Requirements to quality

Ukraine is a country with high requirements for the quality of medicinal products. Quality control is performed at the following stages:

• registration: by expert assessment and approval of the Specification and quality control methods (QCM), labeling information, and verification of the compliance of the manufacturing conditions with the GMP requirements;
• import: by quality control of each imported batch;
• circulation: by planned and unplanned inspections of importers, distributors and pharmacies.

The competent state authority in medicinal product quality control is the State Service of Ukraine on Medicines and Drugs Control (SMDC of Ukraine).

Quality control during registration

The Application for registration includes information about the contact person responsible for quality. The materials of the registration dossier include draft national documents “Quality Control Methods” (QCM) and suggested text to be placed on the labeling.

QCM is prepared on the basis of Module 3.2.P. in the Ukrainian language and include:

• composition of the finished medicinal product, including information about API manufacturers;
• specifications on release and shelf-life;
• description of quality control methods;
• description of package and elements thereof;
• storage conditions and shelf life.

The text of labeling is a structured description of the information printed on the primary and secondary packaging.

QCM and text of the labeling undergo expert assessment in the registration process and may be corrected in accordance with the requirements of the legislation of Ukraine. Documents are approved as integral annexes to the marketing authorization.

Also, the Application for registration must be accompanied by the Decision on compliance of the manufacturing conditions with the GMP requirement or a guarantee letter with the statement that such decision shall be submitted before the end of the registration. GMP confirmation is performed by recognition or by inspection.

After the registration (but before importing the medicinal product into Ukraine) the MAH shall develop graphic mock-ups (artworks) of packaging based on the approved text of labeling and submit them for registration in the Unified Automated Electronic System (UAES) of the SMDC of Ukraine.

Quality control during import

Each imported batch of medicinal products is subject to mandatory state quality control (except for API and in-bulk products). The Resolution of the Cabinet of Ministers of Ukraine No. 902 of 14.09.2005 approves the quality control procedure. 

The importer submits the Application for issuance of opinion on the quality of the imported medicinal product and the package of documents and samples to the SMDC of Ukraine at the place of its business. The cargo containing the medicinal products is quarantined for the period of performance of the state control. 

The SMDC of Ukraine performs the expert assessment of the submitted documents and the visual control of samples for each imported batch. The documentation of the imported batch is verified for consistency with the approved marketing authorization and its annexes. Visual control includes verification of the package’s consistency with the approved and registered mock-ups and verification of the text of the instruction for use.

Laboratory quality control is performed in the following cases:

• first import of the medicinal product into Ukraine, except for products manufactured in EU countries, UK, USA, Canada, Switzerland, New Zealand, Australia, Japan and Israel;
• inconsistencies of the imported medicinal product’s package with the mock-ups registered in the UAES of the SMDC;
• packaging damage which may influence the quality;
• violation of storage conditions of the medicinal product during transportation or storage;
• evidence of inconsistencies with the approved control methods (Specification) or evidence of forgery during visual control;
• prohibition of circulation of other batches of medicinal products in Ukraine;
• inconsistency of the list of indicators or requirements thereto in the quality certificate;
• obtaining official information from competent authorities of other countries.

Certificate of Analysis

Each imported batch of medicinal products must be accompanied by the manufacturer’s certificate of analysis (quality). To obtain the opinion on the quality of the batch, a copy of the certificate of analysis and a Ukrainian translation thereof must be submitted.

The certificate of analysis should be consistent with the QCM approved during the registration and the requirements described in Resolution No. 902. Inconsistencies lead to suspension of issuance of the opinion on the quality and require corrective actions.

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).