OVERVIEW THE LAW ON PHARMACY 2016
The Pharmacy Law No 105/2016/QH13 consists of 14 chapters, 116 articles (in comparison with the Pharmacy Law No 34/2005/QH11 consists of 11 chapters and 73 articles, increasing 43 articles and there are 4 new chapters as 2, 3, 11, 13). This Law was valid from January 01, 2017.
Chapter I. General provisions
Chapter II. State policies on pharmacy and development of pharmacy industry
Chapter III. Pharmacy practice
Chapter IV. Pharmacy business
Chapter V. Registration, sale, recall of drugs and medicinal ingredients
Chapter VI. Herbal ingredients and traditional drugs
Chapter VII. Prescription and use o drugs
Chapter VIII. Drug information, pharmacovigilance, and drug advertisements
Chapter IX. Clinical pharmacology
Chapter X. Management of drugs in health facilities
Chapter XI. Clinical trial and bioequivalence study
Chapter XII. Quality standards and regulations; testing of drugs, medicinal ingredients and primary packages of drugs
Chapter XIII. Drug price management
Chapter XIV. Implementation
Prohibited acts
– Trading a pharmacy business without the Certificate of eligibility for pharmacy business.
– Trading a pharmacy business at a location other than the registered business location.
– Trading drugs and medicinal ingredients for improper purposes or providing drugs and medicinal ingredients for subjects that are not permitted.
– Trading a pharmacy business beyond the scope written in the Certificate of eligibility for pharmacy business.
– Trading a pharmacy business that involves:
- Counterfeit drugs/ Drugs or medicinal ingredients that have to be recalled as requested by a competent authority/ Drugs or medicinal ingredients of unknown origins and sources; expired drugs.
- Drugs or medicinal ingredients on the list of drugs and medicinal ingredients banned.
- Drugs for clinical trial/ Drugs that belong to a National Target Program/ Drugs or medicinal ingredients as samples for registration, testing/ drugs as aid.
– Tampering, fixing documents or certificates of competent authorities and other entities in pharmacy activities.
– Practice of medicine without a pharmacy practice certificate at positions requiring the pharmacy practice certificates.
– Renting, borrowing, leasing out, lending or allowing another person to use the pharmacy practice certificate or Certificate of eligibility for pharmacy business.
– Using a certificate/ results have not recognized by the Ministry of Health to advertise drugs.
– Running sale promotion of drugs against the law.
– Dispensing, selling expired drugs …
– Providing information, advertising, marketing, prescribing, counseling, labeling … giving instructions that non-medicinal products can be used for prevention, treatment, except for medical equipment.
– Exporting herbal ingredients on the list of rare and precious herbs without permission of a competent authority.
State policies on pharmacy and development of pharmacy industry
– Provide investment incentives for manufacture of drugs, medicinal ingredients, essential drugs, drugs for prevention and treatment of social diseases, vaccines, biologicals, herbal drugs, traditional drugs, rare drugs; provide incentives for scientific research into preparation technology, biotechnology for manufacturing new drugs.
– Facilitate procedures of application for the market authorization of the drugs losing patent protections, the first similar biologicals; give priority to procedures of application for the market authorization and licenses to import rare drugs, vaccines have pre-validated by WHO.
Pharmacy practice certificate
– 03 positions requiring pharmacy practice certificates
- The person responsible for pharmaceuticals expertise of a facility pharmacy business.
- The person in charge of quality assurance of a drug or medicinal ingredient manufacturing factory.
- The person in charge of clinical pharmacology of a health facility.
– Conditions for issuance of a pharmacy practice certificate
- Has any degree, diplomas, qualification certificate.
- Has practise time.
- Not be facing a criminal prosecution / serving a court’s sentence or ruling / be suspended from practice…
- Has a certificate of suitable health for pharmacy practice.
- Foreigners and Vietnamese citizens residing overseas: Satisfy the language requirements in pharmacy.
– Reduce the practise time condition before being issued a pharmacy practice certificate from 05 years to 02 or 03 years for some positions, except the chief pharmacist and the person in charge of quality assurance of a drug or medicinal ingredient manufacturing factory still 05 year as before.
– Add to issue a pharmacy practice certificate by form of a national examination, to move the intergration and mutual recognition of pharmacy practice certificate with other countries.
– The power to issue pharmacy practice certificates
- The Ministry of Health: Form of a national examination.
- The Drug Administration of VN: Submit application form for consideration and approval.
– A pharmacy practice certificate does not have an expiration date and is recognized nationwide.
Pharmacy business
Forms of business
– Business activities include trading in drugs/medicinal ingredients and provide a number of relevant services to drugs/medicinal ingredients.
– Addition business activities provision of clinical trial services and provision of bioequivalence study services.
Conditions for issuance of Certificate of eligibility for pharmacy business
– Manufacturer of drugs/medicinal ingredients: must have GMP
– Importer and exporter of drugs/medicinal ingredients: GSP
– Provider of drug/medicinal ingredient storage services: GSP
– Wholesaler of drugs/medicinal ingredients: GDP
– Drug retailer: GPP
– Provider of drug/medicinal ingredient testing services: GLP
– Provider of clinical trial services: GCP
– Provider of bioequivalence services: GLP, GCP
Conditions for trading in controlled drugs
Controlled drugs:
§ Drug, narcotic medicinal ingredients, psychotropic drug, precursor drug
§ Combined drug that contain narcotic ingredients, psychotropic substances, precursors
§ Radiopharmaceutical, Radioactive isotope, Tracer (also carrier)
§ Toxic drugs, toxic medicinal ingredients on the List promulgated by the Minister of Health
§ Drugs, active ingredients on the List of banned substances in some fields and sectors promulgated by the Government
The Government provide for:
– Sequences, procedures for business permits of the controlled drugs and the drugs in the retail limitation list.
– Measures for protecting controlled drugs/medicinal ingredients from loss.
Pharmacy establishments not required to obtain Certificates of eligibility for pharmacy business
– Every non-commercial pharmacy establishment.
– Sale Over-the-counter drugs (OTC) at comsumer goods business establishment that has a drug cabinet.
– Herb farming and picking establishments.
Certificate of eligibility for pharmacy business
– A Certificate of eligibility for pharmacy business does not have an expiry date, periodical audit for eligibility every 3 years or the unscheduled inspection.
– The power to issue certificate of eligibility for pharmacy business:
- The Ministry of Health: Manufacturers/ Exporters, importers/ storage services/ testing services, clinical trial services/ bioequivalence study services of drugs/medicinal ingredients.
- The Drug Administration of VN: Drug retailers.
Registration of drugs and medicinal ingredients
The following entities may register drugs/medicinal ingredients
- Any establishment manufacturing, wholesaling, exporting, importing drugs/medicinal ingredients in Vietnam
- Any foreign establishment trading in drugs/medicinal ingredients and having a representative office in Vietnam
A drug or medicinal ingredient shall be granted the certificate of market authorization in Vietnam when the following requirements are satisfied
§ Safety and efficacy requirements are satisfied
§ It is manufactured by a manufacturer that satisfies the conditions specified in law
§ It is manufactured according to manufacture procedures and satisfy quality standards
The foreign manufacturer must be audited according to the following methods:
- Verifiy documents about manufacturing conditions.
- Mutual recognition of inspection results given by pharmacy authorities regarding the fulfillment of GMP requirements.
- Inspection at the manufacturing facility.
Types of registration of drugs and medicinal ingredients
- Issuance of a certificate of market authorization
- Renewal of a certificate of market authorization
- Adjustment of a certificate of market authorization.
Time limit for issuing, renewing, or adjusting a certificate of free sale
- Not more than 03 months from the receipt of the satisfactory application for renewal or adjustment of a certificate of market authorization.
- Not more than 12 months from the receipt of a satisfactory application for issuance of a certificate of market authorization.
An entity for drug/medicinal drug registration has the obligations to
- Notify the regulatory body of the drug or medicinal ingredient in case of change.
- Retail documents related to the drug/medicinal drug registration and provide them to competent authorities at their request.
- Inspect or assess the manufacturing facility when requested by competent authorities.
Free sale of drugs and medicinal ingredients
– Drugs and medicinal ingredients granted certificates of market authorization.
– Drugs and medicinal ingredients may be sold sale until their expiry dates if they are manufactured before the expiry dates of certificates of market authorization.
– Imported drugs and medicinal ingredients may be sold until their expiry dates if they are delivered at the port of departure in the exporting country before the expiry dates of certificates of market authorization.
– Drugs or medicinal ingredients domestically manufactured or imported before the revocation date of the certificate of market authorization.
A drug must satisfy the following requirements to be sold on the market
§ It meets quality standards and ensures safety and efficacy
§ It complies with regulations on drug labeling
§ The packaging material and method ensure drug quality
A medicinal ingredient must satisfy the following requirements to be sold on the market
§ It is qualified for drug manufacture and ensures safety and efficacy.
§ It complies with regulations on drug labeling in Article 61 hereof and relevant regulations of law
§ The packaging material and method ensure medicinal ingredient quality
Drugs/medicinal ingredients permitted for import and export
Drugs/medicinal ingredients granted certificates of marketing authorization in Vietnam may be imported without licensing, do not restrict the quantity except the controlled drugs (Narcotics, Psychotropics, Precursors,…)
Strengthen in management of drugs quality
Types of recall: Voluntary recall and Mandatory recall
Classification of violations:
- Level 1: the drug shall be recalled from every pharmacy business establishment, health facility, and user within 03 days
- Level 2: , the drug shall be recalled from every pharmacy business establishment, health facility, and user within 15 days
- Level 3: the drug shall be recalled from every pharmacy business establishment within 30 days
Clinical trial and Bioequivalence study
Clinical trial consists of 4 phases and classifies for drug registration
- Phase 1, 2, and 3 shall be carried out before drug registration.
- Phase 4 shall be carried out after drug registration at the request of a competent pharmacy authority.