Mandatory Registration of Medical Representatives

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PRC Board of Pharmacy No. 03: Mandatory Registration of Medical Representatives

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Title Supreme Court: Mandatory Registration of Medical Representatives

Law: Prc Board Of Pharmacy No. 03

Decision Date: Feb 2, 2015

The PRC Board of Pharmacy mandates the registration of medical representatives and professional sales representatives with the Professional Regulation Commission, reinforcing compliance with training requirements to ensure qualified representation in the pharmaceutical industry.

administrative law

regulatory board

A

Definition of Medical Representatives and Drug Establishments

Medical representatives or professional sales representatives are individuals representing authorized drug establishments to promote products to licensed professionals.
Drug establishment refers to any company involved in manufacturing, importing, repacking, or distributing drugs or medicines, as per DOH Administrative Order No. 56, Series of 1989.

Historical Regulations and Previous Requirements

Since 1977, the Board issued a Memorandum Circular requiring medical representatives to possess credentials set by the Board.
Board Resolution No. 2004-07 prescribed the registration procedures and requirements for medical representatives with the Commission and Board.

Training and Accreditation Requirements

Applicants must complete a comprehensive training program conducted by a Board-accredited training provider.
There has been a low number of applications for accreditation of training providers and programs.

Compliance Issues Among Pharmaceutical Entities

Many pharmaceutical companies employ medical representatives without complying with registration and training requirements.

Reinforcement Measures and Resolutions Adopted

Promulgation of Revised Guidelines on Registration, an integral part of the Resolution.
Issuance of a Memorandum Circular directing drug establishments to enforce mandatory registration in conformity with the Resolution and Revised Guidelines.
Authorization for the Standards and Inspection Division (SID) to receive accreditation and registration applications.

Transitional Provisions and Deadlines

Medical representatives who have not undergone training from accredited providers may apply for registration until June 30, 2015.
After this date, only those who have fulfilled the prescribed training and standards will be registered.

Publication and Dissemination of the Resolution

The Resolution is to be published in the Official Gazette or a national newspaper.
Copies to be furnished to U.P. Law Center, Philippine Association of Pharmacists in the Pharmaceutical Industry (PAPPI), Philippine Pharmacist Association Inc. (PPhA), SID, and other relevant agencies for information and dissemination.

END