Legal basis and referenced prior issuances
- The resolution grounds its requirements on Section 12 of Republic Act No. 5921, which establishes that detailmen employed by covered drug establishments must register with the Board of Pharmacy at the beginning of each year and sets fee requirements.
- The resolution specifically explains that Section 12 of R.A. No. 5921 defines a detailman and makes it incumbent on drug establishments to require that employed detailmen possess Board-issued credentials.
- The resolution references an earlier Memorandum Circular issued by the Board on February 1, 1977, which required detailmen employed by drug establishments to possess Board credentials and required notice of cessation of employment to the Board.
- The resolution also notes that the fee provision in Section 12 of R.A. No. 5921 is superseded by PRC Resolution No. 98-560, Series of 1998, which prescribed fees of P200 for original registration and P100 for annual license fee for detailmen.
- The resolution frames its issuance as filling the gap in existing memorandum guidance by providing the guidelines, criteria, qualifications, standards, and procedures for registration.
Policy and reason for issuance
- Section 12 of R.A. No. 5921 requires annual Board registration for detailmen employed in the Philippines by covered pharmaceutical/drug establishments.
- The Board’s resolution is issued to provide the missing operational framework—guidelines and registration procedures—for detailmen/medical representatives.
- The Board decided to draft the registration guidelines after meeting discussions recognizing that the February 1, 1977 Memorandum Circular did not provide the required registration guidelines, criteria, qualifications, standards, and procedures.
Covered persons and regulated activity
- Registration under the Board’s framework applies to persons employed as detailmen by covered entities that operate in the Philippines and promote pharmaceutical/biologic/veterinary products.
- Drug establishments covered by Section 12 of R.A. No. 5921 include pharmaceutical or drug laboratories, manufacturers of medical, dental pharmaceutical, biologic products, and veterinary products, and distributors, dealers, or wholesalers of those products doing business directly or indirectly in the Philippines.
- The registration requirement attaches to employment status: detailmen must register at the beginning of each year.
Definition of a detailman
- A detailman is defined as one who represents a duly authorized manufacturer, dealer, distributor, representative, or wholesaler of drugs, pharmaceuticals, biologic products, and devices.
- A detailman’s primary duty is to introduce or reacquaint products to qualified professionals, as part of a promotion program, through describing:
- use
- composition
- action
- dosage
- administration
- contraindication
- advantages
- and other salient information relative to the products.
- Detailmen promote products to physicians, dentists, pharmacists, veterinarians, or any other qualified person.
Registration timing and fee structure referenced
- Section 12 of R.A. No. 5921 requires that detailmen register with the Board at the beginning of each year.
- Fees under Section 12 of R.A. No. 5921 are referenced as initial and renewal charges, but the resolution explains the fee scheme has been superseded by PRC Resolution No. 98-560, Series of 1998.
- Under the fee supersession described, PRC Resolution No. 98-560, Series of 1998 prescribes PHP 200 for original registration and PHP 100 for annual license fee for detailmen.
- Upon payment of the required fees, proper credential issuance is tied to Board registration under Section 12 of R.A. No. 5921.
Credential obligation of drug establishments
- Section 12 of R.A. No. 5921 makes it incumbent upon covered drug establishments to require that detailmen employed or to be employed by them possess the necessary credentials issued by the Board of Pharmacy.
- Earlier Board guidance (the February 1, 1977 Memorandum Circular) reinforces that credential possession is required for detailmen employed by drug establishments.
Effectivity, publication, and transitory application
- The resolution provides that it takes effect after fifteen (15) days following its publication in the Official Gazette or in any newspaper of general circulation, whichever is earlier.
- The resolution declares that ANNEX “A” and its enclosures (ANNEX “A-1”, “A-2”, and “A-3”) are integral to the resolution for application of the Guidelines.