G/TBT/N/BRA/721  
 
29 May 2017  
(17-2849) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member : BRAZIL   
If applicable, name of local government involved  (Article 3.2 and 7.2) :  
2. Agency responsible:  Brazilian Health Regulatory Agency (A nvisa)  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if different from above :  
National Institute of Metr ology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplic acao=31454  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Medicinal products  
5. Title, number of pages  and language(s)  of the notified document:  Draft 
Resolution  nº 343, 11 May 2017. (18 page(s), in Portuguese)   
6. Description of content:   
This Draft Resolution provides for good distribution and storage practices as well as good 
practices for the transport of medicinal products. It applies to companies that carry out the 
activities of distribution, storage or transport of medicines. This resolution does not apply 
to the distribution storage and transportation activities of raw mat erials, bulk drugs, labels, 
packaging or medicinal gases.  
All parties involved in the production, storage, distribution and transportation should be 
responsible for the quality and safety of the medicines. Shared responsibility covers recall 
actions, wheth er motivated by the health authority, the registrant or the distributor. 
Manufacturers must provide medicines only to companies authorized and licensed by  the 
competent sanitary authority for distribution activities or delivery of medicines to patients. 
The companies involved in the distribution activity should only obtain supplies of medicines 
purchased directly from the companies that hold the registration and should only provide 
to companies authorized and licensed to delivery to patients.  
This resolutio n also establishes provisions regarding the organization and administration; 
staff; quality management system; storage areas installations; storage; expedition and 
receipt; transport and in -transit storage; vehicles and equipments; containers; 
documentatio n; complaints; withdraw; returns; adulterated, falsified, robbed or stolen 
medicines; subcontracted activities; self -inspections; qualifications and validations and 
thermolabile medicines.  G/TBT/N/BRA/721  
 
- 2 - 
 
  This resolution revokes the Ministerial Order nº 802 of 8 October 1 198 and the 
Resolution  – RDC nº 320 of 22 November  2002, and the article  3º of the Ministerial 
Order  nº 2.814/GM/MS of 29 May  1998.  
This resolution comes into force on the date of its publication.  
7. Objective and rationale , including the nature of urgent  problems where applicable: 
Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official Journal (Diário Oficial da União) Nº 90, 
12 May 2017, section 1, page 34/35; (2) Law 9.782, 26 January 1999 (Lei nº 9.782, de 
26 de janeiro de 1999); (3) Brazilian Official Journal; (4) Not stated.   
9. Proposed date of adoption:  To be determined after the end of the consultation period  
Proposed date of entry into force:  This resolution comes into force on the date of its 
publication.  
10. Final date for co mments:  10 July 2017  
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:   
Agency Responsible  
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Ár ea Especial 57  
Brasília – DF/Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br   
http://portal.anvisa.gov.br/documents/10181/2957539/CONSULTA+PUBLICA+N+343+GG
FIS.pdf/2dbf8b62 -68cf-43f9-8bfe-5dc55347718f