Licensing conditions of realisation economic activities of manufacture,

wholesale and retail trade in medical products

Business activities in Ukraine, as in many other states, subject to certain restrictions. First, there is a state monopoly for certain activities. In addition, many activities related to the necessity of licensing.

Licensing procedure is regulated by the Law of Ukraine "On licensing of certain types of business. In our country pharmaceutical activity is subject to licensing, including manufacturing, wholesale and retail of medicines. That is, every entity that operates in the pharmaceutical market must be licensed to conduct business activities, indicating the type of activity - wholesale of medicines, retail pharmaceutical, production of medicines, the production (manufacturing) of medicines in pharmacies.

The license is the only permits that gives the right to conduct the business of manufacturing medicines, wholesale and retail drugs and allows the proceedings mentioned activities throughout Ukraine.

Licensing conditions for the business of drug production, wholesale and retail drugs were

developed and approved by joint order of the State Committee for Regulatory Policy and

Entrepreneurship and the State Inspectorate for Drugs Quality Control № 340.

• The effect of these license terms apply to all businesses regardless of their legal form and ownership.

• Reception of documents submitted to obtain a license, issuance, renewal and revocation of licenses, issuance of duplicate licenses, driving licenses, registers, control within their jurisdiction for compliance with licensing conditions by licensees, issuing orders to eliminate violations of licensing conditions is held by the State Inspectorate Quality of Medicines

• To obtain a gambling license shall submit statement in the prescribed form. The above application is made personally or through an authorized person. In the case of the applicant of the structural units that adopt economic activity based on a license, the declaration indicates their location.

• To the application documents in accordance with Article 10 of the Law of Ukraine "On licensing certain types of business is added. Application and documents attached thereto shall be adopted by label, copy of which is issued to the applicant with the date the documents were received and signed by responsible person.

Application for the license will not be considered if:

1) The application is submitted (signed) by a person who does not have this authority;

2) Documents issued in violation of Article 10 of the Law of Ukraine "On licensing certain types of business”.

On leaving the application for a license without consideration the applicant is informed in writing form with the grounds of abandonment of the application without consideration.

State Inspection of medicines make decision

to grant a license or refusal to issue in time no

later than ten business days from the date of

application for the license and the documents accompanying the

application.

The decision to grant a license or denial of the license is sent (issued) to the applicant in writing within three working days of the

decision. License is signed by State inspection or his deputy and the seal of

the body.

License issued to the applicant personally or by his attorney not later than three business days after receipt of the document confirming payment of license fee.

If the applicant within thirty calendar days after sending him a message about the decision to grant a license did not submit the document confirming payment of license State inspection, which gave expression to the license, is entitled to rescind the decision the license or make a decision on the recognition of such a license.

Licensing is registered in numbered, laced and sealed book of applications and licenses issued in the prescribed form .

License must be reissued if:

• change the name of legal entity (if name change is not related to the reorganization of a legal person) or last name, first name, middle name of natural person - entrepreneur;

• entity changes location or residence of an individual - business entity;

A licensee who submitted the application and relevant documents on the license

renewal may be operating under the certificate of acceptance for consideration of the above documents issued by State inspection. In case of loss or damage of license the licensee must apply to State

inspection the application for a replacement of license.

Thank you for attention!