Escolar Documentos
Profissional Documentos
Cultura Documentos
Department of Health
FOOD AND DRUG ADMINISTRATION
) / HOSPITAL PHARMACY (
) / INSTITUTIONAL PHARMACY (
COMPANY NAME
COMPANY ADDRESS
OWNER
ACTIVITY
:
:
:
:
RETAILING
STERILE COMPOUNDING
MOBILE PHARMACY
NON-STERILE OMPOUNDING
ONLINE ORDERING AND DELIVERY
Directions:
Fill out the form by ticking the applicable box. Provide remarks on the clients column when necessary. Submit in
Portable Document Format (pdf) and word format duly signed by the pharmacist/owner.
DOCUMENTARY REQUIREMENTS:
1. Application Form
Is the integrated application form properly filled out?
Is it duly notarized?
Are the signatories in the application form the authorized
persons as required under the following circumstances?
(a) If single proprietorship the owner as registered in DTI
(unless there is a different authorized person)
(b) If partnership/corporation one of the incorporators or
authorized person as indicated in the board resolution or
Secretarys Certificate
(c) If cooperative authorized person indicated in the board
resolution or Secretarys Certificate of the cooperative
If the signatory is not the owner or one of the incorporators, as
the case may be:
Is there a board resolution or notarized Secretarys
Certificate clearly identifying the person authorized to sign
for and in behalf of the owner or corporation submitted?
No
REMARKS
CLIENT
FDA
2.
Yes
5. Location Plan
Is the sketch submitted indicates certain landmark?
included?
6. Picture of Drugstore with Display of Signage
Does the picture clearly show the signage bearing the exact
business name of the establishment as registered in DTI/SEC
(except for franchise drugstore)
If the signage does not bear the exact business name of the
establishment as registered in DTI/SEC, is there a
certificate/document from the Intellectual Property Office
(IPO) submitted?
7.
Proof of Payment
ADDITIONAL REQUIREMENTS
(ON-SITE INSPECTION ONLY):
1.
2.
Records/E-file
(a) Records of invoices containing the minimum required data such as but not limited to: name of product, complete name
(b)
(c)
(d)
(e)
& address of drug supplier, packaging size, dosage form & strength, batch/lot number, expiry date, date and quantity
received by the establishment.
Prescription book or e-file to be kept for 2 years
Senior citizens, PWD
Menu cards (generics, MDRP, GMAP)
Information, Education and Campaign (IEC) Material
6. Reference Materials
(a) R.A. 3720, R.A 9711, R.A. 6675, R.A. 5921, R.A. 8203, R.A. 9502
(b) WHO Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products and Annex 9 Guide to Good
Storage Practices for Pharmaceuticals
(c) Philippine National Drug Formulary
(d) Standard Practice Guidelines (Phil. PSP)
(e) Pharmacovigilance-related References
(f) Other applicable reference materials, including latest issuance of FDA related to community practice
--- To be filled out by client: --Prepared by:
Signature:
Date: