Summary Of Food and Medicine Administration Proclamation No. 1112/2019
ENGLISH SUMMARY
Overview
This Proclamation establishes a comprehensive regulatory framework for food, medicine, medical devices, cosmetics, and tobacco products in Ethiopia. It repeals Proclamation No. 661/2009 and creates the Food and Medicine Administration to protect public health through quality and safety regulation of regulated products.
Key Definitions
- Food: Any substance for human consumption (processed/semi-processed), including plants, animal products, salt, water, alcohol, but excludes medicine, cosmetics, and tobacco
- Medicine: Substances used for diagnosis, treatment, mitigation, or prevention of human disease
- Medical Device: Instruments, apparatus, implants, software for medical purposes
- Cosmetic: Products for cleansing, beautifying, or altering appearance
- Tobacco Product: Products made from tobacco leaves for smoking, chewing, or snuffing
- Regulated Product: Food, medicine, medical devices, cosmetics, tobacco
Executive Organs and Powers
Executive Organ (Food and Medicine Administration):
- Issue regulations, standards, and implement rules
- Register products and grant marketing authorization
- Issue, suspend, or revoke certificates of competence
- Conduct inspections, detain, seize, or confiscate non-compliant products
- Regulate narcotics, psychotropic substances, and precursor chemicals
Regional Health Regulators:
- Implement proclamation at regional level
- Register and license food trade establishments
- Conduct inspections within their jurisdiction
Food Safety Administration
Requirements:
- All food establishments must register before operating
- Compliance with Ethiopian standards and Codex Alimentarius principles
- Proper manufacturing, storage, transport, and sale practices
- Personnel with direct food contact must be free from communicable diseases
Specific Food Categories:
- Infant Formula: No GMO, no irradiation, non-plastic packaging, protein source labeling
- Food Supplements: Must be registered; safety assessment based on risk
- Fortified Foods: Must meet Ethiopian standards; clearly labeled
- Irradiated Foods: Must meet safety requirements; labeled “irradiated”
Import/Export:
- Import permits required with safety compliance
- Laboratory testing may be ordered at importer’s expense
- Non-compliant food may be returned or disposed
Medicine and Medical Device Regulation
Registration:
- Must be registered and have marketing authorization
- Registration based on quality, safety, and efficacy/effectiveness
- Renewed every five years with annual retention fees
Manufacturing:
- Good Manufacturing Practice (GMP) compliance
- Quality control systems required
- Raw materials must be from legal sources
Institutions:
- Must be registered and licensed
- Pharmacist professionals required
- Cannot transfer certificates to third parties
Narcotic and Psychotropic Substances:
- Special permits required for import/export
- Valid for 90 days for specific consignments
- Cannot be imported through post office or by ship
- Stored in lockable metal cupboards
- Detailed record-keeping required
Clinical Trials:
- Must be authorized by executive organ
- Requires ethics committee review
- Only on persons over 18 with written consent
- Prohibited on pregnant/nursing women, prisoners, minors, mentally ill
Cosmetics Regulation
- Manufacturers, importers, distributors must register
- Notification of product details required before marketing
- Prohibited ingredients strictly regulated
- Good manufacturing practices required
- Safety during storage, transport, and sale ensured
Tobacco Products Regulation
Prohibitions:
- Sale to persons under 21 years old
- Advertising, promotion, and sponsorship completely banned (with limited exceptions)
- Smoking in all indoor public places, workplaces, public transport
- Smoking within 10 meters of doorways/windows of public places
- Sale of flavored tobacco products (characterizing flavors)
- Sale of electronic nicotine delivery systems (ENDS)
- Sale of shisha products
- Import/manufacture of products with prohibited ingredients
Packaging/Labeling:
- Health warnings covering 70% of front and back
- Rotating combined health warnings with images
- “Light,” “low tar,” “ultra light” terms prohibited
- No misleading statements about lesser harm
Tobacco Industry Interference:
- Limited government-industry interactions
- Transparency required
- No government acceptance of tobacco industry contributions
- Industry representatives excluded from tobacco control events
Labeling and Packaging
General Requirements:
- Primary packaging must have labels
- Labels must be accurate and not misleading
- Food and cosmetics: Amharic or English labels
- Essential medicines: Amharic and English inserts
- Barcode required for medicines and medical devices
- Retail price in Ethiopian currency for medicines
Food-Specific Labeling:
- Fortified foods: indicate micronutrients used
- Supplements: cannot claim disease treatment/prevention
- Genetically modified: must state “genetically modified”
- Irradiated: must state “irradiated” or use radura symbol
- Allergens: must clearly identify milk, eggs, fish, wheat, peanuts, soybeans, etc.
Alcohol Labeling:
- Alcohol volume percentage
- Health warning about health problems and pregnancy risks
- Products under 10% alcohol: expiration date required
Inspectors
Powers:
- Enter and inspect licensed institutions during working hours
- Take samples, detain products
- Stop vehicles carrying non-compliant products
- Inspect at ports of entry/exit
- Enter without court order in emergencies
Duties:
- Present identification before inspection
- Maintain confidentiality
- Report non-compliance
- Act within legal limits and code of ethics
Enforcement and Penalties
Civil/Administrative Measures:
- Detention, seizure, confiscation
- Recall from market
- Temporary or permanent import bans
- Closure, suspension, or dissolution of entities
Criminal Penalties:
| Offense | Penalty |
| Substandard/misbranded/counterfeit products | Up to 3 years + 200,000 Birr (or 7 years + 500,000 Birr if grave harm) |
| Harm to person | 7-15 years + 20,000-300,000 Birr |
| Death | 10-20 years + 30,000-400,000 Birr |
| Negligence | Up to 3 years + 50,000 Birr |
| Unlicensed manufacturing/import | 3-5 years + 5,000-100,000 Birr |
| Transferring license to third party | 1-5 years + 10,000-100,000 Birr |
| Unqualified person selling medicine | 3-7 years + 10,000-100,000 Birr |
| Prescribing/selling without prescription | 1-5 years + 5,000-50,000 Birr |
| Illegal tobacco advertising | Up to 3 years + 50,000 Birr |
| Selling tobacco to under 21 | 3 months + 1,000-3,000 Birr |
Repeals and Transition
- Repeals Proclamation No. 661/2009
- Repeals Article 8(5) of Proclamation No. 759/2012
- Existing regulations/directives remain if not contradicting this Proclamation
Effective Dates
| Provision | Effective |
| General provisions | Upon publication (Feb 28, 2019) |
| Medicine labeling (Amharic/English, barcode, retail price) | 18 months after adoption |
| Tobacco health warnings/packaging | 12 months after adoption |
| Alcohol health warnings | 6 months after adoption |
| Alcohol broadcast/billboard advertising ban | 3 months after adoption |
የአማርኛ ማጠቃለያ
አጠቃላይ ቅኝት
ይህ አዋጅ በኢትዮጵያ ውስጥ ምግብን፣ መድኃኒትን፣ የህክምና መሣሪያዎችን፣ የውበት መጠበቂያዎችን እና የትምባሆ ምርቶችን የሚቆጣጠር አጠቃላይ የህግ ማዕቀፍ ያስቀምጣል። አዋጅ ቁጥር ፮፻፷፩/፳፻፩ ይሻራል።
ዋና ዋና ነጥቦች
፩. ትርጓሜ
- ምግብ፦ ለሰው ምግብነት የሚውል ማንኛውም ንጥረ ነገር (መድኃኒት፣ የውበት መጠበቂያ፣ ትምባሆ አያካትትም)
- መድኃኒት፦ በሽታን ለመመርመር፣ ለማከም ወይም ለመከላከል የሚውል ንጥረ ነገር
- የህክምና መሣሪያ፦ ለህክምና ዓላማ የሚያገለግሉ መገልገያዎች
- የትምባሆ ምርት፦ ከትምባሆ ቅጠል ተዘጋጅቶ ለማጨስ/ለማኘክ የሚውል
፪. አስፈጻሚ አካላት
- የምግብ እና መድኃኒት አስተዳደር፦ ምርቶችን መመዝገብ፣ ፈቃድ መስጠት፣ ምርመራ ማካሄድ፣ የማይጣጣሙ ምርቶችን መያዝ
- የክልል ጤና ተቆጣጣሪዎች፦ በክልል ደረጃ አዋጁን መተግበር
፫. የምግብ ደህንነት
- ሁሉም የምግብ ተቋማት መመዝገብ አለባቸው
- ደህንነቱ የተጠበቀ ምግብ ማቅረብ አለባቸው
- የጨቅላ ህጻን ምግብ ከጂኤምኦ ነፃ እና ከፕላስቲክ ያልሆነ ማሸጊያ ሊኖረው ይገባል
- የምግብ ማሟያዎች መመዝገብ አለባቸው
፬. የመድኃኒት እና የህክምና መሣሪያ ቁጥጥር
- ሁሉም መድኃኒቶች መመዝገብ እና የገበያ ፈቃድ ማግኘት አለባቸው
- በየ፭ ዓመቱ ምዝገባ መታደስ አለበት
- የመልካም አመራረት ሥርዓት (GMP) መከተል ያስፈልጋል
- ናርኮቲክ መድኃኒቶች ልዩ ፈቃድ ያስፈልጋቸዋል
፭. የውበት መጠበቂያ
- አምራቾች እና አስመጪዎች መመዝገብ አለባቸው
- የተከለከሉ ይዘቶች እንዳይኖሩ መቆጣጠር
- የመልካም አመራረት ሥርዓት መከተል
፮. የትምባሆ ቁጥጥር
- ከ፳፩ ዓመት በታች ለሆኑ ሰዎች መሸጥ የተከለከለ
- ማስታወቂያ፣ ፕሮሞሽን እና ስፖንሰርሺፕ ሙሉ በሙሉ የተከለከለ
- በሁሉም የቤት ውስጥ የህዝብ ቦታዎች እና የስራ ቦታዎች ማጨስ የተከለከለ
- ልዩ ጣዕም ያላቸው የትምባሆ ምርቶች እንዳይሸጡ
- የኤሌክትሮኒክ ኒኮቲን መስጫ መሣሪያዎች እና ሺሻ እንዳይገቡ/ይሸጡ
- ማሸጊያ ላይ ፸% የጤና ማስጠንቀቂያ መቀመጥ አለበት
፯. ገላጭ ጽሁፍ እና ማሸጊያ
- ምግብ እና የውበት መጠበቂያ በአማርኛ ወይም እንግሊዝኛ ገላጭ ጽሁፍ ሊኖራቸው ይገባል
- መድኃኒቶች ባርኮድ ሊኖራቸው ይገባል
- የችርቻሮ ዋጋ በብር መለጠፍ ያስፈልጋል
- አለርጂ አምጪ ይዘቶች በግልጽ መገለጽ አለባቸው
፰. የኢንስፔክተር ሥልጣን
- በሥራ ሰዓት ወደ ተቋማት መግባት እና መመርመር
- ናሙና መውሰድ እና ምርቶችን መያዝ
- ተገቢ ያልሆኑ ምርቶችን የሚያጓጉ ተሽከርካሪዎችን ማስቆም
- ያለፍርድ ቤት ትእዛዝ በአስቸኳይ ሁኔታ መግባት
፱. ቅጣቶች
| ጥፋት | ቅጣት |
| ደረጃውን ያልጠበቀ/አስመስሎ የተሰራ ምርት | እስከ ፫ ዓመት + ፪፻ ሺህ ብር (ወይም ፯ ዓመት + ፭፻ ሺህ ብር ከባድ ጉዳት ካስከተለ) |
| በሰው ላይ ጉዳት | ፯-፲፭ ዓመት + ፳-፫፻ ሺህ ብር |
| ሞት | ፲-፳ ዓመት + ፴-፬፻ ሺህ ብር |
| ፈቃድ ሳይኖር ማምረት/ማስገባት | ፫-፭ ዓመት + ፭-፩፻ ሺህ ብር |
| ብቃት በሌለው ሰው መድኃኒት መሸጥ | ፫-፯ ዓመት + ፲-፩፻ ሺህ ብር |
| ያለማዘዣ መድኃኒት መሸጥ/ማዘዝ | ፩-፭ ዓመት + ፭-፶ ሺህ ብር |
| ከ፳፩ ዓመት በታች ትምባሆ/አልኮል መሸጥ | ፫ ወር + ፩-፫ ሺህ ብር |
፲. የተሻሩ ሕጎች
- አዋጅ ቁጥር ፮፻፷፩/፳፻፩ ተሽሯል
- የአዋጅ ቁጥር ፯፻፶፱/፳፻፬ አንቀጽ ፰(፭) ተሽሯል
፲፩. የሥራ ላይ መዋል ጊዜዎች
| ድንጋጌ | የሥራ ላይ መዋል ጊዜ |
| አጠቃላይ ድንጋጌዎች | የካቲት ፳፰ ቀን ፳፻፲፩ ዓ.ም (በጋዜጣ ከታተመበት ቀን) |
| የመድኃኒት ገላጭ ጽሁፍ (አማርኛ/እንግሊዝኛ፣ ባርኮድ፣ ዋጋ) | ከፀደቀ ከ፲፰ ወራት በኋላ |
| የትምባሆ የጤና ማስጠንቀቂያ/ማሸጊያ | ከፀደቀ ከ፲፪ ወራት በኋላ |
| የአልኮል የጤና ማስጠንቀቂያ | ከፀደቀ ከ፮ ወራት በኋላ |
| የአልኮል የብሮድካስት/ቢልቦርድ ማስታወቂያ ክልከላ | ከፀደቀ ከ፫ ወራት በኋላ |
የአዋጁ ፋይዳ
ይህ አዋጅ የምግብ እና የመድኃኒት ደህንነትን ያሻሽላል፣ የህብረተሰብን ጤና ይጠብቃል፣ ዓለም አቀፍ ንግድን ያመቻቻል፣ እንዲሁም ከዓለም አቀፍ ደረጃዎች ጋር የተጣጣሙ የምርት ቁጥጥር ሥርዓቶችን ያስቀምጣል።
ማጠቃለያው በአዋጁ ዋና ዋና ነጥቦች ላይ ያተኩራል እና ሙሉውን ጽሁፍ አይተካም። ለሙሉ ዝርዝሮች ኦሪጅናሉን አዋጅ ይመልከቱ።
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