HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

DEPARTMENT OF HEALTH

Subject: Guidelines on the Annual Cut-off Dates forReceipt of Complete Applications for RegulatoryAuthorizations Issued by the Department of Health

• Issued on April 30, 2019

• Published May 12, 2019 – PDI and Philippine Star

• Effectivity date: May 27, 2019

Administrative Order No. 2019-0004

I. RATIONALE

Republic Act No. 11032 also known as “An ActPromoting Ease of Doing Business and EfficientDelivery of Government Services, Amending forthe purpose Republic Act No. 9485, OtherwiseKnown as the Anti-Red Tape Act of 2007, and forOther Purposes”, declared it the policy of theState to establish effective practices aimed at

efficient turnaround delivery of governmentservices.

This Order shall apply to all health facilities and

services regulated by the Department of Healththrough the Health Facilities and Services Regulatory

Bureau and/or the Center for Health Development-

Regulation, Licensing and Enforcement Divisions.

III. SCOPE

A. All applicants shall adhere to the following timelines:

V. IMPLEMENTING GUIDELINES

Type of Application Application Period Annual Cut-Off Date

Department of Health-Permit to

Construct (DOH-PTC)

1st working day of

the year to

November 15 of

the same year

November 15

Certificate of Need (CON) November 15

Initial:

Department of Health -License to

Operate (DOH-LTO)

Department of Health-Certificate of

Accreditation (DOH-COA)

Authority to Operate (ATO)

Certificate of Registration (COR)

November 15

V. IMPLEMENTING GUIDELINES

Type of Application Renewal Period Annual Cut-Off Date

Renewal:

DOH-LTO

DOH-COA

ATO

October 1- December 15 December 15

B. In the event that the cut-off date falls on a weekend or is declared as a regular/special/non-working holiday, or there is force majeure, the cut-off date shall automatically be moved to the next working day following the holiday or weekend.

C. The HFSRB and CHD-RLEDs shall not accept applicationswhether manual or through the Online Licensing and Regulatory System beyond the set cut-off dates of the current year.

D. Applicants who intend to submit via mail or courier shall ensure that their applications shall be received by the HFSRB or CHD-RLEDs on or before the cut-off dates.

E. Applications for renewal of EXPIRED DOH-LTO, DOH-COA, and ATO shall still be processed subject to penalties and sanctions set forth in this Order.

SANCTIONS

Length of Expiry Sanction Remarks

Less than or equal to

three months ( ≤ 3

months) expired

Penalty: 100%

surcharge and Gap in

the Validity of the

authorization

For processing as

renewal.

More than three

months

(> 3 months) expired

For processing as initial.

Application for DOH-

PTC, DOH-LTO/DOH-

COA shall be required.

For EXPIRED authorizations:

B. The Rules and Regulations of the Food and Drug

Administration (FDA) in the processing of late applications

(Hospital Pharmacy and Radiation Facilities) under the

One-Stop-Shop shall remain valid and in effect.

SANCTIONS

REPEALING CLAUSE

This Order repeals Section VI.D.4 of Administrative

Order (A.O.) No. 2012-0012 titled “Rules and Regulations

Governing the New Classification of Hospitals and Other

Health Facilities in the Philippines” and other related

issuances that are inconsistent or contrary to the

provisions of this Order. All other provisions of the

aforementioned A.O. which are not affected by this Order

still stand in effect.

Department Circular

Dated: March 9, 2019

Subject: Restriction on Purchase of Medicines from the Hospital-Based Pharmacies for In-Patients

Status: For numbering

Republic Act (RA) No. 9502, titled as “An Act Providing for

Cheaper and Quality Medicines, Amending for the Purpose

Republic Act No. 8293 or the Intellectual Property Code,

Republic Act No. 6675 or the Generics Act of 1988, and

Republic Act No. 5921 or the Pharmacy Law, and for other

Purposes“ granted to the Secretary of Health the power to

set maximum retail price on drugs and medicines subject to

price regulation. Executive Order No. 821, issued on July 27,

2009, titled “Prescribing the Maximum Drug Retail Prices for

Selected Drugs and Medicines that Address Diseases that

Account for the Leading cause of Morbidity and Mortality”

added some drugs, such as anti-hypertensives, cholesterol-

lowering and anti-neoplastics, to the original list.

Considerable differences between the prices of medicines

were observed between non-hospital-based pharmacies and

hospital-based pharmacies. Though both types of facilities are

regulated by the Food and Drug Administration-Center for

Drug Regulation and Research (FDA-CDRR), through the

issuance of a License to Operate (LTO), and Certificate of

Product Registration (CPR) for the particular medicine, the

cost of procurement varies. The hospital policy which restricts

patients to purchase their medicines only from its pharmacy

forces some patients to shell out additional higher out-of-

pocket expenses, especially when the PhilHealth case rate

benefit for that disease has been consumed, as compared to

purchasing the same medicine from a drug store outside

hospital premises.

The Health Facilities and Services Regulatory

Bureau (HFSRB) has been receiving several

complaints of this nature from patients and

their relatives. The prohibition on in–patients to

purchase their medicines from outside drug

stores is not a licensing requirement, but rather

the hospital’s intent to ensure that the

medicines being given to their patients are of

good quality, efficacious and authentic.

However, Article 2.c of R.A. No. 7394, known as

“The Consumer Act of the Philippines” requires

provision of information and education to

facilitate sound choice and the proper exercise

of rights by the consumer. It is the consumer’s

right to choose products at competitive prices

with an assurance of satisfactory quality, with

the patient as the consumer and the medicine

as the product, in this case.

In view of the above, it is hereby ordered that

the patient’s choice shall prevail, that in-

patients shall be allowed to purchase their own

medicines from any FDA licensed drugstores. No

additional fees shall be charged to the patients

for administration and storage of those procured

drugs. This applies to patients admitted in

private rooms, and not to those who are

admitted in wards or basic accommodation,

wherein no balance billing applies.

Complaints can be filed at the Complaints and

Action Unit (CAU) of HFSRB or at the CHD-RLED.

After due process, hospitals found violating the

above-mentioned order would merit the

appropriate sanctions based on Administrative

Order No. 2007-0022 “ Violations under the One-

Stop Shop Licensure System for Hospitals” and

/or Section 25 of RA 9502.

For strict compliance.

HFSRB Contact Information

• HFSRB EMAIL: hfsrb@doh.gov.ph

• Standards Development Division (SDD): Trunk line: 651-7800 local 2525

• Quality Assurance and Monitoring Division (QAMD): Trunk line: 651-7800 local 2528

• Regulatory Compliance and Enforcement Division (RCED): Trunk line: 651-7800 local 2511

Thank you!