Programme: cerebral palsy (deadline - March 18th, 2022, 18:00, KYI time)

The Order of the Ministry of Health of Ukraine № 1723 from August 11th, 2021 (as amended) approved the nomenclature of medicines, medical devices and auxiliaries to them, including the direction "Medicines for children with cerebral palsy", which will be purchased for budget funds in 2022 year under the budget program 2301400 "Provision of medical measures of separate state programs and complex measures of program character".

The order of the Ministry of Health of Ukraine № 120 from January 19th, 2022 brought to the SE "Medical Procurement of Ukraine" the list of areas of prevention, diagnosis and treatment in 2022, including the abovemetioned area.

According to sub-point 1 of point 1 of the Resolution of the Cabinet of Ministers of Ukraine № 169 from February 28th, 2022 procurement of medicines will be carried out without the use of procurement and simplified procurement procedures defined by the Law of Ukraine "On Public Procurement", according to the list and amounts approved by the order of the Ministry of Health of Ukraine № 434 from March 8th, 2022.

Based on the above, please provide commercial offers for the following medicines and the necessary documents listed below:

INN

Release form

Dosage

Unit

Additional characteristics

Quantity

Botulinum toxin type A 

ampules, vials, syringes 

300 IU or 100 IU - allergan or 100 LD50 IU 

ampules, vials, syringes 

The instructions for use of the medical product should not contain contraindications for children's use (pediatric patients). 

1512

It is worth noting that the commercial offer must contain the following information:

  • prices per unit (per packaging) in UAH, without VAT on the condition of DAP (Kyiv, Kyiv region, Ternopil, Ternopil region). In case of impossibility of delivery to the specified regions, please indicate possible places of delivery;
  • if the goods originate from the Republic of Belarus or the Russian Federation, please indicate this additionally.

Please provide the following documents in addition to the commercial offer:

For registered medicines:

1. A copy of the current registration certificate for the medical product issued by the relevant authorized body in Ukraine. The documents are submitted by the bidder as part of the tender proposal, taking into account the requirements of current legislation of Ukraine, established before the registration of medical products that can be purchased by a person authorized to procure in the field of health care, including Art. 9, 9-1 of the Law of Ukraine "On Medical Products";

2. A copy of the instructions for medical use in the state language or a copy of the instructions for use of the medical product in the state language;

3. A copy of the valid document issued by the State Service of Ukraine for Medicines and Drug Control, confirming compliance with the conditions of production of the proposed medicines to the requirements for the production of medicines in Ukraine;

For unregistered medicines:

  1. A copy of the valid document confirming the registration of the medical product by the competent authority of the country of Manufacturer/Applicant * or the United States of America, the Swiss Confederation, Japan, Australia, Canada, the Member States of the European Union.
  2. A copy of the valid document confirming the use of the medical product in the United States of America, the Swiss Confederation, Japan, Australia, Canada and/or in the territory of the Member States of the European Union (CoPP - Certificate of a Pharmaceutical Product (Certificate of Medical Product for International Trade)),

OR a copy of another valid document issued by the relevant body / institution / establishment in the field of health care from the list of countries defined in this paragraph, confirming the use of the medical product, 

OR a document (letter) issued by the State Enterprise «State Expert Center of the Ministry of Health of Ukraine», which certifies that based on the results of the examination of registration materials for such a medical product, conducted in the prescribed manner, the effectiveness, safety and quality of such a medical product are confirmed and such a medical product is recommended for registration.

  1. A copy of the instructions for use (other information on the use of the medical product) AND the summary of product characteristics ** approved in accordance with the regulatory requirements of the Applicant's country */Manufacturer or the United States, the Swiss Confederation, Japan, Australia, Canada, country members of the European Union according to the results of clinical trials, presented in the original language (language other than the state one), ALSO a translation of the instructions for use of the medicine (other information on the use of the medicine) and a summary of the product in the state (Ukrainian) language.
  2. A written commitment (in any form) of the Applicant */Manufacturer to register the medical product in Ukraine for its use in Ukraine before the delivery. 

In case where, during the registration of a medical product, there is a different Applicant than the Applicant* in the country where the medical product is registered, such a written commitment to register the medical product in Ukraine before delivery may be signed by the Applicant when registering the medical product in Ukraine subject to the submission of a power of attorney (POA) as part of the tender offer from the Manufacturer/Applicant *, confirming the authority to be the Applicant when registering a medical product in Ukraine.

  1. Copies of valid certificates of compliance with GMP requirements for production sites specified in the registration dossier, which are responsible for the release (certification) of a batch of finished medical product supplied (to be supplied) to Ukraine, presented in the original language (language other than the state one), and their authentic translation into the state (Ukrainian) language (if the certificate of compliance with the GMP requirements is included in the EudraGMP database or the US or Canadian FDA electronic register, the Participant may provide a printout of the EudraGMP database or the US FDA or Health Canada electronic register and their authentic translation into the state (Ukrainian) language.

OR 

a copy of the valid document issued by the State Service of Ukraine for Medical Products and Drug Control, which confirms the compliance of the conditions of production of the proposed medicines with the requirements for the production of medicines in Ukraine.

  1. A copy of the valid license for the circulation of narcotic drugs, psychotropic substances and precursors, issued by the relevant licensing authority in the country of the Manufacturer / Applicant, issued in the original language (language other than state), and its authentic translation into state (Ukrainian).

Given the limited time, we ask you to urgently send to the State Enterprise "Medical Procurement of Ukraine" until 18:00 of March 18th, 2022 to the e-mail address: This email address is being protected from spambots. You need JavaScript enabled to view it., a package of documents containing a commercial offer and the above information. If it is impossible to provide one of the documents, please specify this.

Please note that the provision of a price offer does not create any benefits for the market participant in procurement and does not impose any obligations on the State Enterprise "Medical Procurement of Ukraine" in relation to the market participant.

State Enterprise "Medical Procurement of Ukraine" 

+380 63 651 90 25

[email protected]

22 Khreshchatyk Str., 2nd floor, Kyiv, 01001

 

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