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The agreement between the Government of the Republic of Belarus and the Government of the Russian Federation on development of cooperation in the field of production and mutually supply of medicines

of December 14, 2007

The government of the Republic of Belarus and the Government of the Russian Federation which further are referred to as with the Parties

based on the principles of equality, mutual advantage and mutual assistance in the relations,

being guided by the Agreement between the Government of the Republic of Belarus and the Government of the Russian Federation on completion of unification and creation of single system of tariff and non-tariff regulation in the Union State of January 29, 2001,

considering interest of the Parties in further development of mutually beneficial cooperation in the field of production and mutual supply of medicines on long-term and stable basis,

agreed with following:

Article 1

Action of this agreement extends to the legal relationship connected with circulation of medicines, registered or being subject to registration in each of the states of the Parties according to the procedure established by the legislation of the state of the relevant Party, issued and delivered by the manufacturing organizations having licenses for production of medicines (further - producers of medicines).

Article 2

The parties develop and expand bilateral trade and economic, scientific and technical and production ties in the field of production and mutual supply of medicines according to the legislation of the states of the Parties, the conventional principles and rules of international law.

Article 3

The parties develop cooperation in the field of coproduction of medicines, promotion on the foreign markets jointly of the made products, and also in the field of mutual deliveries of products, pharmaceutical raw materials, the processing and laboratory equipment.

Article 4

Each Party does not apply licensing of import of the medicines made in the state of other Party and also licensing of export of the medicines intended for import to the state of other Party.

The parties reserve the right introductions of rationing arrangements concerning the medicines posing threat of life and to health of the population.

Provisions of this Article do not extend to import (export) of drugs, psychotropic substances and their precursors.

Article 5

Each of the Parties carries out registration of the medicines made in the state of other Party according to the legislation of the state of this Party, at the same time the duty in the amount of, established for producers of medicines is paid for state registration of medicines.

Article 6

Each Party recognizes results of preclinical and clinical trials of medicines, including the researches of bioequivalence conducted in the state of other Party provided that they are carried out according to the requirements established by authorized bodies of the Parties.

The parties reserve the right if necessary to appoint carrying out additional researches of medicines.

Article 7

Each Party recognizes in case of registration of declarations of conformity (issue of certificates of conformity) results of examinations of quality of medicines, subject to confirmation compliance, carried out in the state of other Party provided that they are carried out according to the requirements established by authorized bodies of the Parties.

The parties reserve the right if necessary to appoint conducting additional examinations of quality of medicines.

Article 8

Authorized bodies of the Parties perform mutual assessment of producers of medicines regarding compliance to the requirements established by the legislation of the state of the checking Party.

Article 9

The parties within 3 months from the date of the signature of this agreement inform each other on the authorized bodies which provide accomplishment of the obligations provided by this agreement.

Article 10

The changes which are drawn up by separate protocols which become effective according to the procedure, stipulated in Article the 11th this agreement can be made to this agreement in the consent of the Parties.

Article 11

This agreement becomes effective from the date of receipt of the last written notice of accomplishment of the interstate procedures by the Parties necessary for its entry into force. This agreement is signed for a period of 5 years. The validity of this agreement will be extended automatically for the subsequent five-year periods if any of the Parties does not notify other Party in 6 months prior to the expiration of the next 5-year period on the intention to stop its action.

It is made in Minsk on December 14, 2007 in duplicate, everyone in the Belarusian and Russian languages, and both texts are equally authoritative.

 

For the Government

Republic of Belarus

For the Government

Russian Federation

 

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

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