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The president of Infarmed says requests for access to the drugs given to the Portuguese-born sisters were swift.

The President of the National Medicines Authority (Infarmed) this Monday ensured that requests for access to the medicine prescribed to the Portuguese-Brazilian twins were prompt and received through the Santa Maria Hospital.

“It came through the Santa Maria Hospital and that’s where we started working on it. It came solely at the request of the clinical management of the Centro Hospitalar Universitário Lisboa Norte, and it was from there that we started working,” said Ruy Santos Ivo. journalists.

The person in charge added that “the request was received on February 29.” [de 2020] and these (…) requests were made between 2 and 3 March. [do mesmo ano]. As a rule, they [pedidos] fast.”

The President of Infarmed – the National Authority for Medicines and Health Products – was speaking at the entrance to the conference “Medicine shortages: pharmacies as part of the solution”, organized by the National Pharmaceutical Association (ANF) in Lisbon.

“We have authorized two [pedidos] in July 2019 we allowed three, in September 2019 and gave three [autorizações] in March 2020. These deadlines fall within our normal deadlines,” he said.

“This is the medicine [Zolgensma] has already been approved for placement on the United States market. It was evaluated by the European Medicines Agency and was approved by the European Union in May 2020,” he added.

The request for access to Zolgensma for the twins, who also received Portuguese citizenship in a short period of time, was approved in two working days, submitted on Saturday, February 29, 2020, and approved by Infarmed the following Tuesday.

Rui Santos Ivo also explained to journalists that the drug administration processes are “always managed in the same way.”

“What Infarmed does (…) is to check whether a medicine that does not yet have a full registration form can be authorized or cannot be authorized for this authorization. This is exactly what we did,” he emphasized, noting that “processes occur through the platform” anonymously.

Claiming that Infarmed’s intervention was “purely technical”, the person in charge said the request for the Portuguese-Brazilian twins “came through the usual channels”.

In November, TVI published the case of two twin children living in Brazil who have since acquired Portuguese citizenship and traveled to Portugal to receive the drug Zolgensma for spinal muscular atrophy, worth a total of four million euros.

The President of the Republic, Marcelo Rebelo de Sousa, who has already submitted documentation on the matter to the PGR and confirmed that his son Nuno Rebelo de Sousa contacted him about the need for treatment for the children, denies any interference in the process. .

Author: Lusa
Source: CM Jornal

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