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Rules And Regulations Implementing Republic Act No. 8203 otherwise known as the Special Law on Counterfeit Drug (IRR of RA 8203).

País/Territorio
Filipinas
Tipo de documento
Reglamento
Fecha
1996 (2000)
Fuente
FAO, FAOLEX
Título completo
Rules and Regulations implementing Republic Act No. 8203 otherwise known as the Special Law on Counterfeit Drug.
Materia
Ganado
Palabra clave
Medicamentos Sanidad animal Procedimientos judiciales/procedimientos administrativos Infracciones/sanciones Monitoreo Inspección Registro
Área geográphica
Asia, Asia y Pacifico, Mares del Asia Oriental, Pacífico Norte, Asia Sudoriental
Entry into force notes
This Rules and Regulations enter into force 30 days after its publication.
Resumen

These Rules and Regulations regulate unregistered imported drug product without a registered counterpart brand in the Philippines. If the unregistered imported drug product has a registered counterpart brand in the Philippines, the product shall be considered counterfeit. The provisions prohibited under Section 4 of R.A. 8203 are adopted as these rules and therefore punishable by the administrative sanctions. The Food and Drug Regulation Officers (FDROs) in the course of their inspection of a factory, warehouse, establishment or vehicle, processed or raw materials, containers and labelling therein upon the authority conferred by Section 27 of R.A. 3720, shall determine whether the drug products found are counterfeit or not. For the effective implementation of R.A. 8203, the said inspection shall be without prior notice in any place within the Philippines to prevent the parties liable from concealing them and avoiding inspection.

Texto completo
Inglés
Página web
www.fda.gov.ph

Referencias - Legislación

Implementa

Special Law on Counterfeit Drugs (Republic Act No. 8203).

Legislación | Filipinas | 1996

Palabra clave: Salud pública, Fraude, Medicamentos, Sanidad animal, Procedimientos judiciales/procedimientos administrativos, Infracciones/sanciones

Fuente: FAO, FAOLEX