WORLD TRADE  
ORGANIZATION   
G/TBT/N/CRI/118 
17 June 2011 
 (11-3014) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Notifying Member:   COSTA RICA 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Ministerio de Economía, Industria y Comercio , MEIC 
(Ministry of the Economy, Industry and Trade) 
Dirección de Mejora Regulatoria y Reglamentación Técnica 
(Regulatory Improvement and Technical Regulation Directorate) 
Tel.: +(506) 2291-2115, Ext. 206, or +(506) 2291-2015 
Name and address (including telephone  and fax numbers, e-mail and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:  
Centro de Información de Obstáculos Técnicos al Comercio (TBT Enquiry Point) 
Ministerio de Economía, Industria y Comercio, MEIC 
Apartado Postal 10216-1000 Tel.: +(506) 2291-2115, Ext. 206 Fax: +(506) 2291-2015 E-mail: crotc@meic.go.cr  
Website: http://www.reglatec.go.cr/  
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):  ICS code 11.120.01 
5. Title, number of pages and language(s) of the notified document:   RTCR 440:2010:  
Reglamento de Inscripción y Control de Medicamentos Biológicos  (Costa Rican Technical 
Regulation (RTCR) No. 440:2010:  Regulati ons on the registration and control of 
biological medicines) (27 pages, in Spanish) 
6. Description of content:   The notified text establishes requirements and procedures for the 
registration and control of biological medicines for human use.  It covers all such products 
manufactured in or imported into Costa Rica. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human life and health G/TBT/N/CRI/118 
Page 2  
 
  8. Relevant documents:  
- España.  Real Decreto 1345/2007 por el que se regula el procedimiento de 
autorización, registro y condiciones de di spensación de los medicamentos de uso 
humano fabricados industrialmente  (Spanish Royal Decree No. 1345/2007 governing 
the procedure for approving and registering and the conditions for dispensing industrially manufactured medicines for human use).  Official Journal ( Boletín Oficial 
del Estado ) No. 267, November 2007.  Pages 45652-45698. 
- CPMP/BWP/CPMP/5136/03.  EMEA CPMP Biotechnology Working Party.  
Guideline on the Investigation of Manuf acturing Processes for Plasma-Derived 
Medicinal Products with Regard to VCJD Risk.  London, 21 October 2004. 
- World Health Organization (WHO).  Expert Committee on Biological 
Standardization.  Guidelines on Evaluation of  Similar Biotherapeu tic Products (SBPs).  
Available online at 
 http://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/BS2110
Dft_guidelines_Final_HK_IK_29July_09.pdf  
- CPMP/437/04.  Committee for Medicinal Products for Human Use (CHMP).  
Guideline on Similar Biological Medici nal Products.  London, October 2005. 
- EMEA/CHMP/BMWP/42832/2005.  Committe e for Medicinal Products for Human 
Use (CHMP).  Guideline on Similar Biological Medicinal Products Containing 
Biotechnology-Derived Proteins as Active Substance:  Non-Clinical and Clinical Issues.  London, February 2006. 
- EMEA/CHMP/BWP/49348/2005.  Committee for Medicinal Products for Human Use 
(CHMP).  Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance:  Quality Issues.  London, 
February 2006. 
- WHO.  Technical Report Series 771, 1988.  Requirements for human interferons made 
by recombinant DNA techniques. 
- WHO.  Technical Report Series 822, 1992.  Annex 2:  Guidelines for national 
authorities on quality assurance for biological products. 
- Roitt, I. and Delves, P.  Roitt's Essen tial Immunology.  10th edition.  Blackwell 
Science, 2001.  Pages 111-115. 
- WHO, 2010.  WHO Guidelines for the Production, Control and Regulation of Snake 
Antivenom Immunoglobulins. 
9. Proposed date of adoption: 
Proposed date of entry into force:   Date of publication in the Official Journal 
Six months' validity following publication in 
the Official Journal La Gaceta  
10. Final date for comments:   60 days from the date of notification  G/TBT/N/CRI/118 
 Page 3 
 
 
  11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers, e-mail and website addresses,  if available of the other body: 
Centro de Obstáculos Técnicos al Comercio OTC  (TBT Enquiry Point) 
San José, Costa Rica Tel.: +(506) 2291-2115, Ext. 206 Fax: +(506) 2291 2015 E-mail: crotc@meic.go.cr  
Website: http://www.reglatec.go.cr/  
Full text available at:  
http://www.reglatec.go.cr/consulta/biologicosomc2.pdf  
and 
http://members.wto.org/crnattach ments/2011/tbt/CRI/11_1860_00_s.pdf