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
Renewal of medicines
Renewal of medicines in Ukraine
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
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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.