The Dangerous Drugs Board convened representatives from seventy – two (72) pharmaceutical/ chemical companies and hospitals, 19 medical organizations, and nine (9) government agencies in Manila and Cebu last week, for the public consultation on the proposed amendments to Board Regulation No. 1 Series of 2014 or 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", as Amended, and Other Related Board Issuances.”
The Board’s reclassification committee is working on these amendments that also demonstrate the agency’s commitment to the implementation of Republic Act 11032 or the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018”.
In the amended provision, the submission of reports from pharmaceutical/ chemical companies will now be computerized through the Regulatory, Control and Monitoring System (RCMIS). Applications for Certification and Exemption can now also be done online using the Online Application for Certification and Exemption Information System (OACEIS).
Another highlight of the new Board Regulation will benefit Physicians in the country, who can now avail Yellow Prescription for free by requesting to the Department of Health. A report should be submitted to DOH for the replenishment of the yellow prescription used for controlled medicines.
DDB and other members of the Committee commit to take part in the necessary amendments to ensure that this regulation meets the requirements for an efficient and effective application and dispensation of any dangerous drugs.
In a message, DDB Undersecretary Jose Marlowe Pedregosa, Permanent Board Member and Chairman of the Reclassification Committee, emphasized the need to amend the provisions of the regulation to simplify the process and make it more accessible to companies requesting for Certificate of Exemption and Certification.
Usec. Pedregosa assured participating companies that their recommendations would be discussed and considered. Speaking to the participants, he said that their inputs “are much appreciated”.
Among the suggestions raised were on the procedures for application for Certificate of Exemption. A representative from Timex Philippines suggested that in lieu of a Special Permit, they can apply for Certificate of Exemption, which was considered by representatives from DDB and PDEA. Clarification was also raised on definitions of responsibilities of personalities involved in the process such as “pharmacy assistant” and “trained nurse.”
Other companies whose suggestions have not been raised during the public consultation may still submit their position papers until December 9, 2019. The proposed amendments will be discussed and approved by the Board in its regular meeting on December 17, 2019.
Public consultation is one of the requirements mandated by law whenever there is a new regulation or amendments to the existing regulations to be made.