By means of Decree 1787 of 2020, the Ministry of Health established the conditions for the processing and granting of the Emergency Use Authorization (ASUE- by its acronym in Spanish) of medicines for the diagnosis, prevention and treatment of Covid-19, that still do not have the information required to obtain the marketing authorization.

What is the Emergency Use Authorization-ASUE?

It is the authorization issued by the National Institute of Food and Drug Surveillance – INVIMA, allowing the temporary and conditional use of chemical or biological medicines that:

• Still do not have all the information required to obtain the marketing authorization.
• Are intended for the diagnosis, prevention, or treatment of Covid-19.
• Have an ongoing clinical trial, which supports the generation of evidence of efficacy and safety of the product, reviewed and approved by INVIMA or its counterpart in the country where such study is carried out. The evidence and technical support generated in such clinical trial shall conclude that the benefit-risk balance is favorable.

In which cases the ASUE could be granted?

The Health Authorization for Emergency Use – ASUE will be granted only to new chemical or biological synthesis medicines or those that, having a current marketing authorization in the country, opt for a second use or indication covering only unmet therapeutic needs generated by Covid-19. 

For how long is the ASUE granted?

It will be valid for one (1) year, counted from the date of the enforceability of the administrative decision that grants it.

What is the application process for the issuance of the ASUE?

1) Early dialogue with INVIMA: it consists of meetings held between the interested party and INVIMA prior to filing the ASUE application, in order to plan and optimize the study of the procedure, clarify documentary or procedural aspects, allow INVIMA acknowledging a preliminary scheme of quality, efficacy, and safety of the medicine, propose conditions for the progressive delivery of information and new evidence that is generated as the development of the product advances.

2) Submission of the ASUE’s application: This application must be submitted in a common format (CTD – Common Technical Document) at least with the information from module 1 administrative information, module 2 summaries of common technical documents, and the specific requirements according to the type of medicine, established in Article 7 of Decree 1787 of 2020.

3) Study of the ASUE by INVIMA: Once the request with its respective supports has been received, INVIMA will proceed with the evaluation and consequently, should grant or deny the emergency use authorization, orequest the interested complementary  or additional information, for which INVIMA will have a peremptory term of ten (10) business days.

When additional information or clarification of the submitted documents is needed, the interested party will be required only once, to provide the corresponding information, for which the applicant will have a peremptory term of ten (10) business days. If within this period the interested party does not provide the information requested, it will be understood as a withdrawal of the request and, consequently, INVIMA will proceed to declare it.

Once the petitioner files the information requested by INVIMA, this entity will have a new peremptory term of ten (10) business days to deny or approve the emergency use authorization.

How long must the ASUE be issued by INVIMA?

In accordance with the foregoing, the ASUE must be issued within a maximum term of 30 business days if the petitioner has been requested, otherwise, it must be issued within a maximum term of 10 business days.

Can the ASUE be renewed?

The ASUE may be renewed only once, for a term of one (1) year. The renewal request must be submitted to INVIMA no more than thirty (30) business days before its expiration date and will be processed automatically, in accordance with the procedure defined by INVIMA.

Can the ASUE lose its enforceability?

The emergency use authorization issued by INVIMA will lose its status and will cease to have effect in the following cases:

• When the owner fails to comply with obligations that guarantee the quality, efficacy, and safety of the product, determined by INVIMA in the administrative decision of authorization.
• When the negative evolution of the benefit-risk balance of the drug during its use, allows concluding that the initial efficacy and safety information changed and is now unfavorable compared to the time of application.
• When the safety alerts or negative pronouncements in relation to the benefit-risk balance of the drug by other health agencies are known by INVIMA and the interested party.
• When the ASUE is in force and the respective marketing authorization is obtained by the holder, after compliance with the requirements of the current regulations.

Is it allowed the promotion or advertising of medicines with ASUE?

The promotion and advertisement  of medicines with emergency use authorization is strictly prohibited. Information related to the drug (technical sheet and information to prescribe-IPP) that must be available to health professionals, distributors, or authorized dispensers is not included within the scope of the prohibition.

How should medicines with ASUE be labeled?

For imported chemical and biological medicines, the labels, packaging, and inserts must at least indicate in Spanish: the name, composition, and special storage conditions.

For nationally manufactured chemical and biological medicines, the labels, packaging and inserts shall adjust to the provisions of literal i) of Article 22 and literals a), b), d), e), g), h), and j) of Article 72 of Decree 677 of 1995 in accordance with the provisions of paragraph 10 of Article 72 ibid.

For vaccines, labels, packaging, and inserts will be accepted as they come from the country of origin.

Additional aspects:

• There may be no medical or gift samples for the medicines with an ASUE.
• INVIMA must make available in an accessible way on its website, the technical data sheets and other documents of the ASUE, without any exception.
• For medicines with an ASUE, a copy of the informed consent signed by the health professional who prescribed and the patient or their legal representative, in case of being a minor, must be kept in the patient’s medical record, prior to its administration. The foregoing, in order to inform the patient or their representative about the benefits and risks of the medicine, medical device, or in vitro reagent, which they are receiving.
• Throughout all the supply chain of the medicine with an ASUE, records, and data shall be kept, allowing an adequate trace of the same, from its import or local manufacture, through authorized distributors, up to it is dispensed to the patient.
• The holder, manufacturer, or importer must report any adverse event or suspected safety problem that is generated when using medicines with an ASUE.

Author:

Viviana Aguirre I [email protected] I Life Sciences