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Professional approach to the certification of medical products
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г. Киев, ул. Саксаганского, 52а, 2 этаж, офис 6 csplus29@ukr.net csplus29@gmail.com

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Wholesale prices declaring

PE2212_183310“Consuting service plus” offers a service for the change of wholesale prices declaration of medicines and medical products.

On July 15, 2014 the Cabinet of Ministers of Ukraine Resolution from April 02, 2014 No. 240 “Declaration of change of wholesale prices of medicines and medical products questions” came into force.

This Resolution brings innovation and delineates process of declaring for medicines and medical products.

Declaration procedure consists of the following steps:

  1. 1.   Preliminary consultation.

You need to send us an e-mail with scanned copies of primary documents (see the list below). After your documents are received, our staff contact you, send you an agreement on cooperation and provide advice on the procedure and manner of declaration. After payment is received, we begin preparing documents for the change of wholesale prices declaration.

  1. 2.   Submission of documents.

The whole process does not require the personal presence of you employees and it carries out remotely. You send us the documents by mail or courier service. The package of documents is served to the Ministry of Health of Ukraine on your behalf and on behalf of our employees.

  1. 3.   Making amendments to the registry.

Ministry of Health makes the decision on the declaration of wholesale price of medicines and medical products and enters the information in the register of wholesale prices of medicines, medical products and medical products in a period which does not exceed 10 working days from the date of submission of the documents, specified hereafter:

The list of required documents:

I)            for medical products:

  1. The statement on the change of wholesale prices declaration of medicines in the form approved by Ministry of Health, which we will send you by e-mail;
  2. The power of attorney, which confirms the authority of the authorized person to declare changes in wholesale prices of medicines, issued by the owner of the medicine registration certificate, with the translation into Ukrainian, certified in the manner described by law, or a copy of such power of attorney certified in the manner described by law.

II)         for medical devices:

  1. The application for change of wholesale prices of medical devices according to the form approved by the Ministry of Health, which we will send you by e-mail;
  2. A copy of the certificate of state registration of medical devices issued by Medicines Agency and stamped by the applicant;
  3. The power of attorney, which confirms the authority of the authorized person to declare changes in wholesale prices of medical devices, issued by the owner of the certificate of state registration of medical devices, with the translation into Ukrainian, certified in the manner described by law, or a copy of such power of attorney certified in the manner described by law.

If the applicant is a legal entity, these documents will be certified by the signature of its Head and sealed.

Ministry of Health decision on the declaration of prices of medical devices/products is posted within two days after its acceptance on the official website. 

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Адрес:

г. Киев, ул. Саксаганского, 52а, 2 этаж, офис 6 csplus29@ukr.net csplus29@gmail.com