Renewal of medicines
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Renewal of medicines in Ukraine

After completion of the procedure of registration of a medical product a registration certificate shall be issued for 5 years.
After expiration of this period for provision of continuous supply of a medical product it is necessary to carry out the procedure of renewal of a medical product.
In some countries a permanent registration certificate is issued after the procedure of renewal

What is the procedure of renewal?

As practice shows, the process of renewal includes the following stages

01

detailed analysis of a dossier and accompanying documents

02

preparation and submission of an application to the regulatory authority (for Ukraine)

03

preparation and submission of a registration form/application and dossier to the regulatory authority

04

supervision of specialised expertise of registration materials, laboratory analysis of sample medical products (depending on the country of registration)

05

inspection of a production site (depending on the country of registration)

06

in case of receipt of positive conclusions of safety and effectiveness of the applied product –deciding on issue of a marketing authorisation

detailed analysis of a dossier and accompanying documents

preparation and submission of an application to the regulatory authority (for Ukraine)

preparation and submission of a registration form/application and dossier to the regulatory authority

supervision of specialised expertise of registration materials, laboratory analysis of sample medical products (depending on the country of registration)

inspection of a production site (depending on the country of registration)

in case of receipt of positive conclusions of safety and effectiveness of the applied product –deciding on issue of a marketing authorisation

MAXIMA HEALTH RESEARCH OFFERS

preliminary consultation and development of a regulatory strategy

professional analysis of a registration dossier

preparation of accompanying documents in the respective form

completeness and execution of a registration dossier for submission

preparation and submission of an application, registration form and dossier

complex follow-up support of the registration procedure, particularly preparation of comment responses and communication with experts of a regulatory authority

complex follow-up support of the procedure of pre-registration quality control of a medical product in an authorised laboratory, particularly import of samples

control over observance of terms on all stages of examination

verification of confirming documents

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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