Rate of Service Fees for Food, Medicine, Health Professional and Health Institutions Registration and Licensing Council of Ministers Regulation No. 370/2015

COUNCIL OF MINISTER REGULATION No. 370/2015

COUNCIL OF MINISTERS REGULATION TO DETERMINE THE FEE PAYABLE FOR REGISTRATION AND LICENSE OF FOOD, MEDICINE, HEALTH PROFESSIONAL AND  HEALTH INSTITUTIONS

This Regulation is issued by the Council of Ministers pursuant to Article 5 of the Definition of Powers and Duties of the Executive Organs of the Federal Democratic Republic of Ethiopia Proclamation No. 916/2015, Article 17(1) of the Federal Government of Ethiopia Financial Administration Proclamation No. 648/2009 and Article 55(1) of the Food, Medicine, and Health Care Administration and Control Proclamation No. 661/2009.

  1. Short Title

     This Regulation may be cited as the “Rate of Service Fees for Food, Medicine, Health Professional and Health Institutions Registration and Licensing Council of Ministers Regulation No. 370/2015”.

2. Definition

      In this Regulation:

1/  “Proclamation” means the Food, Medicine, and Health Care Administration and Control Proclamation No. 661/2009;

2/  “Regulation” means the Food, Medicine, and Health Care Administration and Control Authority Regulation No.299/2014;

3/  definitions provided for under the Proclamation and the Regulation shall be applicable.

3. Service fee

1/  Service fees shall be payable in accordance with the rate prescribed in a schedule 1 and 2 attached to this Regulation for issuance of certificate of competence, renewal or replacement of certificates in case of loss for manufacturers in food, medicine and cosmetics, to issue permit for new processing line and to issue permit for changes in professionals and address of the institution, for second and third round of pre-license inspection, to permit a new method of manufacturing, for changes of the name of the institution and to issue permit for additional institution for the same purpose.

2/  Service fees shall be payable in accordance with the rate prescribed in a schedule 3 attached to this Regulation for issuance renewal and replacement of certificate of competence in case of loss for importers and wholesale of food, medicine, cosmetics, medical equipment and supplies, and tobacco, to issue permit for additional storage and to issue permit for changes in professionals and address of the institution; for second and third round of pre-license inspection, for changes of the name of the institution and to issue permit for additional institution for the same purpose.

3/  Service fees shall be payable in accordance with the rate prescribed in a schedule 4 attached to this Regulation for issuance, renewal and replacement in case of loss of medicine purchase license for health institutions.

4/  Service fees shall be payable in accordance with the rate prescribed in a schedule 5 attached to this Regulation for issuance and renewal of health professionals’ registration and license.

5/  Service fees shall be payable in accordance with the rate prescribed in a schedule 6 attached to this Regulation for issuance of registration certificate for foreign health professionals’ to be employed in Ethiopia and to an Ethiopian health professional intending to work in a foreign country, and for issuance of letter of good standing.

6/  Service fees shall be payable in accordance with the rate prescribed in a schedule 7 attached to this Regulation for issuance, renewal and replacement certificate of competence in case of loss for health institutions, for second and third round of pre-license inspection, for changes of the name of the institution, professionals and the address of the institution itself and to issue permit for establishment of additional institution for the same purpose.

7/  Service fees shall be payable in accordance with the rate prescribed in a schedule 8 attached to this Regulation at the port of entry and exit for the inspection food which are to be imported and exported.

8/  Service fees shall be payable in accordance with the rate prescribed in a schedule 9 attached to this Regulation at the port of entry for import of medicines, medical raw materials, medical devices, cosmetics, cosmetics raw materials, tobacco, for undertake post mortem inspection and undertaking fumigation for airplanes departing from the country.

9/  Service fees shall be payable in accordance with the rate prescribed in a schedule 10 attached to this Regulation at the port of exit for inspection of export medicines, medical raw materials, medical devices, cosmetics, cosmetics raw materials and tobacco.

10/ Service fees shall be payable in accordance with the rate prescribed in a schedule 11 attached to this Regulation to give license of agent or change of agent, to register additional agent, for renewal and for replacement in case of loss of same for a foreign based food, medicine, medical devices and cosmetics manufacturers.

11/ Service fees shall be payable in accordance with the rate prescribed in a schedule 12 attached to this Regulation to register food, medicine, medical devices, medical equipment and supplies and cosmetics for pre-screening dossier evaluation, for second and third round documents pre-inspection.

12/ Service fees shall be payable in accordance with the rate prescribed in a schedule 13 attached to this Regulation for dossier evaluation to register or reregister food, medicine, medical devices and cosmetics and for registration of major or minor variation.

13/ Service fees shall be payable in accordance with the rate prescribed in a schedule 14 attached to this Regulation to monitor a proper disposal of products or inputs ordered to be disposed and for preparation of certificate.

14/ Service fees shall be payable in accordance with the rate prescribed in a schedule 15 attached to this Regulation to issue or renew Certificate of Pharmaceuticals Products, Free Sale Certificate and Good Manufacturing Practice for local and foreign food, medicine and cosmetics manufacturers.

15/ Service fees shall be payable in accordance with the rate prescribed in a schedule 16 attached to this Regulation to get permit for branch office in Ethiopia for foreign based medicine manufacturers.

16/ Service fees shall be payable in accordance with the rate prescribed in a schedule 17 of attached to this Regulation to issue or renew license or for replacement of license in case of loss for of consultancy service provided in sectors which are inherently under the supervision of the Authority.

17/ Service fees shall be payable in accordance with the rate prescribed in a schedule 18 attached to this Regulation for inspection of Good Manufacturing Practice to be conducted abroad to register and import medicines.

18/ Service fees shall be payable in accordance with the rate prescribed in a schedule 19 attached to this Regulation for clinical trial control.

19/ Service fees shall be payable in accordance with the rate prescribed in a schedule 20 attached to this Regulation for registration, renewal of registration or variation ofmedicine for laboratory test.

20/ Service fees shall be payable in accordance with the rate prescribed in a schedule 21 attached to this Regulation for the authority’s service regarding laboratory test of medicines.

21/ Service fees shall be payable in accordance with the rate prescribed in a schedule 22 attached to this Regulation for the Authority’s service regarding laboratory test of food.

22/ Service fees shall be payable in accordance with the rate prescribed in a schedule 23 attached to this Regulation for the Authority’s service regarding laboratory test of toxicology.

  • Effective date

This Regulation shall enter in to force on the date of publication in the Federal Negarit Gazette.

Done at Addis Ababa, this 11th   day of January, 2016.

HAILEMARIAM DESSALEGN

PRIME MINISTER OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA

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