G/TBT/N/BRA/593  
 
23 June 2014  
(14-3638)  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 Surveillance Agency - ANVISA  
Name and address (including telephon e 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) 2563.2840 
Telefax:  +55 (21) 2563.5637 Email:  barreirastecnicas@inmetro.gov.br  
Website: http://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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable): Draft resolution of the 
pharmacopeial monographs on the heparin sodium from bovine and porcine in the Brazilian 
Pharmacopoeia. 
5. Title, number of pages and language(s) of the notified document: Draft Resolution 
No. 38, 9 June 2014, of the pharmacopeial monographs on the heparin sodium from bovine 
and porcine in the Brazilian Pharmacopoeia (13 pages, in Portuguese). 
6. Description of content: Draft resolution of the pharmacopeial 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 units of a-D-
glucosamine e acid a-iduronic 2-sulfated. The units of a-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 a-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 th e species and the manufacturing process must 
ensure the elimination or the inactivation of infectious agents. 
The heparin sodium from porcine is extrac ted 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 a-D-glucosamine N- and 6- disulfated and acid a-
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 Xa factor inactivation and of the thrombin through the G/TBT/N/BRA/593 
 
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  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 activity 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 manufacturing process 
must ensure the elimination or the inactivation of infectious agents. 
These monograph proposals set standards for the identity, dosage (according to methods 
Anti-factor Xa activity and Anti-factor IIa acti vity / ion-exchange high-performance liquid 
chromatography technique for detection and se paration of possible contaminants of the 
heparin), characteristics, 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, including the nature of urgent problems where applicable: 
Protection of Human Health.  
8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), 10 June 2014; 
Section 1, p. 43, Draft Resolution (Consulta Pública) number 38, 9 June 2014, issued by 
Brazilian Health Surveillance Agency – Anvisa. When adopted, it will be published at the 
Brazilian Official Journal. Available in Portuguese.  
9. Proposed date of adoption:   To be determined after the end of the consultation period.  
Proposed date of entry into force:   To be determined after the end of the consultation 
period.   
10. Final date for comments: 8 August 2014 
11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers email and website addresses,  if available, of other body:   
Agency responsible Brazilian Health Surveillance Agency - ANVISA 
SIA, Trecho 5, Área Especial 57 
Brasília - DF / Brazil CEP: 71.205-050 
Phone.: 55 61 3462-5402 
E-mail: rel@anvisa.gov.br   
Website: 
http://portal.anvisa.gov.br/ wps/wcm/connect/66e64a804451d511a4fcac7f5a7b924e/Consult
a+P%C3%BAblica+n+38+COFAR.pdf?MOD=AJPERES