FDA FAQs On AO 2015-003

Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
FREQUENTLY ASKED QUESTIONS

Administrative Order No. 2015-0053, Implementing Guidelines on the Promotion and
Marketing of Prescription Pharmaceutical Products and Medical Devices
1) Why is the Philippines adopting the Mexico City and Kuala Lumpur
Principles?
The adoption of the two principles is part of the commitment at the Asia Pacific
Economic Cooperation (APEC) in November 2011.
2) Why is the FDA Philippines involved?

Under the said AO, the FDA Philippines shall be the lead office in its
implementation.
3) What are prescription pharmaceutical products and medical devices?

Drugs or pharmaceutical products are defined as:
(a) any article recognized in the official USP-NF, official HPUS, PP, PNDF,
BP, EP, JP, IP, any national compendium or any supplement to any of
them;
(b) any article intended for use in the diagnosis, cure, mitigation, treatment or
prevention of disease in humans or animals;
(c) any article recognized in the official USP-NF, official HPUS, PP, PNDF,
BP, EP, JP, IP, any national compendium or any supplement to any of
them;
(d) any article intended for use in the diagnosis, cure, mitigation, treatment or
prevention of disease in humans or animals;
(e) herbal and/or traditional drugs which are articles of plant or animal origin
used in folk medicine which are:
i. recognized in PNDF
ii. intended for use in the treatment or cure or mitigation of disease
symptoms, injury or body defects in humans
iii. other than food, intended to affect the structure or any function of
the human body
iv. in finished or ready-to-use dosage form; and
v. intended for use as a component of any of the articles specified in
clauses (i), (ii), (iii) and (iv)
Prescription pharmaceutical products are drug products that are dispensed only
upon written order of a validly-registered licensed physician, dentist, or
veterinarian for the management or treatment of a condition or disease.
Medical device, on the other hand, is any instrument, apparatus, implement,

machine, appliance, implant, in-vitro reagent or calibrator, software, material,
or other similar or related article intended by the manufacturer to be used
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Website: www.fda.gov.ph Email: info@fda.gov.ph
alone, or in combination for human beings for one or more of the specific
purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of
disease; diagnosis, monitoring, treatment, alleviation of, or compensation for
an injury, investigation, replacement, modification, or support of the anatomy
or of a physiological process; supporting or sustaining life; preventing
infection; control of conception; disinfection of medical devices; and
providing information for medical or diagnostic purposes by means of in-vitro
examination of specimens derived from the human body. This device does not
achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means but which may be
assisted in intended function by such means.
4) Are over-the-counter (OTC) medicines covered?

OTC products are not covered by this AO but by other issuance related to
promotion, such as:
 Administrative Order No. 65 s. 1989
 Administrative Order No. 119 s. 2000
 Republic Act No. 7394
 And other related issuances
5) When can PPPMD companies use the term “new”?

A product may be promoted as new if it is classified by FDA as “new chemical
entity”, “under monitored release”, or “new medical device”.
6) What do we mean by modest meals and appropriate venue?

Modest meals would mean in moderation, appropriate, and not excessive in the
context of the person and event involved.
Appropriate venue would mean conducive to learning, not in places near

distractions such as bars, casinos.
7) Can medical representatives communicate to patients, even after issuance of

prescription?
No.
8) What does “entertainment that will incur expenses” mean?

It means that any form of entertainment that will incur additional expenses (e.g.
hiring a performing group, a professional actor/actress) to the company is not
allowed. Company performances with company staff are allowed.
9) What does “direct patient benefit” and “related to HCP work” mean?
It means that gifts directly benefit the patient and is related to the HCP work, e.g.
notepads, papers, pens, as these materials are “used by the HCP” for the “benefit
of the patient”. The concept of modest shall also apply.
10) Is the UNDP and government prevailing rate applicable only to CPDs?
Yes.
11) Is it required to submit disclosures of Conflict of Interest for speakers to the
FDA?
No, there is no need. These are kept on file by the PPPMD company and are
readily available whenever FDA asks for it.
12) Are financial rebates for reaching a specific quantity of prescriptions

allowed? How about discounts?
The offer of rebates to doctors and pharmacists who have reached a specific
quantity of prescription prescribed and dispensed, respectively, is considered
unethical. Thus, it follows that a PPPMD company or its representatives are
prohibited to look at prescriptions from clinics/pharmacies/drugstores/outlets.
On the other hand, discounts shall only be applicable to sales promotion activities
in legitimate outlets approved by the FDA. Direct sales of PPPMD company or its
representatives, whether with or without discounts, to patients or consumers is
prohibited.
13) Are public-private partnership projects, advocacies affected by this AO?

Yes. Any program or project endeavored by the government must comply with the
requirements: minimal promotion of the activity.
14) If a PPPMD company would sponsor a lunch or dinner symposium in a

“medical society-organized” or “hospital organized” event, or hold its own
event, should the PPPMD company follow the prevailing government rate or
the UNDP daily subsistence rate?
Not necessarily, but the meals should be modest and the venue is appropriate.
15) If there are less than 100 HCPs attending a meeting, should the PPPMD
company notify FDA?
There is no need, but other requirements of the Administrative Order should be
complied with.
16) Is there a required form for disclosures of speakers?

Annex B of the AO provides for the declaration of conflict of interest of speakers.
17) Is it the responsibility of the PPPMD company to submit the reports on behalf
of the HCPs? The PPPMD company cannot undertake to collate and submit
due to data privacy restrictions.
Yes. There is no issue with data privacy given that every sponsorship must have
an agreement between the HCP and PPPMD company for “return of knowledge”
to the community. HCPs must coordinate with the PPPMD company for the
submission of reports.
18) What specific office in FDA will be in charge of implementing the AO?
The FDA will be establishing committees to be in-charge in the implementation:
 Committee for Networking
 Committee for Enforcement
 Committee for Research
Associations may be part of this committee through expression of intent to
participate.
19) Will FDA be issuing a more specific implementing rules and regulations for
this AO?
For now, FDA will be implementing the AO as it is, but with reports and data
generated, FDA may recommend appropriate recommendations for revision.

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Republic of the Philippines

FREQUENTLY ASKED QUESTIONS

2) Why is the FDA Philippines involved?

3) What are prescription pharmaceutical products and medical devices?

Medical device, on the other hand, is any instrument, apparatus, implement,

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

4) Are over-the-counter (OTC) medicines covered?

5) When can PPPMD companies use the term “new”?

6) What do we mean by modest meals and appropriate venue?

Appropriate venue would mean conducive to learning, not in places near

7) Can medical representatives communicate to patients, even after issuance of

8) What does “entertainment that will incur expenses” mean?

12) Are financial rebates for reaching a specific quantity of prescriptions

13) Are public-private partnership projects, advocacies affected by this AO?

14) If a PPPMD company would sponsor a lunch or dinner symposium in a

16) Is there a required form for disclosures of speakers?

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