Marketing of Special Regulated Products

Throughout the year 2024, the National Authority for Sanitary Regulation ( ANRS ) of the Ministry of Health ( MINSA ) of Nicaragua has been updating its regulatory framework for the registration, importation, distribution and commercialization of regulated products. These updates have great impact and relevance for natural persons, legal entities, national and foreign manufacturers, distributors and importers, regents, as well as for associated and independent registrars who carry out activities on products regulated by the authority.

Through the official website of MINSA, three administrative resolutions dated August 9, 2024 issued by the ANRS were announced, which came into force on September 1, 2024 and which establish the requirements and procedures for the use and commercialization of products regulated by the authority without the need to obtain a sanitary registration, as is generally mandatory for regulated products. These 3 resolutions are: (i) Administrative Resolution No. 0017/2024 “ Procedure for the issuance of authorization for marketing and use of regulated products without sanitary registration in cases of public necessity ”; (ii) Administrative Resolution No. 0019/2024 “ Circumstances in which it is not possible to follow the usual sanitary registration procedure for regulated products ”; and (iii) Administrative Resolution No. 0020/2024 “ Authorization for marketing and use of orphan products without sanitary registration ”.

Administrative Resolution No. 0019/2024 establishes in a general manner the cases in which the usual procedure for sanitary registration of products will not be followed to obtain authorization for use and marketing. These cases are the following:

1. donations;
2. public need declared based on data from the MINSA;
3. orphan products;
4. cases of medical justification;
5. personal use cases;
6. samples to carry out health registration procedures for: (a) medicines, (b) medical devices, (c) food and beverages, and (d) tobacco; and
7. medicines and medical devices, whose use is specifically intended for the public sector and which are acquired by the Pan American Health Organization (PAHO)/World Health Organization (WHO) and other Regional International Cooperation Agencies.

The resolution also contemplates the obligations of the holders of the marketing and use authorization for regulated products without sanitary registration. One of the most relevant of these obligations is the notification of suspected adverse reactions of which they are aware, as established in the current provisions on surveillance, and not to promote and advertise the use of regulated products without sanitary registration and for which the marketing and use authorization has been requested.

For its part, Administrative Resolution No. 0020/2024 regulates the additional requirements to obtain the authorization for the use and marketing of orphan products, generating incentives to promote the research, development and marketing of these products. In accordance with the resolution, for a product to be classified as “orphan”, the following criteria must be taken into account:

1. A product is an orphan product if its promoter can demonstrate that the product is intended for the diagnosis, prevention or treatment of a life-threatening or seriously disabling condition or a serious chronic condition and that, without incentives, commercialisation of the product is unlikely to generate sufficient profits to justify the necessary investment;
2. That there is no satisfactory method in the country for diagnosing, preventing or treating said condition, or that, if there is one, the product will provide a considerable benefit to those suffering from said condition.

For the purposes of approval of use and marketing without registration of an orphan product, it is essential that the applicant submits the following: (i) active ingredients and composition of the product, (ii) proposed therapeutic indication and intended use, and (iii) justification of compliance with the criteria for determining orphan products.

Finally, Administrative Resolution No. 0017/2024 establishes the guidelines necessary to obtain authorization for marketing and use of regulated products without health registration due to public necessity. For this purpose, the interested party must submit the authorization request, which will be admitted based on a benefit/risk analysis of the quality, safety and efficacy data available on the date of submission of the application and product dossier.

The authorization may also be issued through validation or recognitions issued by the WHO or strict regulatory authorities, for which the interested party must submit a copy of the emergency use authorization from a strict regulatory authority or from those that are on the WHO list for emergency use. Approvals for emergency use authorization will be granted for a period of one year and the holder must inform the ANRS of the imports of each batch.

If you wish to obtain more information about the requirements, procedures and scope of the resolutions, please do not hesitate to contact us.

The information provided by ARIAS® is presented for informational purposes only. This information is not legal advice and is not intended to create, nor does it constitute, an attorney-client relationship. Readers should not act on the basis of this information without seeking advice from professionals in the field.