1.
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Notifying Member: PERU
If
applicable, name of local government involved (Articles 3.2 and 7.2):
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2.
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Agency
responsible:
Ministerio de Salud, MINSA (Ministry of Health)
Av. Salaverry 801
Jesús María - Lima,
Lima, Peru
Tel.: (+51-1) 315-6600
Email: webmaster@minsa.gob.pe
Name
and address (including telephone and fax numbers, email and website
addresses, if available) of agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:
Ministerio de Comercio Exterior y Turismo, MINCETUR (Ministry of Foreign Trade and Tourism)
Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 -
Peru
Tel.: (+51-1) 513-6100, Ext. 1223 or 1239
Email: otc@mincetur.gob.pe
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3.
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Notified under Article
2.9.2 [X], 2.10.1 [ ], 5.6.2 [.], 5.7.1 [.], other:
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4.
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Products covered (HS or CCCN where applicable, otherwise national
tariff heading. ICS numbers may be provided in addition, where applicable): Pharmaceutical products (HS tariff heading 30)
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5.
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Title, number of pages and language(s) of the notified document: Proyecto de Reglamento para el Registro Sanitario Condicional de Medicamentos
y Productos Biológicos (Draft Regulation for the
conditional sanitary registration of medicines and biological products) (27
pages, in Spanish)
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6.
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Description of content: The notified Regulation establishes the regulatory provisions of
Article 8 of Law No. 29459 (Law on pharmaceutical products, medical devices
and sanitary products), amended by Law No. 31091, in order to regulate the
conditional sanitary registration of medicines and biological products with
phase III clinical studies.
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7.
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Objective and rationale,
including the nature of urgent problems where applicable: Protection of human health or safety
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8.
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Relevant documents:
1. Law No. 29459, Ley de los Productos
Farmacéuticos, Dispositivos Médicos y Productos Sanitarios.
2. Law No. 31091, Ley que garantiza el acceso
al tratamiento preventivo y curativo de la enfermedad por coronavirus SARS-CoV-2
y de otras enfermedades que dan origen a emergencias sanitarias nacionales y
otras pandemias declaradas por la Organización Mundial de la Salud.
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9.
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Proposed date of
adoption: To be determined
Proposed
date of entry into force: Six months after
publication in the Official Journal, El Peruano
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10.
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Final date for comments:
60 days from notification
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11.
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Texts available from: National enquiry point [ ] or
address, telephone and fax numbers and email and website addresses, if
available, of other body:
Ministerio de Comercio Exterior y
Turismo (MINCETUR)
Calle Uno Oeste Nº 50 - Urb. Corpac -
Lima 27 - Peru
Tel.: (+51-1) 513-6100, Ext. 1223 or
1239
Email: otc@mincetur.gob.pe
Ministerio de Salud (MINSA)
Av. Salaverry 801
Jesús María - Lima, Lima, Peru
Tel.: (+51-1) 315-6600
Email: webmaster@minsa.gob.pe
https://www.gob.pe/institucion/minsa/normas-legales/2104585-1019-2021-minsa
http://extranet.comunidadandina.org/sirt/public/buscapalavra.aspx
http://consultasenlinea.mincetur.gob.pe/notificaciones/Publico/FrmBuscador.aspx
https://members.wto.org/crnattachments/2021/TBT/PER/21_5729_00_s.pdf
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