Law Summary

Introduction

This regulation, adopted on November 17, 1982, outlines the procedures and requirements for registration and licensing of individuals or entities authorized to deal with dangerous drugs and exempt preparations under Republic Act 6425, as amended.

SECTION 1: With Whom to Register and File Application

• Legal Principle: Applications for registration and licensing must be submitted to the Dangerous Drugs Board (DDB) or its authorized representatives.
• Key Definitions:
  • Dangerous Drugs Board: The regulatory body overseeing the registration process.
• Requirements/Procedures:
  • Applications must be filed with the DDB directly or through authorized representatives for those outside Metro Manila.
• Important Details:
  • Special Processing Officers are designated to handle applications in regions outside Metro Manila.

SECTION 2: Requirements to be Complied With

• Legal Principle: Compliance with existing requirements is mandatory until new regulations are implemented.
• Requirements/Procedures:
  • All applicants must adhere to currently imposed registration and licensing requirements.
• Relevant Timeframes:
  • No specific deadlines mentioned, but compliance is ongoing until new rules are established.

SECTION 3: Deputation of Drug Regulation Officers in the Regional Offices

• Legal Principle: Regional Drug Regulation Officers are designated as Special Processing Officers to facilitate local application processing.
• Key Definitions:
  • Special Processing Officers: Regional Drug Regulation Officers authorized to process applications.
• Requirements/Procedures:
  • Officers will receive and approve applications, issue S-licenses, and report monthly to the DDB.
  • Unresolved issues must be escalated to the DDB in Manila.
• Important Details:
  • In cases with multiple officers, the highest-ranking officer is the designated Special Processing Officer.

SECTION 4: Custody of Records

• Legal Principle: The DDB is responsible for maintaining records pertaining to registration and licensing.
• Requirements/Procedures:
  • Records from the Food and Drug Administration must be transferred to the DDB by December 31, 1982.
• Important Details:
  • Regional Drug Regulation Officers will take custody of relevant records from Health Regional Offices.

SECTION 5: Inspections of Authorized Persons or Entities

• Legal Principle: Inspections are mandated under RA 6425, as amended, and must follow specific regulatory protocols.
• Requirements/Procedures:
  • Inspections are to be conducted by designated officers from the DDB, including the Executive Director and other delegated officers.
• Important Details:
  • Compliance with Board Regulation No. 1, series of 1980, is required during inspections.

SECTION 6: Effectivity

• Legal Principle: The regulation becomes effective as of January 1, 1983.
• Important Details:
  • This date marks the commencement of the outlined procedures and requirements.

Key Takeaways

• Applications for dealing with dangerous drugs must be filed with the DDB or its regional representatives.
• Compliance with existing requirements is crucial until new regulations are introduced.
• Regional Drug Regulation Officers are tasked with processing applications and maintaining records.
• Inspections are governed by previously established regulations and must be conducted by authorized personnel.
• The regulation is effective from January 1, 1983, mandating immediate adherence to its provisions.