PHARMACEUTICAL BUSINESS CERTIFICATION APPLICATION DOCUMENTATION

To conduct pharmaceutical business activities, most pharmaceutical businesses need to obtain a Pharmaceutical Business Certificate. So, what are the document requirements for obtaining this certificate, and what is the step-by-step procedure? Let’s delve into these details with LawPlus in the following article.

1. Documents needed

The documents required for applying for a Pharmaceutical Business Certificate are specified in Article 38 of the Pharmaceutical Law 2016 and vary depending on the following cases:

For the first-time issuance or for businesses whose certificate has been revoked:

• Application for the Pharmaceutical Business Certificate.
• Technical documents corresponding to the pharmaceutical business.
• Notarized copy of the business registration certificate or legal documents proving the establishment of the business.
• Notarized copy of the pharmaceutical professional practice certificate.

For businesses with changes in their business type or scope:

• Application for the Pharmaceutical Business Certificate.
• Technical documents corresponding to the changed business conditions.
• Notarized copy of the business registration certificate or legal documents proving the establishment of the business.
• Notarized copy of the pharmaceutical professional practice certificate.

2. Documents for Reissuance of the Certificate

• The Pharmaceutical Business Certificate can be reissued in the following cases:
• Loss or damage to the original certificate.
• Incorrect information on the certificate due to an error by the issuing authority.
• The documents required for the reissuance of the Pharmaceutical Business Certificate include:
• Application for the reissuance of the Pharmaceutical Business Certificate.
• Original certificate with corrections (if applicable).

3. Documents for Adjustment Request

The Pharmaceutical Business Certificate can be adjusted when there are changes in the business name, business address, professional manager, or business scope without changing the business conditions.

The documents required for an adjustment request include:

• Application for the adjustment of the Pharmaceutical Business Certificate.
• Notarized copy of the pharmaceutical professional practice certificate for cases requiring a change in position.
• Notarized copy of the business registration certificate or legal documents proving the changes, in case of changes to the business name or address.

4. Procedure for Obtaining the Pharmaceutical Business Certificate

The business submits the application to the Department of Health where the business is located.

Upon receiving the application, the Department of Health issues a receipt to the applicant.

No amendments or supplements are required; the Department of Health issues the certificate within 20 working days for cases where the facility, technical, and personnel aspects have been evaluated and meet the requirements.

When amendments or supplements are required, the Department of Health informs the business within 10 working days, specifying the necessary documents and content for correction or supplementation.

After receiving the amended or supplemented documents, the Department of Health issues a receipt to the business.

If the amended or supplemented documents do not meet the requirements, the Department of Health notifies the business accordingly.

If there are no amendments or supplements required for the adjusted documents, the Department of Health proceeds as in Step 2.

After the on-site evaluation of the facility, the Department of Health is responsible for either issuing the certificate within 10 working days (for cases without requests for corrections or repairs) or issuing a notice specifying the necessary corrections or repairs within 5 working days.

Within 20 days from the date of receiving the notification and supporting documents proving the completion of corrections or repairs, the Department of Health issues the certificate or provides reasons for non-issuance.

Within 5 working days from the issuance of the certificate, the Department of Health announces and updates the following information on its electronic portal:

Business name and address of the granted certificate.

Full name of the pharmaceutical professional in charge, with their pharmaceutical professional practice certificate number.

Pharmaceutical Business Certificate number.

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