G/TBT/N/BRA/1118  
18 January 2021  
(21-0524) 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 (ANVISA)  
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 Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
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):  Antibiotics 
(HS 2941); Medicaments consisting of two or more constituents mixed together for 
therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. 
goods of heading 3 002, 3005 or 3006) (HS 3003); Medicaments consisting of mixed or 
unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. 
those in the form of transdermal administration" or in forms or packings for retail sale 
(excl. goods of  heading 3002, 3005 or 3006) (HS 3004); Wadding, gauze, bandages and 
the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with 
pharmaceutical substances or put up for retail sale for medical, surgical, dental or 
veterinary purpose s (HS 3005); Pharmaceutical preparations and products of 
subheadings 3006.10.10 to 3006.60.90 (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
number 989, 15 December 2020 (3 page(s), in Portuguese)  
Comment fo rm: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=60955  
6. Description of content:  This draft resolution changes the Resolution – RDC number 47, 
8 September 2009, which establishes technical requirements for the development, 
harmonizatio n, updating, publication, and provision of medicine leaflets to patients and 
healthcare professionals.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  A study conducted in Montes Claros -MG showed the importance of consulting 
the leaflets of THE MIPs in view of their indiscriminate use. In this study, dipyrone, 
paracetamol and acetylsalicylic acid were the major causes of adverse and toxicological 
reacti ons, and 75.74% of the interviewed population had the habit of buying MIPs in 
primary packages. It can be concluded that the lack of information for the use of these 
medicines may result in administration errors. Another study showed that written G/TBT/N/BRA/1118  
 
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  informati on on medicines has been recognized as an important tool for health education. 
Of 28,427 individuals, 59.6% answered that they generally read the leaflets and 98.4% 
considered them necessary. In view of the importance of the package leaflet for the 
patient , the proposal aims to change article 26 of RDC No. 47/2009 in a timely manner 
to allow the package leaflet to be made available also through a digital mechanism printed 
on the primary and secondary packaging of medicines, which can be read through a 
mobil e phone or free internet reading applications, allowing full access to the patient's 
and the most up -to-date health care leaflets contained in the Electronic Package Leaflet 
of Anvisa.; Protection of human health or safety  
8. Relevant documents:  1) Brazil ian Official Gazette 245 on 23 December 2020, section  1, 
page 140; 2) RDC number 47, 8 September 2009; 3) Justification for resolution draft; 
4) Report of Impact Assessment  
https://www.in.gov.br/web/dou/ -/consulta -publica -n-989-de-15-de-dezembro -de-2020-
295784823  
http://a ntigo.anvisa.gov.br/documents/10181/2718376/%281%29RDC_47_2009_COM
P.pdf/cd434aae -fca0-448e-bd40-1b8e85e5570b  
http://antigo.anvisa.gov.br/documents/10181/6165008/Justificativa+ -+CP+989 -
2020.pdf/11f0c4c7 -9adc-4256-9a51-86a180c53514  
http://antigo.anvisa.gov.br/documents/10181/6165008/Relat%C3%B3rio +de+Mapeam
ento+de+Impactos+ -+CP+989 -2020.pdf/9aff7d60 -9456-4b6f-9124-7566e8055a6e  
9. Proposed date of adoption:  To be defined  
Proposed date of entry into force:  To be defined  
10. Final date for comments:  12 February 2021  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF / Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http:// antigo.anvisa.gov.br/documents/10181/6165008/CONSULTA+P%C3%9ABLICA+
N+989+GGMED.pdf/15feb8f0 -c7b9-4a5c-952f-b4e36aec7cea