A Form Should Be Filled in Order to Get a License A

ContentsIntroduction ......................................................................................................................... 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 geStandard for Import/Wholesale Abdi Befekadu , Alemush Tefera and Hawi Befekadu

1. IntroductionThe need for quality, i.e. potent, safe, and effective medications, medical supplies and equipment in the healthcare system is very critical. On one hand the drugs ate toxic substances, and a care should be undertaken during production, transportation, storage and use. There should be a standard that provide guidance for organizations that are involved in these processes. Some of the organizations that are involved in the process include those participate in the Importing/Wholesaling Pharmaceuticals, Medical Supplies and Equipment. The government of Ethiopia and the Control Authority produced a standard. The standard will be discussed in this paper. This standard was produced based on the proclamation number 176/1991. The Ethiopian Pharmaceuticals, Medical Supplies and Equipment Import/Whole standard has five basic parts. 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. Circumstances under which Professional Competence Confirmation Certificate is issued 2.1. Procedure

A form should be filled in order to get a license. Following filling 2-3 inspectors will be sent to for visit and analysis to the organization. Drug inspection and conduct assurance analyze the checklist filled by the inspectors and with some comments bring to the committee. The committee see whether criterion were fulfilled or not, and 10days are given for those in Addis and a month is given for those outside Addis to fulfill the uncompleted criterion. Inspectors are sent to the organization whether those uncompleted gaps are filled or not. Unless the gap is filled, the certificate is not given for the organization to run the business. All activities of the committee should be registered, signed by all members and should be achieved in appropriate place. And a copy should be given to the vice Director of FMHACA.

2.2.

Type of organization that is going to be functions should be identifiedwholesale

1. Pharmaceuticals (Human and Animals), Medical supplies and equipment Import and

2. Medical supplies and equipment Import and wholesale 3. Pharmaceutical (Human and Animals), Medical supplies and equipment wholesale 4. Medical supplies and equipment wholesale Running a business, i.e. involving in Pharmaceuticals, medical supplies and equipment Import/Wholesale is not allowed without professional license certificate, and to get a license fulfilling criterion set by FMHACA is mandatory.

2.3.

Area consideration

1. Environmental conditions The organization buildings should be near to modern infrastructures, ease of transportation, and the area should be free from environmental conditions/hygienic condition that are potentially deteriorating the pharmaceuticals.


2.4.

Professional measurements that should be fulfilled

a. 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. And there should be a registered druggist that acts as assistant technical head or storekeeper head.b. 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. 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.c. 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. And there should be a registered druggist that acts as assistant technical head or storekeeper head.d. 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. And there should be a registered druggist that acts as assistant technical head or storekeeper head or assistant veterinary doctor should be available. The professional that act as a technical head or store keeper head should fulfill the following criteria. He/she should not be the one who was not allowed to work He/she should be free from psychotic disease, physical impairment, alcoholism, narcotic and psychotropic drugs as well as other stimulants use. And a health certificate should be brought.


He/she should bring a clearance and a work experience from previous organization, and if professional license was taken from the authority, it should be brought to FMHACA.

2.5.

Organizational measurements1. Store 2. Hand overing 3. Office 4. Latrine

a. At least the organization should have the following rooms:

b. 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. Store room S/N 1 Importer/ Wholesaler Human Pharmaceuticals, medical supplies and equipment 2 Animal Pharmaceuticals, medical supplies and equipment 3 Human and Animal Pharmaceuticals, medical supplies and equipment 4 Medical supplies and equipment 50 5 3.5 100 5 3.5 50 5 3.5 Area (m2) Width(m) 75 5 Height(m) 3.5

According to the type of import/wholesale there may be a separated store or an isolated area. Area for storing materials that need cool or refrigerator should be isolated. Additionally areas to keep inferior quality products/ Expired or deteriorated products should be separates. There


should be sufficient shelves, locked metal cabinet for storage of narcotic and psychotropic drugs, wall thermometer, fire extinguisher, hygrometer and air conditioner. d. Over-handing room The minimum area is 15m2, minimum width 3m and minimum height of 3.5 m. Dispatch table and sufficient cohesive materials for binding should be available. e. The organization office It should be at least 9m2 with a minimum width of 3m and a height of 3.5 m. f. The technical head office The technical head office should have sufficient tables and chairs, locked cabinet for filing different documents. The organization should have office for administration officer. The latrine of the organization should have sufficient water and a hand washing sink. The organization should have an electric power, telephone, postal services and sufficient water supply. If the organization is importer it should have a fax.


3. Administration Issues3.1. Service feeNew 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, Medical Supplies and equipment Import/Wholesale 2 Veterinary pharmaceuticals, Medical Supplies and equipment Import/Wholesale 3 Human and Veterinary pharmaceuticals, 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

3.2.

Documents

Any organization that is authorized to run a pharmaceutical, medical supplies and prior being involved in the business, it should prepare with its name Store cards, Bin cards, Invoices, Receipts ,Seal, Storage control formats. The professional license certificate that is issued to the organization should be kept in the technical department office in a well visible place. And the organization should also prepare an indicator/tapella on the entrance of the organization.

3.3.

Legal Source of pharmaceuticals, Medical Supplies and equipment1. Only if the pharmaceuticals that the organization intend to import are available on

a. An authorized organization to make an Import

the national drug list2. Only if the pharmaceuticals, Medical Supplies and equipment that the organization

need to import were analyzed by the authority and checked for being registered3. 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.


4. Only can import narcotic and psychotropic drugs if additional permission/license is

issued5. Before importing, all important purchase order documents should be brought to

FMHACA and permission should be obtained. b. Buying pharmaceuticals, Medical Supplies and equipment from Ethiopia 1. From Pharmaceutical manufactures that produce Human pharmaceuticals, Medical Supplies and equipment that are existing in Ethiopia 2. From wholesalers and Importers a. For Imported pharmaceuticals, Medical Supplies and equipment, Import/Wholesale should bring y y y Batch analysis Certificate Country of Origin certificate Pharmaceuticals, Medical Supplies and equipment identification number/batch number, manufactured and expiry date, and other relevant documents must be brought to the authority. b. If the Imported pharmaceuticals, Medical Supplies and equipment are deteriorated, the organization should collect from market, and it should also inform the authority. The cause of the deterioration should be analyzed or identified, and if it is due to the importer/wholesaler, it should accept the decision /measure taken by the authority.

3.4.

License for permanent Import of pharmaceuticals, Medical supplies and equipment

1. For individual use, for scientific research, for registration purpose/service, for public aid, for diplomatic Missionaries, and for others the authority/FMHACA allowed. 2. For drug free cosmetics and sanitary services (for private use or for trading) a. Permission should be gotten from the authority b. Imported products should fulfill the criteria of the authority


3.5.

Inhibition for import

Pharmaceuticals, Medical Supplies and equipment can be inhibited from being imported by the authority if sufficient evidence is available for inhibition.

3.6.

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.

3.7.

Information dissemination

o Any Importer/wholesaler before disseminating Information about pharmaceuticals, Medical supplies and equipment to the general public and health professionals, it should notify the authority to get permission. o The drug should have similar information with that of registered. o Unless for academic and research purpose, drug related information is disseminated for only those registered.

3.8.

Promotion/advertisement

Unless it is allowed by the authority, no one can make adverts.

3.9.

Control of labeling and packaging pharmaceuticalsa. Packaging y The material used for packaging should not be interact physically or chemically with the pharmaceutical and make deterioration. b. Packaging labels Should be easily readable, 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


c. For animal pharmaceuticals i. Scientific name and trade name ii. Quantity and strength iii. Batch number iv. Manufacturer name and address v. Manufactured date vi. Expire date vii. Storage condition viii. For which animal ix. 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. Logo: ONLY FOR ANIMALS

3.10. Package inserts/leafletsFor imported in English, 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.

3.11. Free medical Samples1. Importer/Wholesaler can bring free medical samples if and only if: a. Registered by the authority and allowed for business b. The list should be brought to the authority and permission should be acquired 2. Sale in not allowed 3. There should be a label on the container NOT FOR SALE 4. The free medical sample is distributed for the pharmacists and physicians 5. For narcotic and psychotropic drugs free medical sample is not allowed.

3.12. Filing, documenting and pattern of ReportingThe importer and the wholesaler should y Keep/files documents sent to it

10 | P a g eStandard for Import/Wholesale Abdi Befekadu , Alemush Tefera and Hawi Befekadu

y

Annual report of Imported and distributed as well as deteriorated pharmaceuticals, medical supplies and equipment.

y

Frequently report of imported and distributed narcotic and psychotropic drugs

3.13. Disposal1. Deteriorated pharmaceuticals, medical supplies and equipment should be o Stored on a separated place and FMHACA should be informed. o Inspectors from FMHACA or represented/delegated body by the authority should available during disposal. 2. Certificate should be given by the FMHACA or represented body

3.14. Renewal and Replacement of Licensea. 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. paying renewal If failed to renew in the first two months of the budget year, renewal is possible in third and fourth months of the budget year with additional service fee 50% per month; and any organization does not renew during the time specified in the, it will be counted as the license is dysfunctional and not legal. b. 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

3.15. Unlawful acts/Inhibited actso selling to individual user o Distributing Inferior quality, counterfeited, unsafe and ineffective preparations o Repacking packed preparations o Mobile sales o Distributing unregistered/inhibited pharmaceuticals, medical supplies and equipment


o Making any changes without the knowledge of FMHACA

4. Suspension or Cancellation of Professional License4.1. Reasons for certificate is not issued1. When the director/head of the organization fails to perform day to day activities 2. Distributing to unregistered wholesalers/brokers or health Institutions 3. When criteria for acquiring a certificate is not fulfilled. 4. If the organization made an obstacle on the work of inspectors 5. If the organization is not allowed for trading by a government body 6. If the organization made/work against/opposite to the license 7. Repeated unlawful act/inhibited acts

4.2. Disqualification of License1. If the certificate is given to external/another body 2. If the certificate is owned illegally 3. Unregistered, counterfeited, inferior, contraband, illegally imported, misleading leaflet, 4. Distributing/selling deteriorated pharmaceuticals, medical supplies and equipment. 5. Failed to renew the certificate with in the specified time 6. If the organization stops the business on its good will 7. If the organization is banned from involved in trade

4.3. Returning the certificateOrganization that its certificate of Competence is disqualified Should return the certificate to FMHACA After the license was returned to FMHACA, regarding all the pharmaceuticals, medical supplies and equipment that are found in the store of the organization, the decision of the control authority should be accomplished.
