GMP requirements

Since 2002, Ukraine has introduced control of the compliance of manufacturing conditions of medicines with GMP (Good Manufacturing Practice) standards, which is carried out during marketing authorization (renewal of marketing authorization, variations to marketing authorization) and at the stage of quality control during import.

In 2011, Ukraine became a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international instrument in the field of medicines quality control for compliance with the uniform Good Manufacturing Practice (GMP) standards.

The State Service of Ukraine on Medicines and Drugs Control (SMDC) is the competent authority confirming compliance of manufacturing conditions of medicines with GMP standards.

In 2013, the Order of the Ministry of Health of Ukraine No. 1130 came into force and regulated the procedure for confirming compliance of manufacturing conditions with GMP. The SMDC issues the decision on compliance with GMP in two routes:

• recognition of the GMP certificate of the reference country or
• positive results of the Ukrainian inspection.

Until mid-2020, the GMP certificates of the PIC/S participating countries were recognized in Ukraine, however, from July 21, 2020 the list of countries was significantly reduced. This list currently includes 35 countries:

• 27 EU member states Austria, Belgium, Bulgaria, Greece, Denmark, Estonia, Ireland, Spain, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Hungary, Finland, France, Croatia, Czech Republic, Sweden;
• United Kingdom;
• Countries having a Mutual Recognition Agreement (MRA) with the EU: USA, Canada, Switzerland, New Zealand, Australia, Japan;
• countries having an ACAA agreement with the EU: Israel.

GMP certificates issued by the competent authorities of these 35 states can be “recognized” in Ukraine through a simplified and accelerated procedure. However, this procedure is not unconditional: to obtain a Decision on Recognition, it is necessary to fill in a set of documents, submit it to the SMDC, follow the expert assessment, and, if necessary, respond to deficiencies. 

For manufacturers that do not have a GMP certificate issued by the competent authority of one of the 35 mentioned countries, the decision on GMP compliance is issued based on the results of Ukrainian inspection.

GMP recognition

SMDC performs recognition of a GMP certificate based on the expert assessment of the submitted Application and a set of documents. The procedure does not require an inspection of the manufacturing site.

The SMDC may involve expert organizations in expert assessment; charges of such organizations are the responsibility of the MAH.

Documentation is submitted in paper form with translation into Ukrainian and includes:

1. Application.
2. Certificate of quality of manufactured products.
3. Certificate on the results of inspections of the manufacturing site by the competent authorities.
4. Product list.
5. Copies of marketing authorisation decisions issued in Ukraine, CPP or marketing authorisation decisions issued in other countries.
6. Printout from the EudraGMP website or a legalised copy of the GMP certificate.
7. Printout from the EudraGMP website or a legalised copy of the manufacturing authorisation.
8. GMP certificates and manufacturing authorizations for all intermediate manufacturing sites.
9. A copy of the Site Master File, except for manufacturers whose manufacturing facilities are located in the territory of an EU member state, United Kingdom, or a country that has a mutual recognition agreement with the EU or Ukraine).
10. A copy of the report of the last inspection carried out by the competent authority of the country whose GMP certificate is recognised.

If at least one stage of the manufacture of a medicinal product is carried out not in the countries to which the recognition procedure applies, a copy of the marketing authorization from one of the 35 countries indicated above must be submitted in the set of documents with GMP Application. If a medicinal product is not authorized, then the manufacture of these medicines is inspected for compliance with GMP requirements.

The expert evaluation period should not exceed 15 working days from the date of submission of the Application; however, this period does not include the time required to sign the Agreement and pay for expert charges (if an expert organization was involved), the period of specialized expert evaluation (up to 20 working days) and the time required to respond to comments (up to 30 business days).

The fast-track assessment with the period of not more than 5 working days is performed for:

• medicinal products intended for the prevention, diagnosis and treatment of tuberculosis, HIV/AIDS, viral hepatitis, cancers and rare (orphan) diseases, for medicines that are being authorized in Ukraine under a simplified marketing authorization procedure, for medicines included in the treatment protocols of Ukraine in the case of the official recognition of the disease by WHO as a pandemic and public health emergency of international concern;
• for medicinal products authorized under the centralized EMA procedure (European Medicines Agency) and medicines that have undergone the WHO requalification procedure and are included in the WHO list.

The decision on recognition is issued for the validity period of the reference (to be recognized) GMP certificate, but not more than 3 years. For renewal, it is required to submit a full set of documents and perform an expert assessment. 

The validity of the decision can be extended up to 6 months to avoid a gap between the expiration of the decision on recognition and the issuance of a new one.

The list of medicinal products authorized or submitted for marketing authorization makes an integral part of the decision. Adding products or changing the list is carried out by submitting a notification to the SMDC.

GMP inspection

Issuance of a decision on compliance of medicines manufacture with GMP standards is carried out based on the submitted Application and the package of documents to the SMDC and the inspection of the manufacturing sites.

Documentation is submitted in paper form with translation into Ukrainian and includes:

1. Application.
2. Certificate of quality of manufactured products.
3. Certificate on the results of inspections of the manufacturing site by the competent authorities.
4. Product list.
5. Copies of marketing authorization decisions issued in Ukraine, CPP or marketing authorization decisions issued in other countries.
6. A copy of the Site Master File with all attachments.
7. Printout from the EudraGMP website or a legalized copy of the GMP certificate.
8. Printout from the EudraGMP website or a legalized copy of the manufacturing authorization.
9. GMP certificates and manufacturing authorizations for all intermediate manufacturing sites.

The decision on compliance (GMP certificate) is issued for a period of up to 3 years. After this period, the procedure is repeated.

The list of medicinal products authorized or submitted for marketing authorization forms an integral annex to the Certificate. Adding products or changing the list is carried out by submitting a notification to the SMDC.

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).