Products manufactured outside Colombia

Steps for product registration:

1- Download or request registration solicitude form from website.

2- Pay the applicable fee through electronic bank transfer or at an affiliate of the Davivienda bank.

3- File the registration application at INVIMA’s Oficina de Atención al Usuario (Customer service office) including all the applicable documents. (see below)

4- Redeem the notice issued by the entity.

The official timeline for approval is of 80 days, and the period of registration if of 5 years. (Application for renewal of the marketing authorization must be submitted at least 3 months before the expiry date of the registration) It is possible to follow up on the status of the case via telephone, internet at www.invima.gov.co or personally at the INMIVA office.

Required documents:

1. Request form, signed by empowered or legal representative of solicitor or owner, and including the name of the product, brand (if applicable), name of owner, name of manufacturer, category and statement confirming that the legal and technical information provided is accurate. (Original)

2. GMP certificate from country of origin, if the manufacturer hasn’t been visited by INVIMA (Copy). The validity of this document will be the one stated in it, otherwise it will be set at 1 year.

3. Certificate of existence and legal representation of the solicitor, manufacturer(s), importer(s) and/or packager(s) issued within the last three months (Copy).

4. Power of attorney authorizing representative to file the application (Copy).

5. Certificate issued by the Superintendencia de Industria y Comercio, stating that the brand is registered on the name of the solicitor or that its registration has been requested and is under processing. When the owner of the brand is not the solicitor, authorization for use from the owner must be attached (Copy).

6. Receipt or proof of electronic transfer of the applicable fee (Copy)

7. CPP of origin, compliant with the requirements of Decreto 426 de 2009. The validity of this document will be the one stated in it, otherwise it will be set at 1 year. (Copy)

8. Express authorization from manufacturer or owner to importer, to request marketing authorization, use the brand and commercialize the product, if applicable (Copy).

9. Pharmaceutical form and comercial presentations of the drug product.

10. Composition or quantitative formula, divided in two sections: API and excipients.

11. Structural and condensed chemical formula of APIs.

12. Manufacturing batch formula.

13. Detailed description of manufacturing process.

14. Analytical methods, in accordance to pharmacopoea or properly validated, and validation reports for non-pharmacopoeial methods.

15. Summary of pharmacological information.

16. Stability studies and shelf life, based on international standards such as ICH or official pharmacopoeias.

17. If indicated by the Comision Revisora (Revision Commission), results of bioavailability and bioequivalence studies.

18. Quality specification for raw materials.

19. Quality specification for product-in-process.

20. Quality specification for the finished product.

21.  All labeling material: packaging, labels, leaflets, etc.

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21 Responses to Products manufactured outside Colombia

  1. Ajay says:

    Dear

    Do we need plant GMP certification from INVIMA for product registration in Colombia? If yes, shall i get waiver for plant audit by using any other countries GMP certifications?

    Regards,
    Ajay

    • Maria says:

      Dear Ajay,

      GMP certificates issued by FDA, EMA and WHO are accepted by INVIMA as sufficient GMP verification. If one of those certificates is submitted, INVIMA doesn’t need to inspect.

      Thanks for your question!

      Have a great week!

      Maria

  2. Maria says:

    Dear Ajay,

    Yes, WHO certificates are acceptable.

    Have a great weekend!

    Maria

    • Mauricio Rubio says:

      Dear Maria and Ajay, Looking deeply into this, I think when we refers to WHO GMP Certificates that means the World Health Organization Certificates for programs they have for essential drug medicines, but not the WHO GMP commonly given under the Indian GMP regulatory scheme, I mean, not local Indian GMP which usually Indian Indian manufacturers understood as WHO certificates. So manufacturers with local GMP certificates from Indian or Chinese authorities needs an addtional INVIMA approval, which imply an audit in place by the Colombian Authorithy, unless they have a third party recognized GMP audit like USFDA, EMEA, ANVISA or TGA certificate.

      Sincerely

      Edgar Mauricio Rubio Rubio
      Pharmacist
      Colombia

  3. Ganesan says:

    What is the PV requirements in Colombia?

    • Hi, Ganesan!

      I suggest you get in touch with this company: http://phvlatam.com/ Its specialty is in Pharmacovigilance in Latin American countries. They can provide consulting to fulfill your Pharmacovigilance needs in Colombia and other countries in the LatAm region.

      Thanks!

      Maria

  4. Dr Pradeep Walwaikar says:

    where i can find bioequivalence guidelines for registation of drugs

  5. swati says:

    We wish to invite aythority for our plant inspection , what is the procudure & form required.

  6. Mary Helen says:

    Are there any economic evaluations required?

  7. Chidambaram says:

    Hi Maria
    Thanks for a lot of information here.
    I am in need to know which are the Latin American countries that require ‘Local clinical trials’ for a new product registration, if the product is registered in US or EU.
    We read here, Mexico does, and may be Brazil too, what about the others like Argentina, Chile, Colombia, Costa Rica, Ecuador, Peru, Puerto Rico, & Venezuela
    I appreciate your reply, in advance.

  8. Rajesh Patel says:

    Dear Madam,

    My company is manufacturing Dietary suplement and Body bulding suplement . Nutraceutical products.

    This products required registration ?

    If yes how much time required and which document required ?

    Rajesh Patel

    VOX DEI LABS

  9. Aarti says:

    Hi Maria, if Manufacturing plant is UKMHRA approved, still INVIMA inspection is required?

  10. Somnath Naha says:

    Hi Maria, I have a question. I have some requirement from some companies in India that is willing to sell their products in Colombia. All these companies are looking for Pharmaceutical companies in Colombia that will be interested in registering their products. Some of the companies also do contract manufacturing. Could you please suggest some name of the companies in Colombia who I could get in touch with and offer the line of products. Thanks a lot. Regards, Somnath

  11. sachin Dangwe says:

    Kindly please confirm can we get waiver by using any othe approval from PIC/s member Authorities.

  12. bbtslim says:

    Where can i get more exact Information about registration of Homeopathic medicinal product ind Colombia.

  13. Amit Ranjan says:

    Dear
    Do we require to submit registartion samples, if yes how many quantities and when these sample need to be submitted.
    Other question is are we need to tranlsate dossier in Spanish language?

    Looking forward to get answer for the above

    Thanks!!

    Amit

  14. Adrian says:

    Hi All,
    Any pharmacovigilance outsourcing businesses in Colombia?

  15. Thomas Myers-Kieran says:

    2 Questions for Colombia:

    #1. The regulations indicate there must be a pharmacovigilance program in place supervised by a physician or pharmaceutical chemist. Can I get clarification on whether that person must be located within Columbia or if s/he can be located in any country?

    #2. The regulations (article 6.1) state “Any serious and unexpected adverse event is to be reported within 72 hours from the moment the pharmacovigilance program becomes aware of it, just like any health alerts and measures involving the product issued by the corresponding health authority in other countries”. I believe this to mean they only want domestic serious and unexpected adverse events in 72 hours, but would like you to please confirm this to be accurate (as opposed to domestic and foreign serious and unexpected adverse events).

    Thank you in advance for any and all information.

  16. Thomas Myers-Kieran says:

    Forgive my spelling error – Colombia, not Columbia. (the curse of autocorrect)

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