The law today
On October 6, 2020, an excerpt of Exempt Resolution No. 3853/2020 of the Institute of Public Health (ISP) was published in the Official Gazette, establishing requirements for the notification and execution of market withdrawal activities for the holders of health registrations and participants in the distribution chain of pharmaceutical products, whether they are voluntary withdrawals or withdrawals instructed by the ISP.
For these purposes, withdrawal activities are classified as Class 1, Class 2 and Class 3, according to the potential health risk that the product involved may represent.
Bearing in mind the above, pharmaceutical product recall activities shall be governed by the following rules:
A. The beginning of the withdrawal shall be notified by electronic means, in the following opportunities:
Once the suspicion or verification of failure or deviation of quality is known, or since the cancellation of the sanitary records, within a maximum period of 24 hours.
Within a period not exceeding 48 hours, accompanying the written records of the notification to each one of the establishments of the distribution chain.
B. In the case of Class 1 withdrawals, the owner of the records shall have the obligation to send a warning message to consumers informing them of the dangers or harmfulness of the lots of the product subject to withdrawal.
C. Obligations are determined for the establishment that has received one or more lots subject to withdrawal shall, establishing standards according to whether it has made previous distribution or not.
D. The holder of the sanitary registration shall submit to the PSI the follow-up reports of the withdrawal from the market and, once the withdrawal is finished, shall submit a conclusive report.
E. The destruction of the medicines shall be the responsibility of the holder of the health registration, according to the regulations in force.
On September 30, 2020, Exempt Resolution No. 3422, dated August 25, 2020, of the Institute of Public Health (“ISP”) was published, which instructs holders of health registrations, and applicants for such registrations, to declare the plant species of the starch used as an excipient in the pharmaceutical products containing it in their formulation.
As of that date, the qualitative and quantitative formula expressions of all the pharmaceutical products applying for a health registration, which contain starch in their formulation, must expressly state the vegetable species from which the starch comes, and also state the byproducts that come from modified starch. All this, in the special form indicated by the resolution.
Likewise, in the case of products already registered, the holders of such registrations shall have until September 30, 2021, to comply with the aforementioned, and shall submit to the PSI the information of the vegetable species from which the starch comes, in the special form indicated by the resolution, including the starch by-products that are indicated.
Law No. 21.267 establishes measures to facilitate the acquisition of medicines in the context of a health alert.
On September 22, 2020, Law No. 21.267 was published in the Official Gazette, establishing measures to facilitate the acquisition of medicines in the context of a health alert, whether due to an epidemic or a pandemic. In specific terms, the Law provides for the following measures, in the event of a health alert being declared in the event of an epidemic or pandemic:
A. Pharmaceutical products may be dispensed by any establishment authorized to do so, it is sufficient that the consumer shows a copy of the prescription that prescribes the medicine, in physical or digital format, in any of its forms.
B. Those prescriptions issued 6 months before the declaration of health alert or during its validity, will be valid until 6 months after the end of the alert.
C. The requirement that the electronic prescription must be signed by an advanced electronic signature is eliminated.
The above measures shall not exempt the establishment from its obligation to complete the corresponding records, according to the nature of the medicine and the provisions of the respective regulations.
Finally, it is established that the malicious use of prescriptions presented in digital form will be punished according to Book X of the Health Code, the Criminal Code and Law No. 20,000.
Decree of the Ministry of Health modifies Technical Norm Nº208, on storage and transport of refrigerated and frozen medicines
On September 21, 2020, Exempt Decree No. 49/2019 of the Ministry of Health was published in the Official Gazette, amending Exempt Decree No. 48/2019, of the same portfolio, which approves Technical Standard No. 208 on the storage and transportation of refrigerated and frozen medicines. This modification is intended to redefine the scope of the Norm, since its formulation was based on recommendations of the WHO for “High Production and Distribution” establishments, but not for the Assistance Network; and, in addition, to exclude from its scope pharmacies, medicine cabinets and pharmaceutical warehouses, since its provisions are new, given its position in the logistic chain.
In this way, the reference to pharmacies, first-aid kits and master prescriptions is eliminated from the third paragraph of article 1, and a fourth paragraph is added that expressly declares that the Technical Standard will not be applicable to the mentioned establishments.
Decrees of the Ministry of Health introduce modifications to the regulation of pharmaceutical products in terms of health records and therapeutic equivalence
On August 21, 2020, Decrees No. 54 and No. 65 of the Ministry of Health were published in the Official Gazette, introducing amendments to Decree No. 3/2010, of the same portfolio, which approves the Regulations of the National System of Control of Pharmaceutical Products for Human Use, regarding health registrations and therapeutic equivalence, respectively.
In relation to Decree No. 54, in order to reduce the processing time of health registrations, mainly, in the case of medicines registered in International Regulatory Agencies, the following amendments are determined:
A. During the processing of a health registration, if the evaluation carried out by the Institute of Public Health (ISP) is unfavorable, it may grant a period of time for the applicant to correct accessory issues or submit sufficient information. If the period of time elapses and these objections have not been corrected, the PSI will proceed with the rejection of the registration application, without a favorable pronouncement from the Ministry of Health being necessary.
Nevertheless, the applicant may initiate a new registration procedure within 6 months from the date of notification of the rejection of the registration, and the PSI will have a period of 3 months to verify the background of the new application.
B. The abbreviated registration procedure may be initiated ex officio by the PSI or at the request of the interested party, and no longer requires a substantiated resolution from the Ministry of Health.
C. It is established that the total period to resolve the application for the simplified registration procedure will be a maximum of 5 months, counting from the entry of the application.
D. The accelerated registration procedure is created, which will be available to those medicines registered with Highly Supervised Drug Regulatory Agencies, whose processing may not exceed 3 months from the receipt of the application. Along with the recognition of the registration of the pharmaceutical product, the authorizations and certifications granted by the Agencies, such as the Good Manufacturing Practices, will also be recognized.
Biological products are exempted from the abbreviated procedure, unless there is a well-founded resolution by the Ministry of Health; and when there are public health reasons that prevent it, which will be qualified by a well-founded resolution by the Ministry of Health.
E. A new cause is incorporated to request the modification of the registration of pharmaceutical products, namely, the change of manufacturer, of active ingredients and modifications of the production process.
F. The possibility of requesting the authorization of a new drug manufacturer is incorporated, keeping the already authorized one. In this case, a new health registration number will be assigned, maintaining the other authorized aspects.
With respect to Decree No. 65, in order to facilitate and make more flexible the registration of bioequivalent medicines, a new article 221 bis is incorporated, providing that therapeutic equivalence will be understood to be demonstrated with respect to those pharmaceutical products that have obtained certification of this quality before any of the Highly Supervised Medicine Regulatory Agencies; as well as those that have been prequalified by the World Health Organization.