A significant portion of the pharmaceutical market of the Republic of Armenia is made up from goods imported from foreign countries. Additionally, a considerable amount of medical drugs are taken out of the country. The procedure for the import and export of medicines in the RA, has its own characteristics and certain regulatory requirements. In order to deal with import and export of medical goods within the framework of the law, it is necessary to act in accordance with this procedure.

To begin with, please note that medicines and drugs may be imported or exported only with the certificate of The Ministry of Health of the Republic of Armenia, which is issued for up to one year. Certificate for import and/or export is issued in electronic form, and in case of a written application it is issued in paper form, with three copies. One copy shall be presented to the customs authorities, the second is for the applicant to keep and the third is sent to The Ministry of Health of the RA. This certificate allows for one time only crossing of customs of any EAEU border, whether importing or exporting medical drugs.

To issue a certificate for the import of medical drugs, incoming medicines are checked for quality as per standard existing samples and cross referenced with the requirements of pharmacopoeia of drugs registered in the Republic of Armenia. A directly acquired import/export certificate from the producing organization issued for any type of goods and the specific quantities of goods, may be extended by The Ministry of Health of RA without additional laboratory examinations within the given one year period of the certificate.

The requirements for obtaining a certificate for the import or export of medical drugs to/from the RA:

The right to import or export of drugs are:

• Economic or business entities that have a license for the import and export of drugs and medicines;
• Economic or business entities that have a license for the production of drugs and medicines in the Republic of Armenia, intended for their own commercial use;
• Economic or business entities that do not have a license to import or export, yet whose work is related to the investigation, to testing, to quality supervision and to safety and efficacy of medical drugs.

Only medical drugs that are registered in the Republic of Armenia may be imported into the Republic of Armenia, with the exception of:

• Samples of medical drugs imported to conduct pre-clinical and clinical trials;
• Samples of medical drugs provided for state registration in the Republic of Armenia;
• Samples of medical drugs provided for exhibitions, scientific meetings, or other similar activities, without the right to sell;
• Medicines imported in case of natural disasters, epidemics and other emergencies, as well as, medical drugs imported into the Republic of Armenia in the form of humanitarian aid;
• Medicines that are imported for the purpose of packaging only, that have passed all the stages of production except for packaging and labeling, IE: package with a view to final implementation is not completed, and the final production of which is not registered in the Republic of Armenia.

The quality of imported medicines must comply with the pharmacopeia of the RA and the specifications set by the said register. In addition, for the import of medicinal materials, one is required to provide documents proving the conditions of production of medicines, the certificate of conformity of production activity, manufacturing license and certificate of quality, which are issued by the manufacturer of medicines.

The remaining shelf life of medical drugs and medicines upon import into the Republic of Armenia should not be less than one year. In some exceptional cases, with the permission of The Ministry of Health of RA, one may import medical drugs with a shorter shelf life. The possibility of their use until expiry date should be justified. When total shelf life is one year, or less, at the point of entry the shelf life must not be less than 2/3 of the total period.

The procedure for import of drugs and medicines into the Republic of Armenia:

The Ministry of Health of the RA will issue a permit and/or certificate for the import of medical drugs and medicines into the Republic of Armenia, based on documentary and/or laboratory examinations. Required time for consideration of applications for import permits is 7 (seven) working days from the date of receiving the application. Further examination may take up to 20 (twenty) working days. Regardless of the results of the examination the applicant is required to pay all incurred costs associated with the examination. In the case of a positive result following the examination of documents, representative of The Ministry of Health of RA, in the presence of the applicant and officials from the customs, carry out a prior inspection and seizure of samples of medical drugs and medicines to be imported. The representative then writes up an act of withdrawal of samples in three copies.

Following this The Ministry of Health of the RA carries out a standard procedure to identify the medical drug samples with the ones already registered in the RA, inspects the supporting documents and their compliance with the seized samples. If the examination of documents and identification of medical drugs and medicines gives a positive result, then this group of products is given a certificate for the import. In case of negative result the permission is withheld. Should only a part of the product successfully pass the examination, then the certificate for import will be granted for that part alone.

The procedure for exporting medicines and medical drugs from the Republic of Armenia:

The certificates for the export of medical drugs and medicines are also issued by The Ministry of Health of RA. The applicant must apply for permission to export medical drugs and medicines from the RA. The process may take up to 10 (ten) working days from the date of submission of documents. In case of positive conclusion the export certificate is granted, in case of a negative result, it is withheld.

In order to import or export goods a legal entity or individual entrepreneur must provide for the authorization of The Ministry of Health of the RA, the following documents:

• An application in the required format;
• A copy of the license allowing one to perform the said activity;
• A copy and the original signed contract on purchase of drugs and medicines;
• A copy of the original supplier invoice;
• The original and a copy of the delivery documents;
• The original and a copy of the quality certificate for each batch of medical drugs and medicines, issued by producing organization. If medicines and/or medical drugs are purchased from an intermediary organization, the quality certificate must be stamped by that intermediary organization;
• In case of industrial export of medicinal herbs, the written permission from The Ministry of Health of the RA.

All original documents are returned to the applicant once import and/or export certificate is issued.

In some cases such as the import of humanitarian aid, the samples to be presented at scientific events, or implementation of clinical or pre-clinical trials, The Ministry of Health of RA will require different types of documents, as the established procedures will also differ.

Grounds for refusal to grant certificates for export or import of medical drugs and medicines:

• The documents or data contain errors that have not been corrected within the specified time, or they are obviously false or distorted;
• The proposed medicines and medical drugs do not have state registration in the Republic of Armenia;
• The qualitative indicators of medicines and medical drugs do not meet the criteria adopted in the Republic of Armenia;
• The shelf life of medical drugs and medicines has reached the expiry date;
• The remaining shelf life of medical drugs and medicines is less than one year, and the possibility of their use until the expiry date is not justified (see above);
• The medicines and/or medical drugs and the accompanying documents are not consistent with each other;
• Changes in the packaging of medicines affect the safety, efficiency and product quality, as well as, the original quality certificate is not provided by the manufacturer, or the seal of the exporting company is missing, or a copy of the certificate provided by the manufacturer to the importer countries is false or missing.

12.11.2015