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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).

Country/Territory
Philippines
Document type
Regulation
Date
1996 (2000)
Source
FAO, FAOLEX
Long title
Rules and Regulations implementing Republic Act No. 8203 otherwise known as the Special Law on Counterfeit Drug.
Subject
Livestock
Keyword
Drugs Animal health Legal proceedings/administrative proceedings Offences/penalties Monitoring Inspection Registration
Geographical area
Asia, Asia and the Pacific, East Asian Seas, North Pacific, South-Eastern Asia
Entry into force notes
This Rules and Regulations enter into force 30 days after its publication.
Abstract

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.

Full text
English
Website
www.fda.gov.ph

References - Legislation

Implements

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

Legislation | Philippines | 1996

Keyword: Public health, Fraud, Drugs, Animal health, Legal proceedings/administrative proceedings, Offences/penalties

Source: FAO, FAOLEX