Amending Sections 18 and 19, Article III of Board Regulation No. 3, Series of 2003
On October 13, 2009, the Dangerous Drugs Board of the Philippines amended Sections 18 and 19 of Board Regulation No. 3, Series of 2003, which outlines guidelines for the handling of dangerous drugs and controlled substances. The amendments clarify licensing durations, specifically stating that S-2 licenses will remain valid in accordance with the holder's Professional Regulation Commission registration, with a renewal period of three years. Additionally, a new provision requires registered practitioners to notify the Philippine Drug Enforcement Agency (PDEA) of any retirement or discontinuance of their S-2 license, imposing penalties for non-compliance. The regulation takes effect fifteen days after publication in two newspapers and registration with the Office of the National Administrative Register.
October 13, 2009
DDB BOARD REGULATION NO. 04-09
| SUBJECT | : | Amending Sections 18 and 19, Article III of Board Regulation No. 3, Series of 2003, Entitled "Comprehensive Guidelines on Importation, Distribution, Manufacture, Prescription, Dispensing and Sale of, and Other Lawful Acts in Connection with, Any Dangerous Drugs, Controlled Precursors and Essential Chemicals and Other Similar or Analogous Substances" |
WHEREAS, the Dangerous Drugs Board promulgated Board Regulation No. 3, Series of 2003 providing for the comprehensive guidelines on importation, distribution, manufacture, prescription, dispensing and sale of, and other lawful acts in connection with, any dangerous drugs, controlled precursors and essential chemicals and other similar or analogous substances; DIESHT
WHEREAS, Section 81, paragraph r of the IRR of RA 9165 authorizes the Philippine Drug Enforcement Agency (PDEA) to issue the proper licenses and permits upon payment of the required fees;
WHEREAS, there is no provision in Board Regulation No. 3, Series of 2003, indicating conditions/penalties to be imposed for late or non-renewal of S-2 license.
NOW THEREFORE, be it RESOLVED, as it is hereby RESOLVED, to amend Sections 18 and 19, Article III of Board Regulation No. 3, Series of 2003, as hereunder provided:
SECTION 1. Section 18, Article III of Board Regulation No. 3, Series of 2003 is hereby amended by, clarifying that paragraph 1 refers to all other S and P licenses except S-2 license and amended further by adding a 3rd paragraph, and should now read as follows:
1. A license, except for S-2 license as provided for by paragraph 3 hereof, shall remain in force for one (1) year for new license holder and three (3) years for qualified renewal license holders, unless earlier surrendered, suspended or revoked, and may be successively renewed for a period of three (3) years by application in writing, signed by the applicant and accompanied by the prescribed fee.
2. A permit shall only remain in force for such period as may be specified in it, which in the case of an import for dangerous drugs or controlled chemicals and their preparations shall not exceed six (6) months, and in the case of export permit or transit permit for dangerous drugs or controlled chemicals and their preparations shall not exceed three (3) months.
3. An S-2 license shall remain in force for a period conforming with the validity of the licensee's registered Professional Regulation Commission (PRC) indicated in the S-2 ID Card, unless earlier surrendered, suspended or revoked, and may be successively renewed for a period of three (3) years by application in writing, signed by the applicant and payment of the prescribed fee.
SECTION 2. Section 19, Article III of Board Regulation No. 3, Series of 2003 is hereby amended by adding paragraph 2, which reads as follows:
2. Retirement and Discontinuance of the License Granted
All registered practitioner/s and handler/s of dangerous drugs and dangerous drugs preparations, preparation containing Table 1 controlled chemical as the only active medicinal ingredient or containing Table 1 controlled chemical and insignificant quantities of another active medicinal ingredient, that require a prescription with a practitioner's S-2 license and controlled precursors and essential chemicals respectively shall notify PDEA in writing, the retirement or discontinuance of the S-2 license granted, otherwise, back accounts and penalties shall be imposed and computed as follows:
| First Year | — | Php1,000.00 |
| Succeeding Years | — | Php500.00/year |
SECTION 3. Effectivity. — This Regulation shall take effect fifteen (15) days after its publication in two (2) newspapers of general circulation and after its registration with the Office of the National Administrative Register (ONAR), UP Law Center, Quezon City. HcISTE
APPROVED and ADOPTED, this 13th day of October, in the year of Our Lord, 2009 in Quezon City.
(SGD.) SEC. VICENTE C. SOTTO IIIChairmanDangerous Drugs Board
Attested by:
(SGD.) USEC. EDGAR C. GALVANTESecretaryDangerous Drugs Board