Committee on Technical Barriers to Trade - Notification - Committee on Technical Barriers to Trade - Notification - Peru - Medicines and biological products - Medicines and biological products

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6.

 

1.

Notifying Member: PERU

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

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

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [.], 5.7.1 [.], other:

4.

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)

5.

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)

6.

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.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety

8.

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.

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: Six months after publication in the Official Journal, El Peruano

10.

Final date for comments: 60 days from notification

11.

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