Request for harmless destruction of medicines (including veterinary medicines) and food supplements

Destruction of unusable medicines (following the expiration of the validity period, counterfeit, with quality deficiencies, without documents of origin).

Pharmaceutical or medical company representatives/institutions must submit the required documents either in person at the Medicines and Medical Devices Agency's one-stop window or via e-mail to tatiana.sarbu@amdm.gov.md.

Content of the dossier:

  1. A free-form application (on letterhead) addressed to MMDA, requesting the harmless destruction of medicines within the Republic of Moldova.
  2. Copies of documents confirming the quality of the product.
  3. A copy of the company/institution's order or excerpt from the signed order, specifying the drugs to be destroyed (pharmaceutical form, dose, batches, quantity, term of validity and reason for the the uselessness of the pharmaceutical products).
  4. Copy of the " Invoice " verifying the payment made for the harmless destruction of the medicines.

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  • 1
    Step 1. Application

    The applicant submits the dossier:

    • electronically to either office@amdm.gov.md or tatiana.sarbu@amdm.gov.md
    • mail can be dropped off physically at the one-stop window or in the mailbox situated at the Security Service, the main entrance of MMDA. Mail received from the mailbox is collected once a day.

  • 2
    Step 2. Evaluation of the request received from economic operators

    Upon receiving the application, the chemist will determine the cost of the services and create the invoice within a maximum of 3 days.

  • 3
    Step 3. The issuance and sending of the invoice

    Subsequently, the chemist sends the Invoice to the economic operator via email the requests the acknowledgement of the receipt.

  • 4
    Step 4. Validation of the dossier and collecting the medicines

    Following the economic operator's presentation of the payment confirmation for the services related to the safe destruction of medicines, he submits the medicines for destruction within 60 days (or as per the contract terms) along with the specified documents. The pharmacist checks the documents against the medicines to ensure compliance.

    The package of supporting paperwork will consist of:

    1. The application directed to the economic operator;
    2. The company/institution's order or excerpt from the signed order, specifying the drugs to be destroyed;
    3. Documents confirming the quality of the product;
    • The quality certificate or the register medicines which distribution is approved through organoleptic examination of packaging and labeling.
    • Non-compliance form.
    • Seizure documents for medicines due to violations of import regulations in the Republic of Moldova.

    Upon review of the documentation against the stock of drugs designated for destruction, the Chemist and contracted employees will receive the drugs for harmless destruction. They will then co-sign the Act of receipt of drugs for their subsequent destruction, annex no. 1 to the Regulation on the harmless destruction of medicines with expired, counterfeit, quality deficiencies or without documents of origin (accompanying) to MSPSRM Order no. 9 of 06.01.06 in 2 copies. The economic operator will receive one copy, while the other copy will be retained with the set of documents.

    If discrepancies are discovered in the documentation or the quantity stated in the documents, the Chemist will not accept the medicines.

  • 5
    Step 5. Storage of medicines

    Medicines belonging to the regular group, which are received from economic entities for harmless destruction, are securely stored in designated areas under lock and key. Medicines belonging to the specific category are kept in a secure location within the designated room until the scheduled Permanent Commission for the Harmless Destruction of Medicines (PCHDM) meeting.

  • 6
    Step 6. Organization of the PCHDM meeting.

    PCHDM is scheduled biannually or as needed (as determined by the general director). The timing of the PCHDM event is arranged in consultation with the MMDA director. Later, the chemist create the Extract based on the report detailing the harmless destruction of expired, counterfeit, or low-quality medicines as well as those without supporting documentation in order to release the fiscal invoices.

Agenția Medicamentului și Dispozitivelor Medicale
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