Release of certificate of pharmaceutical product (CPP) in WHO format

The Certificate of Pharmaceutical Product (CPP) is a document issued by MMDA at the request of a registration certificate holder to support the process of registering a medicinal product with other regulatory authorities in another country.

CPP confirms:

1. That the approval by MMDA was based on a full evaluation of the quality, safety and efficacy of the product;

2. The product is manufactured according to good manufacturing practices;

3. The status of registration and marketing of the product in the Republic of Moldova.

CPP is issued only at the request of the holder of its registration certificate.

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  • 1
    Step 1. Submission of the application

    The application can be submitted:

    1) electronically, to the e-mail address: office@amdm.gov.md;

    2) at the single counter or in the mailbox located at the Security Service, the main entrance of AMDM.

    Note: the application is submitted in free form (there is no standardized model), indicating the commercial name of the medicinal product, the name proposed for export (if it is different from the one approved in the Republic of Moldova) and the country where the export will be made.

  • 2
    Step 2. 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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    Step 3. Processing and Review

    Processing the request and evaluating the data received; Preparation of the Pharmaceutical Product Certificate according to WHO recommendations based on the authorization file approved by MMDA.

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    Step 4. Release/deferral/refusal of release

    The CPP is issued through the one-stop shop of the MMDA, at the address of the municipality of Chisinau, 2/1 Korolenko str.

    Note: MMDA Can refuse the issuance of the CPP, if the payment account has not been paid according to the provisions of HG 348/2014 regarding the tariffs for the services provided by the Medicines and Medical Devices Agency

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Agenția Medicamentului și Dispozitivelor Medicale
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