issued by a competent authority of a PIC/S member-country;
- or by inspecting the manufacturing conditions by Ukrainian inspectorate.
Recognition of the GMP certificate is carried out by the State Service of Ukraine on Medicines and Drugs Control (SMDC) with the examination of the documentation and does not require inspection of the manufacturing site. Recognition is only applicable to those manufacturers who already have the GMP certificate issued by a competent authority of a PIC/S member-country (https://www.picscheme.org/en/members). Certificates issued by the WHO or other authorities or organizations that are not members of the PIC/S cannot be the object of recognition.
The procedure for recognition is not an unconditional and requires the preparation and submission of an Application and a package of documentation, passing through procedure of expert evaluation and receiving a conclusion of Recognition. The duration of the GMP certificate recognition procedure is approximately 30–45 working days.
The decision is issued for the validity period of the GMP certificate, which has been recognized.
Issuance of certificates of compliance with the requirements of GMP is also carried out by the SMDC, but a specialized assessment of documentation and inspection can be transferred to the third authorized organizations. The submission of the Application for the issuance of the Certificate involves the preparation and submission of a package of documents, the signing of a contract, the coordination of the program and inspection plan, the payment of expert activities of the competent authority, the conduct of the inspection (usually by two inspectors), the preparation of the report, the issuance of the GMP Compliance Certificate, the settlement of the CAPA.
The duration of the procedure for confirming the compliance of the conditions for the manufacturing of medicinal products with GMP requirements by issuing a certificate is approximately 3 to 5 months (including the evaluation of the documentation by the SMDC, third authorized organizations, inspection, preparation of the report and the Certificate).
The Ukrainian GMP certificate is issued for a period of 3 years from the date of the inspection.
Development and registration of layouts in the Unified Automated Information System (UAIS) of the State Service of Ukraine on Medicines and Drugs Control (SMDC)
When carrying out the state quality control, according to the legislation, the appearance of the group packaging, external (secondary) and internal (primary) packaging are checked for integrity, damage, compliance with the graphic representation of packages, and the availability of approved instructions for use.
For carrying out such a check, at the time of importation of the medicinal product, graphic representations of the primary and secondary packaging are submitted by the Applicant for registration to the Unified Automated Information System (UAIS) of the State Service of Ukraine on Medicines and Drugs Control (SMDC).
Graphical layouts of primary and secondary packaging are compiled on the basis of the approved labeling text (addendum to the registration certificate), made up and issued in accordance with the requirements of Ukrainian legislation.
The formatted layouts that are submitted for registration should include:
- approved text;
- graphical representation about exact location of the text and other packaging elements;
- size and form of the layouts;
- graphical representation and/or description of protective elements;
- designation of printing inks that will be used in manufacturing;
- Braille inscriptions and their location (if applicable);
- location of technical elements;
- other additional information (if necessary).
During incoming quality control (at the import stage), the strict conformity of the package of the medicinal product to the registered layouts in the UAIS SMDC is checked. Even the most insignificant deviations (font type, text flow, size and location of elements, difference in color, technical symbols, etc.) lead to observations, suspension of issuing conclusions about quality and the need for corrective actions.
Subsequently, the Applicant may make changes to the graphic representations of the layouts (provided that the text remains unchanged), for which it is necessary to submit them for registration again.
Certificate of quality (analysis) for a batch
Each imported batch of medicinal products must be accompanied by a certificate of quality (analysis) issued by the manufacturer. In order to obtain a conclusion on the quality of the imported medicinal product, in addition to other documents, it is necessary to submit a copy of the certificate of quality issued by the manufacturer for each batch of medicinal product and its translation.
Ukrainian legislation describes the national requirements for the content of the certificate of quality for batch of medicinal products. Deviations in the form of presentation of information are allowed in the event that they do not change its essence.
Therefore, the quality certificate must comply with:
- requirements of the Ukrainian legislation;
- approved registration certificate, including the Specification in the approved QCM (quality control methods);
- issued Conclusion or Certificate of Compliance of manufacturing of medicinal products with the GMP requirements.
At the stage of import (receiving a conclusion on the quality of the batch), the certificate of quality and its translation are tested for compliance with the legislation and approved documents.
Any deviation leads to observations, suspension of issuing conclusions about quality and the need for corrective actions.
Removal of observations on quality
Observations may occur during importation of a batch of medicinal products and receiving a conclusion on quality, for example:
- discrepancy between the actual package and the registered layouts (location of elements, font and its size, technical symbols, etc.);
- discrepancy between the text of the printed instruction and the approved one;
- discrepancy of the font sizes on the package or the sizes of fonts and line spacing in the instruction with the requirements of the legislation;
- discrepancy of the medicinal product with the requirements of methods of quality control based on visual inspection results;
- lack of information or error in the certificate of quality or its translation (for example, the inconsistency of the list of methods in the certificate to the approved quality control methods);
- errors or discrepancies between the Conclusion on the recognition of the GMP certificate, the registration certificate, the QCM, the certificate of quality;
- suspicion of violation of the storage and transportation temperature conditions, etc.
Such observations may lead to the need to prepare answers to them, take measures to remove the inconsistencies, and carry out laboratory quality control of samples to confirm the compliance of the batch. Such actions require the excellent knowledge and understanding of the national legislation, experience and qualifications.
Services and activities of Cratia:
For more than 12 years our company professionally performs the activities related to registration, safety and quality management of medicinal products in Ukraine. Depending on your needs, we are ready to offer both a full range of activities to fulfill all the regulatory requirements, or any of the listed services:
- assignment (outsourcing) of a contact person in Ukraine, responsible for handling claims for defective products;
- receipt of a Conclusion or Certificate of Compliance of the manufacturing of medicinal products to the requirements of GMP;
- performing routine actions for maintenance of the Conclusion or Certificate of Compliance of the manufacturing of medicinal products to the requirements of GMP;
- registration and update of the layouts of primary and secondary packaging of medicinal products in the UAIS SMDC;
- checking the compliance with the requirements of the national legislation to the certificates of quality, the translation of the certificates of quality of batch;
- interaction with the competent authorities for quality control of medicinal products when conducting quality control at importation;
- activities with complaints about quality.