Table Of Contents (TOC) for PHILIPPINES

PHILIPPINES

Authority

Department of health

website

http://www.doh.gov.ph/

if any

REQUIREMENT FOR PRODUCT REGISTRATION

S.No

CONTENTS

Page: No

1.

Copy of valid agreement between the manufacturer & trader/distributor/importer/exporter.

2.

Unit Dose and Batch Formulation-in metric system.

3.

Technical Specifications of All Raw Materials.

4.

Certificate of Analysis of Active Raw Material(s).

From the Manufacturer (supplier) of the active raw material

From the manufacturer of the Finished Product.

5.

Technical Specifications of the Finished Product.

6.

Certificate of Analysis of the Finished Product (from the same batch or lot of the representative sample submitted).

7

Master Manufacturing Procedure, Production Equipment, Sampling and In-Process Controls, and Master Packaging procedure.

8

Assay and other test procedures including Assay with Data analysis e.g. chromatograms, if applicable.

9

Stability Studies

Accelerated-3 batches 

  Long Term Stability Studies- 3 batches

     ·     If long term stability is not available  provide accelerated  

            Stability data of one at 3 elevated temperatures.

In-use stability Studies (Additional requirements  for         powder for Suspension)

c.1)  1 batch at 300C (7 days) and 2 at 80C (14 days)

c.2)   3 batches at 300C (7 days) and at 80C (14 days)

10

Representative Sample in market or commercial Presentation (at least 1 year before expiry).

11.

Unattached labelling materials.

Facsimile label with actual colour text  (3 copies)

Artworks for label and other labelling material will be prepared by S.M.H.P. This will be based on the manufacture’s original labels but in accordance with BFAD rules on labelling requirements.

12.

Comparative dissolution profile.

13.

For Imported Products (an English translation shall accompany and document not written in English)

Original Certificate of Pharmaceutical Product (issued at least 1 year from the date the application was field.

For Countries not issuing CPP, the following may be accepted:

Certificate of Free Sale from the country of origin, duly authenticated by the territorial Philippine Consulate.

Government Certificate attesting the registration status of the manufacturer, duly authenticated by the territorial Philippine consulate.

14.

For Products in Plastic Container.

General Information.

Studies done on the plastic to substantiate claim that the product is safe to us.

Test Procedures and Limits.

Empty plastic container and closure.

15.

Additional Requirements for New Drug Applications: Reference Standard.