Questionnaire on Donated Medicines

Application for donation of medicine to South Africa

Applicant’s name:

MEDICINES CONTROL COUNCIL

APPLICATION FOR THE DONATION OF MEDICINE TO SOUTH AFRICA

This document needs to be completed for each medicine that any applicant wishes to donate to South Africa. It is not intended as an exclusive approach. Council reserves the right to request for any additional information to establish the safety, quality and efficacy of a medicine and may make amendments in keeping with the knowledge which is current at the time of consideration of data accompanying applications for the donation of medicines. The MCC is committed to ensure that all medicines available that are donated will be of the required quality, safety and efficacy. It is important for applicants to adhere to the administrative requirements to avoid delays in the processing of applications.
First publication released for implementation / May 2003
Version 2:
Updated to include new contact details & reference to MRF1/ZA-CTD dossier / September 2010

REGISTRAR OF MEDICINES

MS M HELA

APPLICATION FOR DONATED MEDICINES

The application must be completed by the applicant who wishes to donate medicines, and returned to:

For attention: (The Medicines Control Officer’s name who helped with the query.)

The Registrar of Medicines

The Medicines Control Council

Private Bag X828

PRETORIA

0001

Or fax it to: (012) 395 9201

6.14 Application donated medicine May03 v2September 2010page 1 of 3

Application for donation of medicine to South Africa

Applicant’s name:

MEDICINES CONTROL COUNCIL

APPLICATION FOR DONATED MEDICINES

Applicant’s Name:
Address:
Fax number:
Telephone number:
International Non-proprietary Names of Medicines involved:

6.14 Application donated medicine May03 v2September 2010page 1 of 3

Application for donation of medicine to South Africa

Applicant’s name:

Question / Answer
1. / Is the medicine donation based on an expressed need and relevant to the disease pattern in this country?
Or, in acute emergencies: Are the medicines among the essential drug list items of Emergency Relief Items?
2. / Are the medicines on the Essential Drug List?
Or:
Are the medicines needed in sudden outbreaks of uncommon or newly emerging diseases? / Specify:
3. / Are the presentation, strength and formulation of the donated medicines similar to those commonly used in this country? / ______
If No,
Specify differences:
4. / Are the medicines registered by the Medicines Control Council? / ______
If Yes,Registration No.:
5. / Were the medicines issued to patients and then returned to a pharmacy or elsewhere, or given to health professionals as free samples?
6. / After arrival in the country, what will the remaining shelf-life be?
If the donation is for a specific health centre, is the responsible profession aware of the shelf-life?
7. / Please indicate whether the following information appears on the label:
Is the label in English?
International Non-proprietary Name (INN)
Batch Number
Dosage form
Strength
Name and address of the manufacturer
Storage condition
Quantity in the container
Expiry date
8. / What is the original pack size of the medicine?
9.1 / Are the medicines packed in accordance with international shipping regulations?
9.2 / Are the medicines accompanied by a detailed packing list, which specifies the contents of each numbered carton by INN, dosage form, quantity batch number, expiry date, volume, weight, and any special storage condition?
9.3 / Does the weight of the carton exceed 50 kilograms?
9.4 / Are the medicines mixed with other supplies in the same carton?
10. / Will the MCC be informed if the medicine donation is prepared or actually under way?
11. / Is the declared value or the donated medicine based upon the wholesale price of its generic equivalent in South Africa,
Or, if such information is not available, on the wholesale world-market price for its generic equivalent,
Or in the case of patented medicines for which there is no generic equivalent, is the wholesale price of the nearest therapeutic equivalent taken as a reference?
12. / Are the costs of international and local transport, warehousing, port clearance, appropriate storage and handling paid by the donor agency? / Recipients’ name
Address
Or otherwise is it agreed with the recipient in advance?
13. / Are the relevant MRF1 PARTs or ZA-CTD Modules attached?
(refer to guideline 5.08 Medicine Donations to South Africa)

6.14 Application donated medicine May03 v2September 2010page 1 of 3