Upharmacia January 2017 (Special Edition) | Page 8

Upharmacia January 2017
2016 YEAR SUMMARY
KEY REGULATORY CHANGES
C hanges in P rocedure for P ublic P rocurements
2016 was the year of the first experience of centralized public procurement of drugs and medical devices
through specialized international organizations, while decentralized procurements were transferred to
Prozorro system. The partners of the MOH have become UNDR, UNICEF and Crown Agents.
N ational E ssential M edicines L ist
On Jan, 12 the Cabinet of Ministers Resolution #1134 came into force. The National List of Essential Medicinal
Products and Medical Devices has been renamed into the National Essential Medicines List. Therefore, the
medical devices shall not be included into this list anymore and shall not be subject to pricing regulation. The
List should be formed with due consideration of world-wide practices of rational pharmacotherapy and phar-
macotherapeutic approach to primary health care of patients with priority pathologic conditions taking into
consideration disease burden and mortality rate, and health care sector standards. The List will consist of
INNs and will updated once a year.
S implified R egistration P rocedure for M edicines
On May 31, the Parliament approved the Law, which provided for the simplified registration of medicinal
products being registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada, and
the European Union in accordance with the centralized procedure.
Such products should be accepted for usage in the territories of the mentioned countries or the EU member
states. The registration procedure for such medicinal products envisages the submission of the smaller
package of documents, reduction of registration terms, and no need for the expertize of the registration
materials.
Decision on registration is issued by the MOH within 17 business days:
— — 10 business days: Review of registration materials by the State expert center.
— — 7 business days: Making the decision by the MOH on registration.
S tate R egulation of P rices
On Nov 9 the Government has adopted the Resolution of the Cabinet of Ministers of Ukraine #862 “On state
regulation of prices for medicines” and #863 “On the introduction of reimbursement of the cost of medicines”.
The new price regulation system will act through:
— — Maximum prices by implementation of price referencing on medicines by the MOH
— — Maximum mark-ups only for reimbursable medicines purchased through decentralized procurements:
wholesale – 5%, retail – 15%.
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