Marketing, Manufacturing, Packaging & Labelling, Advertising
A structured legal guide to marketing, manufacturing, packaging & labelling and advertising in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview.
2. What is the authorization process for the marketing of generic versions of these products?
Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview
3. What are the typical fees for marketing approval?
Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview.
4. What is the period of authorization and the renewal process?
The period of authorization is five (5) years and the renewal process follows the same pathway as the marketing authorization, unless any data in the product has changed. In that case, the marketing authorization holder should verify whether applying for a new marketing authorization or submit the modifications for approval before the renewal takes place.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Post-approval pharmacovigilance is governed by Resolution 2004009455, which establishes the content and frequency of Adverse Events and Adverse Reactions reports to INVIMA The National Pharmacovigilance Program has a platform that can receive all reports associated with the safety of products marketed in Colombia.
Marketing Authorization Holders (MAH) and drug product manufacturers should have a Pharmacovigilance program, to report regularly to INVIMA about the safety of the products marketed in Colombia, as well as alerts or health problems with their product(s) in other countries.
6. Are foreign marketing authorizations recognized?
No. It is mandatory to obtain a local marketing authorization to sell the product in Colombia. However, INVIMA accepts foreign marketing authorizations of drugs approved in a reference country (Japan, USA, Australia, Norway, Germany, Canada, France, Switzerland, Sweden, England, Denmark, and the Netherlands) to improve times and documents during the registration process.
7. Are parallel imports of medicines or devices allowed?
Parallel imports of products in general are allowed due to the fact that our Andean IP Regime (Decision 486 2000) provides a rule for international exhaustion of IP rights. However, in relation to pharmaceutical products, all medicines must have their own marketing authorization to be legally imported. Any drug product placed in the Colombian market has to be registered before INVIMA unless the product is being marketed illegally. This means that parallel imports of medicines are in practice not allowed.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
Law 1438/11 punishes benefits or the like to healthcare professionals, organizations or patient associations whenever they are intended to induce a medicine prescription. There are no circumstances under which offering any sort of gifts to healthcare professionals/organizations is allowed.
Pharmaceutical companies can use internal commercial policies including discounts in case of supply agreements. However, rebates or discounts to healthcare professionals or institutions may be considered as a benefit under Law 1438/2011.
It is possible to pay for services provided by healthcare professionals under formal agreements previously executed between the parties, but the main purpose of the agreement shall be aligned with the corporate purpose of the company.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
It is regulated through Decree 677/95 (medicines) and through Decree 4725/05 (medical devices) by INVIMA and the Health Ministry.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
Yes. Resolution 1160/16 established the GMP manuals and inspection guides for GMP certification, according to the WHO’s GMP manuals and updates.
11. What is the inspection regime for manufacturing facilities?
Manufacturing facilities shall consider Decree 677/95, Decree 549/01 and Resolution 1160/16.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
No. Certifications of GMP can only be issued by INVIMA following their inspection results.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
These requirements depend on the quality conditions established for each product. For instance, products demanding special temperature conditions or packaged as sterile products shall comply with quality standards to assure their stability, safety and efficacy in accordance with manufacturing.
14. What information must be included in medicine and device labeling?
- Name of product or registered trademark, and if applicable, generic name;
- Name and location of manufacturer.
- Expiry date, which must not exceed five (5) years from the manufacturing date;
- Manufacturing batch code/number;
- Quantity contained in the packaging;
- Special storage conditions, when required by the product, specifying the temperature intervals or limit temperature and other conditions required, according to the specifications of the accepted Pharmacopoeias;
- Marketing authorization number granted by INVIMA.
- The sentences “on medical or dental prescription” or “over-the-counter”, when applicable;
For biological products, the following additional information must also be included:
- The product’s physico-chemical composition or biological and immunological characteristics.
- Indication of its activity and of its protective and capacity units, as well as the strain title.
- Indication of the microorganism biological status.
- The legend “Keep out of the reach of children” (“Manténgase fuera del alcance de los niños”).
15. What additional information may be included in labeling and packaging?
Medicinal products under “special control” condition, will include a vertical violet stripe covering the whole width of the packaging item which should not be inferior to a twentieth of the packaging minimum length.
It is also mandatory to include the following legend: “special control medicinal product – use under strict medical surveillance” (“medicamento de control especial – Úsese bajo estricta vigilancia médica”) and, if applicable, “medicinal product that may cause dependence” (“medicamento susceptible de causar dependencia”).
16. What items may not be included in labeling and packaging?
Wording or drawings cannot be included which encourage the consumption of the medicine.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
For medicines, advertising to the public is only allowed for OTC drugs. For prescription (Rx) drugs, advertisement is restricted to health professionals through scientific or technical media.
Advertisements for OTC drugs must be previously authorized by INVIMA considering the following guidelines in the material:
- Highlight the product as a medicine;
- Advise not to exceed its consumption;
- Include the marketing authorization number;
- Advise to read indications and contraindications on the box;
- Advise to consult a doctor if symptoms persist;
- Provide accurate, clear, readable, understandable, sufficient, complete and true information;
- Be aware that any claim encouraging medicine consumption is prohibited
Regarding medical devices, advertising to the public is only allowed for medical devices under class I risk (low risk devices) but supported in the information included in the marketing authorization of the device.
Advertisement for Medical Devices under risk classes IIa, IIb and III intended for exclusive use by health professionals or prescribed by them, may only be advertised or promoted in publications of a scientific or technical nature. However, advertisement on different media can be authorized by INVIMA prior to application asking for their authorization.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Medicines and devices can be sold in drug stores duly authorized by local authorities to store and sell medicines. Medicines and devices can be sold and delivered by post within the country, provided that they are delivered in accordance with the quality and distribution requirements of the medicine.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
The same rules mentioned in the previous question apply to advertising via internet and similar channels.
20. May medicines and devices be advertised or sold directly to consumers?
Yes, OTC medicines and devices under risk class I can be advertised and sold directly to consumers.
21. How is compliance monitored?
INVIMA and other health authorities have internal programs of inspections and audit visits within the Colombian territory to assure all actors involved in the health services field comply with local regulations. They also make inspections upon third parties’ complaints.
22. What are the potential penalties for noncompliance?
Penalties include fines of up to USD 100,000 at the discretion of INVIMA. If the investigation is promoted before the Superintendence of Industry and Commerce, penalties are much higher and up to USD 500,000. As to inducement, penalties of fines of up to USD 130,000 may be imposed.