Chapter IV: System Parameters Page 4-1pdeapress.org/docs/pdea-user's-guide-c04-parameters.pdf · This table contains a list of all dangerous drugs and chemicals being monitored by

Chapter IV: System Parameters Page 4-1

Permits & Licensing System User’s Guide February 2008

Chapter IV

SYSTEM PARAMETERS

TABLE OF CONTENTS ------------------------

A. Accessing the System Parameter Tables …………………..……… 4-2

B. Special Tables …………………………………………………………………………… 4-3

1. The Controlled Substances Table ………………………………. 4-3 a. Table Contents (Green/Red/Yellow Lists) ………………………….. 4-3 b. To View the Controlled Substances List ……………………………….. 4-5 c. To Print the Controlled Substances List ……………………………….. 4-6 d. To Return to the System Parameters Sub-Menu …………………. 4-8 2. The Product Table ………………………………………………..……. 4-9 a. Table Contents (S/P-Licenses & Permits) ………………………….. 4-9 b. To View the Product List …………………………………….……………….. 4-11 c. To Edit a Product Record ………………..………………………………….. 4-11 b. To Create New Products …………………………………….………………….. 4-12 c. To Delete Obsolete Products …………..………………………………….. 4-13 3. The Documents Requirements Table …………………..……. 4-14 a. Table Contents (Requirements for S-Licenses) …………………….. 4-14 b. To View the Document Requirements Checklist……………….. 4-15 4. The Offices Table ………………………………………………..……. 4-16 a. Table Contents (PDEA & BFAD Offices) …………………………….. 4-16 b. To View the List of Offices…………………………………….……………….. 4-16 c. To Edit an Office Record ………………..………………………………….. 4-17 b. To Create New Offices …………………………………….………………….. 4-18 c. To Delete an Office Record ……………..………………………………….. 4-19 5. The Personnel Table ……………………………………………….…. 4-20 a. Table Contents …………………………………………………………………….. 4-20 b. To Create New Personnel ………………………………….……………….. 4-20 c. Login is Disallowed for Not Yet Activated Personnel ………. 4-21 b. To Edit a Personnel Record ……………………………….………………….. 4-22 c. To View the List of Personnel by Office………………………………….. 4-23



5. The Locations Table ……………………………………………….…. 4-24 a. Table Contents …………………………………………………………………….. 4-24 b. To View Locations …………………………………………….……………….. 4-24 6. The ZIP Codes Table ……………………………………………….…. 4-25 a. Table Contents …………,,………………………………………………………….. 4-25 b. To View Zip Codes ……………………………………………….……………….. 4-25



SYSTEM PARAMETERS: A. ACCESSING THE SYSTEM PARAMETERS MODULE: After successful login to the system, you will be presented with the Main Application Menu. The topmost entries in the Main Menu are the System Parameter Options broken down into two (2) groups:

1. Special Tables. 2. Licensee Profile.

Click on any of these two (2) options to activate the corresponding sub-menu.

Parameters Options



B. SPECIAL TABLES: Special Tables are used for validating user entries in the transactions entry and reports programs. When you click on this selection, the following sub-menu will appear:

CONTROLLED SUBSTANCES TABLE:

This table contains a list of all dangerous drugs and chemicals being monitored by PDEA and other International Agencies. The table was set-up using the following lists posted by the INTERNATIONAL NARCOTICS CONTROL BOARD (INCB) on the Internet: a. GREEN LIST. This contains substances listed in Schedule I-IV of the Convention of

Psychotropic Substances of 1971.

Schedule I: Non-Proprietary Names & Trivial Names of Psychotropic Substances under International Control.

Schedule II: Names, synonyms and trade names of psychotropic substances, their

salts and preparations containing psychotropic substances under international control



Schedule III: Pure drug content of bases and salts of psychotropic substances under international control

Schedule IV: Prohibition of and restrictions on export and import pursuant to article 13

of the Convention on Psychotropic Substances of 1971

b. RED LIST. This contains the List of Precursors and Chemicals Frequently used in the Illicit Manufacture of Narcotic Drugs Psychotropic Substances under International Control. This list has been prepared by the International Narcotics Control Board (INCB) as a tool to be used for the identification of substances scheduled in Tables I and II of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.

Part I lists all substances in Tables I and II of the 1988 Convention

Part II lists in alphabetical order the chemical names, synonyms and trade names, etc.,

of the substances included in Part One.

Part III provides a table of conversion factors needed to convert quantities of scheduled substances in their salt form into quantities of pure anhydrous base.

c. YELLOW LIST. This document contains the current list of narcotic drugs under international control and additional information to assist governments in filling in the International Narcotics Control Board questionnaires related to narcotic drugs, namely, form A, form B and form C. It is divided into four parts:

Part I gives a list of narcotic drugs under international control; it is subdivided into three sections: the first section listing those drugs included in Schedule I of the 1961 Convention and/or Group I of the 1931 Convention, the second section listing those drugs in Schedule II of the 1961 Convention and/or Group II of the 1931 Convention and the third section listing those drugs in Schedule IV of the 1961 Convention and/or Group II of the 1931 Convention.

Part II lists the preparations of narcotic drugs exempted from some provisions and included in Schedule III of the 1961 Convention. Part III is a list in alphabetical order of the names given to the narcotic drugs other than the names listed in Part 1, and other designations (mainly trade names) of preparations containing narcotic drugs.

Part IV contains tables showing the pure anhydrous drug content of esters, ethers and salts of narcotic drugs listed in the Schedules as well as the equivalents, in terms of the pure anhydrous drug, of certain extracts and tinctures.



To View the Controlled Substances List:

1. Enter the substance name or part of the substance name in the Pattern Description box. 2. Click the VIEW button. 3. A list of all records containing the substance name and other names containing the substance

name pattern will be displayed. The description of the substance will also be displayed (if available) and notations on which section of which list it was taken from (Green, Red, or Yellow List). Click the BACK & NEXT buttons to move to the previous or next page.

4. Since we don’t have substance codes assigned, a straight numeric series (called our

Sequence Number) is used to identify each record in our Substances Table. 5. To edit any record displayed, simple click on the substance name and the substance record

will be called up onscreen. You may edit the substance name and description. If you make any changes to the record, simply click the SAVE button to save your changes.

6. To return to the VIEW screen, click on the Footer Link at the bottom “CLICK HERE TO

VIEW CONTROLLED SUBSTANCES”.

View Button

Sequence#

Back/Next Buttons



To Print the Substances List:

Save Button Footer Link

Print Button



1. If you want to print the Substances List, click the PRINT button. 2. All reports generated by the system will be in PDF format. The system will prompt you if

you want to OPEN or SAVE the file. You will need ACROBAT READER installed in your computer to read the open the PDF file. This can be downloaded for free from the ADOBE ACROBAT website.

3. When you click the SAVE button, you will be prompted to specify the location where you want to save your reports. A default file name for the report name is suggested. Click the SAVE button to save the report.

Save Button

Save Button



4 After saving the report, the computer will display the following status box which notifies you

that the report download has been completed. Click the CLOSE button.

To Return to System Parameters Sub-Menu:

Click the MENU button.

Close Button

Menu Button



PRODUCT TABLE:

The products or services provided by PDEA are: a. S-Licenses. These are licenses issued to handlers of dangerous drug/s(DD) ,

dangerous drugs preparation/s(DDP/s), Table I Controlled Chemical/s used in the manufacture of drug preparation/s &/or their preparation/s (DP/s). These are:

For Practitioners (Physician, Dentist, Veterinarian) Category Annual Fee (PhP) S-2 License to prescribe DD/DDPs, &/or DP/s containing Table I Controlled Chemical/s 500.00/p.a or 1,500.00 (3yrs).

Category Annual

Fee (PhP)

S-1 Retail of DP/s containing Table I Controlled Chemical/s 500.00 S-3 Retail of DD/DDP/s & /or DP/s containing Table I Controlled Chemical/s 1,000.00 S-4 Wholesale/Distribution of DD/DDP/s/Table 1 Controlled Chemical/s used in the manufacture of drug preparation/s/

&/or their preparation/s 3,000.00

S-5 C Compounding/Manufacture of DD/ DDPs &/or D P/s containing Table I Controlled Chemical/s 5,000.00 S-5I Importation of DD/DDP/s /Table I Controlled Chemical/s used in the manufacture of drug preparation/s &/or their

preparation/s 5,000.00

S-5E Exportation of DDP/s &/or D P/s containing Table I Controlled Chemical/s 5,000.00 S-5D Depot/Storage for S-4 & S-5 license holder (When such address is separate and distinct from the office address of

the license holder) 5,000.00

S-6 License to conduct laboratory analysis or technical research using DD/DDPs &/or DP/s 500.00 b. P-Licenses. These are licenses issued to handlers of Precursors and Essential

Chemical/s or Controlled Chemical/s &/ or mixture/s (PECS).

Category Annual Fee (PhP)

P-1 Retail of Precursor & Essential Chemicals ( PECS) &/or mixture/s 500.00 P-3 End-Use of PECS &/or mixture/s 2,500.00 P-4 Wholesale/Distribution/Trading of PECS&/or mixture/s 3,000.00 P-5-C

Compounding/Manufacture/Repack/Recycling of PECS &/or mixture/s 5,000.00

P-5-D

Bulk Depot/Storage for P4 & P5-Holders ( Such location is deemed separate& distinct from the office address of the license holder)

3,000.00

P-5-E

Exportation of PECS &/or mixture/s 5,000.00

P-5-I Importation of PECS &/or mixture/s 5,000.00 P-5-IM

Importation of PECS to End-Use 5,000.00

P-6 License to conduct laboratory analysis or technical research using PECS 500.00 c. Permits. These are Local Permits to transport dangerous drugs or PECS to local

destinations in the country; Export Permits to export DDs or PECS out of the country; and Import Permits to bring in DDs or PECS into the country.



To View the Product Table:

1. Select the Product Group that you want to view (S-Licenses, P-License, or Permits). 2. Click the VIEW button (or print if you want to print the Product List). 3. The computer will display with a list of products available, their costs, and period of validity. To Edit a Product Record: 1. Click the Footer Link on the View Page, “CLICK HERE TO SET-UP PRODUCTS”. 2. Choose the Product Type and enter the Product Code then click the VERIFY button. 3. You may edit Product Information like the description, cost, and period of validity. 4. Click the SAVE button to save your changes. A “RECORD MODIFIED” message will appear on

the top of your screen to confirm that the changes you entered have been saved.



To Create New Products:

1. Choose the Product Type and enter the new Product Code then click the VERIFY button. 2. Encode the Product Cost and Period of Validity (in years). 3. Click the SAVE button. A “RECORD SAVED” message will appear to confirm that your new

product record has been saved. 6. Click the CANCEL button to clear the screen and get the entry form ready for the next record.



To Delete an Obsolete Product:

1. Select the Product Group of the product that you want to delete from the ComboBox. 2. Enter the Product Type that you want to delete (example “SX”). 3. Click the VERIFY button. The computer will display the contents of the product record. 4. Click the DELETE button. A “RECORD DELETED” message will appear to confirm that your

new product record has been deleted. 6. Click the CANCEL button to clear the screen and get the entry form ready for the next record.



DOCUMENT REQUIREMENTS TABLE:

This table contains a list of all supporting documents when applying for a new (or renewal of) an S/P License or Permit.

REQUIREMENTS FOR RENEWALAPPLICATIONS FOR S-LICENSES:

A. BFAD LICENSE to OPERATE with current official receipt; B. Current Mayor’s Permit with official receipt; C. Current Professional Regulation Commission (PRC) Card of Authorized Pharmacist; D. Current Professional Tax Receipt of Authorized Pharmacist. For government employed- latest certification of employment ; E. Current DTI Certificate of Registration of Business Name /Securities & Exchange Commission Registration; F. Semi-annual report/Record Book ; G. NBI Clearances of either the Owner or President or General Manager (GM), or Branch Manager (BM) or Hospital Director (HD) (whoever is the head of the company) & Authorized Pharmacist); H. Projected importation (for importer only )/ Manufacturing quota (for manufacturers of DDP/s,DP/sonly); I. Previous License to Handle (LTH) DD/DDP/s, Table I Controlled Chemical/s/DP/s &/or official Receipt . REQUIREMENTS FOR NEW APPLICATIONS FOR S-LICENSES: A. BFAD LICENSE to OPERATE with current official receipt; B. Current Mayor’s Permit with official receipt; C. Current Professional Regulation Commission (PRC) Card of Authorized Pharmacist; D. Current Professional Tax Receipt of Authorized Pharmacist. For government employed- latest certification of employment ;

E. Current DTI Certificate of Registration of Business Name /Securities & Exchange Commission Registration; F. NBI Clearances of either the Owner or President or General Manager (GM), or Branch Manager (BM) or Hospital Director (HD) (whoever is the head of the company) & Authorized Pharmacist);

G. Projected importation (for importer only )/ Manufacturing quota (for manufacturers of DDP/s,DP/s only); H. Letter of Authorization from the Owner/President/ General Manager or Hospital Director for the Authorized Pharmacist to handle and transact business in DD/ DP/s / Table I Controlled Chemical/s used in the manufacture of drug reparation/s &/or their preparation/s;

I. Sworn Statement of Authorized Pharmacist re compliance to RA 9165 & its implementing regulations ;

J. TIN(Establishment & Owner/President or GM or BM or HD & Authorized Pharmacist);

K. Company Profile;

L. Floor Plan / lay-out indicating exact location of storage area ;

M. Location / vicinity map of the company;

N. Proof of ownership of land/ building /Contract of Lease;

O. Front view pictures of the establishment showing the signage & storage area for DD/DDP/s/Table I

P. Controlled Chemical/s used in the manufacture of drug preparation/s &/or their preparation/s showing the security locks;

Q. Photocopy of Company ID of the owner/President/GM or BM & the Authorized Pharmacist; One (1) 2 X 2 ID picture & (3)specimen signatures of the Owner or President or GM or BM or HD & Authorized Pharmacist.



To View the Document Requirements CheckList:

1. Select the Product Group, Product Type, and Application Type from the ComboBoxes, e.g.

“S-License”, “S1”, and “New” Application. 2. Click the VIEW button to display the list of documents required to support the specified

License application. 3. Use the BACK & NEXT button to move the display to the previous and next pages. 4. Click the PRINT button to print the Documents CheckList. 5. Click the CANCEL button to clear the screen and accept your new selection set. 6. Click the MENU button to return to the SPECIAL TABLES Sub-Menu.



OFFICES TABLE: This table contains a list of offices where the PDEA Permits & Licensing System will be implemented. This includes not only PDEA Head Office and Regional Offices but also all BFAD Offices. To View the Offices Table:

1. Select the Office Group that you want to view from the ComboBox. 2. Click the VIEW button to display the list of offices. 3. Use the BACK & NEXT button to move the display to the previous and next pages. 4. Click the PRINT button to print the List of Offices. 5. Click the CANCEL button to clear the screen and accept your new selection set. 6. Click the MENU button to return to the SPECIAL TABLES Sub-Menu



To Edit an Office Record:

1. Click the Footer Link on the View Page, “CLICK HERE TO SET-UP OFFICES”. 2. Select the Office Group and the Office Code of the office you want to edit and click the

VERIFY button. 3. You may edit the Office Name, Address, Telephone Number/s, Name of the Head of Office. 4. Click the SAVE button to save your changes. A “RECORD MODIFIED” message will appear on




To Create New Offices:

1. Select the Office Group and enter the new Office Code of the office you want to create and

click the VERIFY button. 2. You may enter the Office Name, Address, Telephone Number/s, Name of the Head of Office. 3. Click the SAVE button to save your changes. A “RECORD SAVED” message will appear on

the top of your screen to confirm that the record has been created.



To Delete an Office Record:

1. Select the Office Group and the Office Code of the office you want to delete and click the

VERIFY button. 2. The computer will display the contents of the office record. 3. Click the DELETE button to delete the record. A “RECORD DELETED” message will appear on

the top of your screen to confirm that the record has been deleted.



PERSONNEL TABLE:

This table contains the list of personnel who will be authorized to access the application. This can be set-up by regular users with access to this module but the user record will be flagged as “FOR ACTIVATION” by the System Manager (SYSMANAGER).

To Create New Personnel:

1. Enter the new personnel’s assigned login name and click the VERIFY button. 2. Specify the Office Group, the Office Code, his User Type, Email Address and Mobile Phone

Number and click the SAVE button. 3. Click the SAVE button to save your changes. A “RECORD SAVED” message will appear on

the top of your screen to confirm that the record has been created.



Login is Disallowed for Personnel Not Yet Activated by the SYSMANAGER:

If the user was created using the this SET-UP PERSONNEL entry program, his user status will be set as “FOR ACTIVATION”. If he has not yet been activated by the System Manager (SYSMANAGER), then he will get the “USER FOR ACTIVATION” message when he tries to login to the system.

User For Activation!



To Edit a Personnel Record:

1. Enter the Personnel’s assigned Login Name and click the VERIFY button. 2. You may edit the Office Name, Address, Telephone Number/s, Name of the Head of Office. 3. Click the SAVE button to save your changes. A “RECORD MODIFIED” message will appear on




To View the List of Personnel by Office:

1. Select the Office Group and Office Code that you want to view from the ComboBoxes. 2. Click the VIEW button to display the list of personnel for the specified office. 3. Use the BACK & NEXT button to move the display to the previous and next pages. 4. Click the PRINT button to print the List of Personnel for the specified office. 5. Click the CANCEL button to clear the screen and accept your new selection set. 6. Click the MENU button to return to the SPECIAL TABLES Sub-Menu



LOCATIONS TABLE: This table contains a list of all Countries, Philippine Provinces, Philippine Regions, Philippine Seaports & Airports. The list of International Airports & Seaports are currently being built. To View Locations:

1. Choose the type of location that you want to view. 2. If you want to print all locations for the particular type, keep the start and end description

fields blank. However, if you want to print a selected list, fill these fields with the proper start and end descriptions. For example, if you want to list all countries with names starting with the letter “U”, enter “U” in both the start and end description fields.

3. Click the VIEW button. This will show the list of selected locations. 3. Use the BACK & NEXT button to move the display to the previous and next pages. 4. Click the PRINT button to print the List of Personnel for the specified office. 5. Click the CANCEL button to clear the screen and accept your new selection set. 6. Click the MENU button to return to the SPECIAL TABLES Sub-Menu



ZIP CODES TABLE: This table contains a complete list of Philippine ZIP Codes. To View the ZIP Code List:

1. Enter the Province Name of the areas that you want to view. 2. Enter the start area name. If you want to list all area for the particular province, keep this

field blank. However, if you want to display a selected list, fill this field with the proper start area name. if you want to list all areas in Cebu with names starting with the letter “M”, enter “M” in the area name field.

3. Click the VIEW button. This will show the list of selected areas with their zip codes. 3. Use the BACK & NEXT button to move the display to the previous and next pages. 4. Click the PRINT button to print the List of Personnel for the specified office. 5. Click the CANCEL button to clear the screen and accept your new selection set. 6. Click the MENU button to return to the SPECIAL TABLES Sub-Menu.