RULES AND CONDITIONS IN EXEMPTING ANTIBIOTIC DRUG PRODUCTS FROM THE BATCH CERTIFICATION REQUIREMENT AMENDING FOR THIS PURPOSE ITEM III (C) AND (D) OF ADMINISTRATIVE ORDER NO. 10…
I. Rationale
On 23 April 2002, Administrative Order (AO)No. 103 series of 2002
was issued to effectively implement the provision of Republic Act No.
3720 as amended by Executive Order No. 175 or the Food, Drug and
Cosmetic Act, as well as, Republic Act No. 7394 or the Consumer Act of
the Philippines requiring the batch certification, prior to the release
for sale or distribution, of a batch of drugs which purport to be, or is
represented as a drug composed wholly or partly of insulin or of any
kind of penicillin, streptomycin, chlortetracycline, chlorampenicol,
bacitracin, or any other antibiotic drug or any derivative thereof. The
same Administrative Order, consistent with the above-cited laws,
provided for the exemption from the requirement of batch certification
with certain exceptions (conditions).
Recently, Republic Act No. 9502, otherwise known as the “Universally
Accessible Cheaper and Quality Medicines Act of 2008” and its
Implementing Rules and Regulations (IRR) were enacted. One of the
objectives under the said law is to ensure adequate access to quality
and affordable drugs and medicines. It is, thus, imperative to redefine
the conditions set forth under Administrative Order No. 103 series of
2002 to align to the above objective.
Hence, this Order is issued redefining the rules and conditions in
exempting antibiotic drug product(s) from the batch certification
requirement and for other purposes.
The issuance of this Order is further reinforced by the legal
mandate, which is hereby adopted as a policy, that in case of drugs,
pharmaceuticals or poisons sold in their original packings, the seal of
which has not been broken or tampered with, the liability that may arise
because of their quality and purity, rests upon the manufacturer or in
its absence, upon the importer, the distributor, representative or
dealer who is responsible for their distribution or sale.
II. Authority/Basis
This Order is issued by virtue of the authority provided under
Section 22 (b) and (c) of Republic Act No. 3720 as amended by Executive
Order No. 175, and Article 34 (b) and (c) of Republic Act No. 7394,
which authorize the Secretary of Health to promulgate regulations
exempting antibiotic drug or class of such drugs from the requirements
of batch certification whenever in his judgment such requirement is not
necessary to insure safety and efficacy of use and good quality.
III. Objective
This Order is issued to: (i) redefine the exemption of antibiotic
drug product(s) from the requirement of batch certification as laid down
under AO No. 103 series 2002 to align to the objective of ensuring
adequate access to quality and affordable drugs and medicines; (ii)
provide for the rules and conditions in exempting antibiotic drug
product/s from the batch certification requirement, (iii) prescribe the
guidelines for the implementation of the exemption from batch
certification and remedies and sanctions in case of infringement of this
Order; (iv) provide for remedies and sanctions in the event that this
Orders is infringed.
IV. Scope
This Order applies to antibiotic drug product/s as
defined in Item V below, as well as, manufacturers or traders of
antibiotic drug product/s and distributors/importers in case such
antibiotic drug product/s is/are imported.
V. Definition of Terms
The following terms are hereby defined for purposes of this Order:
1. Batch Certification – refers to the process of
determination by the Bureau of Food and Drugs (BFAD), from the
technical documents and conduct of analysis of the samples of products
subject of certification submitted by the companies, that a batch of
antibiotic drug product/s has been found to have such characteristics of
identity, strength, quality and purity as prescribed by existing
regulations as necessary to insure their safety, efficacy of use and
good quality.
2. Antibiotic drug product – refers to any drug
product in tended for use by man containing any quantity of any chemical
substance which is produced by a microorganism and which has the
capacity to inhibit or destroy microorganisms in dilute solution
(including the chemically synthesized equivalent of any such substance)
3. Batch Notification – refers to the filing by a
manufacturer, trader or distributor/importer of a notice to the
Department of Health, through the BFAD, concerning the manufactured or
imported batch or batches of antibiotic drug product/s prior to release
for sale, offer for sale, distribution, transfer, donation, or offer
as Physicians Samples of such particular batch or batches of drug
product/s.
VI. Guidelines for Exemption
1. Notification
For purposes of exemption from the required batch certification all
manufacturers, traders or distributors/importers of antibiotic drug
product/s shall notify BFAD of all their manufactured or imported batch
or batches of antibiotic drug product/s prior to their release for
sale, offer for sale, distribution, offer as physician samples (if
they belong from the same batch, otherwise a separate notification is
required), transfer, donation, of such particular batch or batches of
drug product/s, otherwise, Item IX below shall apply. Provided that with
regards to antibiotic products covered under the Principal Certificate
of Product Registration and Listing of Identical Drug Products scheme
provided in Administrative Order No. 2005-0031 dated 07 December 2005,
one notification is required if they belong to the same batch.
2. Conditions for Exemptions
2.1 The manufacturer, trader or distributor/importer of the
antibiotic drug product/s is a holder of a valid License to Operate;2.2 The manufacturer, trader or distributor/importer files a duly
notarized two (2) copies of Antibiotic Drug Product Batch Notification
using the template attached to this Order as Annex “A”[*] together with the following technical documents and samples relating to the product subject of the exemption:a. Certificate of Analysis of the Finished Product;
b. Valid Certificate of Product Registration; and
c. Representative sample (as illustrated below) including the product insert and box in commercial presentation.
Tablet or Capsule 1 blister pack or foil strip Oral Suspension 1 bottle per presentation Granules or Powder for Suspension[1] 1 bottle Cream or Ointment 1 tube per presentation Ophthalmic, Otic, Nasal Drops 1 bottle per presentation Injectables: Liquid Presentations 1 ampoule or vial per presentation Solid Preparations[1] 1 vial [1] Products whose dosage
form is in powder for reconstitution which are of different
presentation or pack size though of the same batch/lot should be applied
individually2.3 Notification Fee which includes payment of antibiotic drug
products’ post-market survellience activity in the amount of Five
Thousand Pesos (PhP5,000.00). The BFAD is authorized to increase the above amounts as the need arises with prior information to concerned parties.
3. Procedure
3.1 The manufacturer, trader or distributor/ importer shall notify
BFAD, by filing at he Laboratory Services Division (LSD) a duly
notarized two (2) copies of Antibiotic Drug Product Batch Notification,
of all the manufactured or imported batch or batches of antibiotic drug
product/s prior to their release for sale, offer for sale, distribution,
transfer, donation, or offer as Physician Samples of such particular
batch or batches of drug product/s, or prior to the intended
investigation use by experts qualified by scientific training and
experience to investigate the safety and efficacy of such drugs,
purposes of exemption from the required batch certification.3.2 The BFAD-LSD shall examine the Notification together with the
above-required attachments so submitted by the manufacturer or
distributor/ importer. The notification shall only be accepted if the
information required in the notification form is completely supplied and
the documents and samples required above are complete as well. Once
accepted, the applicant company will be issued an Order of Payment (OP).3.3 The applicant company shall then proceed to the Accounting Section for verification of the OP.
3.4 After OP verification, the applicant company shall pay the required fee at the Cashier’s section.
3.5 The Official Receipt (OR) shall be presented to the LSD which
shall indicate the OR number in the Notification form, stamp and assign
the corresponding notification number as acknowledgement of receipt of
the same and traceability prior to signing by the authorized signatory.3.6 Notifications filed and accepted in the morning shall be
released in the afternoon and Notifications filed and accepted in the
afternoon shall be released the next working day.3.7 Once the notification is released and received by the
establishment the manufactured or imported batch or batches of
antibiotic drug product/s can now be released for sale, offer for sale,
distribution, transfer, donation, or offer as physician samples.
4. Post Monitoring Surveillance
Notwithstanding compliance with the above procedures, the same shall
not constitute as an agreement by B FAD, in anyway, that the particular
batch of the antibiotic drug product produced or imported meets all
other pertinent regulatory requirements, such as but not limited to, the
product’s conformance to its registered specification or approved
labeling. For this purpose and to insure full compliance of the product
to existing standards, the BFAD shall endeavor to undertake strict post
monitoring surveillance that will involve the active, systematic,
scientifically valid collection, analysis and interpretation of data and
other information about the marketed antibiotic drug.
VII. Grounds for Revocation of Exemption
For the effective implementation of this Order, the BFAD is
authorized to revoke, without need of a hearing, the grant of exemption
from certification of any batch or batches of antibiotic drug product/s
notifying only the concerned establishment of such revocation on the
grounds of commission or the presence of any or all of the following
instances, to wit:
1. In the event that there is subsequent findings of
misrepresentation or falsification in any of the information supplied in
the notification form and the data indicated in the required documents
or the same are fraudulently filed by any manufacturer, trader or
distributor/importer; and/or
2. In case the samples submitted or samples belonging to the same
batch or batches of antibiotic drug product/s collected through post
monitoring surveillance shall be found not to conform to the product’s
registered specifications or approved labeling.
In case any of the above circumstances comes to the knowledge of any
concerned division of the BFAD, the same shall be reported immediately
to the Legal, Information and Compliance Division for appropriate
action. The revocation shall be immediately executory.
VIII. Effect of the Revocation on the Grant
of Exemption from Batch Certification or on Antibiotic Drug Product/s
Released in the Market Without Prior Exemption
Any batch or batches of antibiotic drug product/s granted exemption
from batch certification which has been automatically revoked shall be:
1. Deemed misbranded pursuant to Section 19 (k) of Republic Act No.
3720 as amended or mislabeled pursuant to Article 89(j) of Republic Act
No. 7394 and their prior release for sale or distribution shall be
deemed in violation of Section 11 (a) and (b) Republic Act No. 3720 as
amended, or Article 40 (a) and (b) of Republic Act No. 7394,
respectively; and/or2. Treated as if it was released without batch certification in
violation of Section 11 (m) of Republic Act No. 3720 as amended or
Article 40 (m) of Republic Act No. 7394.
The above shall likewise apply when a batch or batches of antibiotic
drug product/s manufactured or distributed/imported has been released
for sale, offer for sale, distribution, transfer, donation, or offer
as Physician Samples without the required notification filed by the
manufacturer, trader or distributor/importer with, and the same approved
by, BFAD.
IX. Administrative Procedure and Sanctions
The procedure in the conduct of administrative proceeding existing
at the BFAD shall be observed, but the manufacture r, trader or
distributor importer shall automatically cease and desist from further
distribution the batch or batches of the antibiotic product in question
upon receipt of the notice of revocation and pending the administrative
proceeding.
The penalty imposable under Section 22 of Executive Order No. 175
amending Section 29 of Republic Act No. 3270, or Article 39 of Republic
Act No. 7394 shall be imposed after notice and hearing.
X. Authority to Require Batch Certification or Revoke this Order
Nothing in this Administrative Order shall be construed to prohibit
the Department of Health, upon recommendation of the Bureau of Food and
Drugs, from requiring a batch or batches of either one or more
antibiotic drug product/s of a particular manufacturer, trader or
distributor/importer, or from revoking this Administrative Order in
cases where the safety, efficacy and quality of an antibiotic drug
product/s or public health and safety requires the resumption of Batch
Certification process for such one or more or all antibiotic drug
product/s.
XI. Separability Clause
If any part, term or provision of this Administrative Order shall be
declared invalid of unenforceable, the validity or enforceability of the
remaining portions or provisions shall not be affected and this Order
shall be construed as if it did not contain the particular invalid or
unenforceable part, term or provision.
XII. Repealing Clause
The provisions of Item III (C) and (D) of Administrative Order No.
103 series of 2002 and other previous administrative issuances, bureau
circulars, and memoranda inconsistent with this Administrative Order are
hereby withdrawn, repealed and/or revoked accordingly.
XIII. Effectivity
This Order shall take effect fifteen (15) days after publication in a newspaper of general circulation.
Adopted: 02 Dec. 2008
(SGD.) FRANCISCO T. DUQUE III, MD, MSc
Secretary of Health
[*] Text Available at Office of the National Administrative Register, U. P. Law Complex, Diliman, Quezon City