The Government promulgates Decree No. 54/2017/ND-CP to provide guidelines for implementation of the Law on Pharmacy.
This Decree provides for pharmacy practice certificate; pharmacy business; export and import of drugs; registration of herbal ingredients, excipients, capsule shells; assessment of overseas drug manufacturers; power, method and procedures for recalling medicinal ingredients; handling of recalled medicinal ingredients; documents and procedures for issuance of certification of drug advertisement and drug price management.
An application for the pharmacy practice certificate mentioned in Article 24 of the Law on Pharmacy consists of:
a) The application form No. 02 in Appendix I enclosed herewith, 02 portrait pictures (4x6 cm) of the applicant on a white background which was taken within the last 6 months;
b) Certified true copy of the applicant’s qualification. If the qualification is issued overseas, its certified true copy must be enclosed with an equivalence certification issued by a competent authority specified in Clause 2 Article 18 hereof;
c) The original copy or certified true copy of the health certificate issued by a medical facility in accordance with the Law on Medical examination and treatment;
d) The original copy or certified true copy of the certificate of internship (Form 03 in Appendix I enclosed herewith). If the internship took place in more than one facility, the internship duration will be the total duration of internship at the facilities according to the certificates of internship issued by such facilities;
dd) If the scope of practice covered by the pharmacy practice certificate applied for requires different internship durations and facilities, the application shall be enclosed with a certificate of internship of one or several facilities that meet requirements of each position.
e) The original copy or certified true copy of the confirmation of examination result specified in Clause 2 Article 28 hereof if the pharmacy practice certificate has to be obtained after passing an examination;
g) If the applicant is a foreigner or a Vietnamese citizen residing overseas applying for the pharmacy practice certificate without taking an examination, documents proving the applicant’s language proficiency specified in Clause 2 Article 14 of the Law on Pharmacy.
Requirements to be satisfied by retailers of herbal ingredients, herbal drugs and traditional drugs:
a) The chief pharmacist of the retailer of herbal ingredients, herbal drugs or traditional drugs shall satisfy the requirements in Clause 4 Article 18 of the Law on Pharmacy;
b) The retailer has an isolated and fixed store which is firmly built; the store area is suitable for its scope of business, located in a high, dry, airy and safe area, at an adequate distance from sources of pollution and ensures fire safety;
c) The storage area and equipment satisfy the storage requirements written on the labels.
Herbal drugs and traditional drugs must be isolated from herbal ingredients and tradition ingredients.
Toxic herbal ingredients (if any) shall be displayed and stored in a separate area. Otherwise, it must be separated from other herbal ingredients and labeled "dược liệu độc” (“toxic ingredients”) to avoid confusion.
Prescription herbal drugs and traditional drugs (if any) shall be displayed and stored in a separate area. Otherwise, it must be separated from OTC drugs and labeled "thuốc kê đơn” (“prescription drug”) to avoid confusion.
The retailer of the herbal drugs, traditional drugs or herbal ingredients shall have suitable storage areas;
d) Instruments and packages in physical contact with herbal drugs, herbal ingredients or traditional drugs must not affect their quality;
dd) Information about purchases, sales and origins of drugs must be properly recorded;
e) The person who retails herbal ingredients, herbal drugs or traditional drugs (the shopkeeper) shall have one of the documents specified in Points a, c, e, g, i or l Clause 1 Article 13 of the Law on Pharmacy.
Regarding toxic herbal ingredients and prescription herbal drugs, the shopkeeper, who directly sells and counsel buyers, must be a pharmacist;
g) Other goods (if any) must be displayed and stored in a separate area and must not affect the herbal ingredients, herbal drugs or traditional drugs.
An exporter, importer of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors or provider of storage services for these drugs shall:
a) have a separate storage area that meet GSP requirements, is separated from the areas for storing other drugs and have sturdy walls and ceiling with robust doors and locks to store the narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors. b) have a camera system in the storage area of drugs and medicinal ingredients;
c) have a documentary management system according to regulations of the Minister of Health;
d) have a software system for monitoring and managing the inventory of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors.
An exporter, importer or wholesaler of combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors or a provider of storage services for these drugs shall:
a) have a separate area that meet GSP requirements and have sturdy walls and ceiling with robust doors and locks to store combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors. b) have a documentary management system according to regulations of the Minister of Health;
c) have a software system for monitoring and managing the inventory of combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors.
An exporter, importer or wholesaler of radiopharmaceuticals shall manage the inventory of radiopharmaceuticals by a software system and documentary management system according to regulations of the Minister of Health.