GMP certificate

Confirmation of production conditions compliance with GMP requirements, GMP certificate obtaining, medication pattern approval in the Medicines, Healthcare Products and Drug Control Regulatory Agency of Ukraine.

The procedure of working conditions affirmation according to the demands of Good Manufacturing Practice (GMP).

Terms: 1,5 - 2,5 months. These terms include a primary expertize, a specialized examination, taking a decision of handing out a resolution of working conditions affirmation according to the demands of Good Manufacturing Practice (GMP) and it’s signing.

Documents preparation and procedure’s structure:

  • receiving documents from a manufacturer , preparing documents for submission;
  • Confirmation of production conditions compliance with GMP requirements, GMP certificate obtaining, medication pattern approval in the Medicines, Healthcare Products and Drug Control Regulatory Agency of Ukraine.
  • submission of the documents to the State Service of Ukraine on medicinaproducts and narcotics control;
  • primary expertise;
  • specialized examination;
  • decision-making of the determination;
  • conclusion and it’s appendix assignment to the representative of the projects’ relator;
  • conclusion and appendix project approvaand their proceeding for signing.

The procedure of receiving a certificate of accordance to the demands of Good Manufacturing Practice (GMP).

Terms: 1,5 - 2,5 months. These terms include primary and specialized expertise, the inspection of the manufacture, generation of reports about the results of the inspection, taking a decision of handing out a certificate of accordance to the demands of Good Manufacturing Practice (GMP) by an appointing authority;

Preparation of the documents and procedure structure:

  • receiving documents from a manufacturer, their preparation for submission;
  • submission of the documents to the State Service of Ukraine on medicinaproducts and narcotics control;
  • primary expertise;
  • specialized examination;
  • the dates of the inspection coordination;
  • making up a programm and a record of the inspection;
  • the inspection of the manufacture with the experts presence on a manufacturing site;
  • making a report on the inspection results ;
  • the inspection results discussion and taking a decision about the certification;
  • certificate and it’s appendix assignment to the representative of the projects’ relator;
  • certificate and appendix project approvaand their proceeding for signing.