Cover Image
close this bookModel Guidelines for the International Provision of Controlled Medicines for Emergency Medical Care, (WHO - OMS, 1996, 14 p.)
View the document(introduction...)
View the documentLIST OF CONTRIBUTORS TO THIS DOCUMENT
View the documentI. INTRODUCTION
View the documentII. DEFINITIONS
View the documentIII. PURPOSE AND PRINCIPLE
View the documentIV. SCOPE OF APPLICATION
View the documentV. SELECTION OF SUPPLIERS
View the documentVI. OUTLINE OF STANDARD AGREEMENT BETWEEN SUPPLIERS1 AND CONTROL AUTHORITIES OF EXPORTING COUNTRIES
View the documentVII. SUMMARY OF THE REQUEST PROCEDURE
View the documentAnnex 1
View the documentAnnex 2

VII. SUMMARY OF THE REQUEST PROCEDURE

(1) Operator's role

The operator should make a written request for emergency supplies of controlled substances to the supplier, using the attached model form. The operator is responsible for:

- information provided on the form;

- actual handling of controlled drugs at the receiving end or adequate delivery to the reliable recipient;

- reporting to the control authorities of the receiving country (whenever they are available) as soon as possible;

- reporting to the control authorities of the receiving country on unused quantities, if any, when the operator is the end-user or to arrange for the end-user to do so;

- reporting to the control authorities of the exporting country through the supplier, with copy to the INCB, any problems encountered in the working of emergency deliveries.

(2) Supplier's role

Before responding to the request from the operator, the supplier should be convinced that the nature of the emergency justifies the application of the simplified procedure without export/import authorizations. The supplier is also responsible for:

- submitting immediately a copy of the shipment request to the control authorities of the exporting country;

- submitting an annual report on emergency deliveries and quantities of drugs involved as well as their destinations, with copy to the INCB;

- reporting to the control authorities of the exporting country, with copy to the INCB, any problems encountered in the working of emergency deliveries.

(3) Control authorities' role

The control authorities of the exporting country should inform their counterpart in the receiving country (whenever they are available) of the emergency deliveries.

The control authorities of the receiving country have the right to refuse the importation of such deliveries. Emergency deliveries need not be included in the estimate of the receiving country, since they are regarded as having been consumed in the exporting country.

Model Shipment Request/Notification Form for Emergency Supplies of Controlled Substances

Operator:

Name:.......................................................................................................
Address:...................................................................................................
Name of the responsible medical director/pharmacist:..................................
Title:.........................................................................................................
Phone No.......................... Fax No.............................................................

Requests the supplier 1

Name:.......................................................................................................
Address:...................................................................................................
Responsible pharmacist:............................................................................
Phone No.......................... Fax No............................................................

For an emergency shipment2 of the following medicine(s) containing controlled substances:

Name of product (in INN/generic name) and dosage form. amount of active ingredient per unit dose, number of dosage units in words and figures

Narcotic drugs as defined in the 1961 Convention (e.g. morphine, pethidine, fentanyl)

[e.g. Morphine injection 1 ml ampoule; morphine sulfate corresponding to 10 mg of morphine base per ml; two hundred (200) ampoules]
...............................................................................................................
...............................................................................................................
...............................................................................................................
...............................................................................................................
...............................................................................................................

Psychotropic substances as defined in the 1971 Convention (e.g. buprenorphine, pentazocine, diazepam, phenobarbital)
...............................................................................................................
...............................................................................................................
...............................................................................................................
...............................................................................................................
...............................................................................................................

Others (nationally controlled in the exporting country, if applicable)
...............................................................................................................
...............................................................................................................

To the following recipient (whichever applicable)

Country of final recipient:.......................................................................
Responsible person for receipt:
Name:.................................
Organization/Agency:................................................................................
Address:...................................................................................................
Phone No....................... Fax No..............................

For use by/delivery to:
Location:...................... Organization/Agency:.............................

Consignee (If different from above e.g. transit in a third country):

Name:............................... Organization/Agency:.....................................
Address:.................................................................................................
Phone No...................... Fax No................................

Nature of the emergency (Brief description of the emergency motivating the request):
...............................................................................................................
...............................................................................................................
...............................................................................................................
...............................................................................................................

Availability of, and action taken to contact the control authorities in the receiving country:
...............................................................................................................
...............................................................................................................

1 If the operator is exporting directly from its emergency stock, it should be considered as a supplier.

2 Emergency deliveries do not affect the estimate of the recipient country since they have already been accounted for in the estimate of the exporting country.

I certify that the above information is true and correct. My Organization will:

- Take responsibility for receipt, storage, delivery to the recipient/end-user, or use for emergency care (strike out what is not applicable) of the above controlled medicines;

- Report the importation of the above controlled medicines as soon as possible to the control authorities (if available) of the receiving country;

- Report the quantities of unused controlled medicines, if any, to the control authorities of the receiving country (if available), or arrange for the end-user to do so (strike out what is not applicable).

Title:.........................
Location:..................

Date:.......................

...............................
(Signature)