Decree 54/2017/NĐ-CP Details and Guidelines on the Implementation of Specific Articles of the new Pharmaceutical Law
Detailing and guiding the implementation of some articles of Pharmaceutical Law
Pursuant to the Government Organization Law No. 76/2015/QH13 dated 19 June, 2015;
Pursuant to the Pharmaceutical Law no 105/2016/QH13 dated 6 April 2016;
At the request of the Minister of Health,
The government hereby issues the Decree detailing and guiding the implementation of some articles of Pharmaceutical Law.
Article 1. Scope of regulation
This Decree provides guidelines on the certificate for pharmacy practice; pharmaceutical business operations; drug exportation; drug importation; marketing registration of medicinal materials, excipients, capsule shells; the assessment of drug manufacturing establishments residing abroad; powers, format, formalities pertaining to the recall of drug raw materials; handling measures of recalled drug raw materials; drug information; drug advertisement; and drug price regulatory measures.
Article 2. Definition of terms
In this Decree the terms below shall be construed as follows:
1. Drug information is the collection, provision of drug-related information on indications, contraindications, dosage, administration routes, adverse drug reactions, and other information pertaining to drug quality, safety and efficacy, conducted by responsible establishments with the aim of meeting the information requirements of entities, individuals practicing medicine and pharmacy, or drug users.
THE ORIGINAL DECREE:
Edited by: Jean Ngo