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Registration / recurrent registration of medicines

Registration / recurrent registration of medicines

DEAR COLLEAGUES!

If you want to sell medicines in the Ukraine, we can help you with that! We can help you register your medicines in the Ukrainian Ministry of Health quickly and not expensive! We have been doing this for over 12 years, and therefore we can guarantee 100% professionalism and quality of work within strict time!

ALGORITHM OF COOPERATION:

  1. We are making an agreement of confidentiality with you.
  2. You send us a package of necessary documents.
  3. We are conducting a FREE initial examination of a dossier and provide you with the comprehensive information about:
    • The status of the documents and what needs to be corrected and submitted;
    • The cost of government payments and our services with all the extra work that we will need to perform to prepare the registration dossier (preparation of individual parts of the AND, translations, etc.);
    • Deadline for dossiers’ preparation and the total period of registration.
  4. Then you assess the information received, we are making an agreement and begin to work on “turnkey” basis:
    • Perform a thorough examination of the documents submitted;
    • Form the registration dossier;
    • Develop methods of quality control methods of the finished product (QCM) in accordance with the materials of the registration dossier (if they are not available at the customer);
    • Prepare the instructions for medical use;
    • Write cover letters;
    • Make copies of the dossier in triplicate;
    • Make a contract between the applicant and the State Expert Centre (SEC);
    • Submit an application form and micro-dossier in the SEC;
    • Obtain a permission to import samples of the drug and organise the entire process of import and customs clearance and delivery of the product to destination;
    • Get the invoice government payments to the Treasury and SEC;
    • Obtain the confirmation of payment from the Treasury;
    • Submit a dossier to the SEC;
    • Provide support and control at all stages, go through all the trials of the drug, act quickly and respond to the comments;
    • Submit test results in the SEC, withdraw the drug to the commission;
    • Proofread and approve projects of registration documents with the client;
    • Obtain the original registration certificate and deliver it to the client;

The term of the initial examination of documents received – 1 day. Term of document preparation for submission to the Government Agencies – from 3 to 15 days. Date of receipt of the registration certificate from 120 to 160 days.Application form

  • The composition of the registration dossier – a simplified format
  • The composition of the registration dossier – a CTD format
  • The composition of the registration dossier for re-registration of drug
  • Download a confidentiality agreement

FOR DETAILS ON REGISTERING / RECURRENT REGISTRATION OF MEDICATIONS IN UKRAINE

Registration of drug is conducted by State Expert Centre of Ministry of Health of Ukraine. First, an application for registration and a package of documents is needed to submit (micro-dossier). After an initial review of the application form and micro-dossier and payment of state registration fees a full dossier is submitted. The applicant has the right to select the format of the file – “simplified” or CTD format.Prior to the submission of the dossier is needed to sign an agreement with SEC for examination, prepare an application form and “micro-dossier”, apply the documents needed, obtain the certificate of initial evaluation and invoice payments, get confirmation for payment of bills in Treasury of Ukraine.

In the preparation of the dossier, it is necessary to take into account a number of points:

  • Manufacturer must have GMP certificate in Ukraine.
  • Dossier is being submitted in four copies.
  • For each instance of the dossier a sample of the finished product must be provided.
  • The dossier shall include the AND (methods of quality control of the finished product), designed according to the manufacturer’s documentation and the requirements of current legislation.
  • The dossier shall include instructions for medical use submitted in the Ukrainian language.
  • Strict requirements are brought forward to the layout of packaging, size of the font (at least 7 points of Dido), labelling in Braille, etc.

If necessary, materials needed for the registration of the drug can be sent by Centre for further examination, which is held in the expert institutions authorized by the Ministry of Health of Ukraine. Further examination is carried out after the payment of the cost specified in the contract between the applicant and the authorized expert institution. The results of the additional examination are sent to the Expert Centre for consideration.

After receiving a positive conclusion on the chemical-pharmaceutical part of the dossier – is needed to pass a confirmation of reproducibility of methods of quality control in the authorized laboratory.  To do this, samples, standards and other reagents necessary for a complete analysis in triplicate are being imported.

Based on the positive conclusions from the three commissions and positive results of testing methods in the laboratory – a product is being included in the agenda of the next meeting of the State Expert Centre. After approval at a meeting occurs proofreading of projects registration materials and issue of the original registration certificate.

RECURRENT REGISTRATION OF DRUGS carried out in the same manner as the state registration.

Application for recurrent registration of the drug is needed to submit to the Centre not earlier than in 180 days and no later than 90 calendar days prior to the expiration of the license.

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