According to the legislation the Good Manufacturing Practice (including the Eurasian Economic Union Good Manufacturing Practice) compliance inspection is performed by the Center of Drug and Medical Technology Expertise under the Ministry of Health of the Republic of Armenia (hereinafter – the Center). The expenses related to the inspection are covered by the Applicant based on the contract signed between the Applicant and the Center (hereinafter – the Contract).
In order to support the arrangements for inspection processes the Center has elaborated templates of the CONTRACT for Conducting Good Manufacturing Practice Compliance Inspection and Appendix (English versions), which are available at the following link (contract template, contract appendix template)
In order to organize the Good Manufacturing Practice inspections (hereinafter- Inspection) it is necessary to do the following:
Step 1. Agreement of contractual terms
§ The Applicant gets acquainted with the content of the Contract available on the official website of the Center (contract template, contract appendix template)
§ The Applicant forms and sends by e-mail (to ) the relevant letter to the Center (Word format) indicating the name of the Applicant, the name of the director, as well as data for filling the 11th point of the Contract and 1 and 2 point of the Appendix (if the Contract already exists, the data for completing additional Appendix), including at least one option of the preferred inspection time, guided by the schedule available on the Center's website. The letter also indicates the needs to make any additions or amendments to the draft Contract (a standard template of the letter is available at the following link (standard template of the letter)
§ In further correspondence, the parties agree on the term of Inspection and the final version of the draft contract within a maximum of 3 working days.
§ If the same Applicant applies for inspection more than one manufacturing sites, a new Appendix is created for each one, numbering it with a serial number (Appendix 1, Appendix 2, Appendix 3 at etc.).
Step 2. Contract preparation and ratification by the Center
§ The Center sends scan copies of the signed versions of the Contract and it’s Appendix (PDF format) to the applicant by e-mail, and the originals by post, if necessary.
Step 3. Signing the contract by Applicant
§ Applicant signs and seals (if available) the versions signed by the Center
§ Crates the scan copies of the documents (PDF format).
§ Original versions of the Contract and Appendix are sent by Applicant to the Center by post not less than by the end of the inspection, if necessary.
Step 4. Making prepayment by Applicant
§ Payment shall be transferred by terms defined in the Contract.
§ In case of using foreign currency (USD, EURO) the transfer should be made at the exchange rate of this day of the Central Bank of the Republic of Armenia (official website:
Step 5. Submission of application for Inspection to the Center by Applicant
§ Applicant prepares a cover letter` attaching scan copy of Contract (including the Appendix), document confirming the transferring prepayment and other documents defined by the Annex 4 of the Governmental Degree 199-N of February 28, 2019` (PDF format) in Russian or English.
§ the cover letter and the attached documents are submitted to the Center in person or by e-mail or through electronic system or by postal delivery.
Step 6. Receiving the Documents by the Center and starting the inspection process
§ The Center notifies Applicant by e-mail about receiving of the documents.
§ After receiving prepayment into account of the Center, the inspection is started according to the procedure established by the Contract.
Step 7. Finalization of the Inspection process
§ Inspection report shall be provided to the Applicant according to the legislation after receiving the document confirming the receipt of the all inspection’s expenses amount on the relevant bank account of the Center.
Step 8. Getting GMP certificate
Based on the positive conclusion given by the GMP Inspection report, the manufacturer may apply to the Ministry of Health of the Republic of Armenia for getting a GMP certificate in accordance with the procedure defined by Annex 2 of the Governmental Degree No. 199-N of February 28, 2019.
The state tax is defined by Part 50 of Article 20 of the RA Law on State Tax, amounting to 30,000 AMD.
The set amount must be transferred to the state budget.
§ Recipient: RA state budget.
§ Central Treasury account No. 900005001376
Foreign applicants may transfer the amount to the Center's account (through the banks specified in the Contract) in case of payment difficulties. The Center will then secure the transfer to the State Budget by providing the applicant with proof of payment. Transfers in foreign currency (USD, Euro) shall be made at the current exchange rate of this day of the Central Bank of the Republic of Armenia (official website: www.cba.am).
