Mozambique: Medicine Regulatory Authority receives ISO 9001: 2015 Certification – Watch

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Mozambique: Medicine Regulatory Authority receives ISO 9001: 2015 Certification – Watch

7:02 CAT | 21 Jun 2023

Photo: Autoridade Nacional Reguladora de Medicamentos

The National Medicine Regulatory Authority (ANARME) this Tuesday (20-06) formally received the ISO 9001: 2015 Certificate, a seal that attests to the quality management of the institution, helping both in the development and improvement of products and services.

Awarded by Bureau Veritas, an international world leader in audit, test, inspection and certification (TIC) services, the certificate is the culmination of a process of audits, recommendations and follow-ups initiated in 2018 by the now-extinct National Directorate of Pharmacy, following the World Health Organization (WHO) assessment of the Mozambican regulatory system in 2016.

“It is undoubtedly a special moment for the institution, for the health sector and for the country in general,” said Tânia Sitoie, chair of the board of directors of the National Regulatory Authority for Medicines, in her speech when receiving the seal. Site pointed out that the institutionalisation of ANARME and the certification of its services was a challenge for all, in order to guarantee the circulation of safe, effective and quality medicines in the national territory.

Mozambique is now aligned with the Regional Strategy for the Regulation of Medicinal Products, 2016-2025, which provides that all member states must have national regulatory authorities for medicines that are functional and with systems of quality management by 2025, she said.

Tania Sitoe also said that ANARME’s management and functioning processes gain greater trust from its audiences, a factor that will add greater value and good image to the institution.

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The ANARME chairperson ended her intervention by acknowledging everyone who contributed to the success that culminated in the certification. “I would like to reiterate our recognition of the effort undertaken by the Government of Mozambique, through the Ministry of Health, which from the beginning supported the entire process of implementing this system. A special acknowledgment goes to all ANARME workers, especially the Quality Management Department and focal points for this area. Let me also thank the local office of the World Health Organization, the Global Fund and the Promoting the Quality of Medicines programme (PQM+), who from the beginning have supported this initiative, both technically and financially,” Sitoie concluded, further asking everyone’s commitment to the institution maintaining this recognition and achieving many others.

In turn, the representative of Bureau Veritas Beatriz Magalhães congratulated ANARME and the country on having achieved certification and, above all, on having carried out the work that culminated in meeting all the requirements.

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