Article 75Supplement v1, p. 75

COMMERCIAL LAWS SUPPLEMENT

prior to dispensing, its label bears the caution statement

quoted in the preceding sentence.

ARTICLE 31. Licensing and Registration . — a) No person

shall manufacture, sell, offer for sale, import, export,

distribute or transfer any drug or device, unless an

application filed pursuant to sub-article (b) hereof is

effective with respect to such drug or device.

b) Any person may file with the Department, through the

Department, an application under oath with respect to

any drug or device subject to the provisions of sub-article

(a) hereof. Such persons shall submit to the Department:

(1) full reports of investigations which have been made to

show

whether

or

not

such drug or device is safe,

efficacious and of good quality for use based on clinical

studies conducted in the Philippines; (2) a full list of the

articles used as components of such drug or device; (3) a

full statement of the composition of such drug or device;

(4) a full description of the methods used in and the

facilities and controls used for the manufacture of such

drug or device; (5) such samples of such drug or device

and of the articles used as components thereof as the

Department may require; (6) specimens of the labeling

proposed to be used for such drug or device; and (7) such

other requirements as may be prescribed by regulations

to ensure safety, efficacy and good quality of such drug or

device.

c) Within one hundred eighty (180) days after the filing of

an application under this sub-article, or such additional

period as may be agreed upon by the Department and

the applicant, the Department shall either (1) approve the

application if he then finds that none of the grounds for

denying approval specified in sub-article (d) applies, or (2)

give the applicant notice of an opportunity for a hearing

before the Department under sub-article (d) on the

question whether such application is approvable.

d) If the Department finds, after due notice to the

applicant and giving him an opportunity for a hearing,

that

(1)

the reports of the investigations which are

required to be submitted to the Department pursuant to

sub-article (b) hereof, do not include adequate tests by all

methods reasonably applicable to show whether or not

such drug or device is safe, efficacious and of good

quality

for

use

under

the

conditions

prescribed,

recommended or suggested in the proposed labeling

thereof; (2) the results of such test show that such drug or

device is unsafe, inefficacious or of doubtful therapeutic

value for use under such conditions or do not show that

such drug or device is safe, efficacious or of good quality

for use under such conditions; (3) the methods used in,

and the facilities and controls used for the manufacture

of such drug or device are inadequate to preserve its

identity, strength, quality and purity; or (4) upon the basis

of the information submitted to him as part of the

application, or upon the basis of any other information

before him with respect to such drug or device, he has

insufficient information to determine whether such drug

or device is safe, efficacious or of good equality for use

under such conditions; or (5) evaluated on the basis of the

information submitted to him as part of the application,

and any other information before him with respect to

such drug or device, there is a lack of substantial evidence

that the drug or device will have the effect it purports or

is represented to have under the conditions of use

prescribed, recommended or suggested in the proposed

labeling thereof; or (6) based on a fair evaluation of all

material facts, such labeling is false or misleading in any

way; he shall issue an order disapproving the application.

e) The effectiveness of an application with respect to any

drug or device shall, after due notice and opportunity for

hearing to the applicant, by order of the Department be

suspended if it finds (1) that clinical experience, tests by

new

methods,

or

tests

by

methods

not

deemed

reasonably applicable when such application became

effective show that such drug or device is unsafe or

ineffective for use under the conditions of use upon the

basis of which the application became effective, or (2)

that the application contains any untrue statement of a

material fact. The order shall state the findings upon

which it is based.

f)

The

Department

shall promulgate regulations for

exempting from the operation of this Article drugs and

devices intended solely for investigational used by experts

qualified

by

scientific

training

and

experience

to

investigate the safety and effectiveness of drugs and

devices.

g) No person shall manufacture, sell, offer for sale, import,

export, distribute or transfer any drug or device without

first securing a license to operate from the Department

after due compliance with technical requirements in

accordance with the rules and regulations promulgated

by the Department pursuant to this Act.

h) No drug or device shall be manufactured, sold, offered

for sale, imported, exported, distributed or transferred,

unless

registered

by

the

manufacturer,

importer

or

distributor

thereof

in

accordance

with

rules

and

regulations promulgated by the Department pursuant to

this Act. The provisions of Article 31 (b), (d) and (e), to the

extent applicable, shall govern the registration of such

drugs and devices.

i) The Department shall promulgate a schedule of fees for

the issuance of the certificate of product registration and

license to operate provided for under this Article.

ARTICLE

32.

Dangerous

Drugs .

—

The

importation,

distribution,

manufacture,

production,

compounding,

prescription, dispensing and sale of, and other lawful acts

in connection with, dangerous drugs of such kind and

quantity as may be deemed necessary according to the

medical and research needs of the country and the

determination of the quantity/quantities to be imported,

manufactured and held in stock at any given time by an

authorized

importer,

manufacturer

or

distributor

of

dangerous drugs shall be under the jurisdiction and

authority of the Dangerous Drugs Board as provided for

by existing laws and regulations.

ARTICLE 33. Banned or Restricted Drugs . — Banned or

severely restricted drugs for health and safety reasons in

their country of origin shall be banned and confiscated or

its uses severely restricted, whichever is appropriate, by

the

Department. The Department shall monitor the

presence in the market of such drugs and cause the

maintenance and regular publications of an updated

consolidated list thereof.

Certification of Drugs Containing Antibiotics

ARTICLE 34. Certification of Certain Drugs . — a) The

Department

shall,

by

regulations,

provide

for

the

certification of batches of drugs composed wholly or

partially of any kind of antibiotic. A batch of such drug

shall be certified if such drug has such characteristics of

identity, strength, quality and purity, as the Department

prescribes in such regulations as necessary to insure

adequately safety and efficacy of use and good quality,

but shall not otherwise be certified. Prior to the effective

date of such regulations the Department, in lieu of

certification, shall issue a release for any batch which, in

his judgment, may be released without risk as to the

safety and efficacy of its use. Such release shall prescribe

the date of its expiration and other conditions under

which it shall cease to be effective as to such batch and as

to portions thereof. For purposes of this Article and of

Article 89 (j), the term "antibiotic drug" means any drug

intended for use by man containing any quantity of any

chemical

substance

which

is

produced

by

a

micro-organism and which has the capacity to inhibit or

destroy micro-organisms in dilute solution (including the

chemically

synthesized

equivalent

of

any

such

substance).

b) Whenever in the judgment of the Department, the

requirements of this Article and of Article 89 (j) with

respect to any drug or class of drugs are not necessary to

insure safety and efficacy of use and good quality, the

Department

shall

promulgate

regulations exempting

such drug or class of drugs from such requirements.

© Compiled by RGL

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