Nội dung toàn văn Circular 277/2016/TT-BTC fees in the fields of pharmacy and cosmetics
THE MINISTRY OF FINANCE | SOCIALIST REPUBLIC OF VIETNAM |
No. 277/2016/TT-BTC | Hanoi, November 14, 2016 |
CIRCULAR
ON AMOUNTS, COLLECTION, PAYMENT, MANAGEMENT AND USE OF FEES IN THE FIELDS OF PHARMACY AND COSMETICS
Pursuant to the Law on fees and charges dated November 25, 2015;
Pursuant to the Law on State budget dated June 25, 2015;
Pursuant to the Government’s Decree No. 120/2016/ND-CP dated August 23, 2016 on guidelines for the Law on fees and charges;
Pursuant to the Government's Decree No. 215/2013/ND-CP dated December 23, 2013 defining the functions, tasks, entitlements and organizational structure of the Ministry of Finance;
At the request of the Director of the Tax Policy Department,
The Minister of Finance promulgates a Circular on amounts, collection, payment, management and use of fees in the fields of pharmacy and cosmetics.
Article 1. Scope and regulated entities
1. This Circular deals with amounts, collection, payment, management and use of fees in the fields of pharmacy and cosmetics.
2. This Circular applies to payers and collecting authorities of fees in the field of pharmacy and cosmetics and other entities in connection with the collection, payment, management and use of fees in the fields of pharmacy and cosmetics.
Article 2. Payers
Any entity applying to competent authorities for assessment in the field of pharmacy or cosmetics as prescribed in the Schedule issued herewith shall pay a given amount of fee as prescribed.
Article 3. Collecting authorities
Drug administration of Vietnam, Traditional Medicine Administration of Vietnam (affiliated to the Ministry of Health) and Services of Health of provinces and central-affiliated cities that are in charge of tasks prescribed in the Schedule hereof shall be the collecting authorities.
Article 4. Amount
Amounts of fees in the fields of pharmacy and cosmetics shall be specified in the Schedule issued herewith.
Article 5. Statement and payment
1. No later than every Thursday, the collecting authority shall deposit the amount of fees collected of the last week to the account of fees pending payment to State budget opened at a State Treasury.
2. The collecting authority shall make monthly and annual statements and pay fees as prescribed in Clause 3 Article 19 and Clause 2 Article 26 of Circular No. 156/2013/TT-BTC dated November 6, 2013 of the Minister of Finance on guidelines for the Law on Tax administration; Law on amendments to the Law on Tax administration and the Decree No. 83/2013/ND-CP dated July 22, 2013 of the Government.
Article 6. Management and use of fees
1. Each collecting authority shall pay full amount of fees collected to State budget. Expenses associated with assessment and collection of fees shall be covered as specified in the collecting agency’s estimates according to regime and limits of State budget expenditures in accordance with regulations of law.
2. Eligible collecting authorities prescribed in Clause 1 of Article 4 of the Government's Decree No. 120/2016/ND-CP dated August 23, 2016 may keep 30% of the amount of fees collected to cover expenses prescribed in Article 5 of the Government's Decree No. 120/2016/ND-CP dated August 23, 2016. 30% of fees collected shall be paid to State budget according to the applicable State budget entries.
Article 7. Implementation
1. This Circular comes into force from January 1, 2017 and replaces regulations on collection of fees in the field of pharmacy and cosmetics prescribed in Circular No. 03/2013/TT-BYT dated January 8, 2013 of the Minister of Finance on assessment fees for conditional trading; assessment fees for criteria and conditions for medical and/or pharmacy practice; fees for licenses for export/import of medical equipment, medicinal products, medical practice certificates, health facility operation license.
2. If other contents in connection with collection, payment, management, and use of fees, receipt documents and fee collection regime are not guided in this Circular, they shall apply responsive guidelines in the Law on fees and charges, Decree No. 120/2016/ND-CP dated August 23, 2016 on guidelines for the Law on fees and charges; Circular No. 156/2013/TT-BTC dated November 6, 2013 of the Minister of; and Circular of the Minister of Finance on printing, issuance, management and use of documents of collection of fees and charges payable to State budget and their amending documents (if any).
3. Difficulties that arise during the implementation must be reported to the Ministry of Finance for consideration./.
| PP. MINISTER |
SCHEDULE OF AMOUNTS OF FEES IN THE FIELDS OF PHARMACY AND COSMETICS
(Issued together with Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Ministry of Finance)
No. | Description | Unit | Amount (VND 1,000) |
I | Assessment fees for issuance of licenses for marketing, import, certification, declaration in the field of pharmacy, cosmetics |
|
|
1 | Assessment and certification of information about drugs, cosmetics to be advertised | Application | 1.800 |
2 | Assessment for marketing authorization for drugs, medicinal materials |
|
|
2.1 | Assessment for marketing authorization for drugs, medicinal materials with regard to new registration and re-registration | Application | 5.500 |
2.2 | Assessment for marketing authorization for drugs, medicinal materials with regard to registration renewal | Application | 3.000 |
2.3 | Assessment for marketing authorization with regard to application for registration of change of drugs, medicinal materials obtaining marketing authorization (minor or major changes (including minor changes need to be approved and changes according to forms of notification)) | Application | 1.000 |
3 | Assessment for import licenses for commercial drugs with no registration number (other than import of rare drugs, drugs for the special treatment needs, drugs for prevention and combating of epidemic and natural disasters, drugs for medication assistance, non-commercial drugs, drugs used as registration samples or testing samples, drugs for clinical trials, bioequivalence testing, etc.) | Item | 800 |
4 | Assessment for import licenses for herbal ingredients, traditional ingredients | Item | 200 |
5 | Assessment for declaration of cosmetics, declaration of herbal ingredient standard | Item | 500 |
II | Assessment fees for criteria and conditions for practice and trading in pharmacy, cosmetics |
|
|
1 | Assessment of cosmetic good manufacturing practice to issue CGMP certificate in conformity with CGMP - ASEAN | Facility | 20.000 |
2 | Assessment of good manufacturing practice for drugs and herbal ingredients (GMP) | Facility | 20.000 |
3 | Assessment of good manufacturing practice for pharmaceutical packaging | Facility | 20.000 |
4 | Assessment of good storage practice for drugs and herbal ingredients (GSP) | Facility | 14.000 |
5 | Assessment of good laboratory practice for drugs | Facility | 14.000 |
6 | Assessment of good manufacturing practice for traditional medicines, herbal ingredient drugs, herbal ingredients according to road map initiation of GMP | Facility | 6.000 |
7 | Assessment of good distribution practice for wholesale facilities (GDP) | Facility | 4.000 |
8 | Assessment of application of pharmaceutical practice certificate | Application | 500 |
9 | Assessment of good pharmacy practice (GPP) or standard for pharmaceutical practice with regard to pharmacies not compulsory to conform to good pharmacy practice according to the road map | Facility | 1.000 |
10 | Assessment of good pharmacy practice (GPP) for pharmacies in disadvantaged, mountainous, and island areas | Facility | 500 |
11 | Assessment of declaration of drug prices: |
|
|
11.1 | For declaration or re-declaration | Application | 100 |
11.2 | For declaration of lists serving bidding: | Application |
|
a | Regarding proprietary medicines; list of drugs produced at the production facilities that satisfy WHO/GMP standards and obtain certificates of the Ministry of Health of Vietnam and obtain marketing authorizations from regulatory authorities of state members of ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use); list of drugs produced from materials (active ingredients) produced in state members of ICH and Australia; list of drugs produced from materials (active ingredients) obtaining CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) | Application | 1.500 |
b | Regarding bioequivalence drugs | Application | 2.500 |
c | Regarding drug production facilities satisfying GMP-PIC/s and GMP-EU | Application | 450 |
d | Fee for consideration of list of bidders meeting requirements for qualification and credibility in bidding of herbal ingredients, traditional ingredients in accordance with decision of the Minister of Health | Application | 1.000 |
12 | Assessment of application for cards of pharmaceutical sales representative | Application | 200 |
13 | Assessment of cosmetic good manufacturing practice to issue certificate of eligibility for cosmetic production | Facility | 6.000 |
14 | Assessment of standards for practice in business facilities of herbal ingredients, herbal ingredient drugs, traditional drugs (including traditional ingredients): |
|
|
a | Regarding medicine-trading facilities in provinces and central-affiliated cities; midland provinces | Facility | 500 |
b | Regarding medicine-trading facilities in mountainous, remote and isolated provinces | Facility | 200 |
15 | Assessment of good agricultural and collection practices (GACP) | Application | 6.000 |
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