ORDER OF THE GOVERNMENT OF THE REPUBLIC OF ARMENIA

of March 28, 2011 No. 281-N

About approval of procedures for licensing of implementation of activities for production, export, import or wholesale trade by the drugs or psychotropic substances or their precursors established by the Government of the Republic of Armenia, and forms of licenses for implementation of these types of activity

Accepted the Government of the Republic of Armenia on March 18, 2011

According to parts 10, 2 articles 17 and 2 of article 43 of the Law of the Republic of Armenia "About licensing" the Government of the Republic of Armenia decides 3 Articles:

1. Approve:

1) procedure for licensing of implementation of activities for production of the drugs or psychotropic substances or their precursors established by the Government of the Republic of Armenia according to Appendix No. 1;

2) forms of license for activities on production of the drugs or psychotropic substances or their precursors established by the Government of the Republic of Armenia according to Appendix No. 2;

3) procedure for licensing of implementation of activities for export, import or wholesale trade by the drugs or psychotropic substances or their precursors established by the Government of the Republic of Armenia according to Appendix No. 3;

4) forms of license for activities on export, import or wholesale trade by the drugs or psychotropic substances or their precursors established by the Government of the Republic of Armenia according to Appendix No. 4.

2. The procedures approved by this Resolution to recognize as the state body authorized by the Government of the Republic of Armenia, the Ministry of Health of the Republic of Armenia (further - the licensing body).

3. Declare invalid the Order of the Government of the Republic of Armenia of October 3, 2002 No. 1656-N "About approval of procedures for licensing of implementation of activities "production or production of drugs or psychotropic substances in the Republic of Armenia and export or import of drugs or psychotropic substances" and forms of licenses for implementation of the specified types of activity".

4. Determine that licenses for production, the import, export of drugs and psychotropic substances issued before entry into force of this Law are effective before the expiration of the effective period specified in them, and licenses for production of drugs and psychotropic substances for production of precursors of the drugs and psychotropic substances established by the Government of the Republic of Armenia are subject to renewal in 6-month time after entry into force of this Resolution.

5. Determine that persons having licenses for production of drugs or psychotropic substances as of day of entry into force of this Resolution and also persons who obtained the license for production of the drugs or psychotropic substances or their precursors established by the Government of the Republic of Armenia shall bring the activities into accord to requirements of the proper activities for production of drugs approved by the Order of the Government of the Republic of Armenia of November 25, 2010 No. 1603-N till January 1, 2013.

Appendix № 1

to the Order of the Government of the Republic of Armenia of March 18, 2011 No. 281-N

Procedure for licensing of implementation of activities for production of the drugs or psychotropic substances or their precursors established by the Government of the Republic of Armenia

1. General provisions

1. This Procedure establishes the requirements and conditions shown by the licensing body to the organizations which addressed to the licensing body behind receipt of license for activities for production of the drugs or psychotropic substances or their precursors established by the Government of the Republic of Armenia (further - the license).

2. The license is granted by the licensing body for up to three years within 23 working days after submission of all documents provided by the law and this Procedure.

3. Legal entities and individual entrepreneurs can be engaged in production of the drugs or psychotropic substances or their precursors established by the Government of the Republic of Armenia.

4, the Licenses granted according to this Procedure are effective only in the place specified in the license.

5. The licensing body after receipt of the documents specified in Item 9 of this Procedure in 5-day time after implementation of the requirement, stipulated in Item 9.1, will approve it with the interested state bodies.

5.1. For receipt of the license the state fee according to the procedure and the size, established by the Law of the Republic of Armenia "About the state fee" is collected. At the same time:

1) the licensing body within one working day after licensing or its duplicate, prolongation of effective period of the license, renewal of the license, decision making on occupation the same activities which are subject to licensing and in other place informs on it in due form the applicant. The applicant shall be warned by informing about the effects provided by subitem 4 of this Item;

2) the applicant shall pay the state fee established by the Law for rendering the service established by subitem 1 of this Item no later than within five working days after licensing or its duplicate, prolongation of effective period of the license, renewal of the license, satisfaction of the request about occupation the same activities which are subject to licensing and in other place;

3) the applicant can not submit the document confirming payment of the state fee to authorized body. In case of non-presentation by the applicant of the document confirming payment of the state fee, the licensing body after decision making about licensing or its duplicate prolongation of effective period of the license, renewal of the license, occupation the same activities which are subject to licensing and in other place by means of system of treasurer network management or electronic system of the state payments certifies about payment of the state fee and hands or sends to the applicant properly the license, the duplicate of the license, the license with prolonged term, the renewed license, the license for occupation the same activities which are subject to licensing and in other place, and also relevant decisions about it;

4) in case of failure to pay the state fee by the applicant in time, provided by subitem 2 of this Item, the corresponding request is rejected based on failure to pay the state fee. After request variation the decision of licensed body is nullified.

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