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Contents

Introduction ......................................................................................................................... 2 Circumstances under which Professional Competence Certificate is issued .......................... 3 2.1. Procedure...................................................................................................................... 3 2.2. Type of organization that is going to be functions should be identified .......................... 3 2.3. Area consideration ........................................................................................................ 3 2.4. Professional measurements that should be fulfilled ....................................................... 4 a. For Human Pharmaceuticals Medical supplies and equipment Import and wholesale .... 4 b. Medical supplies and equipment Import and wholesale ................................................. 4 c. For Human Pharmaceuticals Medical supplies and equipment Import and wholesale .... 4 d. For Human Pharmaceuticals Medical supplies and equipment Import and wholesale .... 4 2.5. Organizational measurements ....................................................................................... 5 3. Administration Issues........................................................................................................... 7 3.1. Service fee .................................................................................................................... 7 3.2. Documents .................................................................................................................... 7 3.3. Legal Source of pharmaceuticals, Medical Supplies and equipment .............................. 7 3.4. License for permanent Import of pharmaceuticals, Medical supplies and equipment ..... 8 3.5. Inhibition for import ..................................................................................................... 9 3.6. Noticing Harmful practices ........................................................................................... 9 3.7. Information dissemination ............................................................................................ 9 3.8. Promotion/advertisement ............................................................................................ 9 3.9. Control of labeling and packaging pharmaceuticals ....................................................... 9 3.10. Package inserts/leaflets............................................................................................ 10 3.11. Free medical Samples .............................................................................................. 10 3.12. Filing, documenting and pattern of Reporting .......................................................... 10 3.13. Disposal .................................................................................................................. 11 3.14. Renewal and Replacement of License...................................................................... 11 3.15. Unlawful acts/Inhibited acts .................................................................................... 11 4. Suspension or Cancellation of Professional License ....................................................... 12 4.1. Reasons for certificate is not issued ............................................................................ 12 4.2. Disqualification of License........................................................................................... 12 4.3. Returning the certificate ............................................................................................. 12 1. 2.

1|P a ge
Standard for Import/Wholesale Abdi Befekadu , Alemush Tefera and Hawi Befekadu

storage and use. transportation. Alemush Tefera and Hawi Befekadu . There should be a standard that provide guidance for organizations that are involved in these processes. safe. i. potent. and a care should be undertaken during production. Part one: Definition of terms Part two: Executive body Part three: Conditions that should be fulfilled to issue certificate of Professional competence Part four: Administration issues Part five: Various issues 2|P a ge Standard for Import/Wholesale Abdi Befekadu . This standard was produced based on the proclamation number 176/1991. and effective medications.e. Some of the organizations that are involved in the process include those participate in the Importing/Wholesaling Pharmaceuticals. medical supplies and equipment in the healthcare system is very critical.1. The standard will be discussed in this paper. On one hand the drugs ate toxic substances. The government of Ethiopia and the Control Authority produced a standard. Medical Supplies and Equipment. The Ethiopian Pharmaceuticals. Medical Supplies and Equipment Import/Whole standard has five basic parts. Introduction The need for quality.

i. the certificate is not given for the organization to run the business.1. Environmental conditions The organization buildings should be near to modern infrastructures. Unless the gap is filled. Medical supplies and equipment Import and 2. ease of transportation. medical supplies and equipment Import/Wholesale is not allowed without professional license certificate. Medical supplies and equipment wholesale 4. Pharmaceuticals (Human and Animals). signed by all members and should be achieved in appropriate place. 2. Area consideration 1. Medical supplies and equipment Import and wholesale 3. and the area should be free from environmental conditions/hygienic condition that are potentially deteriorating the pharmaceuticals.2. All activities of the committee should be registered. 3|P a ge Standard for Import/Wholesale Abdi Befekadu . Following filling 2-3 inspectors will be sent to for visit and analysis to the organization. And a copy should be given to the vice Director of FMHACA. and 10days are given for those in Addis and a month is given for those outside Addis to fulfill the uncompleted criterion.e. Pharmaceutical (Human and Animals). involving in Pharmaceuticals. Medical supplies and equipment wholesale Running a business. Inspectors are sent to the organization whether those uncompleted gaps are filled or not. The committee see whether criterion were fulfilled or not. 2. Circumstances under which Professional Competence Confirmation Certificate is issued 2. and to get a license fulfilling criterion set by FMHACA is mandatory.2.3. Alemush Tefera and Hawi Befekadu . Drug inspection and conduct assurance analyze the checklist filled by the inspectors and with some comments bring to the committee. Type of organization that is going to be functions should be identified wholesale 1. Procedure A form should be filled in order to get a license.

4. physical impairment. Professional measurements that should be fulfilled a. narcotic and psychotropic drugs as well as other stimulants use. And there should be a registered druggist that acts as assistant technical head or storekeeper head. c. And a health certificate should be brought. Medical supplies and equipment Import and wholesale The technical head should be a pharmacist that has been registered and have at least five years working experience or a medical equipment maintenance man should be available. For Human Pharmaceuticals Medical supplies and equipment Import and wholesale The technical head should be a pharmacist that has been registered and have at least five years¶ experience. For Human and Veterinary Pharmaceuticals Medical supplies and equipment Import and wholesale The technical head should be a pharmacist that has been registered and have at least five years working experience.  He/she should not be the one who was not allowed to work  He/she should be free from psychotic disease. For Veterinary Pharmaceuticals Medical supplies and equipment Import and wholesale The technical head should be a pharmacist that has been registered and have at least five years working experience or a veterinary doctor that has been registered and have at least experience of five years. alcoholism. The professional that act as a technical head or store keeper head should fulfill the following criteria. And there should be a registered druggist that acts as assistant technical head or storekeeper head or assistant veterinary doctor should be available. Alemush Tefera and Hawi Befekadu . And there should be a registered druggist that acts as assistant technical head or storekeeper head. And there should be a registered druggist that acts as assistant technical head or storekeeper head or a medical equipment maintenance man should be available.2. d. 4|P a ge Standard for Import/Wholesale Abdi Befekadu . b.

medical supplies and equipment 2 Animal Pharmaceuticals. Additionally areas to keep inferior quality products/ Expired or deteriorated products should be separates. Latrine a. 2.5 According to the type of import/wholesale there may be a separated store or an isolated area. medical supplies and equipment 4 Medical supplies and equipment 50 5 3. Office 4.5 Area (m2) Width(m) 75 5 Height(m) 3. He/she should bring a clearance and a work experience from previous organization. Store room S/N 1 Importer/ Wholesaler Human Pharmaceuticals.5. Store 2. There 5|P a ge Standard for Import/Wholesale Abdi Befekadu . Alemush Tefera and Hawi Befekadu . The rooms: The floor should be made from cement/timber/bricks Store and over-handing classes wall should be made from stone/bocks/bricks Washable wall paints sufficient air circulation and sufficient light all the rooms should be in the same compartment The rooms should be within living room c.5 50 5 3.5 100 5 3. Organizational measurements 1. it should be brought to FMHACA. medical supplies and equipment 3 Human and Animal Pharmaceuticals. Hand overing 3. At least the organization should have the following rooms: b. and if professional license was taken from the authority. Area for storing materials that need cool or refrigerator should be isolated.

Dispatch table and sufficient cohesive materials for binding should be available. Over-handing room The minimum area is 15m2. The organization should have an electric power. e. locked cabinet for filing different documents. d. hygrometer and air conditioner. fire extinguisher. f. Alemush Tefera and Hawi Befekadu . The technical head office The technical head office should have sufficient tables and chairs.5 m.5 m. The latrine of the organization should have sufficient water and a hand washing sink. The organization should have office for administration officer. 6|P a ge Standard for Import/Wholesale Abdi Befekadu . telephone. wall thermometer.should be sufficient shelves. The organization office It should be at least 9m2 with a minimum width of 3m and a height of 3. minimum width 3m and minimum height of 3. If the organization is importer it should have a fax. postal services and sufficient water supply. locked metal cabinet for storage of narcotic and psychotropic drugs.

Alemush Tefera and Hawi Befekadu .Seal. Legal Source of pharmaceuticals. Documents Any organization that is authorized to run a pharmaceutical. Receipts . 7|P a ge Standard for Import/Wholesale Abdi Befekadu . An authorized organization to make an Import the national drug list 2. Medical 800 Supplies and equipment Import/Wholesale 4 Human and Veterinary Medical Supplies and equipment Import/Wholesale 800 300 100 500 100 600 300 10 3.1. Medical Supplies and equipment Import/Wholesale 2 Veterinary pharmaceuticals. Medical Supplies and equipment Import/Wholesale 3 Human and Veterinary pharmaceuticals.2. Administration Issues 3. it should prepare with its name Store cards. Only if the pharmaceuticals that the organization intend to import are available on a. Invoices. Bin cards. And the organization should also prepare an indicator/tapella on the entrance of the organization. medical supplies and prior being involved in the business. 3. Medical Supplies and equipment 1. Only if the pharmaceuticals.3. The professional license certificate that is issued to the organization should be kept in the technical department office in a well visible place. Service fee New 600 Renewal 300 Replacement 100 To get new or renew or to get replace a professional license certificate S/N Type of license 1 Human pharmaceuticals.3. Storage control formats. Medical Supplies and equipment that the organization need to import were analyzed by the authority and checked for being registered 3. The organization should bring legal delegation from the manufacturer or if it is from legal foreign wholesaler a legal delegation of the wholesaler from the producer.

it should accept the decision /measure taken by the authority. Import/Wholesale should bring y y y Batch analysis Certificate Country of Origin certificate Pharmaceuticals. The cause of the deterioration should be analyzed or identified. the organization should collect from market. and if it is due to the importer/wholesaler. If the Imported pharmaceuticals. Alemush Tefera and Hawi Befekadu . Before importing.4. b. Medical Supplies and equipment identification number/batch number. 2. for scientific research. for registration purpose/service. For Imported pharmaceuticals. b. for public aid. Buying pharmaceuticals. From wholesalers and Importers a. 3. License for permanent Import of pharmaceuticals. and for others the authority/FMHACA allowed. manufactured and expiry date. Permission should be gotten from the authority b. Imported products should fulfill the criteria of the authority 8|P a ge Standard for Import/Wholesale Abdi Befekadu . all important purchase order documents should be brought to FMHACA and permission should be obtained. and other relevant documents must be brought to the authority. for diplomatic Missionaries. Medical Supplies and equipment. Medical Supplies and equipment are deteriorated. From Pharmaceutical manufactures that produce Human pharmaceuticals. Medical Supplies and equipment that are existing in Ethiopia 2. Medical supplies and equipment 1. Only can import narcotic and psychotropic drugs if additional permission/license is issued 5. For individual use. Medical Supplies and equipment from Ethiopia 1. and it should also inform the authority.4. For drug free cosmetics and sanitary services (for private use or for trading) a.

7. o Unless for academic and research purpose.3.9. Control of labeling and packaging pharmaceuticals a. 3. Inhibition for import Pharmaceuticals. drug related information is disseminated for only those registered. Packaging y The material used for packaging should not be interact physically or chemically with the pharmaceutical and make deterioration. b. visible and written in English  Contain at least information o Scientific name and trade name o Quantity and strength o Batch number o Manufacturer name and address o Manufactured date o Expire date o Storage condition 9|P a ge Standard for Import/Wholesale Abdi Befekadu . o The drug should have similar information with that of registered.5. no one can make adverts. Packaging labels  Should be easily readable. 3. Information dissemination o Any Importer/wholesaler before disseminating Information about pharmaceuticals. Medical supplies and equipment to the general public and health professionals. Noticing Harmful practices The importer/wholesale has a responsibility to collect and notify the authority when there is a distribution of a counterfeited/inferior product. Alemush Tefera and Hawi Befekadu . 3.6. 3. Promotion/advertisement Unless it is allowed by the authority.8. Medical Supplies and equipment can be inhibited from being imported by the authority if sufficient evidence is available for inhibition. it should notify the authority to get permission.

Manufacturer name and address v. Alemush Tefera and Hawi Befekadu . For animal pharmaceuticals i. 3. There should be a label on the container ³NOT FOR SALE´ 4. Batch number iv. Manufactured date vi. Logo: ³ONLY FOR ANIMALS´ 3. The free medical sample is distributed for the pharmacists and physicians 5. Quantity and strength iii. Scientific name and trade name ii.11. Importer/Wholesaler can bring free medical samples if and only if: a. Sale in not allowed 3.c. The list should be brought to the authority and permission should be acquired 2. Package inserts/leaflets For imported in English. For narcotic and psychotropic drugs free medical sample is not allowed.10.12. documenting and pattern of Reporting The importer and the wholesaler should y Keep/files documents sent to it 10 | P a g e Standard for Import/Wholesale Abdi Befekadu . 3. Filing. if manufactured in Ethiopia in Amharic or in both Amharic and English The content of the leaflet should be similar to that of information registered in the document/authority. Registered by the authority and allowed for business b. Free medical Samples 1. Storage condition viii. Duration of the drug in the body of the animal or if the animal/product is intended for food duration of waiting before using x. Expire date vii. For which animal ix.

o Inspectors from FMHACA or represented/delegated body by the authority should available during disposal.13. it will be counted as the license is dysfunctional and not legal.y Annual report of Imported and distributed as well as deteriorated pharmaceuticals. medical supplies and equipment should be o Stored on a separated place and FMHACA should be informed. Alemush Tefera and Hawi Befekadu . paying renewal If failed to renew in the first two months of the budget year.15. Disposal 1. and any organization does not renew during the time specified in the. Unlawful acts/Inhibited acts o selling to individual user o Distributing Inferior quality. counterfeited. Renewal and Replacement of License a. renewal is possible in third and fourth months of the budget year with additional service fee 50% per month. Renewal of License Organization that fulfills criterion of FMHACA after inspectors made a checkup professional license certificate renewal is allowed. And the organization should make a service fee payment to renewal in the first two months of the budget year. Deteriorated pharmaceuticals. medical supplies and equipment 11 | P a g e Standard for Import/Wholesale Abdi Befekadu . Replacement of the license  If lost or deteriorated the organization can ask for replacement  FMHACA took the one that was deteriorated and replace with the new one  Evidence for the lost certificate from the governmental body/police  Service fee for certificate replacement 3. medical supplies and equipment. unsafe and ineffective preparations o Repacking packed preparations o Mobile sales o Distributing unregistered/inhibited pharmaceuticals. Certificate should be given by the FMHACA or represented body 3. b. y Frequently report of imported and distributed narcotic and psychotropic drugs 3.14. 2.

regarding all the pharmaceuticals. If the organization made an obstacle on the work of inspectors 5. When criteria for acquiring a certificate is not fulfilled. If the organization made/work against/opposite to the license 7. Returning the certificate Organization that its certificate of Competence is disqualified Should return the certificate to FMHACA After the license was returned to FMHACA. If the organization is banned from involved in trade 4. Repeated unlawful act/inhibited acts 4. If the certificate is owned illegally 3. the decision of the control authority should be accomplished.1. medical supplies and equipment that are found in the store of the organization.2. misleading leaflet. illegally imported. If the organization stops the business on its good will 7. contraband. Unregistered. 5. Failed to renew the certificate with in the specified time 6. 4. Distributing/selling deteriorated pharmaceuticals. When the director/head of the organization fails to perform day to day activities 2. If the certificate is given to external/another body 2. 12 | P a g e Standard for Import/Wholesale Abdi Befekadu . Reasons for certificate is not issued 1. Distributing to unregistered wholesalers/brokers or health Institutions 3. counterfeited.3. Suspension or Cancellation of Professional License 4. medical supplies and equipment. If the organization is not allowed for trading by a government body 6. Alemush Tefera and Hawi Befekadu . inferior. 4. Disqualification of License 1.o Making any changes without the knowledge of FMHACA 4.