State control of the quality of medicines

The state control of the quality of medicines is carried out according to the provisions and on the basis of the documents provided as annexes in Order MH no. 521/2012 on the state control of the quality of medicines.

Applicants submit at the one-stop shop the Application for sampling the average sample and performing the state control of the quality of medicines with the necessary documents as follows:

 A. For control quality medicines manufactured in the Republic of Moldova, the manufacturer submit to the Agency:

1) application form for sampling and performing state control of medicines (annex no. 4);

2) the project of the sampling act, in according to the model presented (annex no. 6)

3) the quality certificate of the medicine issued by the manufacturer, as well as the electronic version; 

B. For control quality import medicines, after import, the applicant submits to the Agency:

1) the application form for sampling and performing state control of medicines imported (annex no. 5);

2) the copy statement customs - 1 copy;

3) copy of the invoice perfect customs - 2 copies;

4) the quality certificate of the medicine issued by the manufacturer

5) the project of the sampling act for state control of medicines imported into​ according to the model presented (annex no. 7) in 3 copies, as well as the electronic version. 

C. For control quality raw materials used in the Manufacturing and / or Preparation of medicines, the applicant submits to the Agency:

1) the application form for sampling and performing state control of substances medicines (annex no. 4);

2) the copy the quality certificate of the substance of medicines issued by manufacturer;

3) the copy statement customs - 1 copy;

4) copy of the invoice perfect customs (in case of import) - 1 copy or invoice of dispatch and transport in case of procurements on the territory of the Republic of Moldova;

5) the project the act of sampling of the raw material, in accordance with the model presented (annex no. 8).

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  • 1
    Step 1. Submission of the application

    1. The application can be submitted online, to the e-mail address: office@amdm.gov.md or


    2. Physical (at the one-stop shop or in the mailbox located at the Security Service, the main entrance of MMDA; Mail received from the mailbox is picked up once a day)

  • 2
    Step 2. Request processing and evaluation, assignment to control type

    Processing the request and evaluating the data received,

    Control types:

    1. preventive,

    2. subsequent-selective


  • 3
    Step 3. Sampling/Sample reception

    In the case of preventive control, the sampling is carried out by MMDA.

    In the case of subsequent-selective control, the samples are presented to MMDA by the applicant and received by MMDA


  • 4
    Step 4. Registering the application in the DQCLM database, issuing the payment slip

    1. Registration of the application in the DQCLM database, internal coding of each series, preparation of the Analytical Sheet

    2. Issuing the payment slip


  • 5
    Step 5. Paying for the service

    Payment can be made:

    1.     through the government electronic payment service MPay ( https://mpay.gov.md )

    2.     through commercial banks, on MMDA's account

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  • 6
    Step 6. Perform quality control

    1. Performing laboratory tests in order to comply with DAN provisions, in the case of preventive control

    2. Carrying out the organoleptic control, in the case of the subsequent-selective control

    3. Entering the results obtained into the DQCLM database

  • 7
    Step 7. Issuance of compliance reports

    1. Issuance of the Quality Certificate/Analysis Bulletin, in the case of preventive control

    2. Issuance of the Medicines Register, in case of subsequent-selective control

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Agenția Medicamentului și Dispozitivelor Medicale
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