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Uzbekistan introduces a simplified medicines registration procedure

On October 25, 2018, the Procedure for recognition of results of the other countries registration entered into force, approved by Decree of the Cabinet of Ministers of the Republic of Uzbekistan No. 862 dated October 24, 2018 “About approval of the Regulations on procedure for recognition of results of the registration of medicines conducted outside the Republic of Uzbekistan”.

The recognition procedure is envisaged for medicines and substances registered by the EMA and the national registration authorities of the USA, Japan, Canada, Switzerland, Australia, Belgium, UK, Germany, Denmark, Ireland, Spain, Italy, the Netherlands, Norway, Slovenia, Finland, France, Sweden, Israel and Korea.

The official term for recognition of registration is no more than 15 business days. This period does not include the time for payment for review of the procedure (no more than 30 calendar days from the date of issue of the invoice for payment).

The cost of review of the Application for recognition of registration is 50 minimum wages, which from November 1, 2018 is about 1,250 USD (excluding VAT). The amount may vary depending on the exchange rate, as well as the revision of the minimum wage.

The medicines recognition procedure requires the submission of an abbreviated set of documents. In addition to the registration materials, samples of the medicine and reference standards in the quantity necessary for the threefold analysis should be submitted. This requirement raises a large number of questions, as the Procedure itself does not provide the conduction of intra-registration control.

The validity of the results of the first recognition (marketing authorization) is 5 years. After the procedure of recognition of the results extension (re-registration) is carried out, the recognition of results is issued for an unlimited term.

The issuance of originals of marketing authorizations is abolished. Registration data is entered in the register of registered finished products and substances, where an appropriate excerpt can be taken, if necessary.

More information regarding state registration of medicines in Uzbekistan by following link.