Chương 3 Luật Dược 2005: Đăng ký, lưu hành thuốc

Chapter III

DRUG REGISTRATION AND CIRCULATION

Article 35.- Drug registration

1. Bases for drug registration includes:

a/ Results of clinical trials of the effectiveness and safety of drugs, except for those exempt from clinical trials defined in Article 55 of this Law;

b/ Technical documents on drugs;

c/ Vietnam's national policies on drugs.

2. Establishments registering drugs must pay registration fee upon filing of dossiers according to the provisions of law.

3. Within six months after receiving complete and valid dossiers, the Health Minister shall grant drug registration numbers. In case of refusal to grant registration numbers, he/she shall have to reply in writing, clearly stating the reasons therefor.

4. The Health Minister shall specify procedures and dossiers for drug registration, the valid duration of drug registration numbers and the withdrawal of drug registration numbers.

Article 36.- Drug circulation

1. Drugs circulated in the market must fully satisfy the following conditions:

a/ Being up to the registered quality standards;

b/ Fully satisfying requirements on labeling of drugs according to the provisions of Article 37 of this Law and other provisions of law;

c/ Being packed with materials and in a form as required to ensure drug quality;

d/ Having a registration number, or having no registration number but being imported according to the provisions at Points a and b, Clause 2, Article 20 of this Law;

e/ Having their prices declared according to the provisions of this Law; for imported drugs, their prices must not be higher than those of drugs imported into regional countries with the healthcare and commercial conditions similar to those of Vietnam at the same time.

2. Home-made drugs for national health programs and imported drugs specified at Points c, d, e and f, Clause 2, Article 20 of this Law must be used for proper purposes and objects; drug labels must comply with the provisions of Article 37 of this Law; and retail packing of such drugs must be printed with the words "Not for sale" except for cases defined at Point e, Clause 2, Article 20 of this Law.

Article 37.- Labels of drugs circulated in the market

1. A label of a drug circulated in the market must fully have the following contents:

a/ The names of the drug;

b/ The preparation form;

c/ The composition of the drug;

d/ Packing specifications;

e/ The name and address of the manufacturing establishment;

f/ The registration number, serial number of the manufacture lot, date of manufacture, expiry date.

g/ Conditions for drug preservation and other necessary information.

For specifics which are composed of single substances, their original names or international generic names must be shown below their specific names.

2. Drugs must have use instructions in Vietnamese.

Article 38.- Withdrawal of drugs

1. Drugs circulated in the market shall be withdrawn in the following cases:

a/ They are not of the right categories due to mistakes in the course of dispensing, delivery and receipt;

b/ They fail to fully satisfy the conditions specified at Points a, b, c and d, Clause 1, Article 36 of this Law;

c/ There are drug withdrawal notices of manufacturing establishments or Vietnamese or foreign agencies in charge of state management over pharmacy.

2. For cases of drug withdrawal defined at Points b and c, Clause 1 of this Article, before the withdrawal, there must be circulation termination decisions of the Vietnamese agency in charge of state management over pharmacy.

3. Upon receipt of drug withdrawal notices of manufacturing establishments or circulation termination decisions of the Vietnamese agency in charge of state management over pharmacy, drug-trading organizations or individuals, medical examination and treatment establishments, drug prescribers and drug users shall have to immediately terminate the trading, information, advertising, prescription, dispensing and use of the drugs stated in withdrawal notices.

4. Establishments importing, manufacturing, registering or supplying drugs shall have to organize the withdrawal subject to circulation termination and pay damages according to the provisions of law.

The agency in charge of state management over pharmacy shall have to inspect the organization of drug withdrawal.

5. The Health Minister shall specify the order and procedures of drug withdrawal, classification of withdrawal, scope of drug circulation termination and disposal of withdrawn drugs.