Publicado: 06 Abril 2018
Medicamentos falsificados Neurobión 25000 DC y Neurobión 25000 HYPAK
http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/255-alerta-neurbion
Santo Domingo.- El Ministerio de Salud, a través de su Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS) realizó los primeros tres talleres para la presentación de la Guía de Autoinspección de Farmacias Comunitarias Privadas, con la participación de más de 200 farmacéuticos y dueños de farmacias de las provincias de Santo Domingo, Santiago y otras demarcaciones.
Además participaron farmacéuticos de las provincias Duarte, Valverde, Santiago Rodríguez, Puerto Plata, Espaillat, Hermanas Mirabal, La Vega, Sánchez Ramírez, Samaná, Monseñor Nouel y La Romana.
Los talleres realizados en el mes de febrero y marzo han contado con el apoyo y participación de los representantes de la Asociación Farmacéutica Dominicana, Asociación Farmacéutica del Norte, Unión de Farmacias, Asociación Nacional de Dueños de Farmacias y de la Universidad Tecnológica de Santiago y han sido realizados en Santo Domingo y Santiago.
La guía de autoinspección es una nueva herramienta desarrollada por el Departamento de Vigilancia Sanitaria de DIGEMAPS, con el objetivo de evaluar el grado de cumplimiento de los establecimientos farmacéuticos con la normativa vigente en materia de medicamentos.
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Más informaciones por el enlace http://www.msp.gob.do/Ministerio-de-Salud-presenta-en-taller-Guia-Autoinspeccion-de-Farmacias
The Ministry of Health is advising the public against the use of unregistered Cannabis Products for medical and therapeutic purposes.
The Ministry of Health recommends that Medical Cannabis products have a maximum Tetrahydrocannabinol (THC) content of 5% and is concerned about the potential negative public health effects that may arise from the use of unregistered cannabis products of which the (THC) content is unknown. Tetrahydrocannabinol (THC) is the main mind-altering ingredient found in the Cannabis plant.
According to the Foodand Drugs Act, any substance manufactured, sold or represented for use in the diagnosis, treatment, prevention of a disease, disorder or symptoms is classified as a drug and must be registered, and the requisite permits obtained from the Ministry of Health.
Additionally, the Dangerous Drugs (Amendment) Act, 2015 which has decriminalized ganja for specific purposes, cannabis remains classified as a controlled drug under the Food and Drugs Act (1975). Also, in accordance with the provisions of the Pharmacy Act, the compounding, dispensing, storing for sale or retailing of drugs must be done at a registered pharmacy and by a registered pharmacist. Therefore, any company that is currently selling cannabis products for medical and therapeutic purposes is in breach of The Food and Drugs Act (1975) and The Pharmacy Act.
Companies are being advised to consult with the Ministry of Health’s Standards and Regulations Department, Pharmacy Council of Jamaica and the Cannabis Licensing Authority if they wish to manufacture or distribute cannabis products, to ensure that proper standards and procedures are followed and that their operations are in keeping with the relevant laws of Jamaica.
There is a process in place for registration of Medical and Therapeutic Cannabis Product that starts with the application for registration by the Ministry of Health.
The Ministry of Health wishes to reiterate that it does not support, for medicinal and therapeutic purposes, the smoking of cannabis and the use of edibles containing cannabis.
13th March 2018
Drug Alert No. 1/2018
Dayamineral ® 240ml Syrup
The Ministry of Health would like to inform the public on unauthorized and suspected falsified Dayamineral ® Syrup 240ml bottle that has been found to be circulating the market and has been confiscated. Investigations conducted by the Ministry are indicative that this Dayamineral Syrup found has not been granted entry into the country by the Ministry of Health and the quality may be compromised.
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For more information go to http://health.gov.bz/www/attachments/article/978/Alert%20No1-2018.pdf
Un total de seis alertas sanitarias ha emitido el Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima) en el último año sobre el producto Vitacerebrina Francesa, el cual no tiene registro sanitario, por lo cual su comercialización en Colombia es ilegal y se considera fraudulento.
Al desconocerse su composición, este producto puede contener sustancias que afectan la salud e incluso comprometan la vida de quienes lo consumen, por lo cual se ha recomendado a las personas no consumirlo y denunciar los lugares donde es comercializado.
Este producto también se vende bajo varios nombres similares como: Mega Vitacerebrina o Mega Max Vitacerebrina Francesa y usan registros sanitarios falsos para engañar a las personas y hacerles creer que son productos legales. Algunos ejemplos de registros falsos: RSAD12L01632, RSAD15I25638, RSAE 12I11504.
Estos productos son promocionados como alimentos con propiedades medicinales que prometen mejorar el coeficiente intelectual, dar vitalidad, energía y curar enfermedades del hígado, riñones, corazón y hasta el cáncer de mama, según lo publicitan en sus empaques.
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Más informaciones por el enlace: https://www.invima.gov.co/%C2%A1ojo%C2%A1,-vitacerebrina-francesa-es-un-producto-fraudulento.html
Por: Ascom/Anvisa
Publicado: 06/03/2018 10:30
Última Modificação: 06/03/2018 10:44
Laboratório Pfizer identificou 11 lotes falsificados que não saíram de sua fábrica. Medicamento para câncer é utilizado em hospitais.
Em resolução publicada nesta segunda-feira (5/3) no Diário Oficial da União (DOU), a Anvisa proibiu 11 lotes falsificados do medicamento oncológico Sutent® na embalagem com 28 cápsulas de 50 mg. São falsificados os lotes 746EE, 747EE, 748EE, 190EE, 045AA, 191EE, 189EE, 985EE, 986EE, 987EE e 749EE.
Mais informações pelo link: http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4131460
• Colômbia, Chile e México avançam sobre questões de cooperação farmacêutica e reduzem a lacuna relacionada com bioequivalência
• No âmbito da reunião realizada em Medellín, Colômbia, as Autoridades Sanitárias criaram uma equipe técnica permanente para consolidar a harmonização e a convergência regulatória
• A integração regional em questões regulatórias responde aos mandatos presidenciais com alcance a longo prazo e benefícios claros para a saúde da população
No âmbito da reunião do Acordo de Cooperação Interinstitucional entre Autoridades Sanitárias da Aliança do Pacífico, realizada nos dias 1 e 2 de março em Medellín, Colômbia, as autoridades da Colômbia, do Chile e do México assinaram um compromisso na sexta-feira que acelerará o registro de medicamentos na Região.
Mais informações pelo link: https://www.invima.gov.co/autoridades-sanitarias-de-la-alianza-del-pac%C3%ADfico-firman-compromiso-para-agilizar-el-registro-de-medicamentos.html
On February 28, 2018, the Health Products Compliance Directorate posted four drug good manufacturing practices (GMP) documents to the Health Canada website. These documents are:
GUI-0001, GUI-0023, and GUI-0031 are revised versions of currently posted documents and GUI-0119 is a new document to replace the sterile products section of GUI-0001. These documents, except for GUI-0023, have an implementation date of October 1, 2018.
GUI-0023 will be implemented effective immediately as it will help you better understand how Health Canada currently assigns the risk rating to GMP inspection findings and the compliance rating for a GMP inspection. There are important changes in this guide as it relates to lower risk products and activities.
These documents have been updated to:
Health Canada will host a series of webinars to review the revised guidance documents, highlight key changes and to answer any related questions. You can expect to receive invitations in the near future to attend webinars scheduled for:
Source: Health Product Inspection and Licensing Division
Información disponible en los siguientes sitios:
El Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED), Autoridad Reguladora Nacional de la República de Cuba, informa sobre la falsificación confirmada de Rocephin® (Ceftriaxona) 1000 mg, polvo para solución i.v en Nicaragua.
Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (Arcsa) da a conocer a la población ecuatoriana la alerta expuesta por la PAHO/WHO-OPS/OMS, sobre el comunicado realizado por la empresa Roche por falsificación del medicamento Rocephin® 1g (ceftriaxone), polvo para solución inyectable lote L.525.
