G/SPS/N/BRA/940  
 
20 June 2014  
(14-3580) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member: BRAZIL  
If applicable, name of local government involved:   
2. Agency responsible: ANVISA - The Brazilian Health Surveillance Agency  
3. Products covered (provide tariff item number(s) as specif ied in national 
schedules deposited with the WTO; ICS numbers should be provided in 
addition, where applicable): Pharmacop oeial monographs on the heparin sodium 
from bovine and porcine in the Brazilian Pharmacopoeia  
4. Regions or countries likely to be af fected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Draft resolution of the pharmacop oeial monographs 
on the heparin sodium from bovine and porcine in the Brazil ian Pharmacopoeia   
Language(s): Portuguese   Number of pages: 13 
http://portal.anvisa.gov.br/wps/wcm/connect/66e64a804451d511a4fcac7f5a7b924e/Co
nsulta+P%C3%BAblica+n+38+COFAR.pdf?MOD=AJPERES  
6. Description of content: Draft resolution of the pharmacop oeial monographs on the 
heparin sodium from bovine and porcine in the Brazilian Pharmacopoeia.  
The heparin sodium from bovine is extracted from the bovine intestine and contains a 
mix of polysaccharide chains with different molecular weight. It is composed of u nits of 
α-D-glucosamine  and acid α-iduronic 2 -sulfated. The units of α-D-glucosamine present a 
more heterogeneous pattern of sulphatation in comparison with the heparin from 
porcine. In special we observe higher proportion of units of α-D-glucosamine non -
sulphated  in the position 6. It has anticoagulant activity by the inhibition of many factors 
of the coagulation system, prolonging the time of coagulation in blood. This occurs 
mainly through potentiation of the Xa factor inactivation and of the thrombin through 
the antithrombin. It contains, at least, 160 units of anti -factor lla activity for mg of 
heparin, respectively, in relation to desiccated substance. The reason of the anti -factor 
Xa activity for the anti -factor lla activity must be of 1.0 ± 0.1. The animals from which 
the heparin is extracted must fulfil the sanitary requirements of the species and the 
manufacturing process must ensure the elimination or the inactivation of infectious 
agents.  
The heparin sodium from porcine is extracted from the intestine of the porcine and 
contains a mix of polysaccharide chains with different molecular weight. It is composed, 
preponderantly, for alternated units of α-D-glucosamine  N- and 6 -disulfated and acid 
α-iduronic 2 -sulfated. It has anticoagulant activity due to the inhibition of many factors 
of the coagulation system, prolonging the time of coagulation in blood. This occurs 
mainly through potentiation of the X a factor inactivation and of the thrombin through 
the antithrombin. It contains, at least, 180 units of anti -factor lla activity for mg of 
heparin, in relation to desiccated substance. The reason of the anti -factor Xa activity for 
the anti -factor lla activ ity must be 1.0 ± 0.1. The animals from which the heparin is 
extracted must fulfil the sanitary requirements of the species in question and the G/SPS/N/BRA/940  
 
- 2 - 
 
  manufacturing process must ensure the elimination or the inactivation of infectious 
agents.  
These monograph prop osals set standards for the identity, dosage (according to 
methods Anti -factor Xa activity and Anti -factor IIa activity / ion -exchange high -
performance liquid chromatography technique for detection and separation of possible 
contaminants of the heparin), c haracteristics, purity assays, biological safety tests, 
packaging, storing and labeling of the heparin sodium from bovine and porcine in the 
Brazilian Pharmacopoeia.  
7. Objective and rationale: [ ]  food safety, [ ]  animal health, [ ]  plant protection, 
[X] protect humans from animal/plant pest or disease, [ ]  protect territory 
from other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.   title or serial number of Codex 
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g.  ISPM number)    
[X] None  
Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available: The 
Brazilian Official Jour nal (Diário Oficial da União), 10 June 2014, 109th edition, Section 1, 
p. 43. Draft Resolution (Consulta Pública) number 38, 9 June 2014, issued by the 
Brazilian Health Surveillance Agency (ANVISA). When adopted, it will be published at the 
Brazilian Offic ial Journal  (available in Portuguese).  
10. Proposed date of adoption (dd/mm/yy) : To be determined after the end of the 
consultation period.  
Proposed date of publication (dd/mm/yy) : To be determined after the end of the 
consultation period.  
11. Proposed d ate of entry into force: [ ]  Six months from date of publication , 
and/or  (dd/mm/yy) : To be determined after the end of the consultation period.  
[ ] Trade facilitating measure   
12. Final date for comments: [ ]  Sixty days from the date of circulation of th e 
notification and/or (dd/mm/yy) : 8 August 2014  
Agency or authority designated to handle comments: [ ]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:  
Ana Paula S. J. da Sil veira e Silva  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br  
13. Texts available from: [ ]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Ana Paula S. J. da Silveira e Silva  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa. gov.br