GMP EU is one of the strictest principles and standards applied to pharmaceutical factories. Let’s learn about it. So what is EU GMP certification?. What kind of dossier using to apply for EU GMP certification ? 

What’s EU GMP certificate ?

GMP EU – Good Manufacturing Practices European Union is a set of principles and standards of Good Manufacturing Practice along the European Union countries. The EU GMP describes the minimum principles that a drug manufacturer must meet during the manufacture of pharmaceutical products. 

Any pharmaceutical manufacturer in the world that wants to put a product on the European Union market must comply with this principle. 

GMP là gì? Các tiêu chuẩn GMP trong sản xuất dược phẩm - ITG

In order to achieve EU GMP certification, manufactured drugs must meet the following minimum requirements:

– Achieve high quality and uniformity between batches and production batches.

– Fit for the intended use.

– Meet marketing authorization or clinical trial authorization requirement.

Dossier of application for EU GMP Certificate and certification 

To achieve EU GMP certification, factories and production facilities must prepare documents and records in accordance with the law. Dossier for assessing compliance with EU GMP for a pharmaceutical business establishment is the application dossier for the “Certificate of eligibility for pharmacy business” certificate.

 2.1 Receipt of documents 

Manufacturers that want to obtain EU GMP certificates and certifications need to prepare and submit 1 set of documents, together with the assessment fee as prescribed, to the receiving agency of the Ministry of Health: 

a) For the manufacturer that applies for the “Certificate of eligibility for pharmacy business” with the scope of only manufacturing herbal ingredients, traditional drugs or traditional medicines at the time of submitting the application, the application will be submitted. at the Department of Medicine and Traditional Medicine. 

b) For a manufacturer that applies for the “Certificate of eligibility for pharmacy business” with the scope of production of medicinal ingredients (excluding herbal ingredients), medicinal chemistry drugs, herbal drugs, vaccines and biological products, The application will be submitted to the Drug Administration of Vietnam. 

c) For a manufacturer that applies for the “Certificate of eligibility for pharmacy business” with the scope of concurrently manufacturing one of medicinal chemistry drugs or medicinal chemistry ingredients specified at Point a of this Clause and one of the drugs and ingredients to make drugs specified at Point b of this Clause at the time of submitting the application, the dossier will be submitted to the Drug Administration of Vietnam. 

Cục Quản lý Dược - Bộ Y tế

2.2 Appraisal of documents 

The application-receiving agency shall issue the “Certificate of eligibility for pharmacy business” within 20 days from the date indicated on the application-receiving slip, in case the physical, technical and personnel facilities have been approved. Examine, evaluate and respond to Good Practice in accordance with the business scope, not organize the actual assessment at the establishment applying for the Certificate of eligibility for pharmacy business.  

Within 7 working days from the date on which the application is received, when there is a request to amend or supplement the dossier, the application-receiving agency shall send a written request to the requesting establishment, which must include documents and contents that need to be amended or supplemented. 

2.3 Results of the EU GMP 

GMP standard compliance level is divided into 4 categories: level 1, level 2, level 3 and level 4.

Depending on the GMP assessment report that concludes to what extent the production facility complies with GMP, there will be separate regulations on the order and processing time of GMP compliance assessment results. 

After all our tireless efforts, achieving GMP certificates and certifications is the pride of any pharmaceutical manufacturing facility or factory. This is the key to open the door to help businesses expand the market, standing shoulder to shoulder with the powers of five continents. 

INTECH is always by your side on the way to getting closer to GMP certification. 


Circular 35/2018/TT-BYT.

Decree 155/2018/NĐ-CP.

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