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Confirmation of compliance of medicines manufacturing conditions with GMP

According to the current laws of Ukraine, an integral part of the process of registration and provision of import of medicinal products to Ukraine is provision of a document to confirm compliance of the medicines manufacturing conditions with GMP:

Conclusion on recognition of GMP certificates issued by the competent authorities member countries of EU, Great Britain, or the countries having a mutual recognition agreement with EU or Ukraine

or​

Certificate of compliance of medicines manufacturing conditions with GMP.

Issue of conclusions or certificates is made by the central executive authority – State Service of Ukraine on Medicines and Drugs Control (hereinafter referred to as the Derzhliksluzhba of Ukraine) – according to the Procedure of Confirmation of Compliance of Medicines Manufacturing Conditions with the Good Manufacturing Practice, approved by Order of the Ministry of Health of Ukraine of 27.12.2012 No. 1130 (hereinafter referred to as the Procedure) and developed in consideration of the requirements of Directive 2001/83/EC of the European Parliament.

Confirmation of compliance of medicines manufacturing conditions to the GMP in force in Ukraine is introduced in order to prove that medicinal products are always manufactured and controlled according to the quality standards meeting their intended purpose, and according to the requirements of a registration dossier, dossier of the investigational medicinal product for clinical trials or specification for this product.

What is the procedure?

Confirmation of compliance of medicines manufacturing conditions with GMP for residents and non-residents is made by the State Service of Ukraine on Medicinal Products by:

expertise of the documents submitted according to the Procedure

inspection of manufacture (in case of receipt of a Certificate)

The period for confirmation of compliance of medicines manufacturing conditions with GMP by recognition of GMP certificates issued by the competent authorities the member countries of EU, Great Britain or the countries having a Mutual Recognition Agreement with EU or Ukraine is on average 30-45 working days.

The period of the procedure of confirmation of compliance of the manufacturing conditions of medicines prescribed for preventive treatment, diagnostics and treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncological and rare diseases, for medicinal products registered in Ukraine according to a simplified procedure of registration according to the Ukrainian law of Medicinal Products, for medicinal products entered into the treatment guidelines of Ukraine in case of official declaration by the WHO of a disease pandemics and extraordinary situation in the sphere of world health care, for medicinal products registered according to the centralised procedure of the European Medicines Agency (EMA), and for medicinal products that underwent the procedure of pre-qualification by the WHO and out on the list of the WHO of pre-qualified medicinal products is 20 working days.

The period of the procedure of confirmation of compliance of medicines manufacturing conditions with GMP by inspection of manufacture with involvement of third authorised organisations is on average about 3-5 months.

The main stages of the procedure of confirmation of compliance of medicines manufacturing conditions with GMP are:

submission to the State Service of Ukraine for Medicinal Products of a relevant application and a set of documents

carrying out specialised expertise of submitted documents

inspection of a production site (where necessary)

checking of a project and obtaining of an Conclusion/Certificate

MAXIMA HEALTH RESEARCH OFFERS

preliminary consultation and development of a regulatory strategy

professional analysis of the regulatory documents required for obtaining of an Conclusion /Certificate

preparation of accompanying documents in the respective form

completeness and execution of a dossier for submission

preparation and submission of an application to the State Service of Ukraine for Medicinal Products together with a dossier

complex follow-up support of the procedure of all stages of it, including with preparation of comment responses and communication with experts

control over observance of the terms of examination

checking of a draft of Conclusion

organisation of inspection of a production site (where necessary)

Result-oriented high-quality service!

MAXIMA Health Research with long-term experience in registration and post-registration support of different kinds and types of products has profound knowledge of requirements of the current laws and offers you to carry out any required regulatory procedures qualitatively and quickly, and most importantly according to the current laws and strategy of the company.

Our company successfully provides services for regulatory activity to pharmaceutical and FMCG companies, so we are ready to answer any of your questions.

Regulatory Intelligence in Life Sciences

Contact information​

The office of MAXIMA Health Research is located in the office center of Delta Medicalat the address:
st. Chornovola, 43, Vyshneve, Kyiv region, 08132, Ukraine

tel.: +38 (044) 593-38-86
tel.: +38 (044) 593-33-55
fax: (044) 593-33-54

Copyright 2020 Maxima Health Research. All rights reserved. 

Regulatory Intelligence in Life Sciences

Contact information​

The office of MAXIMA Health Research is located in the office center of Delta Medicalat the address:
st. Chornovola, 43, Vyshneve, Kyiv region, 08132, Ukraine

tel.: +38 (044) 593-38-86
tel.: +38 (044) 593-33-55
fax: (044) 593-33-54

Copyright 2020 Maxima Health Research. All rights reserved. 

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