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Confirmation of GMP certificates

Confirmation of GMP certificates

Dear colleagues!

We are pleased to offer a range of services for validation of GMP certificate in Ukraine on “turnkey” basis!State Service of Medicines holds and performs the validation.

GMP is being validated for all production sites (including contract areas) involved in the production process of the finished product.

Procedure order of validation of accordance of drugs production with good manufacturing practice (GMP) approved by order of the Ministry of Health of Ukraine №1130 from 27.12.2012.

Conclusion is being given on the term of action of GMP certificate of the manufacturer.The procedure of GMP certificate validation for manufacturers from member countries of PIC/S is passing through a simplified procedure (without a necessity for the commission to attend the factory).

Members of PIC/S Pharmaceutical Inspection Cooperation Scheme:

 

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chinese Taipei (Taiwan)
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Iceland
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Korea
  • Latvia
  • Liechtenstein
  • Lithuania
  • Malaysia
  • Malta
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Romania
  • Singapore
  • The Slovak Republic
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • Ukraine
  • United Kingdom
  • USA

How do we work?

  1. You prepare and send us a list of required documents by an e-mail.
  2. We carry out the technical expertise and make an agreement.
  3. You send us original documents and we create dossiers, submit the documents to the State Service of Medicines and get a Confirmation.

DOCUMENTS REQUIRED:

  • License for production
  • GMP certificate
  • Master file of production site (dossier)
  • Report about the last inspection on manufacture
  • The registration certificates of medicinal products planned
  • Data on medicines (Download the fill-out form)

Call us, our prices will pleasantly surprise you!