G/TBT/W/767  
15 March  2022 
(22-2287) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
COLOMBIA - GOOD MANUFACTURING PRACTICES OF OVERSEAS PRODUCTION  
ESTABLISHMENTS (STC NO. 697)  
TECHNICAL STATEMENT BY COLOMBIA TO THE COMMITTEE ON TECHNICAL BARRIERS TO TRADE  
9-11 MARCH  2022 
The following communication, dated 1 1 March  2022, is being circulated at the request of the 
delegation of Colombia . 
 
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1.  Colombia thanks the European Union for working with the relevant health authorities to clarify 
the concerns raised regarding compliance with Decree No. 162 o f 2021, issued by the Ministry of 
Health and Social Welfare.  
2.  In this regard, we wish to report that the relevant authorities have been working with the 
European Union, through the EU Trade Section in Colombia, on issues related to compliance with 
Decree No. 162 of 2021, particularly in respect of the acceptance of certificates of good 
manufacturing practices, thus responding to the concerns raised regarding the acceptance of 
certificates of free sale (CVL) issued by the competent authorities of the European  Union . As a result, 
the text issued amended Article 22 of Decree No. 1686 of 2012, so as to ensure equal conditions 
regarding the certificate of good manufacturing practices (GMP) for domestic producers and 
producers located outside the national territory , and provided the following four (4) alternatives for 
complying with the technical regulation:  
a. Certificate of good manufacturing practices (GMP), from the manufacturing and/or 
packaging establishment, issued by the relevant authority of the country of ori gin, by the 
accredited certification body or by the authorized third party in the country of origin.  
b. Hazard Analysis and Critical Control Point (HACCP) System certificate or document 
supporting its implementation, issued by the relevant authority of the co untry of origin, 
by the accredited certification body or by the authorized third party in the country of origin 
of the product.  
c. Certification issued by the relevant authority, by the accredited certification body or by 
the authorized third party in the cou ntry of origin of the product, stating that the alcoholic 
beverage and the producer comply with the technical standards, processes or procedures 
or are subject to monitoring and inspection.  
d. Certificate of good manufacturing practices of the manufacturing and/or packaging 
establishment, issued by the National Food and Drug Surveillance Institute (INVIMA).  
3.  Therefore, in order to comply with the requirement in the case of imported beverages, the Decree 
sets out four feasible options that do not disregard the regulations of the country of origin of the 
parties concerned, meaning that such parties can assess each of the above options and apply one 
of them in order to comply with the Colombian regulations.  
4.  The health authorities have reiterated that  certificates of free sale may be included within the 
scope of paragraph (c), provided that they comply with the provisions of that paragraph, namely : 
(i) they are issued by the relevant authority, by the accredited certification body or by the authorized G/TBT/W/767  
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  third party in the country of origin of the product, and ; (ii) they state that the alcoholic beverage 
and the producer comply with the technical standards, processes or procedures or are subject to 
monitoring and inspection.  
5.  Furthermore, Colombia recalls t hat the deadline for implementing the provisions regarding the 
requirements for good manufacturing practices is 1 4 February  2023, in accordance with Article  3, 
paragraph  2, of Decree No. 162 of 2021 : "Paragraph 2 . Establishments producing alcoholic 
beverages located inside and outside the national territory will have until 1 4 February  2023 to 
comply with the good manufacturing practices certification as per this Article . The validity of the 
certificates already granted by INVIMA will be ext ended for a further two (2) years."  
6.  In this context, the relevant authorities have reviewed the documents provided by the 
European  Union and have expressed their willingness to continue working with the EU and the 
industry to resolve the concerns raised in  search of landing zones, in order to comply with the 
technical regulation.  
7.  In light of the foregoing, we invite the European Union to continue its bilateral work with our 
health authorities.  
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