In order to promote the production of drugs in the Republic of Armenia, reduce production costs, and expand the product range, the "Compensation program for the implementation of clinical trials and bioequivalence studies in the Republic of Armenia" was adopted by the Resolution of the Government of the Republic of Armenia No. 349 of March 7, 2024, according to which the Government of the Republic of Armenia provides Partial reimbursement of costs of clinical trials and (or) bioequivalence studies of drugs produced in the Republic.

Mandatory requirements:

The manufactured product must comply with the concept of "drug" defined by the Law of the Republic of Armenia "On Medicines".

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.

Submitted documents:

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

• Reference provided by the SRC (on the lack of administrative proceedings initiated to collect unfulfilled tax obligations at the time of application submission)
• Clinical trial permit issued by the Ministry of Health of the Republic of Armenia
• Application according to form N 1 (In Armenian)
• Summary description of the pharmaceutical product under investigation according to form N 2 (In Armenian)
• Copy of the certificate of the State Register of Legal Entities of the Republic of Armenia.
• The additional information required by points 12 and 13 of the compensation program for the implementation of clinical trials, bioequivalence studies in the Republic of Armenia.

If the documents match, a contract is signed with the beneficiary. (In Armenian)

After completing the research.

• The clinical monitoring report received from the Ministry of Health of the Republic of Armenia.
• Documents justifying the implementation of the research (relevant billing document provided to the beneficiary by the entity conducting the research and a document certifying the payment) regarding the actual costs incurred (payment for clinical trials or bioequivalence studies).

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

1. in the amount of 50% of the costs of clinical trials, but not more than AMD 25 million for each study.
2. in the amount of 50% of the costs of bioequivalence studies, but not more than 30 million drams for each study.

 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 link. (In Armenian)

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