ባለስልጣን Authority ላኪ እና ጅምላ አከፋፋይ ቁጥር 872/2014 Export and Wholesale የካቲት 2014 አዲሰ አበባ፣ ኢትዮጵያ February 2022 Addis Ababa, Ethiopia Preamble WHERE AS, it is necessary to ensure the quality of standards, safety, efficacy or effectiveness of medicine and medical device starting from the raw material during storage, distribution, transportation and handling; WHEREAS, it is necessary to prevent and control the public health from risks emerging out of unsafe, ineffective and poor quality medicine and medical devices; WHEREAS, it is necessary to issue certificate competence to organizations engaged in medicine or medical device, import, export and wholesale trade activities by ensuring compliance to requirements related with facility, professionals and necessary materials as well as storage, handling, distribution and transportation; and make them supply medicines and medical devices that meet their quality, safety and effectiveness requirments. WHERE AS, it is necessary to take appropriate administrative measures against violations of this directive and other relevant laws; NOW, THEREFORE, the Ethiopian Food and Drug Authority issued this directive in accordance with Article 71 (2) of the Food and Medicine Administration Proclamation No 1112/2019. PART ONE GENERAL
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This directive may be cited as “Medicine and Medical Device Import, Export and Wholesale Control Directive No. 872/2022.”
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In this Directive, 1. “Accessory” means an article that supports, complements or enhances the performance of one or more major medical device. 2. “Product” means medicine, medical device and raw materials that are used to manufacture those products. 3. “Suspension” means any administrative measure taken to suspend medicine and/or medical devices trade activities of a person due to his or her violation of or non- compliance with the laws issued by the Authority. 4. Revocation” means any administrative measure taken to terminate medicine and/or medical devices trade activities of a person due to his or her violation of or non- compliance with the laws issued by the Authority. Any revoked entities trade activities shall not lete to continue any time with the name where the Administrative measure taken 5. “Mobile Sale” means the sale of a medicine or medical device without the written, fax or e-mail request of the buyer. 6. “Cold chain devices” means any device used to store or transport mediicnes and other medical products at temperature ranging from -50⁰C to -15⁰C and +2⁰C to +8⁰C; and includes deep freezer or cold room፣ medical rifirigrator, cold box, vaccine carriers, Ice pack). 7. “Internet Sale” means the sale of medicine and medical device to organizations or users using internet. 8. “Import Permit” means the issuance of a permit to import a medicine or medical device that are registered by the Authority. 9. “ Pre-import Permit” means the authorization issued by the Authority upon confirmation of meeting the requirements for the importation of unregistered medicine or medical device. 10. “Self contained” means containing in oneself all necessary service rooms and that do not connect with other service room using doors and windows. This does include common stairs. However, Ceilings for rooms of Condominium houses is considered as a separate. 11. “ Sales Person” means a technical person who sales medicines or medical devices in a legal way to institutions on behalf of medicine or medical device trader 12. “Authority” means the Ethiopian Food and drug Authority. 13. “Person” means a natural or juridical person. 14. Definitions provided under Article 2 of the Proclamation shall also be applicable to this Directive. 15. Any expression in the masculine gender shall also apply to the feminine gender.
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This directive shall be applicable to medicine and medical device importer, exporter and wholesaler. Part Two: Certificate of Competence
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1. Any person who wants to import, export and wholesale medicine and medical device shall first obtain certificate competence from the Authority 2. When an importer, exporter and wholesaler want an additional warehouse, it shall fulfill the requirements for store manager and the information shall be written on the original Certificate of Competence. However, if exporter and wholesaler wants a branch, it shall fulfill all the requirements 3. Any person shall have only one import but different branches of wholsales at different sites of the country. 4. Any person who wants certificate of competence shall met the following requirements: i. Pay the appropriate service fee ii. As per the form priscribed by the Authority, complete the application and attached the following original documents online through electronic regulatory information system (https://www.ilicense.efda.gov.et); a) Educational evidences of technical manager and store manager b) Employment agreement or contract of technical and store manager c) Working experience letter of the technical manager and store manager from the employer that describes his/her resignation d) Proof of evidence if he/she had worked as a technical manager and store manager from health regulatory bodies e) Professional license of the technical and store manager f) Passport size photo of the technical manager g) House rent contract or carta or lease hold title certificate authonicated by Document Authentication and Registration Agency. h) Without prejudice to sub-article 3(ii) of (g) of this article, for government houses, supporting letter from this organization will be acceptable. Moreover, any agreement between Religious houses and other entities that have legal rights and grounds to rent houses are acceptable. i) If the applicant is Private Limited Company (PLC), establishment document and administrative regulation attested by Document Authentication and Registration Agency or authenticated establishment document and administrative regulation (the document may be in one compiled form) from Trade Beuros or any concerned Government office j) Taxpayer identification numbers (TIN) k) For partially completed building, provide authorization for use of the building for service from responsible body
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electronic regulatory information system (eRIS) does not fulfill the requirements and retuned back for the applicant for correction, he/she can re-apply after correction.
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requirements, the organization will be inspected on-site by a team having at least two appropriate inspectors.
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filled inspection checklist by inspectors against the set requirements.
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been met, the applicant shall be informed about the decision in writings by inspection team or inspection directorate as appropriate
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Article, applicants who do not fulfill the requirements notified through electronic regulatory information system, two-round re-inspection may be carried out after the appropriate service fee payment.
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Article, applicants who do not fulfill the requirements after the conduct of two round inspections, the submitted application shall be rejected. However, the application shall be processed if the applicant rents a new houses and apply as new. 11. The inspection reports prepared by the inspectors shall be archived the in electronic regulatory information system (eRIS). 12. Once requirements are met, the Authority shall issue certificate of competence within five working days. 13. Without prejudice to sub-article (12) of this article, in the event of compelling circumstances, by notifying the applicant the certificate of competence may not be issued within the stipulated tim 5. Content of the Certificate of Competence Any certificate of competence issued in accordance with this directive shall have the following information፤ 1. Name and address of the organization 2. Owner name of the organization 3. The organization’s technical manager name and professional license number 4. The organization’s store manager name and professional license number 5. Type of organization 6. Type of service given by organization 7. Type of products to export, import and wholesale 8. Date of issue and expiry date of the certificate competency 9. Signature of authorizerized person who issued the certificate of competence and stamp of the Authority 10. Certificate of competency number 11. Taxpayer identification numbers (TIN) 12. Detail condition and notice on the license 13. Additional Warehouses information 6. Renewal of Certificate of Competence 1. Any person shall renew his/her certificate of competence annually. 2. Without prejudice to sub-article (1) of this article, if any force majours supported by objective evidences, the Certificate of competence may be renewed. 3. To renew a certificate of competence, the applicant can apply for renewal starting three months before expiry of the service period. 4. In accordance with sub-article (1) of this article, a certificate of competence shall be renewed; a. Upon submission of the last three months of distribution, if necessary and b. Confirmation of payment of required service fee 5. If the certificate of competence is not renewed in accordance with sub- article (1) of this article, the certificate of competence shall be considered cancelled. 6. Where the Authority does not accept renewal application request, it shall notify the applicant by stating the reasons in writings. 7. Change of address, ownership, technical personnel, product type/service etype or other change 1. No person shall change location, ownership, technical personnel, types of products/services change of rooms, modification or partition of rooms without prior permission of the Authority. 2. Any person who wants to make a change shall apply using electronic regulatory information system (https://www.ilicense.efda.gov.et). 3. Notwithstanding to sub-article (2) of this article to make changes stated in annex 3 the applicant shall fulfil the requirements stipulated in annex 3. 8. Replacement of Certificate of Competence Any person whose certificate of competence has wrong information made by the Authority or damaged or lost may request replacement by fulfilling the following information: 1. If the certificate of competence is damaged, when the applicant returns it and pay the the required service fee 2. If certificate of competence is lost or burnt, when the applicant has provided proof of evidence from justice organ and pay the required service fee 3. If wrong information is made on the certificate of competence by the Authority, when the applicat returns it and pay the required service fee. 9. Displaying Certificate of Competence Any person shall display the original certificate of competence in the technical manager office of the organization in a conspicuous place where it can be easily seen. 10. Return of Certificate of Competence 1. Where any person wants to return the certificate of competence granted by the Authority due to different reasons, it shall submit letter of declaration that describes status of organization and products available, previousely issued certificate of competence and application letter. 2. Without prejudice to sub-article (1) of this article, any person shall return when:- a. Confirmed that products that are expired or damaged are disposed b. Confirmed that products decided to recal are recalled c. Confirmed that unsold or unused products have been transferred to another institution in accordance with the law. 3. Any technical manager and store manager who wants to leave shall notify to the employer and the Authority one month before release. 4. When the technical manager is absent from his/her work without announcing to the employer and the organization wants to replace; a) the organization shall notify the Authority b) After doing required verification, the Authority shall issue replacement certificate of competence to the organization within 15 days and by doing appropriate inspection and the same shall notify to concerned bodies. 5. When the organization ceases its operation without knowledge of the technical manager and the Authority; a) The technical manager shall notify the Authority b) As appropriate, the Authority may verify information from Trade and Industry, Revenue and Custom, and conducting inspection activities and other necessary verification activities, the authority may revoke the certificate of competence; and the same shall iform to concerned bodies. 6. When the organization refused to give release letter to the technical manager while is in operation as per set timeline, the Authority may accept the request of the technical manager after through verification activities. If the organization doesn’t replace ontime with a new technical manager, the Authority shall take appropriate administrative measures. Part three Organization status and required facilities and equipment
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1. any medicine and medical device trade organization shall not engage in other activities other than enumerated in certificate of competence ,and the organization a) it shall be far from Public toilets, stone crusher areas ,fueldepots, chemical manufacturing and store industries, waste accumulation and disposal areas b) it shall be established in clean and avoid any contamination or shall be constructed in area which is free from flood to ensure the safety ,efficacy and quality of medicines. c) it shall have adequate infrastructures at least telecommunication, power and water supply .and shall have transport access. 2. In one self-contained area, residenceand medicine and medical device import, export and wholesale shall not be allowed. 3. Without prejudice sub-article (2) of this article, building which is constructed for multipurpose (mixed), any medicine and medical device import, export and wholesale shall not be adjacent with residence. However, this doesn’t consider the ceilings for Condominum 4. any organization for medicine and medical device shall be self- contained and shall have a) store b) dispatch area c) technical manger office d) if the technical manager and ownership is same as appropriate administrative and secretary office e) Hand washingand toilet with adequate water ,and f) Independent storage area for medicine and medical device for expired, damaged, or owner initiated recalled or retuned or for market recalled products. 5. Any import ,export, and wholesale organization store, administrative and secretary office shall be within one city and could be in different area 6. Without prejudice sub-article (3) of this article, the technical manager and store shall not be separated in area. 7. Any rooms construction for medicine and medical device trade organization a) the floor shall be constructed with stone, standard block or standard materials which can be used for construction of floor and shall be easily washable with water b) As appropriate if ceiling is required, the ceiling shall be constructed at least with chipboardor similar materials. c) the floor shall be constructed with cement or similar materials d) The room shall have adequate lighting, necessary temperature and relative humidity, adequate air circulation and it shall not have direct sunlight exposure, and it shall have necessary monitoring system. e) if the organization is engaged in import, export and wholesale of narcotic and psychotropicsubstances ,it shall have lockable cabinet f) the store shall have lockable door and prevent from any pest and rodents and shall have controlling system for them 8. Based on import quantity or product type any medicines and medical device import, export and wholesale organization may have one or adjacent stores with a total area of not less than 40m2. 9. the technical manager office shall have adequate office furniture and lockable cabinet
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Any medicines and medical device import, export and wholesale organization to have standard administrative quality shall have below equipment and facilities: 1. if the organization has narcotic and psychotropicmedicines 2. if the organization has temperature sensitive products,it shall have cold sore and temperature monitoring apparatus. If the cold sore has temperature monitoring apparatus connected with it, the organization shall have additional portable temperature monitoring apparatus. 3. Any organization shall have certificate of calibrationby appropriate organization for thermometer and hygrometer. 4. if the medicine storage area has high temperature ,additional air conditionerand ventilators shall be in place 5. The organization shall have fire extinguisher, lockable cabinet for archival, dispatch table, stock and bin card. 6. The organization shall have dust bin, sanitary materials like glove, and mask. 7. If the medicines are administered in accordance with this sub-article (4) of this article, the organization shall have alternative power supply (generator). Part four Profession in Medicine and Medical Trade Organization
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1. Any organization shall fulfill below requirements to have competency of certificate a. To engage in medicine and medical device trade, the technical manager shall be pharmacist and registered by appropriate bodies and he/she shall have three and above years’ work experience in related work. b. To engaged in medical device trade,the technical manager shall have one of below listed educational preparedness ,three and above years’ work experience in related work and shall be registered by appropriate bodies. i. Pharmacist, biomedical engineer or medical equipment maintenance engineer ii. Medical laboratory technologist, dental science professional, ophthalmologist, or radiographic technologies and other related health professionals iii. As per article 1 of sub-article (b, ii) cited professionals will have certificate of competencyfor only medical devices which are related to their professional preparedness. c. If the professional is not denied due to not following the applicable laws d. If the professional is questioned to perform the role and responsibility, the authority may request confirmatory information for mental illness, disability, alcohol addiction, Narcotic and psychotropic and other controlled substance addictions e. He/she shall provide work experience from previous organization f. if he/she has competency of certificate on his/her name, it shall be retuned g. Any organization to engage in medicine and medical device trade shall have warehouse manager professionals who have at least two years of experience as druggist or zero years’ experience for pharmacist and shall be registered by appropriate body. h. Any organization to engage in medical device trade shall have at least zero years’ experienceinpharmacist, biomedical engineering or medical equipment maintenance engineer professionalfor warehouse manager and shall be registered by appropriate body. i. Medical laboratory technologist, dental science professional, ophthalmology, or radiographic technologist and other related professionals can be warehouse manager with zero years of experience for only importers and distributors of medical device related to their professional preparedness. j. without prejudice to article 1 of sub- article (h and I), for any organization who wants to engage in medical device trade shall have at least two years’ experience professional such as equipment maintenance technician, medical laboratory technician ,radiographic technician, ophthalmology technician or dental science diploma and other related professionals and registered by appropriate body and the related professionals shall bring appropriate evidences from the responsible organ 2. Any organizations shall not have any sale workers except degree or diploma professional level cited in article 1. 3. Any technical manager or warehouse manager at the same time shall not work with two or more importers and distributers.
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Responsibility Any professional who works in medicine and medical device trade organization and organization itself shall comply with below listed role and responsibilities. 1. Organization responsibilities a. Implement organization quality assurance system and follow the implementation of it. b. Implement the published national directives and guidelines and ensure the implementation of it. c. has responsibility to look at the professional registration certificate, work experience and control the code of conduct d. shall give notice for the authority in written form when the technical manager and warehouse manager left the organization e. shall notify the sales and purchase invoices (template) for the authority f. Shall comply with any national regulations and laws for medicine and medical device import and export implemented. 2. Technical Manger Responsibilities a. He /she shall perform the responsibilities autonomously. But in his/her absence she/he can delegate professional in written form who fulfill minimum requirements to get competency of certificate for not more than four months within year. This information shall be notified to the authority. But if the delegation is due to illness, the delegation will be as per labour proclamation. b. He/she shall have all information for delegated personnel. c. Shall monitor any service-related information’s anddocuments. d. shall prepare job description (role and responsibilities) of all professions within the organization e. shall give training for professionals about safety ,efficacy and quality or performance of medicine and medical devices f. shall controlled the organization in- stock and out-of-stock distribution ,sales , and all supply management system of medicine and medical devices and shall control the safety ,efficacy and quality or performance of medicine and medical devices. g. Shall comply and implement any national directives and guidelines(Good Storage practice, Good Distribution practice, Good Documentation Practice , professional requirements and design and other layout requirements) h. shall follow the warehouse regulateprocedure is implemented i. Shall notify and aware for janitor of warehouse and shelves about risk associated and their personal protective equipment. j. shall assure that narcotic and psychotropic medicines cabinet is lockable, and the key is within technical manager k. Shall ensure that unfit medicines and medical device are properly disposed as per the available directive. l. If he/she suspected medicine and medical devices have safety, efficacy and quality or performance issue ornoticed that others irrelevant regulations are implemented. He/she shall notice the authority. m. If any medicine and medical devices adverse reaction and quality defects are observed or have information on it, he/she shall immediately notify the authority. n. shall wear appropriate dress and shall maintain personal hygiene o. shall have personal identity badge to reflect his/her name , professional ,work position p. If she/he has planned to leave the organization, she/he shall notify the authority before one month and shall return the certificate of competency. 3. Warehouse Manager Responsibility a. He /she shall perform the responsibilities autonomously.But in his/her absence she/he can delegate professional in written form that fulfills minimum requirements for not more than four months within year. b. He/she shall have all information for delegated professional c. shall monitor any service-related information’s and documents d. Shall control the organization in- stock and out-of-stock distribution, sales of medicine and medical devices and shall control the safety, efficacy and quality or performance of medicine and medical devices. e. Shall comply with any national regulations and laws f. Shall ensure that unfit medicines and medical device are properly segregated and disposed as per the available directive. g. If he/she suspected medicine and medical devices have safety, efficacy and quality or performance issue or others irrelevant regulations are implemented. He/she shall notice the authority. h. Shall ensure absence of eating ,drinking ,smoking or other non- hygienic activities within the warehouse i. shall wear appropriate dress and shall maintain personal hygiene j. shall have personal identity badge to reflect his/her name ,professional ,work position k. If she/he has planned to leave the organization, she/he shall notify the authority before one month and shall return the certificate of competency. 4. Other professionals within the organization a. shall work out as per the responsibility given by organization b. shall be competent enough with current information ,training and competency assessment c. Shall ensure absence of eating ,drinking ,smoking or other non- hygienic activities within the warehouse d. shall wear appropriate dress and shall maintain personal hygiene e. If any medicine and medical devices adverse reaction and quality defects are observed or have information on it, he/she shall immediately notify the authority. f. shall implement the organization in- stock and out-of-stock distribution ,sales , and generally supply management system of medicine and medical devices g. shall have personal identity badge to reflect his/her name, professional, work position h. If he/she has notice that irrelevant regulations not related to the services are implemented. He/she shall notice the authority. Part Five Import and Export
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device 1. Import of any medicine or medical device into the country shall be through the ports of entry that fulfill the requirements. 2. Any person shall not import medicine or medical device into the country without getting import permit from the authority. 3. Any medicine or medical device imported into the country shall be registered by the Authority 4. Any imported medicine or medical device shall come with the same information that was submitted during registration period 5. Without prejudice to the sub articles (3) and (4) of this article, the authority may permit import of unregistered medicine or medical device under compelling conditions. 6. Any person importing Narcotic medicines or Psychotropic medicines, or precursor chemical shall get special import permit from the authority. 7. All information and labels of medicines and medical devices imported by any person shall be written in Amharic or English or both languages. 8. If the medicines to be imported are those listed in the essential medicines list or the medicine is to be widely distributed to different parts of the country, the importer shall provide patient insert written in English and Amhariclanguage. On the other hand, if the medicine is intended to be distributed in a specific region, the labels shall be written in English and working language of the region. 9. Importation of medicines or medical device, by any person, for donation shall be in accordance with procedures of the donation directive. 10. Any person importing un-registered medical device to the country for short- time education , training, or exhibition purposes shall provide supporting letter and the duration of the events from the training center, education institution, or the exhibition organizer and commitment that the medical device shall be returned back to the countryof origin up on completion of the intended mission.
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1. Any person importing medicine and medical devices shall submit the following documents for the imported items port clearance and also the authority`s inspectors may verify registration certificate and import permit or pre-import permit certificates of medication or medical device from the electronic regulatory information system (www.eris.efda.gov.et) a. Original or copy of the Batch analysis certificate for each medicine or medical device b. Original or copy of the Certificate of Origin c. Packing List d. Bill of Loading or Airway Bill e. Commercial Invoice; and f. Pre- import permit certificate and registrat ion certificate g. Certificate of Competence 2. Without prejudice to sub article (1 a) of this article, medical device importers may not be obliged to submit Batch Analysis Certificate for port clearance. 3. Importers of medical devices, as appropriate, shall ship the device`s manual with the medical device. 4. Documents listed in sub- article (1) of this article may be submitted in electronic copy or in hard copy.
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Psychotropic substances, or precursor chemicals 1. Any person importing Narcotic medicine, Psychotropic substances or precursor chemicals into the country shall: a. submit the documents listed in sub-article (1) of Article 17 of this directive: b. submit Special entry permit issued by the Authority c. ensure that the medicine is transported only by air transport in a separate enclosure; and may not be shipped with other products, d. Submit an invoice distinctly prepared only for these products. 2. Without prejudice to sub-article (1) of this article the narcotic medicines, psychotropic substances and precursor chemicals control directive shall be enforced
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materials and packaging materials 1. Any person who imports pharmaceutical raw material or packaging materials shall a. Products listed in article 17(1) except article 17 (1b) b. Submit all documents listed under article (18) with the exception of registration certificate for narcotic medicines or psychotropic substances raw materials 2. Any person who imports pharmaceutical raw material or sample of packaging material shall have a competency certificate granted by the authority and get approval after submitting request letter signed by the company`s authorized person and stamped and clearly stating that the materials are “only for sample purposes”. 3. Importation of samples of Pharmaceutical raw materials or packaging materials shall be permitted only whenthe quantities or volumes are not suspicious for a quantity or a volume meant for commercial purposes. Under such circumstances the authority shall have satisfactory reason for the prohibition of importation such doubtful quantities.
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and spare parts 1. Any importer who has certificate of competence granted by the authority may import medical device accessories &spare parts after getting import permit from the authority. 2. Any importer who has import permit may import medical devices accessories and spare parts even if the medical device`s registration certificate validity is expired. 3. Any personwho is importing medical device accessories and spare parts shall submit the following documents: a. Original or copy of the Certificate of Origin; b. Packing List. c. Bill of Loading or Airway Bill; and d. Commercial Invoice
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1. Any person who intends to import unregistered medicine or unregistered medical devices shall get pre-import permit from the authority. 2. Import permit granted for any registered medicine or medical device will remain valid unless the registration certificate of the product is expired. 3. Import permit granted for unregistered medicine or medical device shall be invalid after one year, from the date of permission, unless extended by the authority under special circumstances. 4. The validity period of Narcotic drugs, Psychotropic substances or precursor chemicals special import permit shall be only for 90 days.
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1. The certificate of origin required in accordance witharticle 17 sub- article (1) of this directive shall at least contain: a. The exporter`s name and address and the medicine or medical devic e manufacturing country 's name b. Mode of transport c. Medicine or medical device type and detailed description d. Name and signature of issuing official; and e. Issue date and Company`s seal / Company`s headed letter
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1. Packing list required in accordance with Article 17 sub- article (1) of this directive shall least contain below detailed information: a. List of medicines or medical devices b. quantity or size of the Medicine or medical device c. As appropriate, Batch Number d. As appropriate, expiry date; and e. The medicine`s or medical device`s shipping box/carton number
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and labelling 1. Anymedicine`sprimary packaging and secondary package label shall be written in English or Amharic; be clear, easily readable and permanent ink, and must contain at least the following information- a. Generic name: b. Strength, quantity, or size. c. Batch number d. expiry date. e. Name and full address of the manufacturer, Except for ampoule primary packaging, f. At least on the secondary packaging, handling procedure and precautions g. If it is for clinical trial, " for clinical trial Only "; and h. If it is a medical sample, “Not for sale free medical sample"; 2. Any medical device`s primary packaging and secondary package label shall be written in English or Amharic; be clear, easily readable andpermanent ink, andmustcontain at least the following information: a. Name of medical device b. model number, serial, or batch number c. Name and full address the manufacturer d. As appropriate, the name and full address of license holder e. Date of manufacture f. As appropriate, Expiry date g. As appropriate, handling procedure and precautionary notes h. For sterile medical devices, the term “sterile” and method of sterilization i. If the medical device is for clinical trial, “For clinical trial only” 3. If direct printing on the medical device is not convenient or the device is too small, information listed in sub- article (2) of this article may be printed on packaging or information insert. 4. Any pharmaceutical raw raw material, as appropriate packaging materials label ,shall be written in English or Amharic in a clear , easily readable and permanent ink and at least shall contain: a. Name; b. Quantity or Size; c. Identification code/ batch number: d. Expiry date; e. Name and full address of the manufacturer; and f. Handling and precautionary notes 5. Radio pharmaceuticals shall be packaged in a specially designed packaging material meant for this purpose 6. Any patient information leafletinserted in the pharmaceuticals packaging or container shall at least hold the following information: a. Generic name ; b. Therapeutic category of the medicine; c. pharmacological activity; d. Indication, dosage form and direction for use; e. Pharmacodynamic properties of the drug; f. Pharmacokinetic properties of the drug; g. Contraindications & precautions; h. drug interaction. i. the manufacturer 's name and address; j. Side effects; and k. Handling and storage conditions.
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equipment 1. Any Medicine or medical device shall have the following remining expiry dates at the time of arrival, at the ports of entry: a. 30 months remaining, if its assigned expiry date is more than 48 months to 60 months, or b. 24 months remaining, if its assignedexpiry date is more than 36 months to 48 months, the remaining term is 24 months; or c. 15 months remaining, if its assignedexpiry date is more than 24 months to 36 months, or d. 12 months remaining, if its assignedexpiry date is 24 months or less 2. The expiry date shown on the labels of any medicine or medical device shall at least indicate the specific month and year of expiry. 3. Without prejudice to the sub- article (1) of this article, the authority may, as appropriate, permit the import of medicines, regardless of the remining expiry period,in view of the urgency of the necessity and duration of consumption of imported quantity of the medicines.
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Any organization may export Medicines and medical devices only if: 1. Medicines and medical devices are approved by the authority; or as appropriate, if the importing country do not require authority`s approval and exported in accordance with the requirements of the recipient country. Any imported products shall not be exported. 2. The organization is a manufacturer registered by the authority or legally authorized agent (representative), and ; 3. the organization get special permit from the authority to export narcotic or psychotropic medicines. Part Six Procurement, Storage, and handling conditions
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1. A medicine or medical device sold or distributed by anypharmaceutical and medical device importer or wholesaler shall be supplied through legal commercial and supply chain. 2. Any person shall not buy medicine or medical devices from or sell to an unauthorised or not licenced organization who do not have certificate of competency or above the standard. 3. Any person may sell or buy only medicines that are registered or authorized by the authority. 4. Any importer or distributor shall sell medicine or medical device only to purchasers who submits diligently filled purchase requests in person. 5. Without prejudice to sub- article (4) of this article, when the procurer can`t submit the request in person, he/she may submit the medicine or medical device purchase request by letter, Fax, or email. Under such circumstances the seller shall record the request in a “purchase request form” get it signed by the technical manager and stamped by purchasing company seal and deliver the medicine or medical device to the client. 6. Medicines or medical devices sold in accordance with sub-article (4) of this article shall be accompanied by buyer`s request, information copied to the “purchase request form” from the buyer`s request; sales invoice and delivery note (form). 7. Information contained in the documents shipped with the sold medicine or medical device in accordance with sub- article (6) of this article shall be similar to the information on the medicine or medical device. 8. Online/internet sell of Medicine and Medical Device is prohibited. 9. Mobile Sell of Medicines or Medical Device is prohibited. 10. Any drug or medical device importer or distributor must issue sales receipt (invoice) for all sold products. The buyer must retain the receipt (invoice). 11. In any case, if the sales or purchase receipt of medicines and medical devices are not retained, the authority will be obliged to investigate the case and take appropriate action both on the company and the product. 12. If legal receipts or invoices are not found at the time of inspection and the company claims that it can provide the legal receipt, it shall sign assurance document to provide the invoice with in the agreed time frame and the authority will verify authenticity of the submitted invoice. 13. Any health institution that intends to purchase medicines or medical devices shall verify that the seller company has valid certificate of competency. 14. Retail price rate posted on any medicine label shall be in accordance with the directive developed for the same purpose. 15. Any drug label shall contain a barcode; the detailed execution procedure of this requirement will be in accordance with the directive developed for the same purpose.
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Storage and handling conditions by any medicine or medical device business firm: 1. The firm shall ensure that all medicines that need special storage conditions are kept under appropriate cold chain in an area specifically dedicated for this purpose until inspection is complete and port clearance is issued. 2. The firm shall always ensure that no physical and chemical damages occur during storage and transportation. 3. Medicines shall not be packaged with, loaded with, and transported with other commodities that bring negative impacts on the quality, safety and efficacy under no circumstances. 4. Firms shall comply with the Authority 's requirements for storage and handling conditions 5. The temperature of medicines that require special cold chain shall be monitored with an appropriate measuring devices (Thermometer) during storage and transportation. 6. Medicines or medical devices with Inflammable and volatile nature shall be stored in a separate area or room. 7. Medicines or medical devices in liquid forms shall be stored on the bottom layers of shelves; and 8. Any damaged or expired medicine or medical devices or that can`t be used for any reason shall be stored in sperate room, be quantified, records be maintained and appropriately labelled until properly disposed after notifying the authority. 9. The authority may, as appropriate, require medicine or medical device transportation related information such as records of data logger. 10. Medicens may be transported by third bodies transporting firms. However, there shall be an appropriate agreement between the transporting firm and the seller or buyer. As same time the transporting firm shall present evidences of establishements for such purposes.
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device 1. Any Medicine and medical device importer and wholesaler may not distribute free samples of medicines or medical devices unless the medicine or medical device is registered and granted marketing authorization by the authority; or it is reviewed and approved by the authority under exceptional condition and the free sample is also approved by the authority. 2. Selling free samples is prohibited. 3. The free sample packing shall contain “Not for sale” or “free sample” description or text written in English, or Amharic, or both. 4. Narcotic and psychotropic medicines free sample offer is prohibited. 5. Any Medicine and medical device importer and distributor may offer free samples only for medical professionals and pharmacy professional and must keep records in a logbook. 6. Free samples must be handled by a proper professional. 7. Any label on the free sample shall be clear, easily readable and everlasting; and it must contain scientific and trade name, strength, contents, quantitative data, batch number, manufacturer`s name and country, expiry date, and handling conditions written in English or Amharic or both.
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1. Any of medicine or medical device business organization: a. As appropriate, shall maintain the registration certificate, batch analysis certificate of each medicine and medical device, receipt /invoice stamped with the procurer`s seal & signed by technical manager, purchase request, purchase and sale invoice for all distributed medicines and medical devices b. Shall maintain Valid copy of certificate of competency of the seller or buyer agency c. Shall maintain Storage monitoring forms, Stock cards, bin cards, Invoices, Receipts, Seal and prepare, daily sales records and properly keep such detailed information. d. Must give a receipt to the buyer and retain its copy e. Shall keep Narcotic and psychotropic medicines purchase and sale documents in under lock and key box. f. Shall keep and implement regulations and relevant information issued and enforced by the authority. g. Must retain records of imported, distributed, stored and as well as exported narcotic and psychotropic medicines and report the same to the authority every three months. h. Shall retain disposal certificates of medicines or medical devices disposed due to expiry, damage or other satisfactory of reasons, i. Shall retain records of or documents containing crucial information about sold medicines or medical device at least one year after the expiry dates of the products and notify the authority before disposal of such obsolete documents j. Any importer shall immediately notify the authority regarding any damaged or suspicious medicine or medical device it has imported and distributed, and it shall be accountable for recalling damaged products from the market. k. Shall immediately notify the authority of any confirmed or doubtful adverse events or quality defects reported on Medicine or medical device; shall retain records and, as appropriate, report to the authority. l. Shall properly prepare and retain detailed information pertaining to stock monitoring forms, stock cards, bin cards, invoices, receipts, seal and other relevant documents in a paper copy or electronically. 2. Without prejudice to sub article (1) (j) of this article, documents whose case is still in progress, and documents under suspension due to court case may remain on hold until the issues or cases are resolved. 3. Without prejudice to sub article (1) (j) of this article, any financial records and documents shall be kept based on the legal requirements of the country 4. Any Medicine invoice shall contain the following information: The generic name of the medicine The trade name of the medicine Batch number Quantity, strength, and dosage form Manufacturer Name Expiry date Overall quantity Unit of measurement Name and Signature of Technical Manager Date of sale Buyer 's name and address Buyer 's signature and seal 5. As necessary, any importer may preserve retention samples of risky medicines in a quantity sufficient to carry out at least one-round full parameters tests. Part Seven Administrative Measures
30
1. The Authority shall take administrative measures on any person who violet the terms and conditions of this directive as per Proclamation no. 1112/2011 and Administrative Measures and Grievance Handling Directive. 2. Without prejudice to sub-article (1) of this article, any person who found to be violation this directive, the Authority shall take the following measures:
31
1. If the violation committed by any institution is not lead to suspension or cancelation of the issued certificate of competencies, as appropriate, the Authority shall issue written warning letter. 2. If institution is fail take the corrective action for violation indicated in the warning letter, the Authority shall take other appropriate administrative measures.
32
1. The Authority shall suspend the certificate of competency for two to six months on any institutions who found to be commit violation in one of the following reasons: a. The institution create obstacle for Authority inspectors during the conduct the inspection activities; this include not able to sign consent form, failure to notify the working hours of the institution, not cooperate with the Authority inspectors during inspection and others similar violations. b. The institution have received warning letters twice or more and found to be failure to take corrective actions for identified violations or new violations identified. c. The institution have certificate of competency and found to be dispensing or distributing of medicines and medical devices above the standard. d. Participate in import, export, distribute or dispense of medicine and medical devices in the absence of technical manager or proper delegation of the technical manager. e. Participate in mobile sale f. Use of professionals which has mental health or physical disability, drug addicted, narcotic and psychotropic drug or other compound +use which cause mental health. g. Selling to individual user without license from the Authority. h. The institution implement changes such as those changes indicated in Annex 3 of this directive without approval from the Authority. i. Allowing professional who does not have professional license to practice in the institution. j. Selling with receipt which does not have the seal and signature of buyer. k. Engage in un authorize practice or holding un authorize products in the facility. l. Selling or distributing or imposing to sale medicines and medical device in violation with allowable chain of commercial transaction. m. Not holding retention samples of the imported and sold products as per requirements of the Authority and proper storage condition. n. Fail to notify samples of receipt and invoice used by the institution. o. Selling of products without written or fax or email orders. p. Store products in un authorized facilities q. Not follow good storage and distribution practices during storage and distribution of medicines and medical devices in the facility. r. Fail to follow records keeping and reporting requirements of the Authority. s. Fail to segregate record and report to the Authority of expired medicines and medical devices. t. The terms and conditions of certificate competency were not maintain during post licensing inspection. u. Measuring devices used in the facility were found to be not calibrated. v. Fail to notify the authority on template of invoice used to sell and buy products. w. The invoice used to sell product found to be not hold necessary information such as batch number and others similar information. 2. The Authority shall suspend the certificate of competency for seven to one year on any institutions who found to be commit a violation in one of the following reasons: a. Impedes the work of inspectors during inspection or during dispersment of inspectors for inspection, or removing or hiding of products during the inspection or other similar violations. b. Fail maintain the temperature of medicines and medical devices that require cold chain. c. Sale or made available to sale free medical samples of Narcotic medicines. d. Sale or made available to sale free medical samples. e. Fail to recall or unwilling to recall products or fail to properly store recall products with suspect or confirmed quality defect. f. Supply (or sell) products from (to) institution that does not have certificate of competency or suspend or revoke certificate of competency. g. Buy medicines or medical devices from local manufacturer that does not have valid license to manufacture such products. h. Found holding other products against the license issued or store medical devices which lead risk of damage or dysfunction; i. Store medicines or medical devices outside of the specified standards and at risk of damage; j. engage in any act which constitutes a violation in accordance with other necessary and justifiable reasons which affect public health and believe by the top management of the Authority. 3. The Authority shall suspend the certificate of competency on the basis of suspension business license of the institution by other concerned government body, until reversal of such suspension is sought by the concerned government body. 4. The Authority shall notify the institution in written on action taken by the Authority and reasons thereof.
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1. The Authority shall revoke the certificate of competency on any institutions who found to be violation for one of the following reasons: a. Possess or hold to sale or sale or distribute medicines and medical devices which are not registered or do not have marketing authorization, adulterated, or spurious, falsified, counterfeit, unknown source, do not have invoice, unlabelled or falsely-labeled. b. Commit violations indicated in article 34 twice and more than twice. c. Obtained its certificate of competence through fraudulent acts or by submitting false documents. d. Found to transfer the certificate of competency issued to other third party. e. Continue in doing its business while the certificate of competency is suspended. f. Participate in medicines or medical devices repacking, re- labeling or sale with affixing other labeling information without getting permission from the Authority. g. Fails to collect or discontinue selling or distributing medicines and medical devices having a quality defect, expired or recalled products. h. engages in any act which constitutes a violation in accordance with other necessary and justifiable reasons which affect public health and believe by the top management of the Authority. 2. Once the certificate of competency is revoked as per sub-article one of this article, the institution shall not participate in this business using certificate competency of other professional and institution. 3. The authority shall revoke the certificate of competency when the institution stops to do business by its own reasons. 4. The Authority shall revoke the certificate of competency on the basis of cancelation business license of the institution by other concerned government body, until reversal of such cancelation is sought by the concerned government body. 5. The Authority shall have an obligation to notify the institution and other concerned bodies in written on the above administrative measures taken.
34
The suspension and revocation of certificate of competency imposed on institution shall be removed after review and accepting the compliant submitted as pert the article 39 of this directive.
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certificate Any institution: 1. To get new certificate of competency when the institution change the service type, place, technical person or level of service to the terms and condition of existing certificate of competency issued. 2. The certificate of competency suspended, revoked or fails to renewed. 3. The technical manager with whom the certificate of competency issued has been dead. Or 4. The Authority believes that the service provided has imposed public health risk or may imposed sudden public health problems In such cases, the certificate of competency shall be returned to the Authority within two days.
36
Any institution who terminate his business by its own, suspended or revoked certificate of competency shall sell or distribute or disposed the useable medicines or medical devices to other institution with valid certificate of competency after getting permission from the Authority.
37
Any person who has compliant related to issuance, renewal suspension or revocation of certificate of competency or other administrative measures taken by the Authority shall appeal to compliant handling body of the Authority within one month. Part Eight Miscellaneous
38
1. The Authority may notify the public when there is misconduct by the institutions, confirmed complaints or on issues that put the public at risk using any of public communication methods. 2. As applicable, the Authority may notify the public on institutions that are pending or cancel or not renewed their certificate of competencies. 3. Any person shall get any information about the Medicine and Medical Devices except information that are considered confidential by the Authority.
39
Any medicines and/or medical devices importers or wholesalers shall notify working hours of the institutions to the Authority when the certificate of competency issued to the institution and always be opened on these working hours.
40
On Articles that fall under the Authority mandate and not address on this directive, the Authority shall address on case by case basis.
41
Any medicine and/or medical device importers or wholesalers (or distributors) who seek a new or renewed or replacement of certificate of competency and pre-licensing inspection shall pay appropriate service fee to the Authority.
42
1. Medicines and medical equipment importer and wholesalers, exporter control directive No. 10/2005 given by the Authority or Medicines and medical equipment importer and wholesalers, exporter control directive No. 350/2013 given by the ministry of justice is here by repealed by this directive. 2. Any working procedure or customary practice which is inconsistent with this directive shall not be applicable with respect to those matters provided for in this directive. 44. Effective date This directive shall enter into force on the date of 08 January, 2021. October 22, 2021 Heran Gerba Director General Ethiopian Food and Drug Authority የብቃት ማረጋገጫ ምስክር ቅጽ ንግድ ድርጅት ዓይነት ወይም የሚልካቸዉ' ባለቤትነት ይያያዝ የታሰበበት አድራሻ፣ ቀበሌ____________ ልምድ (መረጃ ይያያዝ) የተመዘገበ ያያያዝ) ልምድ (መረጃ ይያያዝ) መሣሪያ ንግድ ተግባር ተስማሚ አለዉ የለዉም የለዉም ወንበሮች ቁልፍ ያለዉ ካቢኔት መታጠቢያ ሲንክ አካባቢ መሆናቸዉን አረጋግጣለሁ፡፡ Ethiopian Food and Drug Authority
1 — Annex 1
Application form for obtaining Certificate of Competence of a Medicine and Medical Devices Establishment 1. Applicant Name _______________________________ 2. Address of the Applicant Region _________ Zone _________ Woreda ________ City/Town ___________ Sub-city ___________ Kebele ____________ House Number ______________ 3. Type of Medicine and Medical Devices Establishment to be established a. Medicine and Medical Devices importer b. Medicine and Medical Deviceswholesaler c. Medical Devices wholesaler d. Medical Devices exporter 4. Products to be imported or wholesaled a. Medicine and Medical Devices b. Medical Deviceswholesaler c. Others, specify ___________________ 5. Owner of Medicine and Medical Devices Establishment a. Private b. PLC c. Share company (Attach documents) 6. Address of the medicine and medical device establishment to be established Region _________ Zone _________ Woreda ________ City/Town ___________ Sub-city ___________ Kebele ____________ House Number ______________ 7. Responsibility of the applicant in the establishment a. Owner b. Owner and professional c. Technical Manager 8. Details of Technical Manager a. Full name ____________________________ 62 b. Professional status ____________________________ c. Professional Registration number ___________________________ d. Registration from the authority ___________________________ (attach employment contract if professional is employed) 9. Details of Assistant Technical Manager/ Store man a. Full name ____________________________ b. Professional status ____________________________ c. Professional Registration number ___________________________ d. Registration from the authority ___________________________ (attach employment contract if professional is employed) 10. Facilities of the establishment a. Availability of water supply Yes No b. Availability electric power supply Yes No c. Convenience for Transportation Services Yes No d. Availability of Telephone services Yes No e. Availability of postal services Yes No f. Convenience of the dispatch for trade of Medicine and Medical devices Yes No g. Availability of e-mail address Yes No 11. Premisesof the establishment a. Area of the dispatch room b. Area of the storeroom/ warehouse c. Availability of sufficient shelves in the warehouse Yes No d. Availability of sufficient table in the dispatch room Yes No e. Availability of sufficient table in the dispatch room Yes No f. Availability of fire extinguisher Yes No g. Availability of table and chair for clerical works Yes No h. Availability of Coat hanger Yes No i. Availability of lockable cabinet for keeping Psychotropic drugs Yes No j. Availability of toilet with water supply and hand washing/sink Yes No 63 k. The premises is protected from flood Yes No l. The premises is free from dirt/waste Yes No m. Availability of solid waste disposal facility Yes No 12. I certify that the information I have listed above is correct Name _____________________________ Signature _____________________________ Date ____________________ ዕዝል 2 64 ማረጋገጫ ምስክር ወረቀት መመዘኛ ማሟላታቸዉን ለማረጋገጥ ቅፅ ወረዳ________ ኢሚል_____________ ዘመንና ስራ ልምድ_______ ዘመንና ስራ ልምድ_______ ንግድ ተግባር ተስማሚ መታጠቢያ ሲንክ ስፋታቸዉና ብዛታቸዉ ይገለጽ መሳሪያ መያዣ ባለቁልፍ ቁምሳጥን ቁምሳጥን /ካቢኔት መታጠቢያ ሲንክ ይገለጽ-------------------------------------- የሚያስገባ የተጠበቀ፣ ለመጽዳትና ንጽህናዉን ሁኔታዉ ይገለጽ-------------------- በ----------------ዓ.ም በ--------ሰዓት በሁሉም ሁኔታ የተሟላ/ያልተሟላ ምስክር ወረቀት እንዲሰጥ ፊርማ ቀን ________ _________ _________ Ethiopian Food and Drug Authority
2 — Annex 2
Inspection Checklist for compliance of requirements and standards ofacquiring Certificate of Competence for a Medicine and Medical Devices Establishment applicants. 1. Applicant Name and type _______________________________ 2. Address of the Applicant Region _________ Zone _________ Woreda ________ House Number ________ Tel. No ___________ P.O.Box ___________ Mobile No __________________Fax No ___________ e-mail _______________ 3. Owner’s Name_______________________________ 4. License holder’s details a. Full name _______________________________ b. Professional status __________________Year of services and experience___ c. Professional Registration number ___________________________ 5. Technical Assistant details a. Full name _______________________________ b. Professional status __________________ Year of services and experience ___ c. Professional Registration number ___________________________ 6. Type of products for import and wholesale distribution a. Medicine and Medical Devices b. Medical Devices c. Other, please specify ___________________________________________ 7. Facilities of the establishment a. Availability of water supply Yes No b. Availability electric power supply Yes No c. Convenience for Transportation Services Yes No d. Availability of Telephone services Yes No e. Availability of postal services Yes No 69 f. Convenience of the dispatch for trade of Medicine and Medical devices Yes No g. Availability of e-mail address Yes No h. Availability of toilet with water facility/ sink Yes No 8. Premisesof the medicine and medical devices establishment 1. storeroom/ warehouse a. Area and quantity of the storerooms/ warehouse b. Quantity of shelves and pallets _____________ c. Presence of Refrigerator with thermometer Yes No d. Availability of thermohydrometer in the warehouse Yes No e. Availability of lockable cabinet for keeping Psychotropic drugs Yes No f. Other, please specify ________________________________ 2. Dispatch room a. Availability of sufficient table Yes No b. Availability of packing tools Yes No 3. Office of the technical manager a. Availability of table, chair and computer Yes No b. Availability of lockable cabinet for keeping different documents Yes No 4. Different Administrative offices Yes No a. Availability of toilet with water supply and hand washing/sink Yes No b. The premises is in confined in a single building Yes No 9. Construction and design of the facility a. Explain the condition of the floor of the different rooms __________________ ______________________________________________________________ ______________________________________________________________ b. Explain the condition of the make of the wall and other condition___________ ______________________________________________________________ ______________________________________________________________ 70 c. Rooms are supplied with ceilings Yes No d. Comply for sufficient light and air circulation Yes No e. Sufficient height for protecting from flood Yes No 10. Rooms are protected from dust, different insects and convenient for cleaning Yes No 11. Other conditions to be explained about the establishment ________________ __________________________________________________________________ _________________________________________________________________ 12. We conducted the necessary inspection of the facility on (Date) __________________ EC at ________(time) and confirm that it comply/ not comply, hence support/not support the issuance of certificate of competence. Inspectors Name Profession Signature Date 1. _________________________________ ________________ 2. _________________________________ ________________ 3. _________________________________ ________________ 13. Remark by the team leader ___________________________________________ __________________________________________________________________ ________________________________________________________________ Full Name ________________________ Signature _____________________ Date __________________________ 14. Decision of the head ___________________________________________ __________________________________________________________________ ________________________________________________________________ Full Name ________________________ Signature _____________________ Date __________________________ 71 ዘርፍ ወይም ሌላ ለዉጥ ያለባቸው የኢንሰፔክሽን ሁኔታ የቤት ካርታ ኢንስፔክሽን ይፈልጋል ማረጋገጫ መጠን ውል ደብዳቤ የሰነድ ማጣራት ብቻ ማረጋገጫ ጉርድ ፎቶ ውል ደብዳቤ የሰነድ ማጣራት ብቻ ማረጋገጫ የሰነድ ማጣራት ብቻ ማረጋገጫ የሰነድ ማጣራት ብቻ የሰነድ ማጣራት ብቻ ሰነዶች ኢንስፔክሽን ይፈልጋል Ethiopian Food and Drug Authority
3 — Annex 3
Conditions necessary for change of address, ownership, professional, product type/service sector or other related changes S. No Type of change Necessary requirements to execute Remark about the change inspection 1. Change of Contract agreement or ownership Inspection is Address/location required certificate Payment of service fee Original Certificate competence Photograph of the technical manager 2. Change of Technical Only document Employment agreement Manager Education certificates review Experience Professional license/registration Payment of service fee Original Certificate competence Photograph of the technical manager 3. Change of Storeman Employment agreement Only document / warehouse review Education certificates manager Experience Professional license/registration Payment of service fee Original Certificate competence 74 4. Change of name of Trade registrationlicense Only document the establishment Payment of service fee review Original Certificate competence 5. Change of owner Article /Memorandum of Only document review establishment Payment of service fee Original Certificate competence 6. Change of product Original Certificate competence Only document type/change of review Payment of service fee service type Documents required for change of professional 7. Modification of Payment of service fee Inspection is premises Original Certificate competence required 75