Name Registration requirement of pharmaceutical manufacturer for importers or representative offices
Description Drug Import companies and representative offices shall firstly be registered for pharmaceutical manufacturing just being approved to be registered of Drug productions in the Ministry of Health.
Comments To ensure good manufacturing practice in drug production and to ensure that the drug productions are of high quality agreeing to the international standards
Validity From 01/08/2013
Validity To 31/12/9999
Reference
Technical Code P15
Agency Ministry of Health
Created Date 2023-03-08 06:17:03
Updated Date 2023-03-08 06:17:03
Status publish
Measure Type Registration Requirement
Legal/Regulation Prakas No. 003 on the Procedures and Conditions of the Submission of the registration of Pharmaceutical Manufacturer from Overseas
Un Code 2180-Export Prohibition

Resources

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Procedures


Procedure Name Description Category View Procedure Detail with Relevant Forms
Application for Registration of Pharmaceutical Manufacturer from Overseas Procedure to obtain a Certifcate for Pharmaceutical Manufacturer from Overseas View

This measure applies to commodity/s


HS Code Description
12573 – – Containing penicillins or derivatives thereof: – – – Containing penicillin G (excluding penicillin G benzathine), phenoxymethyl penicillin or salts thereof
12574 – – Containing penicillins or derivatives thereof: – – – Containing ampicillin, amoxycillin or salts thereof, of a kind taken orally
12575 – – Containing penicillins or derivatives thereof: – – – Other
12576 – – Containing streptomycins or derivatives thereof: – – – In ointment form
12577 – – Containing streptomycins or derivatives thereof: – – – Other
12578 – – Containing gentamycin, lincomycin, sulfamethoxazole or their derivatives, of a kind taken orally or in ointment form
12579 – – Containing erythromycin or derivatives thereof: – – – Of a kind taken orally
12580 – – Containing erythromycin or derivatives thereof: – – – In ointment form
12581 – – Containing erythromycin or derivatives thereof: – – – Other
12582 – – Containing tetracyclines or chloramphenicols or derivatives thereof: – – – Of a kind taken orally or in ointment form
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