The Pharma Legal Handbook: Colombia

An intro to the legal situation for orphan drugs and rare diseases in Colombia. 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 119.

 

1. What is the definition of Rare Diseases in your country?

According to Act 1438/2011 Orphan diseases are chronically debilitating, serious, life-threatening diseases with a prevalence of less than 1 per 5,000 people, including rare, ultra-orphan and neglected diseases. Neglected diseases are typical of developing countries and ordinarily affect the poorest population and do not have effective or adequate treatments that are accessible to the affected population.

 

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

No, the designation of ¨Orphan Drug¨ is not supported on the regulatory framework or at the official health authorities (Ministry of Health and Social Protection and INVIMA) websites. However, that designation is commonly known between the regulatory agency and all the health professionals.

The Specialized Chamber of Medicines and Biological Products of the Review Commission, in Minute 27 of 28-10-2008 considers that the terms Orphan Drug and Vital Drug Not Available, essentially have the same connotation. Additionally, the Specialized Chamber said: “Orphan Drugs are understood to be those that are destined for the treatment of infrequent diseases or rare diseases”.

 

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

The regulatory framework for the authorization of an Orphan Drug is the Decree 481 of 2004 which is the same regulatory framework that applies for Vital Drugs Not Available.

 

4. Does your country have pro- visions for relaxed clinical trial/ scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

Yes, considering that these kinds of products are assessed and regulated under a different regulatory framework from other drugs. Furthermore, the Decree 481 of 2004 establishes different requirements for different cases in which an Orphan Drug should be needed such as the authorization of the importation for a specific patient, authorization of importation of Vital Drugs Not Available for exclusive use in urgency cases, or the authorization of importation for more than one patient of Vital Drugs Not Available.

 

5. Is there an expedited pathway for Orphan Drugs?

The pathway for Orphan Drugs is detailed by the Decree 481 of 2004, which in comparison with the pathways of other drugs can be considered as an expedited pathway.

 

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

No, Colombian jurisdiction does not recognize any foreign marketing authorization.

 

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?

Yes, Resolutions 205, 2152 of 2020, and Resolution 1139 of 2022 are the regulatory frameworks for the reimbursement of Orphan Drugs before the ADRES (Administrator of Resources of the General System of Social Security in Health).

 

8. How are the prices of Orphan Drugs regulated?

The prices of Orphan Drugs are regulated under the methodology developed for the direct price control regime for the drugs that are marketed in the national territory. This methodology is supported on Circular 03 of 2013. Currently, the Ministry of Health published what will be the Circular 013 of 2022 with which the list of medicines subject to the direct price control regime is unified and added, and their Maximum Sale Price is set, in addition to issuing new guidelines related to the regulation of prices of Vital Drugs Not Available.

 

9. In case of reference price based on a basket of countries, what countries are included?

The countries are: Argentina, Brazil, Chile, Ecuador, Mexico, Panama, Peru, Uruguay, Spain, EEUU, UK, Australia, Canada, France, Norway, Germany and Portugal.

 

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

There are currently no developments concerning Vital Drugs Not Available in Colombia.

 

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

There are currently no proposals for reform to the regulation of Vital Drugs Not Available.

Also from this Legal Handbook

The key facts about biosimilars and biologics in Colombia. 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 119.

 

1. Are biosimilar medicines considered the same as generic medicines in your country?

No, generic medicines are understood as medicines with the same structure of the active substance as the reference medicine. And biosimilar medicines are those biotech molecules that can have a few structural differences with the biotech molecule of the reference product (due to complexity of biotech products) and, also the biosimilar medicine must show high similarity in quality, safety, and efficacy attributes in comparison with the reference medicine through a comparability assessment.

 

2. Are all biologic medicines, including biosimilar medicines, patentable in your country?

No, In Colombia biosimilar medicines cannot be patentable. However, biologic medicines also include biotech medicines and, these products are patentable in Colombia if are the innovator products.

 

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

Yes, all the biologic and biotech medicines, including also biosimilar medicines are regulated under Decree 1782 of 2014 which is the main core of the regulatory framework. This regulatory framework is composed of Resolutions: 5402 of 2015, 3690 of 2016, 4490 of 2016, 553 of 2017, and 2950 of 2019. Although are some requirements and articles of Decree 677 of 1995 that apply also for biologic including biotech and biosimilar drugs.

 

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

The requirements regarding the data package to obtain approval for a biosimilar drug are the same requirements for the original/innovator/reference biologic drug. These requirements are contained in Articles 72, 73, 74, and 76 of Decree 677 of 1995.

Decree 1782 of 2014 establishes three approval pathways for biological/biotherapeutic drugs in Colombia: the full dossier pathway, the comparability pathway and the abbreviated comparability pathway for evaluation in terms of safety and efficacy, quality and process, pharmacovigilance and quality control. Regardless of which pathway is selected, a common basic information contained in article 6 of the above-mentioned decree must be submitted.

This information that will be essential to provide is the following: 1. detailed description of the process and place of production; 2. expression system; 3. biological identity tests; 4. potency evaluation; 5. physicochemical properties; 6. biological activity evaluation, 7. purity evaluation, 8. immunogenicity tests and 9. risk management plan.

 

5. What are the requirements for the choice of the reference comparator product?

These requirements are detailed in point 4 of the technical annex of the Resolution 2950 of 2019. In summary, the reference product chose must be appropriate to support the marketing authorization application and will be used through all the comparability assessments, the manufacturer of the biosimilar product must demonstrate the similarity between the active substance of the biosimilar and the reference product, the pharmaceutical form of both products must be the same. If the reference product has been approved in Colombia its approval concept has to be done under the full file pathway but, if the product has not been approved in Colombia yet, the reference product must be authorized and widely marketing in reference countries.

 

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

Please refer to point 5. The reference product must be authorized and widely marketing in reference countries that have a regulatory framework with well-established principles and considerable experience in biological drug evaluation and pharmacovigilance activities. The information of the reference product must be available for INVIMA´s assessment, and is important to notice that the acceptance of the reference product for the assessment of a biosimilar product does not imply the approval concept for the biosimilar product by INVIMA to the use of that product in Colombia.

 

7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?

The prices of medicines are regulated under the methodology developed for the direct price control regime for the drugs that are marketed in the national territory, this methodology is supported on Circular 13 of 2022 issued by the Ministry of Health and Social Protection, which established the list of drugs subject to the direct price control regime, set the Maximum Sale Price and the price per regulatory unit of Non-Available Vital Medicine.

 

8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?

The reimbursement regulatory framework for biologic, biotechnological (reference products and biosimilar) medicines are Resolution 568 of 2021 and Resolutions 3512 of 2020.

 

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

No, the biosimilar competition does not impact the reimbursement policy of the reference products. It only leads to increased competition in the market.

 

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

The regulatory framework for drug prescribing and dispensing is composed of the Decree 677/1995, Decree 780 of 2016, and Resolution No. 886/2004.

According to Decree 677/1995, medicinal products can be sold according to the following conditions:

• Over the counter condition (OTC),
• Under medical prescription (Rx),
• Under special control,
• Exclusive hospital use.

 

11. Is the system considering physician-led switching and/ or pharmacy-level substitution (without involvement of the clinical decision maker)?

No, this switching is not considering by the system.

 

12. What are the post-authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

Are periodic reports of security used to monitor the use of the medicines, using information from different notification sources, as established in current regulations, and comply with the Good Pharmacovigilance Practices desired by the Ministry of Health and Social Protection. And is not any difference between requirements for original biologic drugs and biosimilar drugs.

Through Resolution 213 of 2022, the Ministry of Health approved the “Guide for the preparation of Risk Management Plans for Medicines of Chemical Synthesis with new active pharmaceutical ingredients and biological medicines”, the management plans will be part of the documentation of the risk management system, input for the planning and establishment of measures to reduce them, facilitate the quantification of the risk of each medicine or the planning of strategies to minimize them, including the evaluation of the effectiveness of these activities.

Resolution 2950 of 2019 regulates Guidance for the assessment of the Comparability of Biological Medicines.

Through Resolution 5402 of 2015, the manual and instrument for verification of Good Manufacturing Practices for Biological Medicines was issued.

 

13. Are there specific policies and requirements for labelling biosimilar medicines in the event of second medical use patents? Is this any different from the requirements for the original Biologic drug?

In Colombia, for all medicines the second medical uses are not recognized as new entities, this means that is not possible to find second medical use patents on the market.

 

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

Yes, are two Decrees: 697 of 2021 ¨By which the health requirements that will be taken into account in the donation of chemical synthesis, biologics, radiopharmaceuticals, phytotherapeutic products, medicinal gases, homeopathic medicines, medical devices, biomedical equipment, in vitro diagnostic reagents, cosmetics, and household hygiene products and personal hygiene absorbents, and raw materials, to attend the COVID-19 pandemic¨. And Decree 710 of 2021 ¨Whereby articles 9 and 10 of Decree 1787 of 2020 are modified, regarding the issuance, validity, information, renewals, and modifications of the Sanitary Authorization for Emergency Use ASUE¨. Both Decrees impact biosimilars regulatory framework.

 

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

No.

Also from this Legal Handbook

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Colombia. Prepared in association with Cavelier Abogados, a leading law firm in Colombia, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Yes, cannabinoid drugs are authorized in Colombia. However, they are subject to government control and to a specific regulatory framework.

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The following are the most relevant offices:

• Ministry of Health and Social Protection: Authority in charge of granting licences to manufacture cannabinoids and assign quotas for production.
• National Fund of Narcotics (FDE): Authority in charge of overseeing import, exports, distribution, and sale of narcotics.
• Ministry of Justice and Law: Authority in charge of granting licences for seed usage and cannabis cultivation.
• INVIMA: Regulatory Authority in charge of the registry for pharmaceutical products of human use amongst others.
• ICA: Authority in charge of the registry of seeds cultivators, plant breeders and seeds testing, registry of seeds variety and pharmaceutical registry, amongst others for animal purposes.

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

Yes, since 2016 there has been a regulatory framework that seeks to apply from breeding to the sale of Cannabinoid Drugs. However, there is no specific regulation for pricing and reimbursement of cannabinoid drugs.

 

4. Which are the cannabinoid drugs that have received market approval to date?

The first cannabinoid drug to received government approval in Colombia is Sativex from GW Pharma Ltd., a chemically synthesized drug. Then, in 2020, the INVIMA authorized the commercialization of the drug Neviot, from Procaps Laboratory; it becomes the first and only pharmaceutical grade Cannabinoid approved by INVIMA, with scientific support, manufactured in Colombia.

Neviot is recommended for patients suffering from refractory epilepsy and use a no psychoactive component of cannabis.

To the date there is no authorized Cannabinoid drug as a phytotherapeutic product.

 

5. Who can prescribe Cannabinoid Drugs?

Cannabinoid Drugs can be prescribed by any healthcare professional legally authorized to practice medicine in the country.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No, there isn´t.

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

The cannabinoid drug must be authorized to be sold in the country through a sanitary registry/marketing authorization granted by INVIMA.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Any pharmacy or drug store registered at the National Fund of Narcotics.

 

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

Although there is no list of authorized distributors available to the public, the retailers/distributors must be registered before the National Fund of Narcotics and keep record of all sales of cannabinoid drugs.

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

Currently, there are no proposals for significant change to the existing regulation. However, as the regulatory framework dealing with cannabinoid drugs is relatively new, there are possibilities of regulation improvements by the competent authorities.

 

11. When are they likely to come into force?

N/A

 

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

In Colombia, access to cannabis is authorized for medical and scientific use by the Act 1787 and Decree 613/17. Industrial use was added to the regulation by the Decree 811/2021 and Resolution 227/2022.

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

• Ministry of Health and Social Protection: Authority in charge of granting licences to manufacture cannabinoids and assign quotas for production.
• National Fund of Narcotics (FDE): Authority in charge of overseeing import, exports, distribution, and sale of narcotics.
• Ministry of Justice and Law: Authority in charge of granting licences for seed usage and cannabis cultivation.
• INVIMA: Regulatory Authority in charge of the registry for pharmaceutical products of human use amongst others.
• ICA: Authority in charge of the registry of seeds cultivators, plant breeders and seeds testing, registry of seeds variety and pharmaceutical registry, amongst others for animal purposes.

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

REGULATORY FRAMEWORK

Decree 677/1995. Regulatory Framework for drugs sanitary registry

Act 1787/ 2016. Regulatory framework to allow the access to cannabis only for medical and scientific purposes

Decree 780/2016. Regulatory framework for the Health Sector.

Decree 613/2017. Legal and Technical framework to allow the access to cannabis only for medical and scientific purposes

Resolution 2892/2017. License to manufacture cannabis derivatives- Regulatory Framework

Resolution 2891/2017. License to manufacture cannabis derivatives – Government fees

Resolution 577/2017. Licenses to use the seeds and license the cultivation of psychoactive cannabis and non-psychoactive cannabis plants – Regulatory Framework

Resolution 578/2017.  Licenses to use the seeds and license the cultivation of psychoactive cannabis and non-psychoactive cannabis plants – Government fees

Decree 1156 de 2018. Phytotherapeutic drugs – regulatory framework

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Production is regulated by the Health Ministry in conjunction with the National Narcotics Fund. On the other hand, import is regulated by INVIMA through the sanitary registry/marketing authorization of the product and  by the National Narcotics Fund.

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

There are five  types of licenses that can be requested depending on the use to be made of cannabis.

• License to manufacture cannabis derivatives.
• License to manufacture derivates no psychoactive of cannabis.
• License to use seeds for sowing.
• License for the cultivation of psychoactive cannabis.
• License for the cultivation of non-psychoactive cannabis plants.

Regarding licenses for the manufacture of derivatives and cultivation of psychoactive cannabis, additionally, a quota must be requested from the Health Ministry and the Ministry of Justice. This quota refers to the maximum amount of psychoactive cannabis in dry weight that you are authorized to acquire or receive from a licensee.

To import Medicinal cannabis, the product must have the marketing authorization granted by INVIMA.

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Being substances subject to government control, medicinal cannabis advertising is restricted to health professionals only. It cannot be promoted in mass media and the sale can only be under medical prescription. Depending on the nature of the product, chemical synthesis or phytoterapeutic medicine, the general advertising rules for each type of product will apply also.

 

18. How can patients obtain Medicinal Cannabis?

Medicinal cannabis can only be acquired by patients through medical prescription.

 

19. Who can prescribe Medicinal Cannabis?

Dully licensed health professionals can prescribe Medicinal Cannabis.

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

No, there isn´t.

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

Medicinal cannabis must be authorized to be sold in the country through a sanitary registry/marketing authorization granted by INVIMA.

 

22. Where is Medicinal Cannabis available?

Any pharmacy or drug store registered at the National Fund of Narcotics.

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

Although there is no list of authorized distributors available to the public, the retailers/distributors must be registered before the National Fund of Narcotics and keep record of all sales of Medicinal Cannabis.

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

Currently, there are no proposals for significant change to the existing regulation. However, as the regulatory framework dealing with cannabinoid drugs is relatively new, there are possibilities of regulation improvements by the competent authorities.

 

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Opioid drugs are authorized in the country; however, they are subject to specific regulation and government control. The regulatory framework for the use of Opioid drugs is Resolution 1478/2016, article 1 Resolution 262/2009, and article 1 Resolution 2340/2013.

 

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

• National Fund of Narcotics (FDE): Authority in charge of overseeing import, exports, distribution and sale of narcotics.
• INVIMA: Regulatory Authority in charge of the registry for pharmaceutical products of human application amongst others.

 

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

There is no specific regulatory framework regarding pricing and reimbursement of opioid drugs, however every activity involving this type of drug must be registered and authorized by the National Narcotics Fund.

 

28. Which are the Opioid drugs that have received market approval to date?

Nowadays there are several opioid drugs approved in Colombia. Each time the approval of an opioid drug is granted by the sanitarian state authority, it must be informed to the National Narcotics Fund. Some approved are morphine, codeine, tramadol, Oxycodone, methadone, hydromorphone HCI, phenobarbital, among others.

 

29. Who can prescribe Opioid Drugs?

Opioid Drugs can be prescribed by any doctor legally authorized to practice medicine in the country.

 

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

No, there isn´t.

 

31. What approvals or notifications are required to prescribe Opioid Drugs?

The sanitarian registry or marketing authorization granted by INVIMA and the notification to the national Narcotics Fund.

 

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

The National Narcotics Fund controls the sale and distribution of opioid drugs, so it keeps a record of all those authorized for the distribution of these drugs. Additionally, it manages agreements with some authorized pharmacies to sell these drugs to the public when dealing with opioids subject to government control.

 

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

Some opioids, despite being under the control of the state authorities, can be sold by the pharmaceutical laboratories that manufacture them; however, if they are subject of state monopoly, they can only be sold by the Fondos Rotatorios de Estupefacientes or through agreements made by the National Narcotic Fund with pharmacies nationwide. These agreements can be consulted by patients in general.

 

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

Currently there are no proposals for significant reforms to the regulation applying to Opioids.

 

35. When are they likely to come into force?

There are no reforms in consideration.

 

Also from this Legal Handbook

Regulatory reforms in Colombia – a legal guide. 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 119.

 

1. Are there proposals for reform or significant change to the healthcare system?

Yes, currently is in course a modification for the Decree 677 which is the principal regulatory framework for drugs, cosmetics, pharmaceutical preparations based on natural resources, cleaning and hygiene products and other products for domestic use.

With the new Colombian government and therefore, the new appointment of the Minister of Health, a reform of health system is being sought due to alleged deficiencies in the Health Promoting Entities EPS and their role as intermediaries between the actual payer of the system known as the ADRES and the Health Provider Institutions IPS.

 

2. When are they likely to come into force?

In 2023, the reform projects are likely to be presented.

 

Also from this Legal Handbook

Read more to find out about patents and trademarks 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 119.

 

1. What are the basic requirements to obtain patent and trademark protection?

Colombia, as WTO Member, complies with the  Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Therefore, in Colombia patent applications in all technical fields must satisfy the standards of absolute novelty, utility, non-obviousness, and disclosure. The process includes the possibility of oppositions by third parties. The majority of pharmaceutical product may be patent protected, provided that it is novel, inventive and industrially applicable. Non-patentable subject matter is limited to discoveries, living matter as found in nature, and methods of treatment.

There are no specific regulations for pharmaceutical trademarks. The basic requirements are distinctiveness of the sign and the lack of confusable registered trademarks or applications to identify competitive linked products or services.

 

2. What agencies or bodies regulate patents and trademarks?

Regulation on patents and trademarks is limited as such power was transfer to the Andean Community, Colombian entities can only issue regulation related with patent and trademarks if it is necessary to apply and comply with Andean regulation within the country.

The Superintendence of Industry and Commerce is the local Trademark and Patent Office (PTO). Filing and prosecution are handled before this authority. The Administrative Tribunals  handles nullity actions for IP matters. Finally, The Superintendence of Industry and Commerce and the district judges handle IP infringement matters.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

There is no specific limitation on patentability of substances or processes to obtain those substances both for chemical synthesis or biological products, to the extent those products come as a result of human intervention. Process claims are allowed as a chain of steps towards obtaining a product. Non-patentable subject matter is limited to discoveries, living matter as found in nature, and methods of treatment.

All products and services listed in the Nice Classification (NCL) can be protected or covered under a trademark registration.

 

4. How can patents and trademarks be revoked?

Trademarks and patents can be revoked through Nullity Actions before Administrative Tribunals , which is a judicial authority with jurisdiction over patent and trademark validity. Patents and trademarks are presumed valid unless there is a judicial declaration stating to the contrary.  IP rights validity and infringement are discussed through two different pathways, validity has to be brought before administrative judges, while infringement is a matter for ordinary jurisdiction. Also, invalidity might not be raised as a defence against infringement allegations. Another way to revoke patent or trademark rights is by a direct consideration of the Patent and Trademark Office (PTO), provided that the right owner provides the PTO with explicit authorization to do so.

 

5. Are foreign patents and trademarks recognized and, if so, under what circumstances?

The principle of territoriality applies for patents and trademarks under a first to file system. Therefore, foreign rights are not recognized unless they are registered in the country. Of course, priority under Paris Convention rules is available, and Patent Cooperation Treaty (PCT) patent applications are welcome within 31 months following such priority. Moreover, Colombia is the only Latin American Patent Office that is a member of the Patent Prosecution Highway (PPH) Global agreement, allowing accelerated patent prosecution with other Patent Offices around the world.

As for trademarks, Andean registrations (trademarks granted in Colombia, Peru, Ecuador or Bolivia) or trademarks protected in any country member of the Washington Convention can be used as grounds on opposition procedures.

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

Test Data Protection is available for new chemical or biological entities, understood as active principles not included under the Colombian Pharmacological Code. According to this protection, generics or biosimilars would have to provide their own safety and efficacy studies in order to obtain market approval for new chemical entities which protection was requested and granted by INVIMA. Test Data Protection is regulated under Decree 2085 of 2002

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

There are no restriction of medicines or devices that could be protected through patents or trademarks different than the ones already mentioned. Moreover, trademarks cannot describe the product, or only consist in the active principle of the product.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

License agreements do not require a government approval; however, it is mandatory to record these contracts before the local Patent and Trademark Office and the National Customs & Tax Authority in order to regularize royalty payments.

 

Also from this Legal Handbook

Find out about product liability 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 119.

 

1. What types of liability are recognized in your jurisdiction?

Contractual and extracontractual responsibility under the general principle that anyone causing damages to a given person is liable for those damages.

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Manufacturers of medicines might be held responsible for damages caused by the use of a drug under extracontractual liability rules, provided that their evidence beyond reasonable doubt that the damage was caused due to the use of a drug with a side effect that the user was not informed of. With regards of health issues, manufacturers and MA holders are responsible for damages caused by the infringement of the sanitary regulation related to their medicines and devices, and may be subject of investigations, administrative procedure and as the case, of sanctions contemplated in the law.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Usually, liability extends to the manufacturer. There is no caselaw extending such responsibility to corporate executives, employees or representatives.

 

4. How can a liability claim be brought?

Through civil or criminal actions.

 

5. What defenses are available?

Anyone claiming damages has the burden to prove those damages came as an unannounced side effect of the product. Defences against clear and convincing evidence are limited to agreement, knowledge of the user, consent, or misuse of the product.

 

Also from this Legal Handbook

Get the lowdown on traditional medicines and OTC products 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 119.

 

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Traditional medicines are ruled through Decree 2266/2004, Decree 4927/09, and Decree 1156/18 which establishes regulatory requirements for Phyto therapeutics.

 

The main requirements for traditional Phyto therapeutics  are :

1. Pharmaceutical forms: tisanes or any accepted pharmaceutical forms except sterile pharmaceutical forms (injectable and ophthalmic).
2. The medicinal plants used for the production should be included in the Colombian Vademecum of Medicinal Plants. In the event of not being in the Colombian Vademecum of Medicinal Plants, it will be in the Specialized Room of Natural Products or whoever takes charge of approving and including them.
3. Its claim of use is not related to the identification of one or more active ingredients, but to the qualitative definition of ingredients and markers.
4. It will not contain in its formulation substances with narcotic or psychotropic activity.
5. It will not combine the material of the medicinal plant with active substances isolated and chemically defined.
6. The active ingredients coming from material of the medicinal plant that has been processed and obtained in pure form, will not be classified as a traditional phyto-therapeutic product.

It is important to consider that INVIMA will only accept medicinal plants for therapeutic purposes that are included in the list of medicinal plants accepted for therapeutic purposes, based on safety and efficacy criteria.

INVIMA will prepare and update the list of medicinal plants accepted for therapeutic purposes for phyto-therapeutic products of the categories of pharmaceutical preparations based on medicinal plants (PFM in Spanish), for Phyto-therapeutic Products for Traditional Use Manufactured in the country (PFT in Spanish), or imported into the national territory (PFTI in Spanish), using the Colombian Vademecum of Medicinal Plants and incorporating the monographs of the World Health Organization (WHO) and European Medicines Agency (EMA) and those defined by the Ministry of Health and Social Protection in coordination with INVIMA.

• Phyto-therapeutic Products: The current regulations governing phyto-therapeutic products are Decree 4927/09 (which amends Decree 2266 of 2004), Decree 3553/04 (which amends Decree 2266 of 2004), Resolution 5107/05 (which adopts instruments for the verification of compliance with sanitary conditions for laboratories that manufacture phyto-therapeutic products), and Resolution 2266/04 (which regulates the regimes of sanitary registrations, surveillance and sanitary control and advertising of phyto-therapeutic products).
• Dietary supplements: The requirements for dietary supplements are regulated by Resolution 2015/11 (Whereby the Inspection Guide for Good Manufacturing Practices in food plants or factories that manufacture, condition or semi-manufacture dietary supplements is issued), Resolution 3131/98 (Whereby the Manual of Good Manufacturing Practices for pharmaceutical products based on natural resources in force is adopted), Decree 1156/18 (which regulates the health registration system for phytotherapeutic products), Decree 3863/08 (which amends Decree 3249 of 2006), Decree 3249/06 (which regulates the manufacture, marketing, packaging, labelling or labelling, health registration system, quality control, health surveillance and health control of dietary supplements, and repeals Decree 3636/05).
• Homeopathic medicines:Homeopathic medicines are regulated by Decree 1861/06, Decree 3554/04, Resolution 3665/09 and Resolution 4594/07.

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Yes. If these medicines can be sold without prescription, they can be advertised directly to the public prior to authorization from INVIMA.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Advertising of homeopathic and phytotherapeutic medicines that do not need prescription follows the same rules as advertising of OTC medicines.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Regulatory requirements for OTC medications are the same as for prescription drugs, i.e. Decree 677/95 in addition to the Resolution 0114/04

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

The distribution and sale of OTC medicines and OTC homeopathic medicines may be carried out in drug stores, homeopathic pharmacies, legally authorized drugstores that meet the conditions established for storage, chain stores and department stores. These establishments must comply with the authorizations for their operation and must be previously inspected by the local authority, that is the Secretary of Health.

 

6. What health, advertising, and marketing claims may be made for OTC products?

Please refer to Question 17 in Marketing, Manufacturing, Packaging & Labelling, Advertising: Colombia

 

7. Can OTC products be marketed or advertised directly to the public?

Yes, prior to authorization from INVIMA. Please refer to Question 17 in Marketing, Manufacturing, Packaging & Labelling, Advertising: Colombia

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

The mechanism consists in applying for a change of the MA with respect the sales condition of the product. This change implies an evaluation from Sala Especializada de Medicamentos which will issue a technical opinion about the availability of the change as requested, based on technical documents that should demonstrate the safety of the product to become an OTC.

Once this commission approves the switch from prescription only to OTC, then interested party can apply for the change of the sales condition enclosing the approval issued by Sala Especializada de Medicamentos.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Requirements for importing traditional medicines or OTC are the same as for prescription drugs. Each product must have its own marketing authorization.

 

Also from this Legal Handbook

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 119.

 

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 substantial data in the product has changed, such active principle, excipients,  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 9455 of 2004, which establishes the content and frequency of Adverse Events and Adverse Reactions reports to INVIMA The National Pharmacovigilance Program has a platform to submit  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 reduce the number of documents  during the registration process which may facilitate the analysis by INVIMA and so, the registration  procedure.

For cosmetics, cleaning supplies and hygiene products, there is common legislation for the countries of the Andean Community (CAN in Spanish), which has allowed for the implementation of mechanisms more efficient registration mechanisms and facilities for interregional trade, in terms of homologation of the registration process and labelling requirements. This was established in Decisions 516/2002 and 706/2008. Those decisions provide the procedure for the homologation, which consists in that the marketing and/or importation of those products requires the Obligatory Health Notification (NSO in Spanish) submitted to the Competent National Authority of the first Member Country of commercialization. Commercialization of the products may take place after the date of issuance of the NSO Code by the Competent National Authority.

 

7. Are parallel imports of medicines or devices allowed?

Parallel imports of products in general are allowed because applicable legislation regarding industrial property 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 must 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 1438/2011 forbids 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 Act  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), Decree 335 of 2022 (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. Resolution 1160/16, and Resolution 2113/21.

 

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.

They must comply with Good Storage Practices (GSP), which are part of the Integrated Quality Management System and aim to ensure that the inputs (medical devices), drugs and biologicals are stored and distributed in accordance with the quality standards with which they were produced and released by the supplier according to the use for which they are intended. The GSP cover both the operational activities of storage, transport, and distribution as well as control and monitoring as basic requirements.

These are regulated by Law 212/95, Law 9/79, Law 1252/08, Law 1626/13, Decree 2200/05, Decree 0249/13, Decree 1140/13, Decree 1313/13, Decree 1072/15, Decree 4725/05, Resolution 4002/07, Resolution 1160/16, Resolution 5402/15, Decree 2086/10, Decree 1954/12.

 

14. What information must be included in medicine and device labeling?

• For medical devices, local regulation states the following mandatory information in labelling:
  • Name of product or registered trademark, and if applicable, generic name;
  • Name and location of manufacturer.
  • Dosage
  • 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 pharmaceutical 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.

Starting on March 8, 2023, advertisement of chemically synthesized medicines, medicinal, biological, homeopathic gases, and phyto-therapeutic products for sale under option formula optional should also include all information stated in Article 11 of the Decree 344/2022. Such information includes actions, indications, therapeutic uses, contraindications, side effects, administration risks, risks of drug dependence and other precautions and precautions must be specified. warnings, in accordance with what is authorized in the sanitary registration of the product. Likewise, the bibliography on which the information is based must always be cited, and the active ingredient must be identified with its generic name.

 

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. Even though there is no specific regulation on medicines and devices delivery via post, it is important to bear in mind that authority will supervise the compliance with the applicable storage regulations.

 

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 10.000 Minimum Monthly Wage, fines should be appraised by INVIMA considering several criteria as the severity of the infringement and whether there are previous offences by the same subject. In case the investigation is transfer to the Superintendence of Industry and Commerce, penalties are much higher and can reach up to 5.000 Minimum Monthly Wage.

 

Also from this Legal Handbook

The key requirements for conducting preclinical and clinical trials in Colombia. 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 119.

 

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

No. INVIMA accepts clinical trials conducted abroad if they sufficiently demonstrate safety and efficacy of the drug product.

 

2. How are clinical trials funded?

In Colombia, clinical research on humans is currently regulated primarily by Resolution No. 8430/93, that determines the scientific, technical and administrative standards for health research in Colombia.

Resolution No. 2378/08 incorporates the Good Clinical Practices drafted by Technical Working Groups appointed by the member countries of the Pan American Network for Drug Regulatory Harmonization (PANDRH). Resolution No. 2378 is focused on requirements to be met by health institutions performing clinical research in humans.

Access to human genetic resources or sampling of biological material of minor ethnic groups or members of indigenous communities is also regulated through Resolution 3823/97

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

INVIMA has the responsibility to evaluate and approve the clinical research protocols with drugs that are carried out in Colombia Phase I, II, III and IV interventional, which are evaluated by the Clinical Research Group. Any change in a protocol already approved should be notified to the Sanitary Authorities.

Before submitting a new clinical trial to INVIMA, it must be evaluated by a Research Ethics Committee(s) assigned to the Good Clinical Practice certification of a Research Centre. This evaluation must be included in the official documents that the Committee has defined within its statutes or manuals, and these may be subject to subsequent evaluation by INVIMA.

 

4. What are the requirements for consent by participants in clinical trials?

In Colombia this is called informed consent and it must be signed by two participating witnesses and the medical investigator. No ambiguity will be tolerated and the information  provided according to the socio-cultural level of each one of the volunteers. In the same vein, an informed consent is required for genetic samples, wherein aspects such as usage of said samples, conservation time and confidentiality should be explicit. The informed consent must contain:

• Rationale and goals of the research.
• Procedures to be implemented and their purpose, including identification of experimental procedures
• Expected discomfort and risks.
• Expected discomfort and risks.
• Potential benefits.
• Alternative procedures that may be advantageous for the subject.
• A guarantee of getting answers to any questions, clarifications to any doubts about procedures, risks, benefits and other matters related to the research and treatment of the subject.
• Freedom to withdraw his/her consent at any time and retire from the trial, without prejudice to further care and treatment.
• The assurance that the subject’s identity will not be revealed, and that all information concerning his/her privacy shall be kept confidential.
• A commitment to provide the subject with updated information obtained during the trial, even if this may affect his/her willingness to continue the trial.
• Availability of the same medical treatment and compensation to which the subject would be legally entitled, in case of damages caused by the research directly affecting him/her, on the part of the researching institution.
• In case additional costs arise, they shall be covered by the research budget or that of the responsible institution

 

5. May participants in clinical trials be compensated?

Compensation for participating in clinical trials is not forbidden, nor specifically regulated under Colombian law, therefore it is possible to agree on compensation in exchange for participation in a clinical trial. According to Resolution 2378/2008, sponsors must submit the clinical trial budget for the participating centre, specifying, among other items, the budget for participants.

The compensation should be considered as a supportive incentive for expenses due to participation in the trial (transportation, food, work absences).

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

As a general rule, participants in clinical trials are protected through contractual agreements with insurance clauses. In the absence of such agreements, extra contractual responsibility rules would apply for indemnification. In this case, patient bear the burden of proof on any damages suffered as a consequence of the clinical trial.

 

Also from this Legal Handbook

Need to know about regulation, pricing and reimbursement in Colombian pharma? Read on! 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 119. 

 

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

Jurisdiction over drugs, biologicals and medical devices is centralized at the Colombian National Food & Drug Surveillance Institute, better known as INVIMA. This is a decentralized agency of the Ministry of Health, created in 1993. More information available at invima.gov.co.

Additionally, according to Article 132 of Law 1438/2011, the Superintendence of Industry and Commerce (SIC) is the entity in charge of investigating and sanctioning infringements against the price control regulations of medicines and medical devices. The same authority is competent regarding the omission, reluctance to or inaccuracy in the provision of price information to the Medicines Price Information System – SISMED.

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

In Colombia there are two types or regimes of price control for drugs and medical devises:

1. Price report, under which prices are set freely but it has to be reported to SISMED
2. Direct Price control which the authority sets the maximum price. 

The regulatory framework for the authorization of drugs, biologicals and medical devices is framed through Decree 677/95 for chemical synthesis drugs Decree 1484/12 for biologicals,  and Decree 4725/05 is applicable to medical devices. Each of these Decrees has been subject to  additional regulations:

1. Law 1751/2015, regulated by Decree 780/2016, provides the general national framework on health rights and duties in Colombia;
2. Resolution 3951/2016, established the reimbursement procedure at the Fund of Solidarity and Assurance (FOSYGA) for supplying medicines, medical services and health benefits not included in the Health Benefits Plan. However, FOSYGA was substituted in its functions by the Administrator of the Resources of the General System of Social Security in Health (ADRES) since August 1, 2017, as established by Act 1753 of 2015.
3. Price control over drugs and medical devices is determined by National Medicines and Medical Device´s Prices Commission (CNPMD in Spanish according to Act 100/1993, Act 1438/2011, Decree 1071/2012 and Decree 705/2016. The CNPMD annually assign a reference price for all medicinal products marketed in the country. This price is considered a regulatory tool to establish the price for each commercial presentation of the medicinal product. A product will enter on a direct price control system (fixed price control) if: i) It has a higher retail price than the reference price of the corresponding homogeneous group and/or ii) The class of products do not form a homogeneous group, with at least three or more references of the product.The methodology for setting the price of new medicines based on the evaluation carried out by the Institute of Technological Assessment in Health (IETS in Spanish) was set by Circular No. 013 of 2022 which was issued by the National Commission of Medicines and Medical Device´s scope (CNPMD). Circular No. 13 establishes the maximum sales price, the price per unit for the regulation of unavailable vital medicines and other provisions. The National Medicines and Medical Device´s Prices Commission (CNPMD in Spanish) issued on July 25, 2022, Circular No. 014 of 2022. This new piece of law regulated the supervised freedom regime for some products and created the system to report information on prices of medical devices.

 

3. What are the steps to obtaining authorization to develop, test, and market a product?

It is mandatory to obtain a marketing authorization (MA) or health registration to manufacture, sell, import or export a drug product. Requirements and procedures depend on the product, its background, indications of use and risks.

3.A. STEPS TO OBTAINING MARKETING AUTHORIZATION OF NEW DRUG PRODUCTS:

Usually, the marketing authorization for a new medicinal product may take between 9 months to 12 or 20 months depending on the product supporting information. In practice, INVIMA takes more time than the legally established limits.

 

1= TACIT WITHDRAWAL: Should the interested party fail to comply with one or more requirements, the process will be acknowledged as dismissed.

3.B. STEPS TO OBTAINING A MARKETING AUTHORIZATION FOR PRODUCTS INCLUDED IN OFFICIAL PHARMACOLOGICAL REGULATIONS

Usually, the marketing authorization for drug products included in Official Pharmacological Regulations may take from 4 months to 9 or 12 months depending on the product supporting information. In practice INVIMA takes more time than the legally established limits.

 

4. What are the approximate fees for each authorization?

 

GOVERMENT FEES IN USD FOR MARKETING ATHORIZATION FOR A:
Drug Product included in the Pharmacological Code	3,200
New drug	7,000
Biological Products	7,238
Good Manufacturing Practice Certificate	12,035

 

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Marketing authorizations are valid for five years.. Renewals shall be requested for no later than the third month prior to the expiration date.

 

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

1. If it is an innovator or new drug product, the authorization process takes longer because the scientific and technical information is completely new Besides, there is no worldwide data about safety nor efficacy of the new drug.
2. If it is a generic product or a drug product  listed on the Colombian Official Pharmacopeia, the authorization process will be shorter because the technology is sufficiently demonstrated. This rule applies equally for both local and foreign-owned manufacturers. The first phase of the application to market a drug in the country begins with the pharmacological evaluation. “This is the procedure by which the health authority evaluates the usefulness, suitability and safety of a drug. This evaluation is initially carried out by the support group in conjunction with the Specialized Chambers in drugs and biological products of INVIMA. In the case of some generic drugs, Bioequivalence a medicine is equivalent in terms of quality, efficacy, and security in the patient in respect to a reference one and considers that both have the same active principle and doses, but different manufacturing origins.
3. For products of biological origin there are no generics, and biosimilars may take as long as the innovator, but depending on the type of molecule and its size, INVIMA may allow abbreviated routes that may expedite the process.

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

There is no specific regulation for combination drug or biological products. The only regulation is established under Decree 4725/05 for medical devices + drug products. According to what is set in this Decree, combination products will be ruled according to their main indication or function. If it has a pharmacological action, then it will be ruled under drugs regulations. If the main indication or function is to work as a device and the role of the drug is more of an accessory, then the product will be ruled under medical device dispositions.

 

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the expectations and requirements of the US Food and Drug Administration (US FDA) or the European Medicines Agency (EMA)?

Compliance with regulation is monitored and evaluated by INVIMA, as Colombian regulatory authority through periodical inspections scheduled by the authority or upon complaints received anonymously or from third parties. Regulatory regime is based on the local rules for each category of product, and as an authority, INVIMA is autonomous in decision-making but approvals by agencies such as the FDA and EMEA may serve as a reference.

 

9. What is the potential range of penalties for noncompliance?

Penalties include fines of up to10.000 Minimum Monthly Wage, fines should be appraised by  INVIMA considering several criteria as the severity of the infringement and whether there are previous offences by the same subject. In case the investigation is transfer  to the Superintendence of Industry and Commerce, penalties are much higher and can reach up to  5.000 Minimum Monthly Wage.

It is worth mentioning that the Minimum Monthly Wage is set every year, for 2022 it was ser at one million pesos, which amounts to approximately $USD225.

 

10. Is there a national healthcare system? If so, how is it administered and funded?

Colombia has a Social Security System with universal  healthcare coverage which is regulated by the National Government through the Health Ministry. Colombian citizens benefit from the healthcare system by being affiliated to the system, either under the contributory (private) or subsidized (public) regime.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

The Social Security System functions as follows:

1. Contributory Regime (private sector): Refers to all affiliates paying or contributing to the system through a legal fixed monthly fee (as employees or independents). Besides the contributor, relatives in the first degree of consanguinity may be enrolled as beneficiaries: wife/husband and children under 18. In some special cases (people economically dependent on the contributor) children, parents, and relatives up to the third degree of consanguinity may be included.
2. Subsidized Regime (public sector): All citizens who are unemployed and/or pertaining to levels 1 and 2 of the Sisben (a census/survey classifying the poverty levels of affiliates). The subsidized regime includes the affiliates’ families.

 

12. Are prices of drugs and devices regulated and, if so, how?

Price control over drugs and medical devices is determined under the National Medicines and Medical Device´s Prices Commission (CNPMD in Spanish)  according to Act 1438/2011, Decree 1071/2012 and Decree 705/2016. The CNPMD annually assigns a reference price for all medicinal products marketed in the country. This price is considered a regulatory tool to establish the price for each commercial presentation of the medicinal product.

In Colombia there are two types or regimes of price control for drugs and medical devises:

1. Price report, under which prices are set freely but it must be reported to SISMED
2. Direct Price control which the authority sets the maximum price.

 A product will enter on a direct control system (price control fixed) if: i) It presents a retail price higher than the reference price of the corresponding homogeneous group and/or ii) The class of products do not form a homogeneous group, with at least three or more references of the product.

 

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

Resolution 1885/2018 establishes a procedure for reimbursement at the Administrator of the Resources of the General System of Social Security in Health (ADRES in Spanish), whereby an EPS or an ECOC obtains payments for the health technologies not financed with UPC resources or complementary services. Whose supply was guaranteed to its affiliates and prescribed by the health professional or ordered by tutela judgments.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Drugs and devices are dispensed by Health Promotion Entities (EPS), hospitals or healthcare professionals directly. Dispensers are compensated through the ADRES.   The applicable type of distribution varies according with the marketing authorization required for each drug or device.

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

First, they must comply with all regulations applying to reception, storage, transport, distribution and dispensing of drug products. Additionally, they must register at the Special Registry of Health Service Providers.

Products authorized for sale under Rx conditions can only be sold in chemist’s stores and drugstore-pharmacies. The professional must ask for the prescription document before dispensing the medicine and should verify the prescription requirements.

It is forbidden for drugstores to have free samples in their store or to have empty packages of pharmaceuticals. In case a person or a company finds that a drug store has medical samples and is selling them, the interested party may initiate  legal action against the establishment before competent authorities  In any case, drugstores  must provide accurate, verifiable, sufficient and clear information to patients as required in accordance with the drug product, indications, warning or precautions.