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Ethiopia - Apply for a Certificate of Good Manufacturing Practice (GMP )

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Contents

Introduction

Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

A Good Manufacturing Practices (GMP) certificate provides independent verification and certification that the basic manufacturing practices and prerequisites necessary for the implementation of an effective Hazard Analysis Critical Control Point (HACCP) food safety program are being followed.

Many food industry companies have implemented the Good Manufacturing Practice certification scheme for food processing as the foundation upon which they have developed and implemented other quality and food safety management systems.

Good Manufacturing Practices are a set of regulations, codes, and guidelines for the manufacture of:

  • Drug substances and drug products in Ethiopia
  • Medical devices in Ethiopia
  • In vivo and in vitro diagnostic products in Ethiopia
  • Foods in Ethiopia.
  • Good Laboratory Practice


Eligibility

All food manufacturers companies both local and international in Ethiopia are Eligible for this certificate

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Instructions

1. It shall be mandatory for any person to engage in manufacturing medicine shall get Certificate of Competence from the Authority.

2.Certificate of Competence to be issued in accordance with article (1) of this article shall be given in compliance with this directive.

3.In case where manufacturer fails to continually observe applicable requirements after getting the Certificate of Competence the Authority shall take appropriate administrative measures.

Required Information

The key information required is as follows

1. Application is on Good manufacturing practice single product basis

2. Written application stating name of manufacturer and name (and brand, if applicable) of product.

3. Completed FMHACA application form.

4. Certificate of Incorporation with the Corporate Affairs Commission, if a company

5. Five (5) copies of the product dossier

6. Three (3) packs of the products samples

7. Notarized original copy of the duly executed Power of Attorney from the product manufacturer (imported product)

8. Certificate of Manufacture issued by the competent health or regulatory authority in country of origin and authenticated by the Ethiopian Mission in that country (if foreign import). Where there is no Nigerian mission, The British High Commission or an ECOWAS country Mission will authenticate.

9. If contract-manufactured, Contract Manufacturing Agreement, properly executed and notarized by a Notary Public in the country of manufacture.

10. Current World Health Organisation Good Manufacturing Practice Certificate for the manufacturer, authenticated by the Ethiopian Mission.

11. Certificate of Pharmaceutical Products (COPP) duly issued and authenticated

12. Current Superintendent Pharmacists license to practice issued by the Pharmaceutical Council of Ethiopian.

13. Premises Registration License from Pharmacists Council of Ethiopian.

Procedure

Good Manufacturing Practices are enforced in Ethiopia by SGS Ethiopia which is a world leader in third party certification and verification. They help to ensure that regulatory compliance is followed while demonstrating knowledge of the importance of producing and trading safe, quality food. The certificate of Good Manufacturing Practice is issued by the National competent authority.

These are the stages involved in applying for a Good Manufacturing practice certificate.

Stage one - Documentation

Here you are required to present the necessary documents issued by the competent Health Authority in the country of manufacture. These documents differ in some aspect depending on the class of product you want register.The certificate should indicate that the manufacturer has been approved and registered by the National competent authority as a manufacturer of medical products;

  • Some of the documents include Power of Attorney or contract manufacturing Agreement;
  • Manufacturing license and free sale certificate,
  • Trademark registration,certificate of incorporation/business name and many more.
Note
All the necessary documents must be found satisfactory before any other process can be carried out.
Stage Two - Drug production Evidence

There must be evidence that the food product is manufactured according to Good Manufacturing Practice (GMP). in the case of imported drug products (from foreign country),The importer must submit evidence that they are licensed to manufacture Food products for sale in the country of origin.

Stage Three - Authenticated from Health Authority

There must be evidence by the competent Health Authority, that the sale of the product does not constitute a contravention of the food laws of that country. i.e.Certificate of Pharmaceutical Product (COPP) that conforms to WHO format.

The documents in respect of C1-3 shall be authenticated by the Ethiopian Mission in that country. In countries where no Ethiopian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate.

That the manufacturing plant in which the product is produced is subject to inspection at suitable intervals.

Stage Four - Dossier

The applicant shall submit two (2) dossiers made out in accordance with the Agency’s format.

Stage Five

Evidence of Trade Mark Approval for brand name from Federal Ministry of Trade in Ethiopia should be submitted.

Stage Six - Annual License to practice Pharmacist

Copy of current Annual License to Practice as a Pharmacist for the Superintendent Pharmacist issued by Pharmacists Council of Ethiopia should be submitted.

Stage seven - Certificate of registration

Copy of Current Certificate of Registration Retention of Premises issued by Pharmacists Council of Ethiopia.

Stage Eight - Comprehensive Certificate of Analysis

Comprehensive Certificate of analysis of the batch of food product submitted for registration processing shall be submitted.

Stage Nine

After all the documents have been submitted ,a drug product can not be manufactured in Ethiopia, unless the factory is inspected and Certificate of Recognition is issued by FMHACA.Then date of the certificate is issued and the period of its validity.

The certificate should be original and current

The certificate should be authenticated by the Ethiopian Embassy in the country of origin. Were this prove to be difficult, consultation with the Drug Administration and Control Authority is necessary.

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Required Documents

1). Copy of permit and receipt (One copy)

2)Dossier formated according to FMHACA’s requirements (one copy).

3)Vetting Samples (Three of each product)

4)Copy of Current Certificate of Registration Retention.

5)The documents in respect of C1-3

6)There must be evidence by the competent Health Authority.

7)Comprehensive Certificate of analysis .

Fees

All payments to the Agency are payable by bank draft to the Ethiopian Food, Medicine and Health Care Administration and Control Authority

Validity

A successful application attracts a Certificate of Registration with a validity period of four years.

Documents to Use

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Sample Documents

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Processing Time

The registration is done in a period of 3 months.

Office Locations & Contacts

The Ethiopian Food, Medicine and Health Care Administration and Control Authority

Contact Information

P.O. Box 5681

Addis Ababa, Ethiopia

Telephone: +25111552-25-47

Fax: +251115-54-04-77

Website: http://www.daca.gov.et

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Video

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external websites.
Please remove the "&" inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M" Video ID is "Y0US7oR_t3M". 
	

Information which might help

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Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

http://www.fmhaca.gov.et/documents/Directive%20%20for%20Medicine%20Manufucturing%20Establishmen%20%202013.pdf

Others

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