GMP

In Ukraine, certification of compliance with Good Manufacturing Practice (GMP) requirements for the production conditions of medicinal products is mandatory to ensure the quality and safety of medicines. This procedure is regulated by the Order of the Ministry of Health of Ukraine dated December 27, 2012, No. 1130, “On Approval of the Procedure for Confirming Compliance of Medicinal Product Production Conditions with Good Manufacturing Practice Requirements.”

For Ukrainian manufacturers:

Submission of the application: The manufacturer submits a standardized application to the State Service of Ukraine for Medicines and Drug Control (State Drug Control Service) for the issuance of a GMP certificate.

Required documents:

A guarantee letter confirming the absence of significant changes in the production area.
A certificate of the results of inspections of the production area conducted by state control authorities.

Inspection: The State Drug Control Service conducts an inspection of the production area for compliance with GMP requirements.

Issuance of the certificate: In case of positive inspection results, a GMP certificate is issued with a validity period of three years.

For foreign manufacturers:

Submission of the application: A foreign manufacturer or its representative submits an application to the State Drug Control Service for the issuance of a GMP certificate.

Required documents:

A copy of the valid GMP certificate issued by the competent authority of the manufacturing country.
The dossier of the production area.
Other documents required by the legislation.

Recognition or inspection:

If the manufacturer has a GMP certificate issued by a competent authority of an EU member state or a country that has a mutual recognition agreement with the EU or Ukraine, the State Drug Control Service may recognize this certificate without conducting an inspection.
In other cases, an inspection of the production area is conducted.

Issuance of the certificate: After a positive assessment or inspection, a GMP certificate is issued with a validity period of up to three years.

More detailed information and sample documents can be found on the official website of the State Drug Control Service of Ukraine.

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GMP

For Ukrainian manufacturers:

Submission of the application: The manufacturer submits a standardized application to the State Service of Ukraine for Medicines and Drug Control (State Drug Control Service) for the issuance of a GMP certificate.

Required documents:

Inspection: The State Drug Control Service conducts an inspection of the production area for compliance with GMP requirements.

Issuance of the certificate: In case of positive inspection results, a GMP certificate is issued with a validity period of three years.

For foreign manufacturers:

Submission of the application: A foreign manufacturer or its representative submits an application to the State Drug Control Service for the issuance of a GMP certificate.

Required documents:

Recognition or inspection:

Issuance of the certificate: After a positive assessment or inspection, a GMP certificate is issued with a validity period of up to three years.

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