APPLICATIONS FOR REGISTRATION AND LICENSE TO DEAL IN DANGEROUS DRUGS AND EXEMPT PREPARATIONS

Pursuant to the powers vested in the Dangerous Drugs Board under
Section 36(a) and (1) of Republic Act 6425, as amended, the following
procedures governing the registration and the issuance of license to
qualified persons or entities to deal in dangerous drugs and exempt
preparations are hereby prescribed:

SECTION 1.       With Whom to Register and File Application
— All applications for registration and for the issuance of a license
to deal in dangerous drugs and exempt preparations shall be filed with
the Dangerous Drugs Board, or with the Board’s authorized
representatives if situated outside of the Metro Manila area. Persons or
entities situated outside of the Metro Manila area shall file their
applications with the Special Processing Officers deputized as such by
the Board under Section 3 hereof.

SECTION 2.       Requirements to be Complied With
— Until such time as the new or modifying rules and regulations are
passed by the Board and take effect, all requirements currently being
imposed in connection with such registration and applications for
license shall be complied with.

SECTION 3.       Deputation of Drug Regulation
Officers in the Regional Offices of the Ministry of Health as Special
Processing Officers of the Board — Drug Regulation Officers of the
Ministry of Health are hereby deputized as Special Processing Officers
of the Board.  As so designated, these Regional Drug Regulation Officers
shall (a) receive, process, and approve applications for registration
and licensing to deal in dangerous drugs and exempted preparations
submitted by qualified applicants situated in their respective regions;
(b) issue S-licenses; and (c) submit monthly reports to the Dangerous
Drugs Board which shall include information on all persons or entities
registered and licensed to deal in dangerous drugs and exempt
preparations during the month.

When problems which cannot be resolved by the deputized Special
Processing officers arise in connection with the processing and approval
of the applications, the applications together with other papers
pertinent thereto shall be forwarded to the Dangerous Drugs Board in
Manila for processing and approval.

When two or more Regional Drug Regulation Officers are employed in
the Regional Office, the higher ranking Regional Drug Regulation Officer
as determined by the Ministry of Health shall be considered as hereby
deputized.

SECTION 4.       Custody of Records — Custody of
all records pertinent to registration and license to deal in dangerous
drugs and exempt preparations shall, upon effectivity of this
Regulation, repose on the Dangerous Board.  Accordingly, such records as
are in the custody of the Food and Drug Administration shall be turned
over to the Board on or immediately before December 31, 1982 except
those in the Health Regional Offices which shall be transferred to the
custody of the Regional Drug Regulation Officers deputized as Special
Processing officers of the Board under Section 3 hereof.

SECTION 5.       Inspections of Persons or Entities
Authorized to Import, Export, Manufacture, Distribute, Prescribe,
Dispense, Deal In, or Sell Dangerous Drugs or Exempt Preparations —
For the purposes of RA 6425, as amended, all inspections shall be in
accordance with Board Regulation No. 1, series of 1980 and shall be
undertaken by the Dangerous Drugs Board’s Executive Director, the Chief,
Control Regulation and Intelligence Division, and Drug Regulation
Officers and such other officers as may be deputized in writing as Drug
Regulation Officers by the Chairman of the Board.

SECTION 6.       This Regulation shall take effect January 1, 1983.

Adopted: 17 Nov. 1982

(SGD.) J. C. AZURIN
(Minister of Health)
Chairman