Draft Laws

Food and Medicine Administration Proclamation /Draft/

PART FOUR
MEDICINE, MEDICAL DEVICE AND COSMETICS ADMINISTRATION
Section One
Medicine and Medical Device Administration
20. General
1) The rigor of regulatory assessment of medicine and medical device shall be commensurate with the product’s type, nature, and potential risk to human health.
2) The executive organ may not limit the number of agents a manufacture may designate for the purpose of importing or distributing medicine or medical devices.
21. Registration and marketing authorization of medicine and medical devices
1) Any medicine and, as appropriate, medical device shall not be manufactured, imported, exported, stored, distributed, transported, sold, hold, used, or transfer to any other person without registration and marketing authorization.
2) The executive organ shall register and grant marketing authorization in accordance with sub-article (1) of this article after it assesses the quality, safety and efficacy of the medicine, or quality, safety and effectiveness of the medical device.
3) The provisions of sub-article (1) of this article shall not apply in respect of the sale of any medicine compounded by a pharmacist for a particular patient in a quantity not greater than the quantity required for treatment as determined by an authorised medical professional, or any medicine or medical device imported for use by a particular patient as per prescription of an authorized medical professional.
4) Any medicine or medical device shall be registered if the manufacturer complies with good manufacturing practices, dossiers are evaluated and found to fulfill safety, quality, efficacy, and efficacy or effectiveness, and as appropriate fulfills laboratory quality test requirements.
5) Notwithstanding to the provision of sub-article (1) of this article, the executive organ may, in compelling circumstances, grant a permit for the importation or use of unregistered medicine or medical device. Detail implementation shall be determined by a directive.
6) Every medicine or medical device registered in accordance with this proclamation shall have its registration renewed every five years.
7) Without prejudice to the provision of sub-article (6) of this article, any registered medicine or medical device shall pay annual retention fee as determined by a regulation.
22. Variation to a registered product
1) If variation affecting registered medicine’s quality, safety or efficacy, or medical device’s safety, quality or effectiveness is introduced, the product may not be marketed unless the person who registers the product notifies such variation and get approval from the executive organ.
2) Without prejudice to the provision of sub-article (1) of this article, a medicine or medical device with variation having minimal potential on its performance may be marketed provided the manufacturer or the person who registers the product notifies the executive organ of such variation.
3) Detail implementation of this article shall be determined by directives issued by the executive organ.
23. Quality standards and requirements
1) Any medicine, its raw or packaging material shall meet quality, safety and efficacy requirements prescribed in a nationally accepted pharmacopeia.
2) Any medical device shall meet quality, safety and effectiveness requirements issued or adopted by the appropriate organ.
3) Notwithstanding to the provision of sub-articles (1) and (2) of this article, where national standard is not issued or adopted, the executive organ may regulate medicine and medical devices in accordance with requirements prescribed by international organizations, other countries, and requirements or guidelines issued by manufacturing companies acceptable to the executive organ.
24. Registration of medicine and medical device institution
1) No medicine or medical device institution may engage in medicine or medical device trade unless it is registered and licensed, as appropriate, by the executive organ or regional health regulator.
2) It shall be prohibited, in any manner, to transfer a medicine and medical device institution certificate of competence to a third party.
3) Details about medicine and medical device institution licensing and renewal shall be determined by a directive issued to implement this proclamation.
25. Personnel working in medicine and medical device institution
1) Every medicine and medical device institution shall hire a health professional upon ensuring that the professional is duly registered and competent to perform the task.
2) Every health professional working for a medicine or medical device institution shall have the duty to immediately report risks of public health significance related to the quality, safety and efficacy or medicine or quality, safety and effectiveness of a medical device, as appropriate, to the executive organ or a regional health regulator.
26. Medicine and medical device manufacturing and importation
1) The manufacturer of medicine or medical device shall have the duty to ensure the quality and safety of raw materials and the legality of its supplier.
2) It shall be the duty of the manufacturer or importer, as appropriate, to ensure that every medicine or medical device is produced in accordance with the appropriate good manufacturing practice.
3) No medicine or medical device may be imported through a port of entry unless authorization is granted by the executive organ.
4) Every importer of a medicine or medical device shall be responsible for ensuring that its imported product is from a manufacturer recognized by the executive organ.
5) If the quality, safety, and efficacy or effectiveness of a medicine or medical device are not in compliance with the law, the executive organ may order the manufacturer or importer, as appropriate, to properly dispose or return it to its country of origin.
6) Details about importation of donated medicine or medical device shall be determined in accordance with a directive issued to implement this proclamation.
27. Storage, transport, and sell of medicine and medical device
1) The medicine or medical device institution or another appropriate person shall ensure that every product under its possession is stored, transported, and sold in accordance with good storage and distribution practices and in such a way that its quality, safety, and efficacy or effectiveness is maintained.
2) Every manufacturer, importer, wholesaler and retailer of a medicine or medical device shall install a quality control system that ensures the safety and quality of the product.
3) Every part of a transportation equipment having direct contact with the medicine or medical device shall be clean and shall not render the product to cause any chemical, physical, or microbiological contamination.
4) No medicine or medical device institution may transfer any medicine or medical device under its possession outside of the recognized trade chain without having a legitimate ground and, as appropriate, notifying the executive organ or regional health regulator.
5) A retailer of medicine or medical device shall not engage in the wholesale trade of any medicine or medical device.
6) No medicine wholesale or retail institution may sell a medicine unless its label contains the retail price of the product affixed by the manufacturer or importer in accordance with this proclamation and directive issued to implement this proclamation.
7) It shall be the responsibility of the health institution to ensure that the type of medicine it possesses are in accordance with its level, and the health professional who has access to the medicine has appropriate authorization.
28. Clinical trial
1) A clinical trial shall be conducted on human beings only in accordance with this proclamation and regulation issued to implement this proclamation.
2) The executive organ shall authorize clinical trial on human subjects only after the clinical trial protocol is evaluated and accepted from scientific, legal and ethical perspective.
3) It shall be prohibited to introduce any change to the terms and conditions of an approved clinical trial protocol unless the executive organ is duly notified.
4) The executive organ may require review and monitoring of the approved clinical trial study by an appropriate national, regional or institutional review organ.
5) Clinical trial on human beings shall be conducted if the person is over18 years, has capacity under the Ethiopian Civil Code, and agree in writing to the clinical trial.
6) Clinical trial on nursing and pregnant women, prisoner, person under the age of 18, mentally ill person, other judicially incapable person, or person dependent on the professional or the institution conducting the clinical trial shall be prohibited unless there is a necessary ground and a special permission granted by the executive organ in accordance with applicable regulation.
7) It shall be the responsibility of the primary investigator and sponsor of the clinical trial to ensure the safety of the participant, provide adequate information to prospective participants about the risks, medical benefits, and treatment alternatives available to the participant.
8) It shall be the responsibility of the primary investigator and sponsor of the clinical trial to ensure appropriate scientific conduct, making required reports to the executive organ, record keeping, reporting any adverse event, and adhering to applicable protocol, practices, and laws.
9) In approving investigational medicine or medical device, the executive organ may require submission of laboratory experiment and animal testing data in order to determine its safety.
10) The use of investigational medicine or medical device beside clinical trial shall have prior approval from the executive organ.
11) A Clinical Trial Ethics Committees Supervisory Body directed by a higher official of the executive organ shall be established.
29. Antiseptics and disinfectants
1) Every regulated person shall comply with applicable requirements issued about antiseptics and disinfectants.
2) The registration and related regulatory assessment of antiseptics and disinfectants shall be commensurate with the product’s potential risk to human health.
3) Details requirements about regulated antiseptics and disinfectants shall be determined in accordance with a directive issued by the executive organ.
30. Radiopharmaceutical and radiation emitting medical device
1) No one may manufacture, import, export, wholesale or store any radiopharmaceutical or radiation emitting medical device unless he gets a certificate of competence from the executive organ and appropriate body.
2) Extemporaneous preparation of a radiopharmaceutical product may only be carried out in a health facility having a certificate of competence to perform this activity.
3) In effectively regulating radiopharmaceuticals or radiation emitting medical devices, the executive organ shall work together with the appropriate body.
4) For the purpose of this article “radiopharmaceuticals” means a medicine which has one or more radionuclide substance used in the diagnosis and treatment of human disease and includes nonradioactive reagent kit used for a preparation of medicine and radionuclide generator.
5) Detail of radiopharmaceutical or radiation emitting medical devices responsibilities of the executive organ shall be determined by a directive issued to implement this proclamation.
31. Blood and blood components
1) Any person who engages in the collection and distribution of blood and blood products shall get a certificate of competence from the executive organ.
2) Blood and blood products donation, collection, and distribution shall be performed in accordance with principles of humanity, and such products used for the purpose of saving life or scientific research may not financially benefit both the donor and recipient.
3) Blood and blood components for transfusion or further manufacturing or processing may not be put into use unless its safety and quality are in compliance with applicable regulatory requirements.
4) Blood activities shall be classified and regulated based on its potential risk to the safety of whole blood and blood components, the donor, and the recipient.
5) Every potential risk associated with blood donation shall be communicated to the donor and the recipient of transfusion.
6) Health facilities, laboratories, blood banks and other establishment engaged in blood and blood component activities shall make sure it is collected, tested, processed, screened, pooled, irradiated, washed, stored, labeled and distributed in accordance with applicable regulatory requirements.
7) For the purpose of this article “blood” include human blood, blood collected for transfusion or processed blood.
8) For the purpose of this article “blood product” means a product prepared from human blood or liquid blood for medical purposes.
32. Narcotic and psychotropic medicines, and precursor chemicals
1) A special permit from the executive organ shall be a prerequisite to manufacture, import or export any narcotic and psychotropic medicine, or precursor chemical.
2) Anyone who engages in manufacturing, import, export, wholesale, store, transport, hold or sell any narcotic and psychotropic medicine, or precursor chemical shall comply with this proclamation, and regulation and directives issued to implement this proclamation.
3) A special permit for the import or export of narcotic and psychotropic medicine, or precursor chemical shall apply for a specific consignment and shall be valid for 90daysfromthedateofitsissuance.
4) It shall be prohibited to import or export narcotic and psychotropic medicine, or precursor chemical through the post office or by ship; or packed together with other medicines or goods.
5) Narcotic and psychotropic medicines and invoices, registers, and prescriptions shall be stored in a lockable metal cupboard or in a special room the key of which shall at all times remain in the hands of the authorized pharmacy professional.
6) Every manufacturer, importer, wholesaler, retailer, or health institution involved in narcotic and psychotropic medicine, or precursor chemical activities shall keep relevant records, perform demand projections, and submit reports in accordance with directives issued by the executive organ.
7) Any person who gets narcotic and psychotropic medicine, or precursor chemical purchase order from the executive organ shall report when the product is imported, or if it is not imported for whatever reason it shall be reported within 10 days from the expiration of the purchase order.
33. Prescription of narcotic and psychotropic medicines
1) Any licensed medical professional may only issue narcotic and psychotropic medicines prescription in the health institution where he is authorized to work.
2) No medical professional may prescribe narcotic and psychotropic medicine for himself.
3) The prescription of a narcotic or psychotropic medicine shall be made on a special narcotic or psychotropic prescription paper respectively.
4) If any medical professional made a mistake on the narcotic or psychotropic prescription paper, he shall fold away and leave the leaf paper containing the error intact within the prescription folder.
5) After issuance of the original of any narcotic or psychotropic prescription to the patient, its copy shall remain in the prescription folder.
6) Every folder containing a copy of prescribed narcotic or psychotropic medicine shall be returned, as appropriate, to the executive organ or regional health regulator.
7) Provisions of this proclamation provided in respect of dispensation of prescription medicine shall be applicable to narcotic or psychotropic medicine, as appropriate.
34. Dispensing narcotic or psychotropic medicine
Every authorized health institution and medicine retailer may only dispense a narcotic or psychotropic medicine upon confirmation that:
1) the prescription paper contains the name of the prescriber and the institution’s stamp;
2) the prescription is original, and the writing or print on the paper does not contain an error;
3) narcotic or psychotropic medicine is prescribed using narcotic and psychotropic medicine prescription paper respectively;
4) no more than one type of narcotic or psychotropic medicine is not prescribed using one prescription paper;
5) the prescription paper contains readable series number; and
6) the issue date is within the past fifteen days.
35. Medicine compounding
1) Medicine compounding shall only be performed by an authorized pharmacy professional and within an authorized institution.
2) It shall be the responsibility of the pharmacy professional to ensure that any compounded medicine prepared for a patient in accordance with a prescription issued by a medical professional does not contain an unapproved ingredient in accordance with applicable law or standard and is not unusually harmful to the user.
3) Every pharmacy professional who is authorized to perform medicine compounding shall ensure that any active pharmaceutical ingredients used to compound a medicine are an authorize component in other medicine registered by the executive organ.
4) The pharmacy professional, health institution, or medicine trade institution shall be jointly and severally responsible for any health or bodily harm caused as a result of using the unapproved active pharmaceutical ingredient.
36. Medicine prescribing and prescription paper
1) Medicine may only be prescribed by an authorized medical professional.
2) Every medical professional shall prescribe a medicine in accordance with the appropriate prescription paper and uniform medical service and prescription procedure.
3) Every medical professional shall prescribe a medicine by using its generic name.
4) Every medical professional authorized to prescribe a medicine shall ensure that all required information in the prescription paper is filled out.
5) The amount and manner of anti-microbial medicine prescription shall comply with the uniform medical service delivery requirements.
6) A prescription shall be given only after the patient has got a medical record and the prescription information is sufficiently provided in the record.
7) For the purpose of this part, “generic name” means a chemical term by which a medicine is addressed without referring to its brand name.
37. Medicine dispensing, and over the counter medicines
1) Medicine shall only be dispensed by a pharmacy professional acting within his scope of practice.
2) Notwithstanding to the provision of sub-article (1) of this article, the executive organ, by a directive, shall determine compelling circumstances when dispensing by other health professional categories may be appropriate.
3) Every medicine dispensing shall be made as per the paper or electronic prescription.
4) Notwithstanding to the provision of sub-article (3) of this article, the executive organ shall determine a list of over the counter medicines to be sold in medicine retail shops.
5) Every pharmacy professional may dispense a generic medicine prescribed using its brand name unless, in special circumstances, a regulation and directive issued to implement this proclamation determine otherwise.
6) While dispensing a medicine, every pharmacy professional shall ensure that the patient is informed about the identity, use, instruction for use, precautions, side effects, and other relevant information about the dispensed medicine.
7) It shall be prohibited to dispense or sell, in any way, expired, damaged, substandard, diverted or illegal medicine.
8) The pharmacy professional shall ensure the legality and completeness of a paper or electronic prescription before any dispensation.
9) After dispensation of medicine in accordance with this article, the information provided under the prescription shall be logged into a paper or electronic logbook prepared for this purpose, and the prescription shall be filed after being stamped, named, signed and dated by the prescriber.
10) Every professional shall notify the regional health regulator or executive organ when he knows of defects associated with the quality, safety, and efficacy of medicine.
38. Classification of medicine and medical device
1) The classification of any medicine and medical device shall be determined by the executive organ based on the nature of the product and standard of the health institution.
2) The classification of medicine issued in accordance with sub-article (1) of this article shall be as follows:
a) medicine that will be available on the advice of a pharmacy professional, without a prescription from an authorized prescriber, and available only in authorized medicine retail institution;
b) medicine that will be available only on the prescription of an authorized medical professional, and dispensed by a pharmacy professional;
c) medicine that will be available only on the prescription of an authorized medical professional and dispensed by a pharmacist professional, and subject to the control measures prescribed in accordance with the United Nations Conventions on narcotic drugs, psychotropic substances, and illicit traffic in narcotic drug or psychotropic substances;
d) medicines classified in accordance with the standard of health institutions, and
e) medicines that will be used for rare diseases or conditions.
3) It shall be the responsibility of the user to ensure the quality, safety, and effectiveness of a medical device made for a particular individual.
39. Post marketing surveillance
1) Every manufacturer and importer, as appropriate, shall perform periodic monitoring of the quality, safety, and efficacy or effectiveness of its manufactured or imported medicine and medical device.
2) Every manufacturer, importer, or wholesaler of a medicine or medical device shall, when required by the executive organ or on its own will, perform a post-marketing surveillance that would enable it to continuously monitor its medicine or medical device; establish a vigilance system, and furnish adverse event information and other required information.
3) The executive organ may periodically undertake post-market surveillance of medicine and medical devices and may require its manufacturer or importer, as appropriate, to cover the associated cost.
4) The manufacturer or importer of any medicine or medical device shall be responsible for damages caused as a result of quality and safety problem associated with the product.
40. Prevention of illegal medicine and medical device circulation
1) Any person involved in the business of medicine and medical device trade shall take every precaution to ensure the legality of its suppliers, use legal receipt, and make an immediate report to the executive organ and other appropriate law enforcement organ when the illegality of the medicine and medical device is known to him.
2) Every medicine and medical device found to be illegal shall be confiscated by, as appropriate, the executive organ or regional health regulator.
3) Without prejudice to the provision of sub-article (2) of this article, the executive organ or regional health regulator together with the appropriate body shall ensure the appropriate disposal of confiscated medicine and medical devices.
4) The executive organ or regional health regulator shall pay a cash reward to any person who gives information leading directly to the apprehension of an illegal medicine or medical device.
5) Detail implementation of this article shall be determined by directive.
41. Refurbished and remanufactured medical device
1) Every refurbished and remanufactured medical device shall
a) have a permit from the executive organ;
b) contain, on its labeling, the word “refurbished or remanufactured” as appropriate, and a user manual; and
c) mention the length of its prior use or date when it is refurbished or remanufactured.
2) For the purpose of this article, “refurbished medical device” means a medical device whose service year is yet to expire or has already expired and undergone the appropriate renovation and effectiveness testing for use in medical purpose.
3) For the purpose of this article, “remanufactured medical device” means a medical device which is taken back to a manufacturer after use by a health institution and rebuilt based on the effectiveness and safety specification of the original manufacturer.
4) Detail implementation of this article shall be determined by a directive.
42. Public health pesticides
1) No person may manufacture, import, export, wholesale, or sell public health pesticide unless the executive organ or a regional health regulator grants certificate of competence.
2) Any person who has a certificate of competence in accordance with the provision of sub-article (1) of this article shall keep and transmit relevant record with regard to the public health pesticide it manufactures, imports, distributes, or sales to the executive organ or regional health regulator.
3) Any person who gets a certificate of competence in accordance with this provision shall be responsible for monitoring and ensure every public health pesticide is packaged, transported, stored, or distributed with the least possible risk to human, animal, and the environment.
4) The manufacture, transport, storage or sale of every public health pesticide shall be in segregation from other products.
5) The labeling of every public health pesticide shall at least be in Amharic language.
6) The executive organ shall work with other appropriate bodies to ensure the manufacture, transport, storage, use, and disposal of public health pesticide does not pose a threat to public health.

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