Since 08.08.2001, the Republic of Armenia has had a law “On Licensing”, which regulates activities of medical nature. This law defines the criteria by which the Republic of Armenia issues the relevant license.

Chapter 7 of this law, which specifies the list of activities subject to licensing, refers to the field of healthcare.

It turns out that the implementation of medical activities on the territory of Armenia mandatorily requires a license, and of a complex kind, because the “medical business” itself is undoubtedly one of the most complex.

It is also mentioned in the article 18 of the RA Law “About the medical care, the service for the population”.

On the basis of the mentioned RA Law the license is issued in two forms: a simple license and a complex one.

The issuance of a simple license takes only 3 days from the date of application and does not require the approval of the Licensing Commission.

The Armenian state obliges medical organizations to undergo a complicated licensing procedure because such organizations deal with human health and even life.

According to Article 43 of the RA Law “On Licensing” the following more specific list of the types of works (services) in the sphere of health care subject to licensing is established

Production of medicines

Trade in medicines

Trade in medicinal herbs

Pharmacy

Rendering of medical assistance and provision of medical services by organizations or individual entrepreneurs

Genetic engineering activities

Realization of secondary and higher medical educational programs

Subjects of the license are medical organizations, other organizations, individual entrepreneurs, who are going to carry out medical activity, by performing certain works and services.

To get a license in Armenia it is necessary to apply to the RA Ministry of Health, the licensing body (Article 28 of the RA Law “On License”).

The following information must be mentioned in the license application form below, in order for it to be accepted, reviewed and then a positive decision is given.

For a legal entity For an individual entrepreneur

-Name and legal form of organization

-Location and place of business

-Name, surname

-Place of residence and activities

-Type of activity to be licensed – Type of activity to be licensed

It is necessary to attach to the application:

-a copy of the statute

– A copy of the certificate of state registration

-A copy of the registration certificate

-A document confirming the person’s professional qualification; -A document confirming the person’s professional qualification.-Other documents foreseen by RA Law – Other documents foreseen by RA Law

Note that the submitted package of documents for obtaining a license must not be incomplete, deliberately false or distorted, otherwise the licensing body will simply reject your application and you will lose the most valuable resource – your time.

If you still filed an incomplete package of documents, the term of consideration will only be counted from the date of delivery of all documents required by RA Law.

An application for a simple license is rejected by the licensing authority within three days, and in the case of a complex license – within thirty days.

Within the mentioned period the licensing body shall verify the completeness and accuracy of the information contained in the mentioned applications and documents, including the verification of the subject’s compliance with the licensing requirements.

The decision to reject an application must clearly state the reasons and legal grounds for rejection so that you do not make the same mistake when reapplying (Article 29 of the RA Law “On Licensing”).

In order to avoid receiving a rejection decision it is better of course to entrust the licensing procedure to a professional lawyer who will perform everything at the highest level and save your time and nerves.

The licensing authority will issue you a license if, as a result of reviewing the application and the documents attached thereto, it does not find any violations.

At the legislative level in Armenia, the following licensing requirements are established for entities wishin .

The head (his/her deputies) of a medical organization and an individual entrepreneur must have a higher professional education

Persons wishing to carry out medical activity must have work experience in their specialty.

Subjects must have concluded labor contracts of employees having secondary, higher, postgraduate and (or) additional medical professional education as well as a specialist certificate (for specialists having medical education)

Entities must also have employment contracts of employees who perform maintenance of medical devices. This includes apparatuses, equipment, devices, instruments, etc.

Let us clarify at once that within five days before the beginning of its activity the medical institution which is being licensed must submit to the Ministry of Health of the Republic of Armenia information about its employees. More precisely, it is necessary to provide information about the qualifications of the staff.

The Republic of Armenia has introduced a simplified licensing procedure.  There is currently an electronic system for obtaining licenses on the territory of Armenia. To become acquainted with it, click on the following link:

www.e-gov.am/licenses.

It is very convenient because you can observe the license issuance process online and save your time.