Enterprises are in need of importing and trading pharmaceutical products through the website but do not know the conditions and required certificates,… T2H Lawyers would help you answer these questions.
Legal grounds:
- Law on Enterprises 2014
- Law on Pharmacy 2016
- Decree No.54/2016/NĐ-CP (Amending by Decree No. 155/2018/NĐ-CP);
- Circular 07/2018/TT-BYT;
- Law on advertising 2012;
- Circular 09/2015/TT-BYT.
- Conditions for enterprises:
– The enterprise must have a business registration certificate or legal documents proving the establishment of the base;
– Enterprises must have certificates of satisfaction of drug trading conditions with the scope of drug wholesale;
– Persons in charge of pharmacy expertise have a pharmacy practice certificate;
– Website must notify the Ministry of Industry &Trade;
– When advertising on the website, enterprises must send dossiers of information registration and advertising to the Drug Administration of Vietnam.
- Conditions for pharmaceutical products
- Having Certificate of Free Sale
- Having Certificate of Pharmaceutical Product Certificate of Pharmaceutical Product (CPP), in the absence of CPP can be replaced with FSC and GMP;
- When importing drugs, it is required to design drug labels and sub-labels and have technical documents clearly showing the quality and properties of drugs;
- Test slip for each batch of imported drugs.
And other dossiers and certificates in the process of carrying out import procedures and registration with state agencies
Please contact us for detailed advice.
T2H Law Liability limited company
Head office: G4-4A, Dormitory 708, Lien Ninh, Thanh Tri, Hanoi
Branch office: Floor 4, no.2, 115 Chien Thang Street, Van Quan Ward, Ha Dong District, Hanoi.
Phone: 0242 242 9900 – 0989 656 682
Website: https://t2hlawyers.vn
Email: contact.t2h@t2h.vn – huong.le@t2h.vn
