G/TBT/N/BRA/870  
 
6 June 2019  
(19-3894) Page: 1/3 
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:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2918  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle commen ts 
regarding the notification shall be indicated if different from above:   
The Brazilian Health Regulatory Agency (ANVISA)  
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):  
HS Codes: 3003; 3004; 3005; 2941.  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
(Consulta Publica) number 653, 21 May  2019. Published on D.O.U, 27 May 2019, page  57. 
(2 page(s), in Portuguese)  
Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=47328  
6. Description of content:  This Draft Resolution corresponds to the adoption of the Guide 
to Good M anufacturing Practices for Medicinal Products of the Pharmaceutical Inspection 
Convention and Pharmaceutical Inspection Co -operation Scheme (PIC/S) of 1 July 2018 . 
The resolution – RDC represents the Part 1  of the guide that applies to all medicines 
without distinction. The Normative Instructions (IN) correspond to the annexes  of the 
guide related to specific aspects of the good practices for the manufacture of medicines.  
RDC - Good Practice Guidelines for the Manufacture of Medicines : corresponds to Part I 
of the PIC/S  guide;  
IN Complementary guidelines to the manufacture of sterile medicinal products  
(corresponds to annex 1 of the PIC/S guide);  
IN Complementary guidelines to the manufacture of biological  medicinal substances and 
products for human use  (corresponds to annex 2 of the PIC/S  guide);  
IN Complementary guidelines to the manufacture of radiopharmaceuticals  (corresponds 
to annex 3 of the PIC/S  guide);  G/TBT/N/BRA/870  
 
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  IN Complementary guidelines to the manufacture of herbal medicinal products  
(correspo nds to annex 7 of the PIC/S guide);  
IN Complementary guidelines to the manufacture of medicinal ga ses (corresponds to 
annex 6 of the PIC/S  guide);  
IN Complementary guidelines to the sampling o f starting and packaging materials  
(corresponds to annex 8 of the PIC/S  guide);  
IN Complementary guidelines to the manufacture of liquids, creams and ointments  
(corresponds to annex 9 of the PIC/S  guide);  
IN Complementary guidelines to the manufacture of pressurised metered dose aerosol 
preparations for inhalation  (corresponds to annex 10 of the PIC/S  guide);  
IN Complementary guidelines to computerised systems  (corresponds to annex 11 of the 
PIC/S  guide);  
IN Complementary guidelines to the use of ionising radiation in the manufacture  of 
medicinal products  (corresponds to annex 12 of the PIC/S guide);  
IN Complementary gu idelines to the manufacture of investigational medicinal products  
(corresponds to annex 13 of the PIC/S guide);  
IN Complementary guidelines to the manufacture of medicinal products derived from 
human blood or plasma  (corresponds to annex 14 of the PIC/S  guide);  
IN Complementary guidelines to the qualification and validation  (corresponds to annex  15 
of the PIC/S  guide);  
IN Complementary guidelines to the reference and retention samples  (corresponds to 
annex 19 of the PIC/S  guide);  
Considering that this is the adoption of a set of guides widely adopted internationally, it 
is not desirable that in Brazil be adopted divergent good manufacturing practices 
(BPF) requirements, unless a necessity to adopt different requirements to r each an 
adequate level for protection to health be proved.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health  
8. Relevant documents:   
• Guide to Good Manufacturing Practice for Medicinal Products of the 
Pharmaceutical Inspection Convention and Pharmaceutical Inspection 
Co-operation Scheme (PIC/S) part I of 1 July  18. 
http://portal.anvisa.gov.br/documents/10181/5389382/PE_009_14_GMP_Guide
_Part_I_Basic_Requirements_for_Medicinal_Products_.pdf/bc4b65e3 -b22d-
438f-b33c-e13f05e79f3e  
• Guide to Good Manufacturing Practice f or Medicinal Products of the 
Pharmaceutical Inspection Convention and Pharmaceutical Inspection 
Co-operation Scheme (PIC/S), Annexes.  
http://portal.anvisa.gov.br/documents/10181/5389382/PE_009_14_GMP_Guide
_xAnnexes_+%281%29.pdf/ba0e51c1 -eb74-49f4-a7d5-d84cd222fb60  
9. Proposed date of adoption:  To be determined after the end of the consultation period.  
Proposed d ate of entry into force:  To be determined after the end of the consultation 
period.  
10. Final date for comments:  1 August 2019  G/TBT/N/BRA/870  
 
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  11. Texts available from:  National enquiry point [X] 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://portal.anvisa.gov.br/documents/10181/5389382/CP+653.pdf/62eebe70 -a553-
4b21-89ab-3924dfcd8e84