On July 4, 2024, the decision N 1034-N "On approving the fee (fees) and cost compensation program for drug registration and re-registration examinations" was adopted, according to which the Government of the Republic of Armenia provides the resident organizations of the Republic of Armenia operating in the field of drug production in the Republic of Armenia and Reimbursement of fees (fees) for registrations and re-registrations of drugs of the Eurasian Economic Union, registrations and re-registrations of drugs of strategic importance, registration and re-registrations of drugs to be used only in Armenia, examination fees for registrations and re-registrations of drugs manufactured in the Republic of Armenia by individual entrepreneurs registered in the Republic of Armenia, and examination costs of registrations of Armenian-made drugs abroad.

Mandatory requirements:

As of the moment of submission of the application in order to receive compensation, the applicant should not have initiated administrative proceedings regarding collection of unfulfilled tax obligations.

If the amount of fees (fees) or expenses is expressed in foreign currency, it is calculated at the exchange rate set by the Central Bank of the Republic of Armenia for the given day as of the date of the actual payment of the fee (fee) or actual execution of the expense by the applicant.

The amount of compensation expected from the state provided for in the application should not exceed the balance of financial resources determined for the given year by the law on the state budget for the implementation of the project as of the date of the application submission (in case of exceeding, we are guided by the 10 with the -th point).

Submitted documents:

In order to receive compensation, the applicant submits to the Ministry of Economy of the Republic of Armenia

• Application according to Form No. 1 (In Armenian)
• A copy of the registration certificate issued by the authorized body for the given product, and in the case of examinations of the registration of Armenian-made drugs abroad, a copy of the document justifying the registration of the drug abroad
• A copy of the contract signed with the authorized body (if available), and in the case of examinations of the registration of drugs of Armenian production abroad, a copy of the contract signed with the body carrying out the registration of the drug abroad (if available)
• Copies of relevant documents certifying the expenses incurred (copies of accounting document, payment receipt and other documents)
• Copy of the certificate of the RA State Register of Legal Entities
• Bank account number (certificate document, reference)
• Information according to Form N 2 (In Armenian)
• Declaration according to Form N 3 (In Armenian)
• Other information at the request of the applicant.

In case of conformity of documents, it is signed with the beneficiary contract (In Armenian)

The amount of compensation provided to the beneficiaries within the framework of the program:

1. Reimbursement of fees (fees) for examinations of Eurasian Economic Union registrations and re-registrations in the field of state regulation of drug circulation is provided with state funding in the amount of 50% for each drug, but not more than AMD 1.05 million.
2. Reimbursement of fees (fees) for examination of registrations and re-registrations of drugs to be used only in Armenia is carried out with state funding in the amount of 50% for each drug, but not more than 550 thousand drams.
3. Compensation of 50% of fees (fees) for examination of registrations and re-registrations of strategically important drugs is included in the amount of funding specified in points 4 and 5 of the program, because points 4 and 5 of the program may have to be drugs that will be of strategic importance.
4. Reimbursement of the costs of registration examinations of Armenian-made drugs abroad is carried out with state funding in the amount of 50% for each drug, but not more than 2.5 million drams.

In order to get more detailed information about the program (including the procedure and conditions for providing assistance, the format of the application), you can go to the following by reference .

For additional information, you can call +374 11 597 125.

  HOT! LINE : 81-40