Research (Continued)

Who can be A Marketing Authorization Holder (MAH) in the Philippines?

Marketing authorization (MA) refers to the approval granted by FDA to a marketing

authorization holder allowing a drug to be legally marketed in the Philippines after having
undergone a process of evaluation to determine the safety, efficacy and quality of the product
and the appropriateness of the product information.1

In brief, various entities can serve as MAHs for drug products in the Philippines, including
manufacturers, importers, distributors, the Department of Health, Local Manufacturers Intending
to Export and entities involved in managing donations. This can be found out in
https://www.fda.gov.ph/draft-for-comments-rules-and-regulations-on-the-issuance-of-authorization-for-registration-applications-

of-drug-products-and-drug-substances-by-the-food-and-drug-administration/ by the FDA and is also mentioned

below:-

Draft for Comments || Rules and Regulations on the Issuance of Authorization for
Registration Applications of Drug Products and Drug Substances by the Food and Drug
Administration

B. General Conditions

1. Eligibility requirements

a. For the marketing authorization of locally manufactured drug products and drug substances,
only applications from establishments with a valid LTO (The License to Operate) as drug
manufacturer or trader and a GMP Clearance from FDA are acceptable. For the marketing
authorization of imported drug products and drug substances, only applications from

1 https://www.fda.gov.ph/draft-for-comments-rules-and-regulations-governing-the-issuance-of-an-
authorization-for-an-in-vitro-diagnostic-medical-device-ivd/#:~:text=The%20MAH%20may%20be
%20a,performance%20evaluation%20of%20the%20IVD
establishments with a valid LTO as drug importer and a GMP Clearance of the Foreign Drug
Manufacturer issued by FDA are acceptable. For applications of Certificate of Listing of
Identical Drug Product (CLIDP), only applications from establishments with a valid LTO as drug
distributor are acceptable.
b. For authorization of drug products for DOH-use, only applications from the DOH are
acceptable.
c. For authorization of export-only drug products and drug substances, only applications from
local drug manufacturers intending to solely market their product outside of the country are
acceptable.
d. For clearance of drug products donated by foreign entities, applications from individuals,
organizations, institutions, both public and private, and all levels of government engaged in the
importation, facilitation and management of all regular donations of foreign origin covering drug
products during non-emergency situations are acceptable.
2. For drug products, registration application shall be for FDA authorization to allow the use (for
marketing, export, DOH-use, or as donation) a finished drug product to/by patients or healthcare
providers. Through the approval of the application, it is ensured that the drug product is safe,
efficacious, and of good quality when used according to its intended purpose.
3. For drug substances, the registration application shall be for FDA authorization to allow the
production and marketing of the drug substance as a raw material to other pharmaceutical
companies. Through the approval of the application, it is ensured that the drug substance is of
good quality for use in the manufacture of drug products.
4. When applying for the registration of a drug product or drug substance, the applicant must
ensure that all information contained in the application is true, correct and is not misleading. It
shall be the responsibility of the applicant to inform the FDA of any emerging information that
may affect the risk-benefit assessment of the drug, as soon as the applicant becomes aware of
such information. Failure to fully disclose material information about the drug is a ground for
disapproval of registration application and a basis for cancellation of the establishment’s LTO as
provided in Book II, Article 1, Sec. 4-A of the IRR of RA 9711.
5. The standards for the drug product and drug substance authorizations, the application
requirements and the evaluation procedures shall be established and updated to all covered drug
products through appropriate FDA isusances.
Here's the breakdown:

1. Locally Licensed Manufacturer or Trader: This includes establishments with a valid

License to Operate (LTO) as a drug manufacturer or trader, along with a Good
Manufacturing Practices (GMP) Clearance from the FDA for locally manufactured drug
products and substances.
2. Importer: Entities with a valid LTO as a drug importer, accompanied by a GMP
Clearance of the Foreign Drug Manufacturer issued by the FDA for imported drug
products and substances.
3. Distributor: Entities with a valid LTO as a drug distributor, applicable for the Certificate
of Listing of Identical Drug Product (CLIDP).
4. Department of Health (DOH): For drugs intended for DOH usage, only applications
from the DOH are acceptable.
5. Local Manufacturers Intending to Export: For authorization of export-only drug
products and substances, only applications from local drug manufacturers intending to
solely market their product outside of the country are acceptable.
6. Entities Managing Donations: Individuals, organizations, institutions (public and
private), and all levels of government engaged in the importation, facilitation, and
management of regular donations of foreign origin covering drug products during non-
emergency situations can act as MAHs for clearance purposes.

In essence, MAH for pharmaceutical products in the Philippines may be a locally licensed
manufacturer or trader, an importer, a distributor, the Department of Health for drugs intended
for their usage, or local manufacturers intending to export their products.
Additionally, entities involved in managing regular donations of drug products during non-
emergency situations can also act as MAHs for clearance purposes.

Furthermore:-

V. GENERAL GUIDELINES

A. All manufacturers, traders and distributors of drug products and raw materials shall secure a
Clearance for Customs Release (CFCR) from the FDA prior to importation/exportation.

The CFCR shall be issued to the Marketing Authorization Holder (MAH) with valid License to
Operate (LTO) as manufacturer/trader/distributor and valid only for the specific
importation/exportation of drug products with valid Certificate of Product Registration (CPR)
and to manufacturers, traders and distributors with valid LTO that imports/exports raw materials.