+38 044 332-42-94,
+38 044 221-71-29,
Medicines: human drugs and biologics
— Market requirements for medicines
— Establishment of new registration
— Variations (changes)
— Renewal of registration
— Inspection of manufacturing site
— Pharmacological vigilance
— State registry of medicines
— Ukrainian legislation
— Our partners

Inspection of manufacturing site

During expertise of registration materials an expertise for compliance to requirements of good manufacturing practice must be evaluated for medicinal products that are submitted for new registration (renewal of registration), in the order specified by Ministry of Health. 

Expertise for compliance to requirements of good manufacturing practice of medicinal products that are submitted for registration (renewal) is not performed in case of presence of document issued by State Authority of Medicinal Products that confirm compliance of manufacturing site to requirements of good manufacturing practice. 

Thus, according to recent legal requirements, expertise of Applications for new registration and for renewals is allowed only in case if manufacturing site has a certificate of GMP issued by State Authority of Medicinal Products. 

 Inspection of manufacturing site | Cratia

GMP certificate is issued for manufacturing sites that have certificates from PIC/S will follow by simplified procedure of "recognition" of existing PIC/S GMP Certificate. 

Manufacturing sites without PIC/S GMP certificate must follow procedure with inspection. 

 

Procedure of issue of Ukrainian GMP certificate for manufacturing sites that have PIC/S GMP is as follows: 

- filling the Application and dossier (list of necessary documents you can find below); 

- translation of the dossier into Ukrainian; 

- submission of the dossier to State Authority of Medicinal Products;  

- specialized expertise in authorized state organization; 

- issue of Conclusion that manufacturing site is PIC/S GMP certified; 

Sites that do not have PIC/S GMP Certificate must be inspected by Ukrainian inspectors. 

Inspection of manufacturing site | Cratia 2

Conclusion will be issued for the period of validity of PIC/S GMP Certificate, but not more than for 3 years. 

Following documents must be submitted for GMP certification process:

  • Annex 1: Application: 
  • PIC/S GMP certificate, properly legalized; 
  • Manufacturing license, properly legalized;  
  • Annex 2: conclusion on quality of products that are manufactured; 
  • Annex 3: conclusion on results of inspections performed by state authorities; 
  • Annex 4: full list of manufactured products; 
  • copy of Site Master File (stamped by Applicant); 
  • copies of certificates for marketing authorization of all medicines registered in Ukraine; 
  • Power of Attorney for representing of your interests in State Authority, properly legalized; 

 

Cratia offers professional services of organization of recognition of existing PIC/S GMP certificate or organization of Ukrainian GMP certification. We have great experience in that area, excellent knowledge of Ukrainian and international legislation, friendly relations with state authorities. We will guide you through the whole process, assist in filling the Application and dossier and perfrom procedure in short terms. 

You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.